Features

Accuray CEO Euan Thomson: CyberKnife is the "true robotic system"

May 7, 2012 by Arezu Sarvestani

Accuray CEO Euan Thomson discusses the finer points of robotic prostate cancer treatment and the motivation behind a head-to-head clinical trial pitting its CyberKnife radiosurgery system against Intuitive Surgical's da Vinci.

Accuray CEO Euan Thomson

Sunshine Heart's David Rosa: "Patients don't like being tethered to a device"

April 30, 2012 by Arezu Sarvestani

In an exclusive podcast interview with MassDevice.com, Rosa told us about the company's beginnings, his optimism for the still-sluggish heart failure treatment landscape and why it's so important that patients can disconnect from Sunshine Heart's flagship, outside-the-bloodstream C-Pulse heart assist device.

Click here to listen to the podcast

Sunshine Heart CEO David Rosa

"In the U.S., for Class III heart failure there are about 1.5 million patients," Sunshine Heart CEO David Rosa told MassDevice.com in an exclusive podcast interview. "That's about 7 times the Class IV market, which is traditionally where LVADs participate."

Q&A: New Quest CEO Steve Rusckowski

April 5, 2012 by Brad Perriello

In his last interview as CEO of Philips Healthcare before taking the corner office at Quest Diagnostics, Steve Rusckowski tells MassDevice why 2011 was a tough year for the world's 7th-largest medical device maker, why things are looking up this year and how innovation can go hand-in-hand with lower costs.

Philips Healthcare CEO Steve Rusckowski

It's not exactly news that the med-tech industry is under pressure from a variety of fronts – an uncertain regulatory environment, a looming tax burden and, not least, downward pricing pressure from its health care provider customers.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Intuitive Surgical's Guthart: "The first rule of being disruptive is having people who believe they can change the world"

March 28, 2012 by Brian Johnson

MassDevice discusses innovation, robotic surgery and Silicon Valley culture with Intuitive Surgical CEO Gary Guthart.

Gary Guthart knows a little something about disruptive innovation.

The hack-able body: Are device makers doing enough to shield patients from hackers?

March 7, 2012 by Arezu Sarvestani

The threat that the fusion of humans and medical machines may leave patients vulnerable to the hackers and bugs of the digital world is beginning to resonate with device makers.

Laptop image

Karen Sandler was 31 years old, working at a non-profit organization providing free legal help to computer programmers, when she was diagnosed with an enlarged heart and informed that she'd need a machine to help keep her alive.

Her mother accompanied her the day a doctor recommended that Sandler undergo surgery to implant a medical device into her chest. He handed Sandler a pager-sized machine called a cardioverter defibrillator – a miniature, implantable equivalent of having EMTs follow her around all day with defibrillator paddles should her heart stop.

Accuray CEO Euan Thomson: "We've never paid much attention to the opinions or messages of our competitors"

March 5, 2012 by Arezu Sarvestani

Accuray CEO Euan Thomson tells MassDevice about being a small fish in a big pond, managing growing pains and his strategies for breaking out in a well-established market.

Euan Thomson

When Euan Thomson landed in the corner office at radiosurgery device maker Accuray (NSDQ:ARAY) in 2002, the company was just preparing to penetrate a very well-established market.

MassDevice Q&A: Teleflex CEO Benson Smith

February 27, 2012 by Brad Perriello

After more than a year in the corner office of the newly pure-play medical device maker, Teleflex CEO Benson Smith tells MassDevice about dealing with the vagaries of Wall Street, what attracted a onetime history major to the medical device field, why Teleflex is poised to give the big kids on the block a run for their money and what the company looks for in potential acquisitions.

Teleflex CEO Benson Smith

Teleflex (NYSE:TFX) made news last year when it began a series of divestitures aimed at eliminating its non-medical-device holdings, ditching a cargo systems business and its aerospace arm.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: LayerWise co-founder Peter Mercelis

February 21, 2012 by Arezu Sarvestani

LayerWise co-founder Peter Mercelis tells MassDevice about the disruptive potential of 3D printing in the medical device space.

LayerWise custom jaw implant

LayerWise made headlines this month when it unveiled the world's first custom-made total lower jaw implant, "printed" from a 3D schematic.

The device was constructed layer by layer from a digital file mapped to the patient's jaw, a process called "metal additive manufacturing" that Belgium-based LayerWise has used in making custom spinal implants, cranial plates and acetabular implants.

MassDevice.com Podcast: ConforMis CEO Philipp Lang

February 15, 2012 by MassDevice staff

ConforMIS CEO Philipp Lang talks to MassDevice.com on how the custom orthopedic implant maker plans to spend its most recent $90 million funding round and on what makes his company stand out in the crowded orthopedics arena.

MassDevice.com Q&A: CoforMIS CEO Philipp Lang

Philipp Lang has ConforMIS looking to get a leg up on the knee replacement industry.

Last week, the Burlington, Mass.-based orthopedic implant maker said it raised $89 million in a Series E round from several investors, bringing the total nut raised by ConforMIS over the last 3 years to more than $140 million – a somewhat remarkable amount, given the fundraising climate over the past few years.

MassDevice Podcast: Soteira CEO Larry Jasinski

February 7, 2012 by Arezu Sarvestani

Soteira CEO Larry Jasinski talks to MassDevice about overcoming the odds with spinal fusion devices and managing a 510(k) win even after the FDA switched things up mid-stream.


Gulfo podcast

Click to play

Soteira CEO Larry Jasinski is no stranger to adversity.

MassDevice.com Q&A: Medtronic CEO Omar Ishrak

January 10, 2012 by Brad Perriello

Medtronic CEO Omar Ishrak tells MassDevice.com about how he screens potential acquisitions, his plan to re-shape the company and handling the controversy over the Infuse spine treatment.

MassDevice.com Q&A: Medtronic CEO Omar Ishrak

Just a few days into his tenure as CEO of Medtronic (NYSE:MDT), Omar Ishrak was confronted with a major crisis: The Spine Journal devoted its entire June issue to to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.

MassDevice Q&A: James Mazzo, Abbott Medical Optics

December 26, 2011 by Brian Johnson

MassDevice goes one-on-one with the senior VP of Abbott Medical Optics and the chairman of AdvaMed about the state of the device industry.

James Mazzo

You don't get more dialed-in to the device industry than James Mazzo, and you definitely don't get busier.

In addition to his duties as senior VP of Abbott Medical Optics Inc., an ophthalmic company he spun out of Allergan (NYSE:AGN) and then sold to health care giant Abbott (NYSE:ABT) in 2009, Mazzo has been the chairman of the Advanced Medical Technology Association, or AdvaMed, for the past two years.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Brown ranks high with med-tech makers

December 19, 2011 by Arezu Sarvestani

Sen. Scott Brown, the junior senator and Republican from Massachusetts, garners big bucks in campaign donations from med-tech makers as he rallies against the device tax and gears up for re-election.

Scott Brown speaking

Sen. Scott Brown (R-Mass.), a vocal advocate for the medical device industry, has collected thousands in individual donations from med-tech executives and industry political action committees during the 2011-2012 campaign, federal documents show.

Between January and October, Brown received more than $42,000 in PAC donations and individual contributions from medical device groups and executives as he campaigned for re-election.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Tackling paralysis with Alfred Mann Foundation CEO David Hankin

December 14, 2011 by Arezu Sarvestani

Alfred Mann Foundation CEO David Hankin tells MassDevice how to make an artificial nervous system using microstimulators that communicate wirelessly through the body.


MassDevice.com podcast

Click to play

David Hankin became CEO at health research institute The Alfred Mann Foundation in a rather roundabout way.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Joe DeVivo

December 5, 2011 by Brad Perriello

The newly minted CEO of AngioDynamics on his unique family business background, the importance of good neighbors and the company's path along the mergers & acquisitions trail.

MassDevice.com Q&A: AngioDynamics CEO Joe DeVivo

AngioDynamics (NSDQ:ANGO) CEO Joe DeVivo's deep roots in the medical device industry are common knowledge. The former CEO of RITA Medical Systems (acquired, as it happens, by AngioDynamics in 2006) spent four years at the helm of Smith & Nephew's (NYSE:SNN) orthopedics division.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Sanovas CEO Larry Gerrans

November 21, 2011 by Brad Perriello

Sanovas CEO Larry Gerrans on Sanovas Inc.'s breakthrough catheter-based platform for treating lung disease and why he thinks it's a game-changer.

Sanovas CEO Larry Gerrans

The numbers on pulmonary disease in the U.S are staggering – more than 203,000 people were diagnosed in 2007 alone, according to the Centers for Disease Control, which lists nearly 160,000 lung cancer deaths for that year.

Add in other pulmonary afflictions like chronic obstructive pulmonary disease (126,000 deaths in 2005, according to the CDC) and the numbers pass from staggering to mind-boggling.

Three questions for Edwards Lifesciences CEO Michael Mussallem

November 16, 2011 by Brian Johnson

MassDevice talks with Edwards Lifesciences CEO Michael Mussallem about why the medical device industry is a good fit for him and the biggest mistake of his career.

Michael Mussallem

If the good people of Orange County felt a gale force wind a few weeks back, it may have been a sigh of relief coming from the Irvine, Calif. headquarters of Edwards Lifesciences Corp. (NYSE:EW) after the FDA finally gave a much-anticipated green light to the company's Sapien transcatheter aortic valve.

Edwards had been hanging fire since July, when an FDA advisory panel recommended that the federal watchdog agency approve the device.

MassDevice Podcast: Capsule Tech's Stuart Long talks connectivity, innovation and momentum

October 31, 2011 by Arezu Sarvestani

Capsule Tech's newly appointed North America president Stuart Long tells MassDevice about the company's surging growth and what it means to be a "middleware" service provider.


Capsule podcast

Click to play

When Stuart Long accepted the keys to the corner office at Capsule Tech. North America earlier this month, he walked into a period of skyrocketing growth for the medical device connectivity company.

End of an era: Ray Elliott steps down as CEO of Boston Scientific

October 17, 2011 by Arezu Sarvestani

J. Raymond Elliott left an indelible mark on med-tech goliath Boston Scientific during two years in the corner office. As he passes the torch to interim CEO Hank Kucheman, MassDevice looks back on one of the most boisterous CEOs in the device space.

J. Raymond Elliott

In two years in the corner office at Boston Scientific Corp. (NYSE:BSX), J. Raymond Elliott left an indelible stamp on the medical device goliath. As he steps down today, handing the keys over to interim CEO Hank Kucheman, he leaves some mighty big shoes to fill.

MassDevice Podcast: AccuVein CEO Ron Goldman

October 12, 2011 by MassDevice staff

AccuVein CEO Ron Goldman tells MassDevice about his firm's hand-held vascular imaging technology.

Accuvein

Venipuncture – drawing blood or establishing an intravenous feed – is the most common invasive medical procedure. For many patients, it's a painful exercise in frustration when clinicians struggle to find a blood vessel, sometimes requiring multiple needle sticks.

AccuVein and CEO Ron Goldman aim to change all that with the company's AV300 vascular illumination device. The wireless, handheld module uses a pair of lasers to paint a patient's arm with light, making otherwise invisible or hard-to-find blood vessels apparent to the naked eye.

MassDevice Q&A: GI Dynamics CEO Stu Randle

October 5, 2011 by Brian Johnson

Stu Randle, CEO of GI Dynamics, discusses the company's recent Australian IPO in an interview with MassDevice.

Randle

GI Dynamics (ASX:GID) has been the talk of the medical device industry lately.

MassDevice Podcast: Mela Sciences' CEO on the MelaFind odyssey

October 3, 2011 by Arezu Sarvestani

Mela Sciences CEO Joseph Gulfo tells MassDevice about the path from nearly assured clearance in June 2009 to the brink of clearance more than two years later.


Gulfo podcast

Click to play

EXCLUSIVE: Former Medtronic CEO Bill Hawkins on the one that got away

September 27, 2011 by Brad Perriello

Former Medtronic CEO Bill Hawkins, in an exclusive interview with MassDevice.com, tells us about the one that got away: Guidant Corp.'s stent-making operation.

EXCLUSIVE: Former Medtronic CEO Bill Hawkins on the one that got away

There's no shortage of ink spilled over the feeding frenzy over Guidant Corp., which ended in Boston Scientific Corp.'s (NYSE:BSX) ill-fated $26 billion acquisition in 2006. But there's one nugget from the spectacle that hasn't received much attention.

Patent reform and med-tech: The America Invents Act promises to be a game-changer

September 19, 2011 by Arezu Sarvestani

Seasoned patent attorney David Dykeman takes us through the America Invents Act in a podcast interview highlighting the challenges and opportunities the reform bill poses for the medical device industry.

patent reform, USPTO

This week President Barack Obama is expected to sign a patent reform bill marking the most dramatic changes to the patent system in decades, drawing adulation and ire from varying sectors of the innovation economy.

The American Invents Act, six years in the making, contains several sweeping changes, but the main bone of contention is a transformation of the U.S. patent system from a first-to-invent application process to a first-to-file process.

Boston Scientific's new CEO: Who is Michael Mahoney?

September 14, 2011 by MassDevice staff

Boston Scientific makes a generational move in choosing Johnson & Johnson executive Michael Mahoney, but who is the 46-year-old medical device veteran?

Michael Mahoney

Michael Mahoney

In naming Michael Mahoney as the heir apparent to J. Raymond Elliott, Boston Scientific Corp. (NYSE:BSX) fired another salvo in a long-running blood feud with Johnson & Johnson Corp. (NYSE:JNJ).

MassDevice Podcast: Neuronetics CEO Bruce Shook

August 27, 2011 by Arezu Sarvestani

Neuronetics president & CEO Bruce Shook on treating an incurable psychiatric disorder, chasing reimbursement and turning psychiatrists into medical device proceduralists.

NeuroStar Coil system
Neuronetics' NeuroStar TMS therapy system

Neuronetics Inc. is paving the way for a new type of depression therapy, a non-invasive electromagnetic field treatment designed to stimulate brain cells linked to depression.

Bruce Shook, co-founder, president & CEO, talked to MassDevice about pioneering the market for the only FDA-cleared transcranial magnetic stimulation system to date, his company's NeuroStar TMS system.

The therapy, which won the FDA nod in 2008, is a rarity in the med-tech world: A device-based approach to a psychiatric disorder.

MassDevice Exclusive: Former Medtronic CEO Hawkins on the Sprint Fidelis recall

August 22, 2011 by MassDevice staff

Former Medtronic CEO Bill Hawkins, in the second installment of an in-depth interview with MassDevice.com, gives us an inside look at one of the most high-profile medical device recalls ever – the Sprint Fidelis pacemaker lead.

Former Medtronic CEO Bill Hawkins
Former Medtronic CEO Bill Hawkins at MassDevice
global headquarters.

In October 2007 Bill Hawkins was only three months into his tenure as CEO of the world's largest pure-play medical device maker when he faced the toughest choice of his career – cancel shipment on the company's top product, the Sprint Fidelis pacemaker lead, already implanted in some 268,000 patients – or stand pat and keep the potentially lethal products on the market.

MassDevice Exclusive: Former CEO Hawkins on leaving Medtronic

August 17, 2011 by MassDevice staff

Former Medtronic CEO Bill Hawkins, in the first installment of an in-depth interview with MassDevice.com, tells us why the time had come for him to leave the world's largest pure-play device maker – and fills us in on his plans for the future.

Former Medtronic CEO Bill Hawkins

Bill Hawkins

They gave him a sword and he handed them the world.

When William Hawkins officially flipped the keys to Medtronic Inc. (NYSE:MDT) over to successor Omar Ishrak, he offered a simple message and a gift. The message was clear – don't lose sight of founder Earl Bakken's mission to alleviate pain, restore health and extend life while "striving without reserve for the greatest possible reliability and quality."

What keeps you up at night? | The MassDevice Big 100 Regional Roundtable CEO Panel

August 15, 2011 by MassDevice staff

Industry leaders discuss the challenges facing their fields and in medical devices as a whole at the MassDevice Big 100 Regional Roundtable.

Regional Roundtable

Med-tech leaders came together for a meeting of the minds at MassDevice's first Big 100 Regional Roundtable in Waltham, Mass., July 11. Four CEOs, each representing an interesting and important sector of the life science industry – the fascinating juncture between orthopedics and minimally invasive techniques, genomics and personalized medicine, the cutting edge of bio-interactive nanotech coatings and the mid-cap medical device world – shared their thoughts on the particular challenges facing their businesses and the life sciences industry as a whole.

Cancer: Allegro Diagnostics hunts lung cancer's "canary in the coal mine"

August 15, 2011 by Arezu Sarvestani

Allegro Diagnostics is in clinical trials for its flagship diagnostic assay, designed to detect the early stages of lung cancer, the deadliest cancer on the planet.

Avrum Spira in the clinic

Dr. Avrum Spira in the clinic

If Allegro Diagnostics' clinical trials go as planned, the Maynard, Mass.-based company will be on its way to commercializing a test to detect the "canary in the coal mine" of the planet's deadliest cancer: Early-stage lung cancer.

With a patented molecular diagnostic assay, Allegro co-founder and Boston University associate professor Avrum Spira has garnered over $3.5 million in funding from the National Institutes of Health and $8.9 million from investors.

MassDevice Podcast: Covidien's Joe Almeida at the MassDevice Big 100 Roundtable

July 25, 2011 by Brian Johnson

The new CEO of Covidien plc, Jose "Joe" Almeida, speaks with MassDevice publisher Brian Johnson about his vision for the company at the MassDevice Big 100 Regional Roundtable in this exclusive interview.

Joe Almeida

Covidien CEO Joe Almeida at the MassDevice Big 100 Regional Roundtable, July 11, 2011

Putting some brains behind the software

July 25, 2011 by Arezu Sarvestani

Nuance Communications VP of health care solutions marketing, Carina Edwards, on major shifts in medical transcription and voice recognition technology and how to put artificially intelligent supercomputers to good use.

Nuance Dragon Software

If Nuance Communications (NSDQ:NUAN) had its way, medical transcription would be a two-way conversation between man and machine.

The company is looking to transform the transcription process into a back-and-forth between the physician and an intelligent software program that prompts for details and suggests potential courses of treatment based on a more holistic view of the patient story.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

What keeps you up at night? Obstacles and opportunities in med-tech at the MassDevice Big 100 Regional Roundtable

July 12, 2011 by Gretchen Baker

Med-tech industry leaders came together for a meeting of the minds at MassDevice's first Big 100 Regional Roundtable in Waltham, Mass., last night.

Jeffrey Shuren
FDA CDRH chief Dr. Jeffrey Shuren addresses the
audience in a live Q&A

Hundreds of representatives from New England's medical device industry gathered last night at the MassDevice Big 100 Regional Roundtable at the Westin Hotel in Waltham, Mass., to share their experiences and ideas for the industry's future.

MassDevice Q&A: Delcath CEO Eamonn Hobbs

June 30, 2011 by Arezu Sarvestani

Eamonn Hobbs, president & CEO of Delcath Systems, on his company's volatile stock, surprising FDA decisions and how to keep chemotherapy where it belongs.

Delcath chemo delivery system

Delcath Systems Inc. (NSDQ:DCTH) CEO Eamonn Hobbs is in a good mood these days.

Introducing the MassDevice CEO Class of 2011

June 20, 2011 by MassDevice staff

MassDevice.com names 28 chief executives in the medical device industry, who exemplify cutting-edge leadership and innovative thinking, for its inaugural CEO Class of 2011.

MassDevice.com

MassDevice.com, the online business journal for the medical device industry, is proud to name 28 chief executives whom we feel represent cutting-edge leadership and innovative thinking for our inaugural CEO Class of 2011.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Hack this: Researchers develop device to shield pacemakers

June 15, 2011 by Arezu Sarvestani

A radio signal transmitter developed by researchers at MIT and UMass Amherst is the first to provide a non-invasive solution to hacking vulnerabilities in implanted medical devices.

IMD Shield

Wireless devices have changed the way health information moves, making data more abundant and more accessible. But it's also made medical devices more vulnerable.

Researchers at MIT and the University of Mass. Amherst are the first to develop a technology that could protect the millions of existing medical device implants without altering or replacing them.

Wireless technologies made their mark on medical devices in a big way, attaching themselves to everything from pacemakers and defibrillators to insulin pumps and nerve stimulators.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Medical device makers spend $620k on 2011-2012 election cycle

June 9, 2011 by Brad Perriello

Medical device makers dropped at least $623,000 in donations to legislators and political action committees (PACs) for the 2011-2012 election cycle.

Political donations

Medical device makers dropped at least $623,250 on the 2011-2012 election cycle, according to a MassDevice examination of a federal database that tracks corporate donations to legislators and political actions committees, known as PACs.

Abbott Laboratories (NYSE:ABT) alone accounted for more than 45 percent of the donations, spending a total of $282,000 — nearly $100,000 to individual members of Congress and the rest to various PACs, according to the Federal Election Commission's online database.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Draper's tiny bio-MEM tech goes from a head-scratcher to a no-brainer

June 8, 2011 by Arezu Sarvestani

Draper Labs has watched micro-electro-mechanical technologies go from a head-scratcher to a no-brainer in the last 10 years, with possible commercial partnerships right around the corner.

Draper MEM

A bio-MEM drug delivery device developed by Draper Labs

Draper was into bio-MEMs before they were cool.

Micro-electro-mechanical systems, also known as MEMs, are tiny electrical machines that are common in consumer electronics and automotive sensors. Their presence in medical technology, however, is a much newer phenomenon.

In the last 10 years, as bio-MEMs technology has gone from being a head-scratcher to being a no-brainer, Jeffrey Borenstein has had a front-row seat.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice podcast: Echo Therapeutics CEO Dr. Patrick Mooney

May 31, 2011 by Brian Johnson

Echo Therapeutics CEO Dr. Patrick Mooney on the story of his company, which is developing a transdermal continuous glucose monitoring device for the diabetes market.

MassDevice podcast: Echo Therapeutics CEO Dr. Patrick Mooney

Dr. Patrick Mooney took an interesting path to the top seat at Echo Therapeutics Inc. (OTC:ECTE), a Philadelphia, Pa.-based company developing a non-invasive, wireless, transdermal continuous glucose monitoring device for the diabetes market.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Medtronic CFO Gary Ellis

May 26, 2011 by Brian Johnson

Medtronic CFO Gary Ellis on the company's fourth-quarter and FY2010 earnings, why the cardiac rhythm management market is depressed and whether there's been any fallout from canceling a GPO deal with Novation.

MassDevice Q&A: Medtronic CFO Gary Ellis

The waters around the good ship Medtronic Inc. (NYSE:MDT) have been a bit frothy these days.

The world's largest pure-play medical device maker has had a busy 2011: The Fridley, Minn.-based company announced a new CEO (Omar Ishrak) to replace the retiring William Hawkins, spiked a $2 billion contract with one of the largest group purchasing organizations in the hospital industry and is one of three combatants in a battle royale over market share in the suddenly chilly cardiac rhythm management market.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice podcast: Sagentia CEO Brent Hudson

May 16, 2011 by Christian Holland

Brent Hudson, CEO of U.K.-based research and development consulting firm Sagentia, talks about his company's recent expansion in the U.S. and how it helps med-tech startups avoid mistakes in the development of highly complex technology.

MassDevice podcast: Sagentia CEO Brent Hudson

Sagentia is a company that thrives on complexity. Its business is built around helping both established and emerging technology companies avoid the uncertainties of innovation.

"We operate best where there is a complex scientific or technical problem that needs resolving as part of product development," CEO Brent Hudson told MassDevice.

Hudson, who joined the research and development consulting firm in 2009, describes the services they offer as having a little 'r' and a big 'D.'

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Orthopedic survey: Stryker, Zimmer the most innovative companies in hips and knees

April 27, 2011 by MassDevice staff

The MedPanel Innovation Pulse, a MassDevice exclusive, is a survey of orthopedic surgeons showing high marks on the innovation front for Stryker and Zimmer and low marks for Wright Medical, Biomet and Smith & Nephew.

Stryker Corp. (NYSE:SYK) and Zimmer Holdings Inc. (NYSE:ZHM) are the most innovative companies in the intensely competitive hip and knee markets, according to a new survey of orthopedic surgeons.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice podcast: Hamilton Thorne CEO Meg Spencer

April 15, 2011 by Christian Holland

Meg Spencer, CEO of laser manufacturer Hamilton Thorne Ltd., on how the company stays on the cutting edge of life science technology and its footprint in stem cells and regenerative medicine.

Hamilton Thorne CEO Meg Spencer

Laser-based lab equipment maker Hamilton Thorne Inc. (CVE:HTL) derives a major part of its revenues from the life sciences R&D market. CEO Meg Spencer says that requires the company to surf the leading edge of several life science research waves, including stem cells and regenerative medicine.

The Beverly, Mass.-based company looks to help solve some of the problems scientists encounter as they develop their research on stem cells into regenerative medicine techniques. Those often involve the growth of millions — or even billions — of cells, so anything that can accelerate or automate that process is vital to innovation in the space.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice podcast: BG Medicine CEO Dr. Pieter Muntendam

March 24, 2011 by Brad Perriello

BG Medicine's biggest innovation isn't its test to predict heart failure, according to CEO Dr. Pieter Muntendam — it's the first-of-its-kind business model for diagnostics development the company is pioneering.

MassDevice podcast: BG Medicine CEO Dr. Pieter Muntendam

When BG Medicine (NSDQ:BGMD) took itself public last month, three years after first announcing (then scuttling) its first initial public offering, investors seemed to like what they saw. Sure, the company cut its share price in half just ahead of the $7-per-share offering Feb. 11, but shares have averaged nearly $8.41 since then — a 20.1 percent increase.*

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Q&A: Dual CEO Rahul Aras

March 24, 2011 by MedCity News

Rahul Aras, the CEO of SironRX Therapeutics and Juventas Therapeutics, on the challenges of his dual role and his companies' stem-cell-based technology.

Q&A: Dual CEO Rahul Aras

Many business professionals likely dream of the day when they’ll run a company as chief executive, but how many hope to lead two start-ups simultaneously?

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Nano Surfaces CEO Joe Gatto

February 25, 2011 by Brad Perriello

We're on the cusp of a significant new era in medical device design, Nano Surfaces CEO Joe Gatto tells MassDevice, in which their very surfaces will build themselves and be able to operate at the molecular level.

<p>Coming generations of implanted medical devices will interact with the human

Coming generations of implanted medical devices will interact with the human body at the molecular level, using sophisticated nano-coatings to not only thwart microbial growth but to perform biological operations.

That's the prediction of Nano Surfaces founder, president and CEO Joe Gatto. The Boston-based firm is developing technology it's licensed from Cornell University to create self-assembling, anti-microbial coatings on a nanotech scale — and Gatto says that's just the beginning. To prove it, he's hitting to road to raise a Series A round from institutional investors.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Semprus BioSciences CEO David Lucchino

February 7, 2011 by Christian Holland

Semprus BioSciences Corp. hopes to reduce the 60,000 deaths and $11 billion in costs related to "surface failures" of vascular catheters with its Sustain technology for coating medical devices.

Semprus BioSciences CEO David Lucchino

Medical device developers have long sought to reduce the risks involved with implants by applying coatings to prevent both bacteria and blood from sticking to the objects once they're inside the body.

But coatings can wear off or otherwise lose their effectiveness. Semprus BioSciences Inc. is developing a solution to this fundamental limitation of implanted medical devices with its Sustain technology, which CEO David Lucchino describes as a "physical extension" of the device's material.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Mining the innovation gap

January 31, 2011 by Brian Johnson

The use of data, algorithms and social networks has changed the way we consume pop culture. Can it also change the way we innovate?

Mining the innovation gap

There's a lot of loot sitting on the med-tech sidelines these days. According to research by MassDevice.com, the top five medical device companies are sitting on a combined $17 billion in free cash.

With all that money to burn, you'd think that the med-tech mergers & acquisitions market would be a busy place. But aside from a few blockbuster deals and some lower-value transactions, medical device M&A activity is in a slump.

But there are also a slew of med-tech start-ups slavering for a taste of all that cash, hoping to land a corporate sponsor who will shepherd them through the development phase and buy the technology outright once it (presumably) proves out.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Edwards Lifesciences CEO Michael Mussallem

January 12, 2011 by Brian Johnson

After a stellar 2010, Michael Mussallem, CEO of Edwards Lifesciences Corp., is feeling bullish on transcatheter heart valves and the future of the Irvine, Calif.-based cardiac device maker.

MassDevice Podcast: Edwards Lifesciences CEO Michael Mussallem

You could forgive Michael Mussallem if he didn't want to bid farewell to 2010.

While the rest of us were still trying to pull our heads out of the lingering effects of the so-called "Great Recession," the 57-year-old chief executive of Edwards LifeSciences Corp. (NYSE:EW) was busy watching his company clean up on Wall Street and set itself up for a sweet run this year.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Avedro Inc. CEO David Muller

December 22, 2010 by Brian Johnson

Two decades after pioneering the technology that became Lasik, Avedro Inc. CEO David Muller is working to make the procedure safer and more effective.

MassDevice Podcast: Avedro Inc. CEO David Muller

More than 20 years ago, David Muller led a revolution in the world of vision correction.

As chairman and CEO of Summit Technology, he led a team that brought the first excimer laser through the Food & Drug Administration for use in reshaping the cornea. The technology, later dubbed Lasik, is a worldwide phenomenon and has helped tens of millions of patients shed glasses and contact lenses.

Decades later, Muller is at it again as the chief executive of Waltham, Mass.-based Avedro Inc., looking to finish what he started, this time with a new vision correction procedure he says will make Lasik safer and more effective.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Retina Implant CEO Walter Wrobel

December 9, 2010 by Christian Holland

Retina Implant AG's sub-retinal implant — a microchip inserted into the eye to restore vision — is currently undergoing a second clinical trial with commercialization in Europe as close as a year off.

MassDevice Podcast: Retina Implant CEO Walter Wrobel

Restoring vision to the blind is the sort of feat reserved for ancient religious texts and modern science fiction novels. But a company in Germany did just that with an eye implant.

Retina Implant AG is in the process of developing a sub-Retina Implant, designed to be inserted into the eye to treat back-of-the-eye disorders. A first clinical trial showed that the device can enable people suffering from a certain type of macular degeneration to see. The patients had retinitus pigmentosa, an inherited and incurable degenerative condition that causes tunnel vision and often, eventually, complete blindness. Retina Implant estimates that the condition affects about 200,000 people in the U.S. and Europe.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: GE Healthcare's Earl Jones

November 22, 2010 by Christian Holland

MassDevice speaks with GE Healthcare's eHealth vice president Earl Jones on how information transparency might help control the healthcare costs, improve outcomes and dishes on the politics of healthcare IT.

MassDevice Podcast: GE Healthcare's Earl Jones

The term "liberated information" may sound like it was taken from a science fiction novel, but to General Electric's (NYSE:GE) Earl Jones, it's a means to improve access and quality to healthcare while at the same time making it cheaper. Jones is the vice president and general manager of the eHealth division of GE Healthcare, overseeing the development of information technology platforms that customers ranging from small doctors' offices to state governments are implementing into their everyday operations.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Medical device legend Dr. Tom Fogarty

November 11, 2010 by Brian Johnson

Dr. Thomas Fogarty, the founder of the Fogarty Institute for Innovation, discusses the investment climate for medical innovation, venture capital and explains why his passion for winemaking is actually an extension of his medical career.

MassDevice Podcast: Medical device legend Dr. Tom Fogarty

The man Stanford University once dubbed "The Mickey Mantle of medical device inventors" still has his swing, or at least his sway in the industry, judging by the reaction Dr. Thomas Fogarty received in Boston recently at a round-table discussion of medical device innovation.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: Medtronic CEO William Hawkins

November 2, 2010 by Brian Johnson

William Hawkins, chairman and CEO of Medtronic Inc., dishes on mergers and acquisitions, the Food & Drug Administration and healthcare reform.

MassDevice Podcast: Medtronic CEO William Hawkins

For William Hawkins, Medtronic Inc. (NYSE:MDT) runs in the family.

Inside his corner office at the Fridley, Minn.-based medical device goliath, Hawkins, chairman and CEO of one of the world's largest medical device companies, keeps a picture of two customers he says not only shaped how he sees his company but how he sees the world.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Podcast: InfraReDx CEO Dr. James Muller

October 18, 2010 by Brian Johnson

Listen to MassDevice.com's podcast with InfraReDx CEO Dr. James Muller, as he discusses the difficulty of finding financial backers to believe in his technology, the technology behind the IVUS "vulnerable plaque" imaging device and how innovative medical technologies can help drive down the cost of healthcare.

MassDevice Podcast: InfraReDx CEO Dr. James Muller

InfraReDx Inc. is on a roll this fall. The Burlington, Mass.-based medical device maker won 510(k) clearance from the Food & Drug Administration in early September for its LipiScan IVUS coronary imaging system and pulled in $21 million in an equity offering a month later, which it plans to use to fund the U.S. rollout of the device.

The LipiScan IVUS uses both so-called "near-infrared" spectroscopy and intravascular ultrasound technology to give cardiologists a grayscale IVUS image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA user fees: Industry pushes for better guidance

September 21, 2010 by Ingrid Mezo

The second in a two-part series examining the Food & Drug Administration's user fee program, payments from medical device makers for FDA review of their products.

FDA user fees: Industry pushes for better guidance

The Food & Drug Administration's user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA user fees: Faster, more user-friendly guidance needed, industry says

September 21, 2010 by Ingrid Mezo

The second in a two-part series examining the Food & Drug Administration's user fee program, payments from medical device makers for FDA review of their products.

FDA user fees: Faster, more user-friendly guidance needed, industry says

The Food & Drug Administration's user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Industry troubled by performance trends in FDA user fee program

September 20, 2010 by Ingrid Mezo

The first of a two-part look at the Food & Drug Administration's user fee program, payments from medical device makers for FDA review of their products.

Industry troubled by performance trends in FDA user fee program

It takes 20 percent longer to obtain a final decision on a 510(k) submission than it did in 2002, despite the millions the Food & Drug Administration has collected from medical device makers in so-called "user fees," according to AdvaMed's Janet Trunzo.

Trunzo, AdvaMed's executive vice president for technology and regulatory affairs, was one of several industry association speakers who expressed disappointment in the medical device user fee program at a Sept. 14 workshop held to gain stakeholder input on the program.

"Our companies are concerned that the link between performance and fees has broken down," said Medical Imaging and Technology Alliance executive director David Fisher.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Absorption Systems CEO Patrick Dentinger

August 23, 2010 by Christian Holland

Absorption Systems CEO Patrick Dentinger dishes on growing a contract research organization amidst a recession and parlaying his drug testing business into the medical device development arena.

MassDevice Q&A: Absorption Systems CEO Patrick Dentinger

Absorption Systems LP is well-positioned in several sense of the word. The Exton, Pa. and San Diego-based contract research organization managed to expand during the Great Recession, buying medical device toxicology firm Perry Scientific last summer.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Accuray president and CEO Euan Thomson

August 16, 2010 by Brad Perriello

Euan Thomson, president and CEO of Accuray Inc., on how his company managed to fare well despite the capital expenditure market's downturn, its distribution and R&D deal with Siemens and why healthcare reform could have a big upside for Accuray.

MassDevice Q&A: Accuray president and CEO Euan Thomson

Accuray Inc. (NSDQ:ARAY) has a tough row to hoe: Cultivate a market that crosses medical specialty lines for a product that costs millions. The Sunnyvale, Calif.-based company's CyberKnife system is a pioneering device in radiosurgery, using precisely targeted, massive doses of X-ray radiation to non-invasively destroy tumors.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Cook Medical vice president Rob Lyles

July 26, 2010 by Brad Perriello

Rob Lyles, who heads up Cook Medical's peripheral intervention business, on the company's origins in a two-bedroom apartment, the impact of gift bans on the medical device industry and developments in treating diseased blood vessels in the legs.

MassDevice Q&A: Cook Medical vice president Rob Lyles

Cook Medical Group and Boston Scientific Corp. (NYSE:BSX) both got their start with catheter-based devices, but the medical device giants' similarities don't stop there. As Boston Scientific founder John Abele told MassDevice last month, his firm got its start in an unlikely place: the basement of a Catholic Church in Belmont, Mass.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Abiomed CEO Michael Minogue

July 9, 2010 by Christian Holland

Abiomed president and CEO Michael Minogue on his company's Impella heart pump and its prospects for gaining a larger share of the cardiac assist market.

MassDevice Q&A: Abiomed CEO Michael Minogue

Abiomed Inc. (NSDQ:ABMD) makes cardiac assist devices powerful enough to pump more than a gallon of blood through the heart each minute and small enough to be placed inside the heart via catheter. It's a highly specialized, highly competitive market that's difficult to break into.

At an investors meeting in Boston last week, the company sought to deliver the message that its devices offer a less invasive option than ventricular assist devices and don't need to be combined with inotropic drugs as is often the case with intra-aortic balloon pumps. It's been two years since Abiomed won 510(k) clearance from the Food & Drug Administration for its Impella 2.5 device; at the conference, CTO Dr. Thorsten Siess acknowledged that physicians have been slow to adopt the device.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: LifeImage CEO Hamid Tabatabaie

June 30, 2010 by Christian Holland

MassDevice talks to LifeImage president and CEO Hamid Tabatabaie about his company's e-sharing application for medical imaging.

MassDevice Q&A: LifeImage CEO Hamid Tabatabaie

If you’ve ever had a CT scan, X-ray or MRI, you were likely given a CD to tote around in case you wanted a second opinion. That’s because there isn’t a universal network or database for medical image files, even in an industry that demands standardization.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: John Abele, Part II

June 10, 2010 by Brad Perriello

Boston Scientific Corp. co-founder John Abele, in the second installment of a lengthy interview, on the early days with Peter Nicholas, his take on demands for increased transparency and his frustration with some of the company's recent low points.

MassDevice Q&A: John Abele, Part II

Boston Scientific Corp. (NYSE:BSX) co-founder John Abele told us about the origins of the medical device giant in the first installment of a lengthy chat with MassDevice, detailing its start in the basement of a famed Czech mystic's lab in a Catholic church rectory.

In the second installment, Abele touches on how he and co-founder Peter Nicholas engineered the Boston Scientific's launch, how his involvement with the Natick, Mass.-based company evolved over the years and how being a "cheap son of a bitch" helped drive creativity and innovation in the early days.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Boston Scientific co-founder John Abele

June 9, 2010 by Brad Perriello

Boston Scientific Corp. co-founder John Abele, in the first installment of a lengthy interview, on the company's origins in the basement of a church rectory, its connection to a famous Czech mystic and how it overcame doctors' early skepticism about its catheter-based technology.

MassDevice Q&A: Boston Scientific co-founder John Abele

There aren't many multi-billion-dollar companies that can say they got their start in the basement of a Catholic church rectory. Still fewer can claim a connection to a famous Czech mystic credited with pioneering research into human consciousness (and, not incidentally, with inventing the steerable catheter).

But according to co-founder John Abele, Boston Scientific Corp. (NYSE:BSX) can. The Natick, Mass.-based medical device maker got its start with the steerable catheter invented by Itzhak Bentov, leveraging the platform into a family of catheter-based products that changed the way medicine is practiced.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Practice Fusion founder and CEO Ryan Howard

June 9, 2010 by Christian Holland

Practice Fusion's founder and CEO on the electronic medical record provider's free, advertising-based EMR offering.

MassDevice Q&A: Practice Fusion founder and CEO Ryan Howard

To raise the seed money for Practice Fusion, founder Ryan Howard sold his house and car.

"I was really going all in," the 34-year-old CEO told MassDevice.

Howard might have made a smart bet. According to Practice Fusion, the company has the fastest-growing user base of any electronic medical record company in the country, at 40,000 members. Its offering is free for physicians, using a largely advertising-based business model.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: OmniGuide chairman Yoel Fink

June 1, 2010 by Christian Holland

MassDevice talks to OmniGuide's Yoel Fink and Yair Schindel about their company’s business development strategy.

MassDevice Q&A: OmniGuide's Yoel Fink and Yair Schindel

When Yoel Fink began his groundbreaking work with mirrors at MIT in the late 1990’s, he didn't know he would be creating a material that would be used to carry lasers into areas as hard to reach as the inner ear or brain. He was working on a problem that the Defense Advanced Research Projects Agency, the research and development arm of the U.S. military, wanted solved. For reasons still unknown to Fink, DARPA wanted large-area, low-cost surfaces more reflective than a mirror that could reflect light from all angles. Eventually, his work led to a PhD thesis and OmniGuide, the company where he is currently chairman. OmniGuide, which employs 120 workers, just last week celebrated its 10th year of business.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Molecular Biometrics CEO Jim Posillico

May 3, 2010 by Brad Perriello

Molecular Biometrics co-founder, president and CEO Jim Posillico on how metabolomics can revolutionize in vitro fertilization — and lower healthcare costs along the way.

MassDevice Q&A: Molecular Biometrics CEO Jim Posillico

Jim Posillico has a long academic and commercial pedigree in reproductive medicine, having spent time as a researcher at Harvard Medical School, Serono Laboratories, the Ares-Serono Group, InterMune Life Sciences and SAGE BioPharma.

So when he learned of a metabolomics platform being developed at McGill University, he was quick to realize its applicability to a variety of potential conditions and disease states. The technology allows the comparison of biomarkers produced by cell metabolism monitor the progress of diseases like Parkinson's and Alzheimer's.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Levitronix CEO Kurt Dasse

April 7, 2010 by Brad Perriello

Levitronix CEO Kurt Dasse on the company's roots at Thermo Fisher Scientific, why its magnetic levitation technology is so well-suited to implantable cardiac assist devices and how the medical device excise tax could force consolidation in the medical device industry.

MassDevice Q&A: Levitronix CEO Kurt Dasse

Kurt Dasse, the CEO of Waltham, Mass.-based Levitronix, counts a stint as chief scientific office for Thermo Electron Corp., better known today as Thermo Fisher Scientific as key to his professional career. His tenure at Thermo proved fateful, as it was there that Dasse came under the wing of the legendary George Hatsopoulos and his fervent devotion to starting new companies.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: GenomeQuest CEO Ron Ranauro

March 16, 2010 by Brad Perriello

CEO Ron Ranauro on GenomeQuest's customizable API, the falling cost of human genome sequencing and the ethical implications of widespread access to personal genome data.

MassDevice Q&A: GenomeQuest CEO Ron Ranauro

Ron Ranauro spent the better part of two decades in the computer industry, watching as the personal computer and the Internet transformed the business. It's growing maturity coincided with early efforts to sequence the human genome, leading Ranauro in the late 1990s to apply his computing chops to the life science scene.

MassDevice spoke with Ranauro as GenomeQuest launched an application programming interface that allows developers to customize apps for their labs' research programs. We asked him about the API, what sets his venture apart from other sequencing data management firms (hint: it's in the clouds) and got his take on the ethical implications of widespread access to genome sequencing technology.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: BioBehavioral Diagnostics CEO Byron Hewett

March 8, 2010 by Brad Perriello

Byron Hewett, the CEO of Cambridge, Mass.-based BioBehavioral Diagnostics, on the importance of being able to quantify the symptoms of Attention Deficit Hyperactivity Disorder, helping families cope with an ADHD member and how the Food & Drug Administration let the horse out of the barn when it comes to regulating the diagnostics industry.

MassDevice Q&A: BioBehavioral Diagnostics CEO Byron Hewett

We first spoke with Byron Hewett, the CEO of Cambridge, Mass.-based BioBehavioral Diagnostics Co., late last summer, following a $2.5 million funding round that saw the company sell convertible debt securities to a trio of investors.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: PatientKeeper CEO Paul Brient

February 4, 2010 by Brad Perriello

PatientKeeper Inc. president and CEO Paul Brient on why healthcare IT won't save the healthcare system, why it's still crucial to healthcare reform and how it could revolutionize the practice of medicine.

PatientKeeper CEO Paul Brient

Paul Brient, the president and CEO of PatientKeeper Inc., has spent 20 years in the healthcare IT trenches, first with the physician practice management software start-up he founded and ran, BCS Inc. After stints at McKesson Corp. (NYSE:MCK), HPR Inc. and The Boston Consulting Group, he joined PatientKeeper in 2002.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Myomo CEO Steve Kelly

January 28, 2010 by Brad Perriello

Myomo Inc. CEO Steve Kelly on his company's portable, robotic device for stroke rehabilitation and the coming wave that will revolutionize the medical device industry as we know it.

Myomo's e100 NeuroRobotic System

Steve Kelly's spent three decades watching new technology that originated in consumer electronics wreak havoc on well-established industries. The CEO of Myomo Inc. bore witness as new technologies redefined the home computing market in the 1980s, the telecom space in the 1990s and the changes voice-over-IP technology brought to telephony in the last decade.

Kelly sees a similar wave heading for the shores of the medical device industry. MassDevice spoke with him to hear his take on where the sector is headed and why.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: CeQur CEO Jim Peterson

January 21, 2010 by Brad Perriello

CeQur CEO Jim Peterson on his personal ties to diabetes technologies and why his company is poised to be the leader in next-generation insulin delivery devices.

CeQur CEO Jim Peterson

Jim Peterson spent the better part of 20 years helping to improve the quality of the world's blood supply at Haemonetics Corp. (NYSE:HAE), where he was CEO from 1998 to 2003. And while he was passionate about the importance of that work, his new role as chief executive for CeQur Ltd. might be even closer to his heart.

Peterson spoke with MassDevice just before giving a presentation on the patch-like device CeQur is developing for insulin delivery at the OneMedPlace Finance Forum in San Francisco Jan. 13. He told us about the personal connection he feels to his current work, which stems from the fact that his daughter has diabetes, and why he sees Montreux, Switzerland-based CeQur's device as a potential market leader.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Covidien medical devices president José Almeida

January 11, 2010 by Brad Perriello

Covidien's medical devices division president on reviving the company after its spinout from Tyco Healthcare and how it turned around in a down economy.

MassDevice Q&A: Covidien medical devices president Joe Almeida

José Almeida knows what it takes to succeed. The native of Brazil, a mechanical engineer by training, put down roots in the U.S. 20 years ago and never looked back.

Since then he's worked his way up the corporate ladder at firms including Acufex Microsurgical, Johnson & Johnson (NYSE:JNJ), Greatbatch Technologies and Tyco Healthcare. When the latter spun out into Covidien in late June, 2007, Almeida had been in his current role for a year already after spending the better part of 12 years with the company.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Researchers take on the FDA

January 7, 2010 by Brian Johnson

Researchers Sanket Dhruva and Rita Redberg on the hornet's nest they stirred up with their study of the Food & Drug Administration's approval process for high-risk cardiovascular devices.

Researchers take on the FDA

It's not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.

But that's exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices."

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Robert Creeden of Partners Innovation Fund

December 30, 2009 by Brian Johnson

Robert Creeden, managing director of Partners Innovation Fund, on reviewing business plans and the state of innovation.

Bob Creeden

Robert Creeden knows a little something about how to invest in early-stage companies. A former vice president at the Massachusetts Technology Development Corp. and a general partner at Egan-Managed Capital, Creeden has spent countless hours on due diligence for new ventures.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Serica Technologies CEO Greg Altman

December 28, 2009 by Brad Perriello

Serica Technologies Inc. president and CEO Greg Altman on leveraging a platform product and the importance of creating a "learning organization."

Serica Technologies CEO Greg Altman

Thirteen years ago Greg Altman, president and CEO of Serica Technologies Inc., blew out his knee playing football. After reconstructive surgery on his ruptured anterior cruciate ligament, the former All-American at Tufts University found the rehabilitation process so challenging that he set out to develop an alternative.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

At Employ+Ability, work is good

December 24, 2009 by Joe Nowlan

Employ+Ability Inc., like many of its disabled employees, has been defying the odds for nearly 30 years.

At EmployAbility work is good

Like many of its 33 employees, for more than 27 years Employ+Ability Inc. has been defying the odds.

As with many American manufacturers, this small original equipment maker in Braintree, Mass., faced the brink when competition from China began prying away business in 2004. The company, which primarily makes hot and cold packs for companies like Covidien (NYSE:COV), Johnson & Johnson (NYSE:JNJ) and Inverness Medical Innovations (NYSE:IMA), lost a $10 million contract to the Far East and the future looked a little grim.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Advertising executive Bruce Lehman

December 23, 2009 by Brian Johnson

Advertising executive Bruce Lehman on the challenges and opportunities in marketing medical devices for the masses.

MassDevice Q&A: Advertising executive Bruce Lehman

Bruce Lehman's been in the advertising game since the late 1970s, but the principal at Lehman Millet, a Boston-based marketing and communications agency, has been focused on the medical device and diagnostics industry solely since the 1990s, making it a powerful player in the industry despite its relatively small size.

Today, Lehman Millet's client mix includes biotechnology, biomaterials and specialty pharmaceutical firms, along with its core medical device customers. MassDevice: spoke with Lehman, 59, about an ever-present question: "How, exactly, do you market a medical device?"

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Thermo Fisher Scientific CEO Marc Casper

December 7, 2009 by Brad Perriello

Thermo Fisher Scientific's new CEO Marc Casper on taking the reins from Marijn Dekkers and his cautious optimism about 2010.

A MassDevice.com Q&A with Thermo Fisher Scientific CEO Marc Casper

To outside observers, Marijn Dekkers' departure from the corner office at Thermo Fisher Scientific (NYSE:TMO) might have seemed abrupt. After a seven-year run during which he led a profound re-shaping of the laboratory equipment and supplies manufacturer (and boosted revenues from the $2 billion range to about $10.5 billion a year), Dekkers resigned as CEO of the Waltham, Mass.-based firm to take the helm at German pharma giant Bayer AG.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Winning the arms race: The centuries-old quest to build a better prosthetic

November 25, 2009 by Alan Siegel

Advances have been few and far between since Ambroise Paré invented modern prosthetics in the 16th century. But the wars in Iraq and Afghanistan might just change that.

Winning the arms race: The centuries-old quest to build a better prosthetic

JUNE 22, 2008 WAS A GORGEOUS EARLY SUMMER DAY, with partly cloudy skies and 80-degree temperatures.

Taking advantage of the weather, Greg Reynolds, a muscular 24-year-old veteran of Operation Iraqi Freedom, hopped on his yellow Suzuki TL1000R racing bike to spend the morning at Colt State Park in Bristol, R.I., a swath of land on Narragansett Bay some 17 miles south of his house in Dighton, Mass.

The TL1000R is not a motorcycle for the casual rider. Its 996C, 4-stroke engine is capable of 9,500 RPM — or zero to 60 miles per hour in about 3.6 seconds — giving the rider the feeling of being strapped onto the nose of a rocket.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

The rebuilding process begins

November 20, 2009 by Alan Siegel

Greg Reynolds had to rebuild himself, physically and mentally, to recover from his accident and from the post-traumatic stress disorder he brought back from Iraq.

It wasn't until after the accident that Greg Reynolds realized he was suffering from post-traumatic stress disorder. The cloud of invincibility that first came over him in Iraq lingered long after he returned to Massachusetts. He even worked as a guard for cash-handling company Loomis Armored – and didn't wear a bullet-proof vest.

And he just couldn't relax. He drove friends crazy with his strict daily schedule.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

The prosthetic fitting process

November 20, 2009 by Alan Siegel

Fitting an amputee for a prosthetic takes advantage of the latest, cutting-edge design and manufacturing technologies.

The prosthetic fitting process

Prosthetist Luke Richards' small office is tucked deep inside the Jamaica Plain branch of the VA Boston Healthcare System. One morning this spring, a patient's carbon fiber leg rests by his desk. A chrome briefcase, with a picture of Greg Reynolds' new arm on it, sits on the window sill.

Here, in the E Wing of the hospital, veterans are fitted for prosthetic devices. It doesn't end with arms, legs, hands and feet, either. For example, Reynolds is itching to get back to regularly riding his ATV. So Richards suggested a sleeve that will fill out Reynolds' shirt while he's riding.

For Richards, the question is always the same.

"What do we need to do," he says, "to get [the patient] doing what he used to do?"

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

To Iraq and back

November 20, 2009 by Alan Siegel

Greg Reynolds survived more than a year in Iraq without a scratch. It was only after his return that an accident nearly killed him.

To Iraq and back

Somehow, amid the chaos of the ambush, Greg Reynolds felt invincible.

It happened on Nov. 9, 2003, near Balad, Iraq.

"We were rolling up on a couple of Humvees that were broken down," Reynolds writes in an e-mail. It didn't take long to see that his unit was under fire. "I get out of the truck tactically and realize, 'Holy shit.'"

Bullets whizzed by his head. Civilians hid nearby.

"We were about 50 yards behind the lead vehicle, taking hand signals from them," he recalls. "Then we start raking rounds around the civilians. The enemy was dug in the brush, scattered around a 30-40 yard area. We hit it with everything we had."

The Humvees kept moving. With two critically injured soldiers in tow, it was the only option.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: GE Healthcare's David Freeman

November 17, 2009 by Brad Perriello

The general manager of parameters for GE Healthcare on the company's FCC petition for a dedicated wireless spectrum for medical devices and his vision for the hospital of the future.

MassDevice Q&A: GE Healthcare's David Freeman

It's no secret that wireless technology is in a growth spurt. From WiFi cars on commuter trains to the omnipresent Bluetooth and iPhone devices, as the saying goes, "There's an app for that."

The medical industry is no exception. Wireless medical devices are becoming more and more common, with innovations like pacemakers that can send data directly to physicians. GE Healthcare is looking to push the envelope even further, with a vision for wireless medical monitoring systems that would eliminate the rat's nest of cables that spring up around hospital patients.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: American Well CEO Roy Schoenberg

November 11, 2009 by Brian Johnson

The web-enabled, on-demand healthcare service firm's chief on why 2009 will be a watershed year and the similarities between fundraising and warfare.

MassDevice Q&A: American Well CEO Roy Schoenberg

Roy Schoenberg seems to have the gift of good timing.

The 42-year-old is CEO of American Well, a Boston-based company that's developed a web-enabled, on-demand healthcare service so patients can speak directly to physicians at any time. The system could prove to be a low-cost solution to getting healthcare to the uninsured or under-insured — pretty fortuitous timing, when you consider Washington's struggle to figure out a way to control spiraling healthcare costs while increasing access to care.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Maggie Pax

October 23, 2009 by Brian Johnson

The business development VP for the implantable drug/device developer on innovation through diversity and her keynote address at the Medical Product Outsourcing Symposium.

MassDevice Q&A: Maggie Pax, MicroCHIPS business development VP

MicroCHIPS Inc. may have been the result of divine inspiration (as the story goes, MIT professor Robert Langer thought of the idea while watching PBS), but it took people like Maggie Pax to turn his vision into a suite of implantable devices that could one day revolutionize medicine.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Michael Frazzette

October 23, 2009 by Jim Montalto

The Smith & Nephew Endoscopy president on how arthroscopic techniques have evolved and the importance of staying focused on customers and core business.

MassDevice Q&A: Michael Frazzette

After 20 years in the medical device business, you might think Smith & Nephew Endoscopy president Mike Frazzette had grown jaded. But the industry innovations, ranging from the mechanical tissue shaver that started it all for Smith & Nephew Endoscopy to current work with bioabsorbable materials, continue to amaze and engage him.

MassDevice asked Frazzette about how his endoscopy business has evolved and the way Smith & Nephew leverages its developing technologies in adjacent business segments.

MassDevice: How did you get your start in medical devices?

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Steve Atkinson & Scott Schorer

October 19, 2009 by Brad Perriello

The CEO and Americas president, respectively, of wound care giant Systagenix on the carve-out from Johnson & Johnson and putting together a multi-million dollar deal amid economic turmoil.

MassDevice Q&A: Steve Atkinson & Scott Schorer

When Systagenix Wound Management, the former professional wound care business of Johnson & Johnson's Ethicon subsidiary, was carved out late last year, the timing wasn't propitious. Credit markets were frozen and the global economy was staring into an abyss with another Great Depression at the bottom.

Nearly a year later, it's a different story. The credit crisis has eased, there are signals that the recession may be coming to an end and Systagenix is on a roll, having engineered the spinout with help from backers One Equity Partners and JP MorganChase.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Patrick O'Donnell

October 15, 2009 by Brad Perriello

The CEO of Prochon Biotech on moving the company from R&D to commercialization, other markets for its BioCart knee cartilage regeneration technology and potential pitfalls facing orthopedic device makers.

MassDevice Q&A: Prochon Biotech CEO Patrick O'Donnell

Prochon Biotech, the Woburn, Mass.-based company that's developing biologic knee repair technology, got its start in an unlikely sphere.

The company is leveraging its core technology, a patented fibroblast growth factor variant, grew out of research into achondroplasia, a skeletal condition that leads to so-called dwarfism.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: William Rutan

October 14, 2009 by Brian Johnson

The CEO of Mederi Therapeutics on the challenges of increasing awareness of bowel incontinence and his company's minimally invasive alternative to colostomy surgery.

MassDevice Q&A: Mederi Therapeutics CEO William Rutan

How do you get people to talk to their doctors about something so embarrassing they'll barely admit it to themselves?

That's the challenge facing Greenwich, Conn.-based medical device startup Mederi Therapeutics and the minimally invasive treatment for fecal incontinence it says will eliminate the need for drastic colostomy procedures.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Campbell Rogers

October 9, 2009 by Brad Perriello

Cordis Corp.'s chief scientific officer on the move from bedside to boardroom, and what Cordis has in its development pipeline.

MassDevice Q&A: Campbell Rogers

Campbell Rogers, the chief scientific officer for Johnson & Johnson subsidiary Cordis Corp., knows interventional cardiology from both sides of the clinical trial.

As the former director Brigham & Women's Hospital's catheterization lab and principal investigator of the Brigham's interventional vascular biology laboratory, Rogers led multi-center device and pharmacologic trials before joining Cordis in July 2006.

There he finds himself on the other side of the process as head of Cordis' research and development team — a role the company created for him.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Mass Device Q&A: Dave Kroll

October 5, 2009 by Jim Montalto

The founder of Kroll Associates on why distance doesn’t matter and the role small, focused firms will play in the expansive and varied medial devices field.

Mass Device Q&A: Dave Kroll

Dave Kroll, the founder and principal of Kroll Associates, works out of his office in western Massachusetts, which, according to him, proves there is life in design and product development beyond Worcester and the Greater Boston area.

In fact, Kroll sees his distance from Boston as an advantage, since he can also tap New York, Vermont, Connecticut, New Hampshire and beyond for new work.

He has clients in and around Boston, sure — one of his biggest is in Waltham — but his ties to New England universities, contractors and manufacturers, and his persistence in maintaining a presence with clients, either virtually or through office visits, keeps him on top of the industry.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Charles Mathews

October 1, 2009 by Brad Perriello

The Boston Healthcare Associates reimbursement expert dishes on the healthcare reform push and how it will affect medical device makers, ahead of his keynote speech at the MassMEDIC 11th Annual Medtech Investors Conference.

MassDevice Q&A: Charles Mathews

Charles Mathews is no stranger to Capital Hill, having worked as a legislative aide to Reps. David Price (D-N.C.) and Rob Andrews (D-N.J) in the early years of the decade. That experience comes in handy in his role a director at Boston Healthcare Associates, where he's keeping tabs on the ever-evolving debate over healthcare reform in Washington.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Dave Bergstein

September 30, 2009 by Brad Perriello

The Zoíray Technologies founder and CEO on the next big thing in diagnostics, why his startup might be the company that delivers it and making his pitch at the MassMEDIC Investors Conference.

MassDevice Q&A: Dave Bergstein

Ask Dave Bergstein about the next big thing in diagnostics and his eyes light up. The Zoíray Technologies Inc. founder and CEO runs startup that's developing a next-generation multiplexed immunoassay platform Bergstein thinks will become the new state-of-the-art standard for studying proteins.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Richard Packer, CEO of Zoll Medical

September 27, 2009 by Brian Johnson

The CEO of Zoll Medical Corp. talks about healthcare reform and the Chelmsford, Mass.-based resuscitation products maker's future.

Zoll Medical CEO Richard Packer

Richard Packer probably doesn't get confused for Konosuke Matsushita very often (first off, Packer's a lot taller), but listening to the CEO of Zoll Medical Corp. speak about his vision for the company can conjure images of the legendary founder of Panasonic and his 250-year business plan.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Richard Schumacher

September 21, 2009 by Brad Perriello

The Pressure BioSciences founder, president and CEO on how it took seven college majors for him to find his niche, making it through the recession and why his firm's pressure cycling technology could revolutionize scientific research.

Pressure BioSciences CEO Ric Schumacher

Richard Schumacher is no stranger to successful start-ups. The Pressure BioSciences founder, president and CEO had a hand in five early-stage life science ventures, including Boston Biomedica.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Philipp Lang

August 27, 2009 by Brad Perriello

The ConforMIS Inc. founder and CEO on custom-made implants, how the company was able to raise $50 million in a difficult investment climate and why ConforMIS is a lot like Dell Computers.

Philipp Lang wears a lot of hats. Besides being the founder, president, chairman and CEO of ConforMIS Inc., he's a radiologist and former director of the Musculoskeletal Radiology and Distinguished Weissman Chair at Brigham and Women's Hospital in Boston and associate professor at Harvard Medical School.

But ConforMIS and its breakthrough custom knee implant technology aren't Lang's first forays into the startup medical device world. He also founded Imaging Therapeutics Inc. (where he remains chairman) and served on the board at ViOptix Inc.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: John McDonough

August 4, 2009 by Joe Nowlan

The T2 Biosystems CEO on the company's innovative, miniaturized diagnostic tool, the importance of de-risking before you hit the fundraising trail and why the U.S. intelligence community is interested in T2's technology.

John McDonough, CEO of Cambridge, Mass.-based T2 Biosystems Inc., is an optimist.

Bullish on his 22-employee company's prospects (the estimated $40 billion diagnostics market might have something to do with that), McDonough (far left in the picture at right) spoke with MassDevice about the technology behind T2's diagnostic device, which uses a miniaturized version of a magnetic resonance imaging machine to deliver near-instant test results from just about any blood, urine or saliva sample.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Thomas Taylor

July 21, 2009 by Brian Johnson

The president of Roush Life Sciences and incoming MassMEDIC chairman on his deep ties to the Michigan auto industry and why you should always listen to your mother.

Tom Taylor grew up in Grand Blank, Mich., just a short drive from Flint and the belly of General Motors'manufacturing machine.

The son of an auto executive and a registered nurse, the president of
Roush Life Sciences
always felt the pull of the two industries.

While a plastics engineering student at Ferris State University, Taylor worked at the GM technology center. But the idea of spending a career locked in a cube as a "right panel guy" forced him reconsider his options, a decision that today looks positively prescient.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Jean-Marc Wismer

July 14, 2009 by Brian Johnson

The CEO of Switzerland's Sensimed looks to peel back the lid on glaucoma testing.

You literally cannot see glaucoma coming.

Although it's one of the leading causes of blindness in the world, frighteningly little is known about a disease group that affects 4 percent of the world's population over the age of 40. No cure is on the horizon. And due to the insidious nature of the disease, which stars gradually affecting sight from the periphery, most people don't even know they're suffering from glaucoma until it's too late.

Swiss diagnostics company Sensimed AG sees this mysterious disease as a real opportunity.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Dean Kamen

July 8, 2009 by Brian Johnson

The inventor of the DEKA arm, the iBOT, the Segway (and others) on healthcare reform, the contrast between the pace of innovation and its adoption by society and how he'd like to be remembered.

Dean Kamen is rarely at a loss for words. In fact, the man is rarely at a loss for anything.

At a recent conference at Boston University, Kamen, 58, took up more than triple his allotted time for a keynote speech as he worked the assembled tech-heads and computer geeks into a near-frenzied lather amid shouts of "Dean for President," and basked in the warm embrace of a nearly five-minute standing ovation. Definitely not your average conference fare.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Stuart Randle

July 7, 2009 by Brad Perriello

The GI Dynamics president and CEO on the importance of maintaining an even keel, finding the right people at just the right time and the next generation of bariatric products.

Stuart Randle, president and CEO of Lexington-based GI Dynamics, has a long career in medical devices under his belt. Originally a mechanical engineer with a degree from Cornell University, Randle got into the device world during his MBA studies at Northwestern University and never looked back.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Charles Remsberg

July 1, 2009 by Brian Johnson

The CEO of robotic rehab equipment maker Hocoma's U.S. division on how robotics will change rehabilitation and why thinking Swiss has helped the company weather the downturn.

Charles Remsberg literally learned the medical device business from the ground up.

The 47-year-old's first job in the industry was sweeping the floors in a warehouse. That's also where he learned that it's more important to be judged by your work than your alma mater's pedigree.

The Long Island native's resumé includes stints ranging from clam digger to his current role as CEO of the American division of Hocoma Inc. in Rockland. Switzerland-based Hocoma produces the Lokomat, a robotic rehabilitation system that helps people suffering from spinal cord injuries and brain trauma learn how to walk again by acting as their legs.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Shawna Gvazdauskas

June 30, 2009 by Brian Johnson

Medical device industry veteran and Isis Biopolymer's new chief commercial officer on why the company's drug patch platform is revolutionary and the keys to bringing medical devices to market.

Shawna Gvazdauskas has a knack for bringing medical devices to market. The 53-year-old is on the third start-up of her 30-year career. In March, she left insulin management maker Insulet, where she helped bring the company's flagship Omnipod to market, for a new challenge at Isis Biopolymer Inc., which is developing a new generation of non-invasive drug delivery patches.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Kevin Outterson

June 23, 2009 by Brian Johnson

The Boston University law professor and pharmaceutical industry monitor on the origins of the Massachusetts gift ban and how medical device makers came to fall under its rules.

Kevin Outterson, an associate law professor at Boston University, is an expert on patent law and intellectual property as it applies to the pharmaceutical industry. He works to balance the incentives behind innovation with making sure low-income people have access to life-saving therapies.

MassDevice spoke with Outterson about the background behind states' efforts to rein in industry, specifically "Big Pharma," and how medical device makers came to be folded into the strict Massachusetts regulations governing industry payments to physicians.

MassDevice: Can you give us a quick history of the roots of the gift ban in efforts to regulate the pharmaceutical industry?

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Amar Sawhney

June 19, 2009 by Brian Johnson

The founder of six companies, including Waltham's I-Therapeutix, on market conditions and the future of medical devices.

Amar Sawhney has a knack for turning gel into gold.

Over the years, the serial entrepreneur managed to leverage his work in hydrogel technology at the University of Texas into the basis for six companies, including one snapped up by Genzyme early in the decade and another that Covidien predecessor Tyco Healthcare acquired in 2006.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Michael Phalen

June 10, 2009 by Brad Perriello

The president of Boston Scientific's endoscopy division on putting patients first and why he's worried about the medical device industry's ability to innovate.

MassDevice Q&A: Michael Phalen

Michael Phalen, president of Boston Scientific Corp.'s endoscopy division, began his long tenure at the Natick devices giant in 1988 as a sales rep. After several crossings between the outside sales world and inside marketing positions, he was named president of the endoscopy operation in 2001.*

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Jeff Burbank

June 10, 2009 by Jim Montalto

NxStage Medical founder and CEO Jeff Burbank on the importance of people, better home devices and improving on what works.

More than 20 years of developing, marketing and manufacturing products for end-stage renal disease patients led NxStage Medical Inc. founder, president and CEO Jeff Burbank to a realizations: The key to improving care is to look beyond the hospital and into the home.

The Lawrence-based company makes a home dialysis system that allows patients with kidney disease to better manage their own treatment. Burbank talked with MassDevice about how the success of the product hinges on improving patients' quality of life and how the success of the company relies on the timing of finding and keeping great employees.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Mark Tauscher

June 9, 2009 by Jim Montalto

The president and CEO of PLC Medical Systems on the FDA, the credit crunch and how his roots as a physiologist made him a great fit for the medical device industry.

Mark Tauscher joined PLC Medical Systems Inc. in January 2000 after more than 20 years in medical product sales, marketing and management. When he spoke with MassDevice, the company had just announced strong sales and narrowed losses for the first quarter, largely due to strong international sales.

Tauscher told us about the rocky road PLC traveled in getting FDA approval for its first device, a transmyocardial laser revascularization system, how it decided the RenalGuard device would be its follow-up and why he sees the global credit crunch as the industry's biggest challenge.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Paul Nickelsberg

June 9, 2009 by Jim Montalto

Orchid Technologies president and CTO Paul Nickelsberg on the conflict between getting devices to market fast and keeping the FDA satisfied, doing business in a down economy and what med-tech electronic breakthroughs are on the horizon.

Orchid Technologies Engineering & Consulting president and CTO Paul Nickelsberg is an electronics industry veteran, with experience ranging from high-end computing design to networking and telecommunications under his belt.

But it was his "try anything once" attitude that helped him break into the medical devices market.MassDevice caught up with Nickelsberg recently to get his ideas on coming challenges for the medical device market and his strategy for keeping clients happy during uncertain economic times.

MassDevice: How did your company get into medical devices?

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Chris LaFarge

June 9, 2009 by Brad Perriello

The MedicaMetrix president and CEO on how its Prostaglove aims to revolutionize prostate care, looking to Europe for capital and why he wishes he'd stayed away from venture backing.

Chris LaFarge, president and CEO of MedicaMetrix, is betting on his firm's ProstaGlove device to change the way doctors track and treat the prostate. The product is essentially a disposable rubber glove armed with sensors LaFarge says will provide a quantitative method for tracking the volume and growth rate of the prostate — the only human organ that never stops growing.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Pumped up

June 3, 2009 by Alison Carter

Insulet Corp. aims to change the way diabetics treat their disease with its OmniPod insulin management system.

Insulet Corp.'s OmniPod insulin management system

The symptoms had started about three weeks before — feeling constantly tired and thirsty, going to the bathroom frequently and losing a drastic amount of weight.

My doctor told my parents to bring me to the Children's Hospital of Philadelphia, where I would learn how to adjust my diet and schedule, administer medication and deal with the illness.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Extra credit

May 27, 2009 by Robin Ellington

Medical device companies, especially early-stage start-ups, stand to save a bundle by taking advantage of a tax credit for research and development expenses.

For companies with a burn rate that's hot to the touch, there could be a little bit of relief from an unlikely source.

There's a little-known credit in the federal tax code for research and development expenses that could save early-stage companies a boat load of money.

But most firms either overlook the credit entirely, or find it too mystifying to bother with, meaning that this powerful accounting tool isn't getting the kind of play it should with the companies that need it most.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Letting in the light

May 19, 2009 by Jim Montalto

A pair of Andover sister companies, Amorphex Therapeutics and Vista Scientific, are hoping to advance the treatment of serious eye diseases like glaucoma using sophisticated contact lens technology.

There's a certain irony to Amorphex Therapeutics working in the dark basement of a 100-year-old Andover mill building.

"It’s atrocious, but classic," president and CEO Robert Thompson laughs, trying to explain the peculiarity of scientists working on cutting-edge ophthalmic technology in an antiquated former mill complex.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

VasoTech gears up to go global

May 12, 2009 by Jim Montalto

The stent startup's founder, Tim Wu, may have started out in his garage, but he aims to take the lead in developing the next generation of drug-eluting stent.

VasoTech founder Tim Wu

It would have been easy for Tim Wu, cardiologist and founder of VasoTech Inc., to give up on his vision for the next generation of drug-eluting stent. He didn’t.

Instead, he invested $50,000 of his own money to set up shop in his garage and build a better stent, wrapping three state-of-the-art elements — a cobalt chromium stent, a biodegradable polymer and a potent combination of two anti-restenosis drugs — into a single device he calls the PowerStent. And he's counting on that power to take his fledgling company global.

The next generation

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: MassMEDIC president Tom Sommer

May 1, 2009 by Brad Perriello

The president of the nation's largest regional medical device council tells MassDevice why device makers are happy to toil in obscurity, the problem with the Massachusetts gift ban and what's in play now that there's a new administration in Washington.

Tom Sommer's been a major player on the Massachusetts medical device scene for more than a dozen years. As president of the Massachusetts Medical Device Industry Council (MassMEDIC), Sommer runs the nations largest regional medical device council, addressing the needs of more than 400 member companies.

With the council's May 5 annual conference on the horizon, MassDevice visited Sommer at MassMEDIC's offices at the Boston Medical Center (PDF) campus to find out what's on the minds of the device company executives he visits each week, how they're coping with a down economy and the challenges imposed by the Bay State's stringent gift ban.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Dr. Obama is in the house

April 21, 2009 by Katie Quackenbush

More than $1 billion from the American Recovery and Reinvestment Act is earmarked for comparative effectiveness research. What will that mean for the Commonwealth's medical device sector?

Apples and oranges

Suzanne Ryan has a bum knee. If she doesn’t spend most of the day sitting down, she ends up coping with a lot of pain.

Her doctors say there are two options for the semi-retired elementary school teacher: Knee replacement surgery, using state-of-the-art plastic implants, or periodic injections to reduce inflammation and pain and improve joint flexibility.

When MassDevice first speaks with Ryan, in March, she's unsure which offers the best chance of regaining mobility.

"I’m not sure which treatment I’ll choose,” Ryan says. "The device or the drugs."

President Barack Obama wants to help her decide.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Banned in Boston

April 6, 2009 by Chris Markuns

Massachusetts enacted the nation's strictest law governing industry payments to physicians. What does the so-called "gift ban" mean for the Commonwealth's medical devices sector?

Say goodbye to the promotional pen

Pharma is sexy. Big drugs, big money, big news. In the life sciences arena, perhaps only biotech commands a higher political and public profile.

So it isn’t surprising that the medical device industry’s groundbreaking inclusion in Massachusetts’ new code of conduct garnered relatively little attention.

But the new rules governing industry payments to physicians — the so-called "gift ban" — include provisions aimed at curbing what some call undue and improper influence by medical device manufacturers.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Medical devices: A safe harbor in the economic tsunami?

March 30, 2009 by Davin Wilfrid

Despite the worldwide recession, there's hope for the medical device manufacturing sector.

The conventional wisdom that healthcare companies are immune to economic turmoil has gone the way of subprime derivatives and credit default swaps, as reduced consumer spending and tight credit markets have squeezed even the most “recession-proof” industries.

But there are signs of hope for medical device and diagnostics companies, as nervous investors seek quicker returns than pharma or other life science firms can offer.

Experts say the local job market for medical device professionals remains comparatively strong, despite the downturn, and the New England device industry remains an attractive target for government grants and other efforts to stimulate innovative sectors of the economy.

The big picture

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Thinking small to solve big problems

March 30, 2009 by Joe Nowlan

The Institute for Pediatric Innovation is on a mission to develop medical devices and drugs for children.

Dr. Timothy Tracy of Hasbro Children's Hospital. Photo by Jane Fox.

When it comes to little children, medical devices can be a very big problem.

Take Dr. Thomas Tracy, a professor of surgery and pediatrics at Brown University. Virtually every day, Tracy deals with the fallout from the lack of child-sized medical devices.

“It just impacts your life every day, when you turn around and there’s yet another [device] you can’t apply to a kid,” says Tracy, professor of surgery and pediatrics at Brown University and pediatric surgery chief at Hasbro Children’s Hospital in Providence, R.I.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Smart Surfaces aims to put bedsores to rest

March 30, 2009 by Alan Siegel

The (literally) visionary "rolling diaphragms" in the Billerica, Mass., startup's mattress are designed to eliminate pressure ulcers.

Smart Surfaces founder Tim Moutafis. Photo by Kat Duncan.

Tim Moutafis has visions.

Sitting in his racing green Triumph TR7 convertible one summer afternoon in August 1993, the Smart Surfaces Inc. founder envisioned miniature robots roaming around the human body, fixing problems. A decade later, daydreaming at work, he saw a living, breathing blob.

“A blob that knows your body very well and listens to it,” Moutafis explains from his office at Science Research Laboratory in Somerville, Mass.

“It sends information, it sort of heals you, protects you, rejuvenates you.”

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Organic growth

March 30, 2009 by Brandie Jefferson

Canton’s Organogenesis hopes to stake its turf as the worldwide leader in tissue regeneration.

A worker readies an Apligraf sample. Photo by Connor Gleason.

It turns out the secrets of science aren't always on the tip of your nose.

At Organogenesis, a Canton-based tissue regeneration firm, the company’s signature product, Apligraf, is derived from the cells of foreskins donated by the mothers of newborn baby boys. A single donor can eventually generate up to two football fields’ worth of Apligraf, according to Dario Eklund, the company’s VP of bioengineering and bioaesthetics.

That’s because the newborn donors’ cells are "so young, so robust, so full of life, that they can divide and build cell banks," Eklund explains.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Susan Windham-Bannister, Part I

March 30, 2009 by Brian Johnson

The head of the Bay State's Life Sciences Center explains the difference between $1 billion and $33 million.

Susan Windham-Bannister. Photo by Kimberly Moa.

The Massachusetts Life Sciences Center cuts a high profile these days. Created by the state Legislature in June 2006 to foster research and economic development in the Commonwealth’s substantial life science sector, the center has money to burn, thanks to the Life Sciences Act the Bay State passed last year.

Led Susan Windham-Bannister, a former healthcare policy wonk turned business strategy consultant turned state life sciences czar, the quasi-public agency is charged with dispensing a mix of public and private funding to cultivate the state’s medical device, biotech and pharmaceutical sectors.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Running in place

March 30, 2009 by Brian Johnson

Cambridge's InVivo Therapeutics is charging toward a cure for paralysis. Will investors come along for the ride?

Cambridge's InVivo Therapeutics is charging toward a cure for paralysis

CORRECTION

Inc. magazine ran the following correction Dec. 1:

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

MassDevice Q&A: Susan Windham-Bannister, Part II

March 2, 2009 by Brian Johnson

The second installment of a long conversation with Susan Windham-Bannister, head of the Massachusetts Life Sciences Center.

Susan Windham-Bannister. Photo by Kimberly Moa.

The Massachusetts Life Sciences Center cuts a high profile these days. Created by the state Legislature in June 2006 to foster research and economic development in the Commonwealth’s substantial life science sector, the center has money to burn, thanks to the Life Sciences Act the Bay State passed last year.

Led by Susan Windham-Bannister, a former healthcare policy wonk turned business strategy consultant turned state life sciences czar, the quasi-public agency is charged with dispensing a mix of public and private funding to cultivate the state’s medical device, biotech and pharmaceutical sectors.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Syndicate content
Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp