• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Report: More than 75% of med-tech companies go overseas first

Report: More than 75% of med-tech companies go overseas first

October 6, 2011 By MassDevice staff

FDA

High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.

Of 350 medical device company employees reviewed, 22 percent said high costs of FDA review sent them overseas and 14 percent blamed a lengthy and complicated U.S. review process, according to a report by researchers at Northwestern University.

Nearly all of the remaining 63 percent of respondents cited unpredictability as the main reason for going abroad before applying for FDA clearance, the researchers reported.

The study, which was paid for by the Institute for Health Technology Studies, drew responses from employees of small, medium and large med-tech companies recently involved in 510(k) submissions. The institute is a non-profit funded by the medical device industry.

The findings and analysis were sent to the FDA as a counter to the Institute of Medicine’s controversial report, released this summer. The IOM recommended that the federal watchdog agency scrap the 510(k) program altogether and start from scratch with an "integrated pre-market and post-market regulatory framework."

The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, wasn’t binding on the agency but caused a stir in med-tech circles and draw the attention of members of Congress.

The report was met with support from the the New England Journal of Medicine, which wrote that the 510(k) process was outdated.

"As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness," wrote NEJM executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. "The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated."

The IOM recommendations also drew the ire of med-tech industry representatives, who viewed the report as a non-started.

"Industry indicated that the IOM’s recommendations were so far outside the scope that the report does not provide meaningful answers to the questions FDA asked," industry reps told the FDA during negotiations over re-authorizing the Medical Device User Fee & Modernization Act. "Industry also expressed concern with the IOM’s statement that the 510(k) program is not designed to address safety and effectiveness, and encouraged FDA to rebut this contention."

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms, Institute of Medicine

In case you missed it

  • FDA advisory panel endorses J&J’s single-dose COVID-19 vaccine
  • DTW Podcast: Geoff Martha updates Medtronic’s new course; AJAX CEO Duke Rohlen is funding innovation differently
  • ReWalk Robotics closes $40M private placement
  • Fusion Robotics wins FDA clearance for 3D imaging robotic targeting system
  • FDA authorizes Q-Collar to help protect athletes’ brains
  • The top 7 medtech CEO quotes on COVID-19, one year later
  • Forest Devices touts study of stroke detection tech
  • iRhythm’s revenue jumps 33% in Q4
  • Thermo Fisher completes Mesa Biotech acquisition
  • ICU Medical dips despite Street-beating Q4
  • Silk Road Medical touts results of large TCAR study
  • Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
  • 8 drug delivery innovations you need to know
  • Terumo to acquire Health Outcomes Sciences
  • Axonics acquires Contura and its Bulkamid bulking agent for $235M
  • NuVasive reports mixed Q4 results
  • Is J&J’s COVID-19 vaccine linked to tinnitus?

RSS From Medical Design & Outsourcing

  • FDA authorizes Q-Collar to help protect athletes’ brains
    The FDA announced today that it authorized the Q-Collar made by Q30 Sports Science for protecting the brain during sports activities. Q30 Sports Science’s Q-Collar is a C-shaped collar worn around the neck designed to apply compressive force to the neck and increase blood volume to help reduce movement of the brain within the cranial… […]
  • The top 7 medtech CEO quotes on COVID-19, one year later
    The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world… […]
  • Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
    The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Pfizer asked… […]
  • 8 drug delivery innovations you need to know
    The drug delivery space has seen plenty of innovation over the years, and there are no signs of that slowing down any time soon. Improvements upon established technologies like insulin delivery devices and inhalers have been presented by some, while others have unlocked new ways of delivering drugs through a variety of means. Among the… […]
  • Hoffer Plastics gains MedAccred certification again
    Injection molding company Hoffer Plastics (South Elgin, Ill.) announced that it has received the MedAccred re-certification from not-for-profit medtech audit provider MedAccred. MedAccred is a supply-chain oversight program of the Performance Review Institute. It conducts critical-process audits for its member OEMs to ensure their suppliers adhere to global regulations and requirements, and helps reduce the number… […]
  • UK passes post-Brexit medical device regulation
    The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by… […]
  • Integrated Polymer Solutions acquires IRP Group
    Integrated Polymer Solutions (“IPS”), a portfolio company of Arcline Investment Management, announced this week that it has acquired IRP Group. IRP designs and manufacturers elastomeric sealing components from its facilities in Southern California. Founded in 1999, the company is focused on the Class I and II medical device market as well as the aerospace &… […]
  • Interpower debuts plugs in new colors
    Interpower announced that its NEMA 5-20 hospital-grade plugs for use in North America now come in molded colors of clear, black or gray on 10-foot lengths of flexible cord. These molded plugs complement the company’s NEMA 5-20 hand-wired hospital-grade plugs. The North American 18A hospital-grade power cord on 14 AWG SJT cable and North American… […]
  • Portescap motors gain certification
    Portescap announced that its slotless brushless DC motors for respirators have received ISO 13485:2016 certification. Expanding on ISO 9001, this standard contains specific requirements for parts traceability and risk management activities throughout the design and development stages. It also requires process and software validations at defined intervals. Independent risk management and quality compliance firm DNV… […]
  • Instron launches update to product testing system
    Materials testing equipment and software developer Instron announced the launch of the Torsion Add-On 3.0 for universal testing systems. Recently redesigned to take advantage of the latest functionality offered by the new Instron 6800 series, this system offers a simpler, safer, and more intuitive user experience, according to Norwood, Mass.-based Instron. Instron introduced the Torsion… […]
  • Abiomed CEO Michael Minogue appointed as AdvaMed chairperson
    Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately. Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the board… […]

Leave a Reply Cancel reply

You must be logged in to post a comment.

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS