Consulting | MassDevice

Medical Device Technology Consultants Ltd

Vicarage Farm, Upthorpe Road

Bury St Edmunds, Suffolk

Suffolk

––

IP31 2AP, UK

United Kingdom

+44 (0)1359 250859

www.mdtconsultants.co.uk

Product(s):

Full-service contract research organization and consulting firm that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics and combination products

Emergo Group, Inc.

Overview:

Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Mexico, Europe, Russia, China, Japan, Brazil and Australia. We have grown to become one of the leading medical device regulatory consultants with expertise in CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, China SFDA registration, Japanese device approval, in-country representation and many other areas.

1705 S. Capital of Texas Hwy, Suite 500

Austin

TX

78746

United States

1.512.327.9997

1.512.327.9998 (FAX)

www.emergogroup.com

Product(s):

Regulatory charts and consulting

Management:

Chris Schorre

Bridgehead Solutions eyes Ohio

January 26, 2010 by MedCity News

Consulting company that helps foreign medical device firms establish beachheads in the U.S. is considering the Buckeye State.

By Brandon Glenn

DUBLIN, Ohio — Startup Bridgehead Solutions LLC, which aims to help foreign device firms enter the U.S. market, could be headed to Ohio, but it’s going to take $2 million to $3 million to ensure the company finds its way to the Buckeye state.

Login or register to post comments
Read more

Q2 less than perfect for Parexel

January 26, 2010 by MassDevice staff

Parexel International Corp. reports a $3.5 million second-quarter profit, down nearly a third as restructuring costs trim $14.3 million from the bottom line.

Restructuring costs cut deeply into second-quarter profits at Parexel International Corp. (NSDQ:PRXL) during the three months ended Dec. 31, with severance and related expenses costing the clinical research organization $14.3 million during the quarter.

The Waltham, Mass.-based clinical research organization recorded net income of $3.5 million, or 6 cents per share, on $284.7 million in revenues during its fiscal second period. That compares with a $5.2 million profit, or 9 cents per share, and $275.8 million in revenues during the year-ago quarter. In addition to severance payments, the bottom line was affected negatively by a client default, lease penalties associated with facility closings and a $6.1 investment impairment charge.

Login or register to post comments
Read more

Parexel International boosts Q2 earnings forecast

January 11, 2010 by MassDevice staff

Reversing previous predictions, contract researcher organization Parexel International Corp. expects improved earnings for the second quarter ended last month and for calendar year 2010.

Contract research lab Parexel International Corp. (NASQ:PRXL) boosted its forecast for the three months ended Dec. 31, 2009, and for calendar 2010, reversing downbeat predictions made in October.

The Boston-based contract research organization is now saying it expects to report net earnings of between $3.5 million and $4.6 million on revenues of up to $285 million during the second quarter. It also issued its initial forecast for calendar 2010, predicting profits of between $35 million and about $40.5 million on between $1.115 billion and $1.145 billion in revenues for the 12-month period.

Login or register to post comments
Read more

Clearing a path to reimbursement

January 8, 2010 by Edward Berger

"Do you have a reimbursement code?" is wrong question when it comes to ensuring reimbursement for a new medical technology. Here's what you need to know to clear a path to reimbursement for an innovative device.

When pitching to potential life sciences technology investors, entrepreneurs know that they need to demonstrate a clear path to reimbursement. Angels, VCs and strategic partners don't want to commit resources to develop something that won't get adequately paid for in a reasonable timeframe. That makes perfectly good sense. Indeed, I'd argue that the need to assess a technology's likely reimbursement status begins even earlier than the investment pitch.

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?"