Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Contract Manufacturing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • Suppliers
    • The Big 100
      • Archive – The Big 100 (2018)
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • Leadership
    • Women in Medtech
    • 2020 Winners
    • 2019 Winners

Biomaterials: Is there a better way for FDA to regulate them?

December 5, 2017 By Chris Newmarker

innovation materials biomaterials FDA

[Image from Unsplash]

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials?

Mike Drues thinks the answer is “yes.”

“It really will encourage companies to use new materials and not be hamstrung with materials that have been … used for decades or in some cases even a century,” said Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA.

Drues, who is president of Vascular Sciences, also says the new approval pathway needs to be specific enough to prevent potentially costly and even life-threatening mistakes.

In MDO’s latest podcast, Drues discusses how the medical device industry might go about proposing a new FDA approval pathway that prequalifies innovative materials.

You may also like:

  • Capitol Hill Congress medical device innovation tax reform
    Did Congress just kill medical device innovation?
  • medical device labeling intended use
    Medical device labeling: You need to design it, too
  • army real world
    Real-world evidence for medtech: what you need to know

Related Articles Read More >

Q-Collar
FDA authorizes Q-Collar to help protect athletes’ brains
UK passes post-Brexit medical device regulation
Boston Scientific has another serious recall on the same heart device
Fifth round of medtech user fee talks set to begin soon

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.

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Tweets by MedTechDaily

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Medical Tubing + Extrusion
  • MedTech 100
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertising
  • Subscribe to Enewsletter
  • Subscribe to Print Magazine
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our Device Talks Tuesdays Discussion

Copyright © 2021 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Contract Manufacturing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • Suppliers
    • The Big 100
      • Archive – The Big 100 (2018)
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • Leadership
    • Women in Medtech
    • 2020 Winners
    • 2019 Winners