By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    An Expert’s Guide To Building and Improving Endurance
    June 30, 2022
    medical assistants
    What Do Medical Assistants Do On a Day to Day Basis?
    April 5, 2022
    superfoods to help with prostate health
    10 Healthy Foods That Can Help Protect Your Prostate
    August 29, 2022
    Latest News
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    pfizer and clinical data transparency
    Pfizer to Expand Clinical Trial Data Access, Takes Step Toward Transparency
    December 6, 2013
    Improving Healthcare Services And Management Through Tech Integration
    June 9, 2020
    obamacare and the uninsured
    Why Hospitals Are Still Gouging the Uninsured
    January 7, 2014
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Where is the Device Industry’s Seat at the “Network of Experts” Table?
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > Global Healthcare > Where is the Device Industry’s Seat at the “Network of Experts” Table?
BusinessGlobal HealthcareHealth ReformMedical DevicesMedical InnovationsNewsPolicy & LawTechnology

Where is the Device Industry’s Seat at the “Network of Experts” Table?

Patti Doherty
Patti Doherty
Share
4 Min Read
SHARE

Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process.

Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process. Despite the fact that the FDA has more than 800 scientists, engineers and clinicians, the agency believes that it is impractical to expect CDRH staff to keep current with so many new and complex technologies surfacing.

The network of experts is designed to be a resource for CDRH, particularly to address questions on emerging and unfamiliar technologies. The outside organizations that are being considered by CDRH for inclusion in the network “…will include professional scientific and medical organizations and academic institutions.”  Even though we have not yet heard what organizations the FDA will use in a pilot program to assess their new process, a number of organizations are interested in participating in the program. Industry also would like a seat at the table.

AdvaMed voiced concerns in a written response to the draft policies. The trade organization raised the following issues:

More Read

Medical Debt and FICO store
How Does Medical Debt Affect Your FICO Score?
How to Get Kids to Wear Face Masks
8 Top Healthcare Revenue Cycle Management Partners
How Many Uninsured Will Medicaid Cover After Health Reform?
Cybersecurity Tips for the Health Industry
  • How will confidential information such as intellectual property and trade secrets be kept confidential?   What mechanisms will the FDA deploy to maintain confidentiality?
  • When reaching out to experts in a particular area, it is very likely those individuals have been involved in the development and design of a similar device, especially if the technology is new. This brings up the potential for conflict of interest. AdvaMed makes the point that conflict of interest is a concern in industry as it is in academia and that a process for excluding any potential conflicts should be implemented prior to the exchange of information. The organization also points out that academic institutions are often involved in industry-sponsored programs and may have ties that could create a conflict.
  • The FDA needs to create a balanced and diverse selection of experts to avoid bias.  All stakeholders, including industry, should be allowed to nominate organizations and nominees should include industry scientists. It is preferable that the FDA not select from a pool of experts who are regularly called upon to consult since this may not allow for an objective assessment of a novel device.
  • Efficiency and timeliness: There is skepticism that the FDA could provide a rapid turnaround (i.e., two weeks) when engaging the network of experts on a particular topic.   Large institutions are not known for making decisions in a rapid and efficient manner.

As life science consultants who represent many companies within the device industry, we are closely monitoring the FDA’s draft policies. It will be interesting to see who will be a part of the network of experts and how they will provide their expertise. We wonder, will CDRH be able to comply with its own rule of conduct for transparency while at the same time maintaining confidential and proprietary information at the review level?

Who do you think should be part of the network of experts?  What should the vetting process be? Is there even a need for a network of experts?  Please share your thoughts with us here or email me directly at doherty@popperandco.com.

 

This article originally appeared on the Popper and Co blog.

TAGGED:drug developmentFDANetwork of Experts
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025
Telemedicine Apps
Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
Health
July 20, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
How IT and Marketing Teams Can Collaborate to Protect Patient Trust
Global Healthcare Policy & Law
July 17, 2025
paramedics in surgical gloves and masks
How Health Choices and Legal Actions Intersect After an Injury
Health care
July 16, 2025

You Might also Like

An Archipelago of Health Information Islands

December 28, 2012

Lucky Us! How New Medicines Are Cheating Death

March 20, 2015

Obama Working Behind the Scenes on Latest Pre-ACA Snafu

August 4, 2013
eHealthMedical RecordsTechnology

Three Practical Uses For Wearables In EHR

August 26, 2019
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?