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
    UV damage to eyes
    Warning Signs of Long-Term UV Damage to Your Eyes
    December 9, 2021
    degree for healthcare job
    The Ultimate Healthcare Recruiting and Staffing Guidebook
    March 21, 2022
    medicare part d benefits
    Everything that You Need to Know About Medicare Part D
    August 15, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 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
    falsified drugs
    What Are the Health Risks of Falsified Drugs?
    July 15, 2024
    doctor patient communication software
    Patient Communication Software Is Vital in Healthcare
    June 18, 2024
    Medicare Underpays Physicians Locally
    August 25, 2017
    Latest News
    Strengthening Healthcare Systems Through Clinical and Administrative Career Development
    June 13, 2025
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Is Europe A Better Place To Build A Medical Technology Company?
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 > Business > Is Europe A Better Place To Build A Medical Technology Company?
Business

Is Europe A Better Place To Build A Medical Technology Company?

HerinaAyot
Last updated: September 11, 2017 8:38 pm
HerinaAyot
Share
6 Min Read
SHARE

Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies. Companies have seen a vast difference in the approval processes in Europe vs. the U.S. A study released by Stanford indicated that the cost of bringing a technology to market is dramatically lower in Europe. Workshops and Panel discussions at OneMedForum NY 2011 are on track to discuss the increasing difficulty in approving both devices and drugs in the U.S. Getting approval on a timely basis can be the difference between success and failure. The discussions will look at winning strategies. A previous panel discussion at OneMedForum San Francisco discussed the controversy surrounding FDA approval in the U.S. A study funded by InHealth allowed both industry players and government regulators an in depth look at the challenges and facts about the 510k process. Additionally, Advanced Medical Technology Association (AdvaMed) recently released a report, “FDA Impact on U.S. Medical Technology Innovation,” which garnered responses from more than 200 companies concerning their experiences in working with the FDA. Participants were also asked about their experiences working with European regulatory authorities in order to offer a comparison between aspects of the two dominant regulatory systems. “In general, survey respondents viewed current U.S. regulatory processes for making products available to patients as unpredictable and characterized by disruptions and delays,” the results summary states. “Forty-four percent indicated that part way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation. Thirty-four percent of respondents also reported that appropriate FDA staff and/or physician advisors to the FDA were not present at key meetings between the FDA and the company.” The report goes on to highlight that those factors contribute to significant delays in navigating FDA regulatory processes, with premarket process for 510(k) pathway devices (of low-to moderate risk) taking an average of 10 months from first filing to clearance. Devices requiring a clinical study for low- to moderate-risk devices before making a regulatory submission, the premarket process took an average of 31 months from first communication to being cleared to market while, in comparison, it took an average of seven months in Europe. For higher risk devices seeking premarket approvals, responding companies indicated that it took an average of 54 months to work with the FDA from first communication to being approved to market the device. In Europe, it took an average of 11 months.” Beyond the time gap comparing FDA and Europe approval processes, the survey also showed that the average total cost for a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities. For a higher-risk PMA product, the average total cost from concept to approval was approximately $94 million, with $75 million spent on stages linked to the FDA. According to the report, these statistics result in a “significant, measurable cost to U.S. patients in the form of a device lag. Respondents reported that their devices were available to U.S. citizens, on average, nearly two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country.” Stephen J. Ubl, president and CEO of AdvaMed, says, “This report is a wake-up call for those who want to promote medical innovation and preserve American jobs. A regulatory environment that is marked by needless delays and inefficiencies makes it harder for medical innovation to thrive and companies to survive. These delays particularly hurt small companies and their ability to produce next generation technologies. Ultimately, growth within the life sciences will continue at a quick pace during the next few years, with development of R&D pipelines, alliances, and partnerships being a key factor for success. The audience is ripe – as more than 100 million people in the U.S. alone are living with chronic diseases, more than 133 million American adults are either overweight or obese, and life expectancy is climbing to all-time highs – and the medical device companies are addressing these needs. As the economy continues to chug back to full force, the only obstacle appears to be the differing of opinions between the medical device manufacturers and the FDA. Perhaps if they come to a meeting of the minds, these growth projections will not just be projections but will be the reality of a growing field that is quickly, and effectively, delivering what the U.S. healthcare system requires.

TAGGED:health care business
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

beyond nutrition
Beyond Nutrition: Everyday Foods That Support Whole-Body Health
Health Infographics
June 15, 2025
Transcranial Magnetic Stimulation (TMS) Therapy
How TMS Therapy Helps with Treatment-Resistant Mental Illness
Mental Health Therapies
June 13, 2025
Strengthening Healthcare Systems Through Clinical and Administrative Career Development
Global Healthcare Policy & Law
June 11, 2025
magnesium supplements
The Wide-Ranging Benefits of Magnesium Supplements
Health
June 11, 2025

You Might also Like

Global Trend in Bariatric Surgery

December 16, 2011
healthcare money image
Business

“How Much is That?” = Quest for VALUE

December 19, 2012
Image
BusinessMedical RecordsNews

Siemens Moves into Health Information Exchange

February 24, 2012
New York State of health
BusinessHealth ReformPolicy & Law

Surprises in New York A.C.A. Enrollments

January 19, 2014
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?