Evidence map›Paper›PMID 35288821›Full record

ReviewJournal of cardiovascular translational research2022

Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.

Aaron E Lottes, Kenneth J Cavanaugh, Yvonne Yu-Feng Chan, Vincent J Devlin, Craig J Goergen, Ronald Jean, Jacqueline C Linnes, Misti Malone, Raquel Peat, David G Reuter and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of cardiovascular translational research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Smart Catheters for Diagnosis, Monitoring, and Therapy.Advanced healthcare materials · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Autonomous Implants.Advanced materials (Deerfield Beach, Fla.) · 2025
    Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Aaron E LottesPurdue University Weldon School of Biomedical Engineering, West Lafayette, IN, USA. lottes@purdue.edu.
Kenneth J CavanaughCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Yvonne Yu-Feng ChanAgile Science Consulting, New York, NY, USA.
Vincent J DevlinCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Craig J GoergenPurdue University Weldon School of Biomedical Engineering, West Lafayette, IN, USA.
Ronald JeanCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jacqueline C LinnesPurdue University Weldon School of Biomedical Engineering, West Lafayette, IN, USA.
Misti MaloneCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Raquel PeatCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
David G ReuterSeattle Children's Hospital, Allegro Pediatrics, Seattle, WA, USA.
Kay TaylorBecton Dickinson & Company, Indianapolis, IN, USA.
George R WodickaPurdue University Weldon School of Biomedical Engineering, West Lafayette, IN, USA.

Funding

Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
NCATS NIH HHS UL1 TR002529
6 · The paper itself

Abstract

Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators. A multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a review of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders. Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices.

Indexed as

CommunicationMedical device regulationRegulatory scienceTranslational science

Identifiers

PMID35288821
PMCPMC8920055

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.