# Overcoming Submission Deficiencies due to Biocompatibility

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-09-01
- Length: 29m
- Episode: 278
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility
- Listen: https://podcast.greenlight.guru/episode/overcoming-submission-deficiencies-due-to-biocompatibility

## Summary

Chris Parker, Associate Department Head of In-Vivo Biocompatibility at LabCorp (formerly Toxikon), explains how medical device manufacturers can avoid and resolve FDA submission deficiencies related to biocompatibility. He details the two primary paths for addressing deficiencies—risk assessment/memo or retesting—and emphasizes the importance of proactive engagement with regulatory bodies and toxicologists during the early prototyping phase. The discussion covers material screening for Prop 65 and European CMR regulations, the challenges of testing small-surface-area devices like stents, and the financial impact of remedial work on company timelines.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=0) Introduction and LabCorp's Biocompatibility Services
- [5:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=321) Understanding FDA Deficiencies and Response Options
- [8:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=504) Proactive Strategies: Upfront Dialogue and Material Screening
- [11:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=665) Navigating Standards: Passivation, Fabrics, and Chemical Characterization
- [13:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=811) Competitive Intelligence and Early Consultant Engagement
- [16:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=1014) Prop 65, CMRs, and Global Regulatory Alignment
- [21:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=1298) Testing Burdens: Surface Area and Device Size Challenges
- [25:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=1523) The Financial Cost of Deficiencies and Remedial Work
- [27:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility#t=1645) Advice on Selecting Experts and Partners

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- LabCorp (company)
- Toxikon (company)
- FDA (other)
- ISO 10993 (other)
- Prop 65 (other)
- MD&M West (other)
- Green Light Guru (company)

## Related episodes from other shows

- [232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-01-232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibili) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)
- [Elad Einav | How To Engineer Covered Medical Device Stents](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-10-09-elad-einav-how-to-engineer-covered-medical-device-stents) (Being an Engineer)
- [093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti) (Let's Combinate)
- [035 - “Safety is Safety” with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-01-overcoming-submission-deficiencies-due-to-biocompatibility. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.