# 261 - Getting Pharma/Device Products Into Clinical Trials: INDs, IDEs & FDA Meetings

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-11-02
- Length: 37m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/261---Getting-PharmaDevice-Products-Into-Clinical-Trials-INDs--IDEs--FDA-Meetings-e3rigm8

## Summary

Dr. Robert Bilkovski, a fractional chief medical officer and author of 'Make Your Story Believable,' explains the clinical development strategy for drug-device combination products, focusing on getting INDs and IDEs approved for first-in-human studies. He details the process of bridging known drugs to new delivery devices, such as autoinjectors, and the critical role of pre-IND and Q-Submissions in aligning with the FDA on study design, endpoints, and manufacturing quality. Bilkovski emphasizes the importance of site selection, IRB approval, and sponsor oversight, noting that early feasibility studies in regions like Latin America can de-risk both development and investment before US trials.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=0) Introduction: Dr. Robert Bilkovski and his background
- [3:48](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=228) The role of the fractional Chief Medical Officer in startups
- [7:55](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=475) Clinical strategy for bridging known drugs to new devices
- [13:48](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=828) Obtaining IND/IDE clearance and IRB approval
- [18:48](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=1128) Site qualification, activation, and sponsor oversight
- [23:43](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=1423) Global site selection: Europe, Australia, and Latin America
- [28:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=1680) Pre-IND and Q-Submissions: Preparing the data package
- [31:51](https://hardwarepodcasts.com/podcast/lets-combinate/2026-11-02-261-getting-pharma-device-products-into-clinical-trials-inds-ides-fda-meetings#t=1911) Strategy for FDA meetings: Targeted questions and precedent

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Hospira (company)
- GE Healthcare (company)
- Abbott Molecular (company)
- Flu Guide (company)
- Make Your Story Believable (product)

## Related episodes from other shows

- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [#338: Site Selection for Clinical Trials](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-06-338-site-selection-for-clinical-trials) (Global Medical Device Podcast)
- [Understanding the Investigational Device Exemption (IDE) Process](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-12-19-396-mastering-device-descriptions-the-cornerstone-of-medical-device-submissions) (Global Medical Device Podcast)

## Citing this page

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