# 063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-12-14
- Length: 48m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/063---Combination-Products-Regulatory--Going-Wide--and-Patient-Impact-with-Niedre-Heckman-e1s3d5e

## Summary

Niedre Heckman, Director of Regulatory Affairs Strategy at Takeda, discusses the complexities of global regulatory strategies for combination products, highlighting the challenge of harmonizing US definitions with international frameworks where devices and drugs are often regulated separately. She explains how these regulatory differences directly impact patient adoption and product design, such as the choice between home self-administration and clinical infusion settings based on psychosocial factors. Heckman also details her career path of 'going wide' across drugs, biologics, and devices, and shares her unique approach to 'reading the room' in corporate settings, influenced by her albinism and public health background.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=0) Introduction: Niedre Heckman and Takeda
- [2:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=120) Reading the Room: Albinism and Communication Style
- [7:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=459) Peer Influence and Teamwork Dynamics
- [18:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=1108) Career Trajectory: From Standalone to Combination Products
- [21:36](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=1296) Global Regulatory Harmonization Challenges
- [26:04](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=1564) Building Wide Expertise in RA, QA, and IVD
- [33:04](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=1984) The Appeal of Regulatory Affairs and Storytelling
- [37:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=2247) Cultural and Psychosocial Factors in Drug Delivery
- [45:58](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he#t=2758) Final Thoughts: Temple Grandin and Future Products

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

large enterprises

## Mentioned

- Takeda (company)
- Baxter International Inc. (company)
- Shire (company)
- Baxalta (company)
- 3M (company)
- GSK (company)
- FDA (other)
- RAPS (other)
- ASQ (other)
- EUMDR (other)
- Temple Grandin (other)
- Thinking in Pictures (product)

## Related episodes from other shows

- [#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)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (Global Medical Device Podcast)
- [How to Construct an Effective Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-14-063-combination-products-regulatory-going-wide-and-patient-impact-with-niedre-he. 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 Let's Combinate.