# 156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-10-02
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/156---Combination-Product-Governance--Big-Pharma-to-Medical-Device-Startups--Risk-Management--Scale-Up-Challenges--Drug-Delivery-Innovations--and-Home-Administration-with-Laxman-Halleppanavar-e2p4887

## Summary

Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, discusses the complexities of combination products, contrasting his experience at large corporations like Pfizer and GE Healthcare with his current work in medical device startups. He highlights key industry trends including the shift toward home administration of drugs, sustainability goals, and the engineering challenges posed by high-viscosity, long-acting drugs and large injection volumes. Halleppanavar also explains the significant differences in risk management and regulatory scrutiny between medical devices and pharmaceuticals, noting the increased complexity when drugs are involved in combination products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma#t=0) Introduction: Subi Seday and Laxman Halleppanavar
- [0:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma#t=56) Medical Device vs. Pharmaceutical Governance and Risk
- [8:12](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma#t=492) Transitioning from Big Pharma to Startup Funding Realities
- [14:49](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma#t=889) Trends in Injection Delivery: Home Administration and Sustainability
- [28:13](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-02-156-combination-product-governance-big-pharma-to-medical-device-startups-risk-ma#t=1693) Scaling Up Challenges and CDMO Relationships

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Sustainability & circular products](https://hardwarepodcasts.com/topic/sustainability-and-circularity)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

large enterprises, early-stage companies

## Mentioned

- Credence MedSystems (company)
- Pfizer (company)
- GE Healthcare (company)
- Hospira (company)
- BMW (other)
- iPhone (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)
- [#385: The Trouble with Home-Use Devices, Pt. 1](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-04-385-the-trouble-with-home-use-devices-pt-1) (Global Medical Device Podcast)
- [S4E49 Derek McKenney | Medical Device Engineering Leadership](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-12-22-s4e49-derek-mckenney-medical-device-engineering-leadership) (Being an Engineer)

## Citing this page

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