# #448: MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-02-23
- Length: 1h 00m
- Episode: 448
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care
- Listen: https://podcast.greenlight.guru/episode/medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care

## Summary

Ivanny Franklin, Managing Partner at MedSight Capital, discusses her investment thesis for revenue-generating medical device companies, emphasizing the necessity of clear regulatory pathways (510(k) vs. PMA) and clinical evidence. She highlights the shift toward at-home monitoring and OTC diagnostics, noting the tension between patient empowerment and physician adoption, while explaining how Special Purpose Vehicles (SPVs) allow family offices to invest nimbly in specific deals. Franklin also addresses the high failure rates in AI-integrated devices due to evolving regulations, advising founders to prioritize safety, efficacy, and honest communication regarding reimbursement codes to avoid immediate disqualification from funding.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=0) Introduction: Ivanny Franklin and MedSight Capital
- [2:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=148) Global Regulatory Strategy: NMPA, FDA, and Clinical Evidence
- [8:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=531) The At-Home Monitoring Shift and Patient Data
- [18:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=1084) Investment Non-Negotiables: Revenue and Regulatory Clarity
- [22:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=1371) Diligence, Deception, and Reimbursement Codes
- [27:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=1638) SPV vs. Hedge Fund Models in MedTech
- [38:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=2333) Diagnostics Trends: OTC, STIs, and Multiplex Testing
- [46:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care#t=2784) AI in Medical Devices: Regulatory Risks and Investment Pass

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Crowdfunding & preorders](https://hardwarepodcasts.com/topic/crowdfunding)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- MedSight Capital (company)
- NAMSA (company)
- NMPA (other)
- FDA (other)
- CFDA (other)
- MDR (other)
- IVDR (other)
- PMA (other)
- 510(k) (other)
- CMS (other)
- LSI (other)

## Related episodes from other shows

- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [S5E8 Aaron Call | How to Find Money for MedTech Startups](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-23-s5e8-aaron-call-how-to-find-money-for-medtech-startups) (Being an Engineer)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [S5E7 Matt Zachek | Medical Device Engineering Leaders 7](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-16-s5e7-matt-zachek-medical-device-engineering-leaders-7) (Being an Engineer)
- [Medical Kits, They're The Future](https://hardwarepodcasts.com/podcast/the-amp-hour/2020-03-30-medical-kits-theyre-the-future) (The Amp Hour)

## 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/2026-02-23-448-medtech-investment-outcomes-regulations-and-the-shift-to-at-home-care. 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.