# #405:  Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-05-05
- Length: 40m
- Episode: 405
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-05-405-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-1
- Listen: https://podcast.greenlight.guru/episode/405-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-1

## Summary

Regulatory strategist Dr. Mike Drues of Vascular Sciences explains the regulatory distinctions between prescription (Rx) and over-the-counter (OTC) medical devices, emphasizing that OTC status depends on intended user, environment, and risk rather than just device class. He highlights label expansion strategies, citing CPAP machines and continuous glucose monitors (CGMs) as examples of devices moving from Rx to OTC, and discusses the critical importance of usability testing that reflects diverse patient populations rather than just healthcare professionals. Dr. Drues also addresses the misconception that home-use devices are automatically safe or OTC, noting that many Rx devices are used at home, and outlines the characteristics required for OTC status, including self-diagnosis, self-selection, and low potential for misuse.

## Outline

1. Introduction: Defining OTC vs. Prescription Devices
2. Market Size and Categories of OTC Devices
3. Label Expansion: Moving from Rx to OTC
4. Intended Use Environment and Parameters
5. Examples of OTC Devices Across FDA Classes
6. Home Use Devices vs. True OTC Status
7. Characteristics Qualifying Devices for OTC Status
8. Usability Testing and the Lowest Common Denominator
9. Starting OTC First vs. Wellness-to-Rx Strategies
10. FDA Perspective on Safety and Misuse

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- CPAP (product)
- continuous glucose monitors (product)
- Dexcom (product)
- Philips (company)
- Levels (company)
- FDA (other)
- CVS (company)
- Walgreens (company)

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- [072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-15-072-oxo-pfs-drug-device-usability-toothbrushes-for-children-epicurious-series-an) (Let's Combinate)
- [043 - “Half Knowledge Can Hurt” with Shadeed Salam](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)
- [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)

## 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/2025-05-05-405-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-1. 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.