# 094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-07-19
- Length: 36m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/094---Connected-Combination-Products--Product-Traceability--Regulating-New-Products--Pre-Determined-Changes-and-AIML-with-Rumi-Young-e272bjr

## Summary

Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), discusses the regulatory challenges of smart connected combination products, such as insulin pens and on-body injectors, which integrate sensors, apps, and AI/ML. She explains how unit-level traceability using RFID can optimize manufacturing and clinical trials, while highlighting the current regulatory silos at the FDA that hinder consistent policy for these cross-therapeutic technologies. Young advocates for a single source of truth within the FDA to streamline the use of tools like comparability protocols and predetermined change control for post-market algorithm updates.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=0) Introduction: Subi Sedate and the evolution of combination products
- [3:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=183) Regulator attitude towards AI/ML and new technologies
- [9:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=565) Connected devices: Insulin pens, on-body injectors, and apps
- [12:53](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=773) Unit-level traceability and RFID in manufacturing
- [17:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=1057) Data-driven process validation and clinical trials
- [23:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=1381) RFID vs. UDI and information storage capacity
- [25:44](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=1544) Policy gaps: Siloed FDA review and need for a champion
- [32:08](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products#t=1928) Comparability protocols and predetermined change control

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

large enterprises

## Mentioned

- Becton Dickinson (company)
- FDA (company)
- CDRH (company)
- CDE (company)
- RFID (tool)
- iPhone (product)
- Insulin pens (product)
- On-body injectors (product)
- Autoinjectors (product)
- Infusion pumps (product)
- Syringes (product)
- 510 K (other)
- PMA (other)
- BLA (other)

## Related episodes from other shows

- [CDRH Proposed Guidance for FY 2023](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023) (Global Medical Device Podcast)
- [Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc) (Global Medical Device Podcast)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)
- [#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-18-460-fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead) (Global Medical Device Podcast)
- [#350: The Evolving Landscape of AI in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech) (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/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products. 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.