What’s Happening at MD&M West!

Global Medtech CDMOs: Update on Supply Chain Drivers and M&A Trends
This presentation will provide insights into global medtech contract manufacturing trends and the European supply chain. By comparing European market trends with US opportunities and reviewing M&A activity from 2023, we will shed light on the industry’s global performance. The presentation of the trends will be followed by a fireside chat panel with OEM and CDMO business leaders who will discuss global supply chain trends and address critical industry challenges expected in 2024. The presentation will also mark the release of the 2024 edition of Alira Health’s annual 2024 Global MedTech Contract Manufacturing (CDMO) Report.
Time: 9:45 a.m. -10:30 a.m. 
Location: Room 212AB

Confidence in Validation for CMM Inspection Processes
Validation of inspection processes for medical components is essential for complying with FDA requirements. However, many medical device manufacturers that inspect medical components using CMMs aren't always sure what a comprehensive validation approach for these systems must include to meet FDA regulations. What does the FDA actually require when it comes to the validation of CMMs, metrology software, and inspection processes? How should medical device manufacturers approach validation in a way that is complete, efficient, and effective for their applications? Zeiss Industrial Quality Solutions has established guidelines and validation methods from extensive research to comply with FDA regulations, including 21 CFR Part 11 and 21 CFR Part 820.
Time: 10:30 a.m. -11:15 a.m.
Location: MedTech Theater

Getting the Most Out of Medical Batteries
With the advancements in electronic and manufacturing technologies, medical devices have become smarter, miniaturized, and packed with more functionalities, such as the capability to communicate with smart phones. In addition, in order to have all-around care for the patients, many of these devices are designed to be portable or even wearable on the patients. In order to support these design needs, the energy demand of these devices become increasingly higher. As a result, medical batteries must be smaller and more powerful to catch up with the growth of these devices. In this presentation, the latest developments in the lithium ion rechargeable batteries will be introduced.
Time: 1:15p.m.-1:40 p.m.
Location: Medical Battery Conference – Booth #268

ISO 10993-1 Committee Draft and FDA Guidance Update: Key Biocompatibility Changes and Regulatory Status
Last year, a Committee Draft of ISO 10993-1 was submitted for review by ISO experts, reflecting the latest developments in biocompatibility evaluation. Simultaneously, FDA introduced a new Guidance on Biocompatibility, marking significant strides in this field, particularly in light of next-gen design and emerging technologies. In this presentation, we will delve into the evolving concepts within these documents, with a keen focus on their relevance to next-gen design and emerging technologies, and provide insights into their current regulatory acceptance. Furthermore, we will address the latest comments on the draft and resolutions arising from the ISO committee meeting. Attendees will gain knowledge about:
• What new requirements, especially those pertaining to next-gen design and emerging technologies, are under discussion in the standard and FDA guidance?
• What novel concepts, particularly related to cutting-edge technologies, are currently under consideration?
• How are medical devices designed for skin contact, especially those utilizing emerging technologies, being assessed?
• What lies ahead for both of these critical documents, considering the rapid pace of innovation and technological advancement in the field?"
Time: 1:15p.m. to 2p.m.
Location: Room 202AB

Conformity Assessment Process MDR (EU) 2017/745 including regulatory update / timelines
This presentation is an overview of the activities and process medical devices manufacturers must undergo to sell their products on the European market. Topics covered will include an overview of services offered by TUV USA / TÜV NORD CERT, the basic overview of obtaining certification, the timelines set by the EU Commission in regard to MDR certification, and what obstacles manufacturers must overcome in order to complete certification and put their products on the market. Obstacles will be outlined and include changes to the classification of medical devices, changes to the general safety & performance requirements (GSPR) required under MDR, changes to clinical trials and equivalent devices, and more.
Time: 3:30 p.m. to 4:15 p.m.
Location: MedTech Theater