MD+DI Managing Editor’s Must-Attend List for BIOMEDevice

As the final touches are being made in preparation for BIOMEDevice in Boston, MA, this MD+DI editor is excited to highlight some of the sessions she is sure to attend onsite.

As the managing editor for MD+DI with an avid interest in the supplier and manufacturing side of medtech, femtech, innovation, and the importance of regulatory compliance, here are just a few of the sessions I’m planning to attend during the Sept. 20–21 conference.

Chemical Characterization of Medical Devices: An Overview

Taking place in the Tech Theater on Wednesday Sept. 20 from 12:30pm to 1:15pm EST, Stephen Doherty, head of analytical chemistry at Lapcorp, will dissect the importance of chemical characterization as a component in the safety evaluation of medical devices. Additionally, he will discuss how the characterization shouldn’t be siloed, but instead used in conjunction with the Toxicological Risk Assessment to provide needed context to the chemical results.

Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17

Presented by Russell Sloboda, principal toxicologist at Nelson Laboratories, this session will take place in the Tech Theater on Wednesday Sept. 20 from 1:30pm to 2:15pm EST. The presentation will provide an overview and deep dive into some of the key changes happening with the release of the revised international standard for toxicological risk assessment of medical devices, ISO 10993-17.

Usability Success Factors: 4 Keys to Successful Human Factors Validation

Speaker Denise Forkey, director of human factors and a human factors specialist at UserWise, will highlight key ways to integrate human factors engineering into product development to understand intended use and usability of a product that will ultimately translate into regulatory and commercial success. The session will be held in Conference Room 52B on Thursday Sept. 21 at 10am to 10:45am EST.

Design and Manufacturing of Medical Devices Requiring Micro Motion Systems

Taking place in the Tech Theater on Thursday Sept. 21 at 10:30am to 11:15am EST, John Chandler, control systems director at Faulhaber, will discuss common performance metrics, specialized design tools, analysis techniques, and integration practices when using micro motion systems in medtech manufacturing.

Everything Your Need to Know About QMS Right Sizing and Regulatory Compliance

Mark Cox, president and founder at AlvaMed will run his audience through how to right-size your Quality Management System (QMS) to be compliant without overly burdening your organizational resources. The discussion will share the “good, bad, and ugly of what, why, when, and how to implement your QMS.” The presentation will be held in Conference Room 52A on Thursday Sept. 21 from 11am to 11:45am EST.

From Concept to Contracept: A Case Study In the Medical Device Development of a FemTech Combination Product

Taking place in the Tech Theater on Thursday Sept. 21 at 12:30pm to 1:15pm EST, Jaimee Robertson, director of consulting services at Cambridge Polymer Group, will dive into a case study on the development of a polymeric drug-release contraceptive device, absorbing valuable insight into overcoming challenges when bringing such a product to market.

Biggest Challenges Faced by the Manufacturers in EU as MDR Becomes in Full Force

Antal Solyom, director of the medical device unit at HungeroTrial CRO, will present bottlenecks and challenges to be aware of in order for manufactures to be able to save time and money when obtaining a CE mark as MDR is implemented in full force. The session will he held at the Center Stage on Thursday Sept. 21 at 3:15pm to 4pm EST.