Velentium, an engineering firm that develops and manufactures therapeutic and diagnostic active medical devices, announced that Albert Rodriguez, Director of Human Factors, and Christopher Gates, Director of Product Security, will each host presentations at MD&M Minneapolis, March 2-30. to be held at the Minneapolis Convention Center November 3 through November 3, 2022.
User-Centered Design for MedTech Devices: Lessons Learned in Human Factors
Rodriguez said, “I am honored to be welcomed as a speaker at MD&M Minneapolis. The conference brings together medical manufacturers, industry experts, thought leaders and academics to solve medical technology challenges. One of these challenges is our approach to user-centered design (UCD). While UCD isn’t always as intuitive or universal as the design team assumed, there are principles that can reduce support costs, increase market penetration, reduce project delays or regulatory challenges, and even mitigate recalls.”
Rodriguez’s presentation on day one of the conference focuses on how, in practice, achieving user-centric design (UCD) is seldom as easy as it seems. In his presentation, Rodriguez gives an overview of the UCD principles; explain how, when and why these principles should be introduced into existing design processes; and show how and how not results of UCD activities can be translated into product requirements and functions.
Align FDA expectations with EU MDR cybersecurity regulations
Gates said, “It’s gratifying to be speaking about medtech safety at another MD&M conference. As cybersecurity requirements change in pre-market submissions, it is important to understand the deliverables and processes required to efficiently and cost-effectively create secure medical device systems.”
In Gates’ presentation on day two, he will discuss new cybersecurity laws and regulatory requirements for medical devices, and review FDA-anticipated activities from the new manufacturer, including the expected 41 cybersecurity findings. Gates will focus on how to add cybersecurity processes to the development lifecycle that meet FDA requirements and secure a medical device system without incurring massive cost burdens or development delays.
Velentium’s presence at the event will be multi-faceted, with presentations and representation at a stand on the floor where attendees can learn more about the company, its capabilities, partnerships and previous projects.