Velentium, an engineering firm that designs and manufactures therapeutic and diagnostic active medical devices, has announced that director of human factors Albert Rodriguez and director of product security Christopher Gates will each host presentations at MD&M Minneapolis held at the Minneapolis Convention Center on 2-3 November 2022.
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Minneapolis
User-Centered Design for MedTech Devices: Lessons Learned in Human Factors
Rodriguez said: “I am honoured to be welcomed as a speaker at MD&M Minneapolis. The conference brings together medical manufacturers, industry experts, thought leaders, and academics to solve challenges in medical technology. One of those challenges is our approach to user-centred design (UCD). While UCD may not always be as intuitive or universal as the design team may have 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 achieving user-centred design (UCD) in practice is rarely as straightforward as it seems. In his talk, Rodriguez will provide an overview of UCD principles; explain how, when, and why to introduce those principles into existing design processes; and show how and how not to translate outcomes from UCD activities into product requirements and features.
Aligning FDA Expectations and EU's MDR Regulations for Cybersecurity
Gates said: “It is satisfying to speak at another MD&M conference on medtech security. As cybersecurity requirements in premarket submissions change, it is important to know the deliverables and processes necessary to create secure medical device systems efficiently and cost-effectively.”
In Gates’ presentation on day two, he will discuss the new medical device cybersecurity laws and regulatory requirements and review the new manufacturer's activities expected by the FDA, including the expected 41 cybersecurity deliverables. Gates will focus on how to add cybersecurity processes to the development lifecycle that will satisfy the FDA and secure a medical device system without generating massive cost burdens or development delays.
Velentium’s presence at the event will be multi-faceted, with presentations and representation at a booth on the floor where attendees can learn more about the business, its capabilities, partnerships, and previous projects.
