Overcome the latest medical device design challenges


Technology is fundamental to the existence of modern society. It helps people interact and collaborate, creates efficiencies, and helps solve complex problems, a statement that rings especially true in healthcare. Recent advances in medical technology have improved the functionality of devices and made healthcare more widely accessible to the general population through the maturation of non-invasive techniques and home monitoring devices while fueling more stringent and standardized regulations. , thereby improving patient care outcomes.

This rapidly changing landscape has caught the attention of the FDA, for example, which recently released draft content guidance for pre-market submissions for device software functions – encompassing software in a medical device. (SiMD) and software as a medical device (SaMD) – in the hope the new document will promote the safe and efficient development of medical devices using software functions.

But before the final product is produced, design engineers must consider many challenges in order to manufacture a high-performance, reliable medical device that incorporates all of this new applied technology, including new iterations of the highly regulated landscape.

Eric Steuben, SVP of Operations at Calyxo, will take on these challenges and more at the upcoming BIOMEDevice Silicon Valley Smart Event. The must-see regional event, held in person December 8-9 at the San Jose McEnery Convention Center, aims to advance the development of digital health and personal diagnostics and hosts educational content from the most prominent players in industry influencing the future of medical technology and devices. design.

With the event on the horizon, I enjoyed sitting down with Eric, where we explored his next session, “Panel: Essentials for Design Strategy – Be an Effective Front-End Collaborator” and what attendees can do. expect to learn.

Nice to talk to you Eric. You are speaking at BIOMEDevice Silicon Valley as part of a panel dealing with the essentials of the medical device design strategy. What can participants expect to learn?

Steuben: We have a fantastic panel with extensive experience in in-house and contracted medical device design and development. Participants will learn about the challenges faced by development teams, how to overcome them, and tips for successfully moving from concept to design and manufacture.

You bring over 30 years of experience to the round table. What changes have you observed over the years in the design of medical devices?

Steuben: Technology has led to revolutionary innovations. Some notable advancements that come to mind are 3D scanning (transition from physical to digital world), 3D processing planning, big data, artificial intelligence (all in the digital world) and 3D printing (shifting from the digital world to the physical world). Obviously, robotics played a notable role in improving treatment outcomes; we can treat patients less invasively, more safely, with much better outcomes, while lowering healthcare costs for the entire system. I am so proud to be part of this vibrant community. It gives me a bounce in my process to know that I am part of a movement that is making such a positive difference in people’s lives.

Where do you see the most opportunities?

Steuben: I see a tremendous opportunity to equip surgeons to achieve superior results with better tools, through technologies such as robotics, AI, imaging, better usability, treatment planning based on past cases and the automation of repetitive tasks. In general, anything we can do to focus more on harnessing the knowledge and expertise of surgeons and enabling medical devices to perform better in a more intuitive and effortless way. Ultimately, it’s about better patient outcomes, less invasive treatments, faster surgeries, and lower costs. We can do all of these things in tandem through technology and innovation.

What excites you the most about engaging in person with your community in December at BIOMEDevice?

Steuben: Online meeting platforms have been an incredible tool for communicating during the pandemic, but there is no substitute for in-person collaboration. The impromptu meetings, networking, and connections from an in-person event like BIOMEDevice are invaluable. I like seeing trusted colleagues and meeting new ones. Come join me at the show and say hello please!

To attend the session, purchase an Expo or Conference pass for BIOMEDevice Silicon Valley here. For those who cannot participate in person, in addition to the in-person experience, educational sessions will be accessible through an online platform four weeks before and after the event.


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