Following this past April’s Medical Device Technology Exchange (MDTX) 2018 event in New Jersey, MDTX made its way to the West Coast yesterday, showing up in the San Diego area. Day 1 offered several workshops and discussion sessions, as well as the keynote presentation, “Designing for Cradle to Grave—A holistic perspective of a product lifecycle in the design phase,” given by Bill Greenblatt, V.P. of Quest International. The keynote addressed essential elements that biomedical engineers should consider during the design phase of development and how to avoid post-production operations/services pitfalls.
Quest International is a third-party service organization that works directly with original equipment manufacturers (OEMs) to support devices on a global basis. The company also provides necessary IT services. Greenblatt noted that Quest’s services span four different silos: depot repair, field service, supply-chain logistics, and OEM professional services.
Greenblatt spent time talking about factors that have impacted OEMs, such as healthcare consolidation. “Hospitals want to keep equipment longer, and they want more connectivity among their equipment,” he noted. “That has created service challenges for the OEMs, because it leads to hospitals with clinical engineering and biomedical departments wanting to service the equipment themselves. That means the service revenue of the OEMs goes down in many cases.”
Keynote speaker Bill Greenblatt from Quest International talks about how to avoid common design mistakes when creating your medical device.
Another point of interest was FDA recalls, which Greenblatt considers a significant factor. “From 2014 to 2017, there were 161 medical device recalls,” he said. “In 2017 alone, there were 32 recalls, representing over 9 million medical devices. Think about what has to happen—the time, effort, and resources to be able to bring all that equipment back in and get all of that upgraded.
“The question becomes: What are the problems that leads to recalls?” he added. “We’re not sure, but the point is that it’s costing the OEMs a lot of time and money, and it’s a major industry trend.”
Security breaches, or cybersecurity, was another topic discussed. With the large amount of money tied into ransomware, Greenblatt stated that it’s important for engineers to work to counteract these issues.
Moving on, discussions focused in on software and compliance, hardware design, and service support. Greenblatt touched on a number of points that surround these areas.
Several other workshops and sessions took place at MDTX Day 1. Companies represented include Maxon Precision Motors, Rockwell Automation, Protolabs, Onshape, and more. Stay tuned for more coverage from MDTX Day 2.