Can FDA Change Control Plans Speed Up Innovation?
The FDA recently released some new guidelines on Predetermined Change Control Plans (PCCP) for medical device companies. This guidance lets companies make updates without needing a new 510(k) or premarket approval supplement. These changes mostly apply to devices using artificial intelligence or machine learning and consider the device's intended use, technological characteristics, and regulatory history.
VitaTek POV - Jason Scherer, CEO: We've seen for ourselves that making regulatory updates more efficient is great, but having a dedicated in-house regulatory team is even better for getting things done quickly and accurately. The real secret to speed is bringing your team together in one place with clear, shared goals.
Apple’s Entry into MedTech
Apple's AirPods Pro 2 are gearing up to work as legit hearing aids, and the new Apple Watches will soon be able to spot sleep apnea. With features like heart rate monitoring, atrial fibrillation detection, fall detection, and fertility planning, Apple is really making a mark in the MedTech space.
VitaTek POV - Matt Newman, President of Sales: It's no surprise that tech giants like Apple are getting into MedTech. Here at VitaTek, we're keeping up with these advances and getting our engineering and regulatory teams ready to tackle the challenge of integrating cutting-edge tech into our future device designs.
FDA Guidelines for Medical Device Marketing
The government has set up rules to make medical device marketing more transparent. The FDA has reminded us it is not allowed to offer extravagant incentives to healthcare professionals, and companies have to get regulatory approval before promoting anything. They also can't use words like "safe" or "no adverse effects" without solid evidence.
VitaTek POV - Patrick Hodgdon, VP of Marketing: We have always prioritized transparency and compliance in our processes, even when marketing our devices.
These guidelines help us uphold the highest ethical standards in the way we market and promote our devices. Building trust through our transparency and iterative process is key to serving our clients and their patients as best as possible.
Undergraduate engineers are the future of medical devices
Undergraduate engineers are leading medical device innovation. The NIH and VentureWell recently awarded $160,000 in prizes for student innovations, including a bladder irrigation system from Rice University, a rapid saliva test for lead exposure from Cornell, and a 3D-printed bionic knee from the University of Utah.
VitaTek POV - Rich Thompson, President of R&D and Engineering: Creativity is strong with recent grads. We currently employ many recent graduates and routinely take interns because they provide great creativity, energy, drive, and the ability to learn quickly. We look forward to supporting their growth as they shape the future of MedTech.
Can Compass MED actually streamline development?
Cognition Corporation released Compass MED, designed to streamline medical device development by enhancing collaboration, improving documentation accuracy, and optimizing risk management. With features like guided design controls, real-time traceability, and collaborative document reviews, its goal is to help engineering, R&D, quality, and regulatory teams work more efficiently. Compass MED’s mission is to innovate faster by automating critical processes and offering real-time analytics while maintaining the highest quality and compliance standards.
VitaTek's POV - Jason Scherer, CEO: No matter what tool you use, the FDA will always be a bottleneck. The real key to success is having an experienced team that works closely across engineering, regulatory, and manufacturing functions. That’s where VitaTek shines—our in-house team is your true advantage in accelerating product development.
The Importance of Material Selection
Gavin Braithwaite of Cambridge Polymer Group emphasizes the importance of selecting the right materials early in the design process, particularly considering sterilization methods and regulatory pressures that could impact product longevity.
VitaTek POV - Rich Thompson, President of R&D and Engineering: We prioritize material selection early in our development process. We begin with the core materials used in our manufacturing, leveraging our expertise and testing. If deviations are needed, we collaborate with suppliers and our engineering and regulatory teams to evaluate options.
We work with various standard plastics, unique soft durometers, and handle complex applications like insert and over-molding. This approach ensures our material choices meet regulatory and sterilization requirements from the outset, keeping your project on track and future-proofed.
Plastic Surgery the Meeting
We’ll be attending Plastic Surgery the Meeting in San Diego, CA from September 26-29 at booth 126. Join our elite sales leadership team—Frankie Mead, Asifa Mirza, and Kristian Killian—along with Marketing Director Nate Bliss and Industrial Designer Reese Wilson. Don’t miss the chance to check out Brekka and StingRay, our implant delivery devices that are revolutionizing the industry.
Welcome to Our New Midwest RVP, Kristian Killian
We’re thrilled to welcome Kristian Killian, a sales powerhouse in the hydrophilic coatings industry. He has decades of medical device experience - first as a military-trained surgical assistant, then as an orthopedic total joint sales representative, an independent medical device distributor, and most recently, experience in business-to-business in the hydrophilic coating space.Kristian’s skill set, knowledge, and vast surgical experience are centered on keeping complex things simple, asking the right questions, solving problems, and moving only in the forward direction, with an unwavering commitment to his clients.
Kristian will drive new business and manage key accounts like Brekka and StingRay in the Midwest region.
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