Here’s the online interactive version of the Handbook: Everything you need to know about medical device creation
Let’s face it: Medtech development is hard
Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining – and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement.
The shift toward making medical devices “smarter” means that medical product makers need to know more about sensors and software, too.
The good news is that the companies serving the medical device industry have become specialized experts, and we harness their expertise through our annual Medical Device Handbook. We request articles from medical device designers, outsourcers and consultants that avoid marketing pitches and instead provide useful information for the medical device development community.
Here are a few examples of the expertise to be found in this year’s Handbook:
- As the medical industry migrates more to multi-layer, multi-lumen tubing for various uses, the extrusion die design and manufacturing supply chain has likewise evolved. That includes new crosshead designs, said Bill Conley, sales manager at Guill Tool & Engineering.
- While manual resistance welding is common in the device manufacturing industry, automated electrode welding processes can enhance the consistency, quality, performance and efficiency of electrode ring assemblies, according to Paul McCormick, senior research and development engineer for Integer.
- Impregnating vulcanized silicone with active drugs is a promising method to reduce colonization of bacteria on implantable medical devices, said Andrew Gaillard, global director of Healthcare and Medical at Trelleborg Sealing Solutions.
- Digitizing processes such as informed consent can streamline studies to rapidly collect quality data while reducing costs, according to Michael Tucker, senior product solutions specialist at Medidata.
- Vaporized peracetic acid (VPA) has become a game-changer in medical device sterilization, providing for a room-temperature process designed to preserve newer device materials and components, said Mason Schwartz, R&D and operations director for Revox Sterilization Solutions.
- Advances in catheter components are paving the way for improved, more sophisticated devices, according to Zeus. A super-thin-walled PTFE catheter base liner presents new opportunities for smaller devices. MRI-compatible LCP braiding is stronger than previous non-metal braidings and rivals the strength of some stainless steel braidings.
- When it comes to getting medical device product development back on track, a “red team” or “tiger team” approach leverages an independent team of experts to question assumptions, validate (or refute) previous findings and identify new paths to investigate, explained Jeff Champagne and Eric Claude at MPR Associates.