When hardware and firmware are developed by separate vendors, diagnosing issues like symptoms of non-performance becomes slower and more complex. Unified engineering teams are essential to MedTech success.
Medtech innovator GeniPhys received 510(k) clearance from the FDA for its platform product, Collymer Self-Assembling Scaffold (SAS).
How does combining AI with Lean Management significantly improve efficiency in MedTech engineering? AI, much like IDEs or CAD tools before it, is becoming an essential enabler in reducing friction throughout the product development lifecycle—from onboarding and requirements generation to coding and testing—ultimately enhancing both productivity and innovation. By identifying and targeting inefficiencies using Lean principles, MedTech engineering organizations can unlock AI’s full potential to accelerate development and deliver higher-quality healthcare technologies.
This silent crisis has dire consequences. Patients face delays, errors increase and the entire system suffers. This cannot continue. But in the face of such crippling challenges, how can healthcare practices look to improve the interoperability of their systems?
Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to allow the heart to receive proper blood flow. Most of these procedures — 80-85 percent — are only guided by traditional angiography, an x-ray of the blood vessels that requires a contrast agent to be flushed into the heart to identify where the blockages are.
The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.
MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.
Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of rejection. Its non-ferromagnetic nature makes it MRI-safe, and its durability supports better healing outcomes compared to materials like stainless steel. Though more expensive, titanium’s costs are becoming more manageable, and demand is expected to surge with the aging population. Innovations like beta-titanium alloys, surface treatments, and 3D-printed implants continue to expand its medical potential.
For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.
In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?