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Large MedTech organizations and university founded startups alike often fall into the same trap. A promising innovation prototype fails to make the transition from a “working” blockbuster idea into a commercially successful product. It is frustrating. Shouldn’t demonstrating its critical clinical or technical capabilities represent the ultimate key to unlocking a product’s success? Unfortunately, this...
While the Predetermined Change Control Plan (PCCP) framework for making changes to medical devices was highly anticipated, many regulatory and medical device manufacturers have opted ‘no thanks’ given the immense upfront overhead of predicting the future of changes and how to validate the future changes after launching AI/ML devices. Instead, companies are sticking with locked algorithms and...
WESTBOROUGH, Mass.–(BUSINESS WIRE)–Full Spectrum, a rapidly growing product development and consulting company specializing in the medical device, digital health, and life science industries, today announces significant growth and expansion at the mid-year mark, with the organization growing by 50 percent compared to this time last year, the addition of 12 new clients, and the strengthening...
In mid-March of this year, prominent medical device manufacturer Stryker was the victim of a cyberattack resulting in global disruption to the company’s Microsoft environment. While no connected devices or products were affected, thousands of internal company devices were wiped, crippling communication and manufacturing operations and delaying shipments. Three weeks later, Stryker announced it was...
AI has rapidly become a standard tool in medical device product development, offering the potential to dramatically accelerate documentation, testing, and design activities. But without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the...
Full Spectrum CEO Adam Hesse explains why the Stryker attack marks a watershed moment for medtech and how manufacturers must prepare for inevitable perimeter breaches in the connected device era.
Despite economic and geopolitical turmoil, medical device manufacturers remain cautiously optimistic about the future of the industry.
While medical imaging leads the way with AI in healthcare through improved diagnostic accuracy, the rest of the industry lags behind the broader market. It is clear that AI is more than a fad, and as opportunities abound, pressure mounts to continue innovating amid relentless competition.
Explore how AI and Lean principles are transforming MedTech engineering by increasing efficiency, improving quality, and expanding what's possible in healthcare innovation.
Artificial intelligence is often celebrated for its ability to generate code, but its true value lies in reducing friction across the entire software development lifecycle—improving efficiency, communication, and outcomes.