From Promise to Practice: Why the Next Phase of Medical Device Innovation Will Be Defined by Execution, Evidence, and Real-World Impact

By Edward Cappabianca, CEO, Ingenion Medical

This January, I joined healthcare leaders, investors, scientists, and policymakers at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. This recognised gathering is always an excellent check of where our industry is headed. What stood out most this year, above all the headlines and deal announcements, was a palpable shift in the conversation: innovation in healthcare is no longer defined by raw potential or visionary concepts alone, but instead by execution, evidence, and tangible impact on patients and systems.

The need to deliver in practice

For decades, medical innovation was driven by breakthrough ideas and compelling future-facing narratives. Today, stakeholders across the life sciences, whether in biotechnology, AI, or medical devices, are focused increasingly on what technologies actually deliver in practice. Those in the healthcare sector want proof of durable performance and clear pathways to cost-effective implementation routes…as they should! Overall, everybody is looking for measurable clinical outcomes and, understandably, want solutions that improve quality of life now, not sometime in the uncertain future.

This paradigm echoes strongly within the medical device sector. The shift from promise to proof means that transformative products must overcome a higher bar; not only must they be safe and novel, but they must also demonstrate real-world impact through robust evidence, clinical data, and operational viability. Execution is no longer optional, it is essential.

Demonstrating measurable benefit

At Ingenion Medical, our lead product, cymactive™, reflects this evolution in innovation. Designed as a patient-controlled urinary catheter that enables natural voiding and reduces reliance on traditional indwelling systems, cymactive™ tackles one of the most persistent and uncomfortable challenges in urological care for men with chronic urinary retention. Equipped with a patent-protected UroValve™ mechanism that uses an external magnet to allow patient-controlled bladder emptying, cymactive™ represents both a technical and human-centred re-thinking of catheter design that is long overdue.

Having a promising device is only the first step. What cymactive™ (and our whole company) is committed to is evidence generation and demonstrating measurable benefit in real clinical settings. Achieving the CE mark for cymactive™ has allowed us to begin broader European commercialisation, but more importantly, it has empowered us to gather real-world performance data, support clinical evaluations, and engage with healthcare professionals and patients to understand how this innovation affects patient quality of life, supports the reduction of infection rates, and overall healthcare costs.

At J.P. Morgan, this theme of tangible evidence resonated across sectors. Speakers and private discussions repeatedly returned to the importance of bridging the gap between early promising results and large-scale clinical validation, workflow integration, and quantifiable quality-of-care improvements. Technologies that cannot show measurable outcomes, whether in trials or in everyday practice, are increasingly unlikely to attract the partnerships or adoption they need.

For medical device innovators, this means designing not just products, but execution plans: strategic, agile, backed by data, and aligned with the economic realities of payors, providers, and patients. It means listening and generating evidence that speaks both to clinicians and to health system leaders. It also means being ready to demonstrate real-world impact, not just in controlled settings, but in everyday practice.

The right approach

For Ingenion Medical, this approach is foundational. We are committed to building the evidence base for cymactive™ through clinical collaborations, real-world evaluations, and transparent reporting that prioritises patient outcomes and health system value. This commitment is not just good science; it is the new currency of meaningful innovation.

We are at an inflection point in medical device innovation. The era of speculative optimism is yielding to an age of pragmatic ambition. Here, ideas are important, but execution, evidence, and impact are everything. For patients living with chronic conditions, that shift cannot come soon enough.

Find Out More

To find out more about cymactive™, and in which countries it is available, please contact us using our contact form.