Commercializing AI-driven medtech solutions is about demonstrating value, building evidence, aligning with payers, and ensuring clinical ease-of-use.
By Brent Ness, Aclarion
Aclarion CEO Brent Ness has previously held leadership roles at Cleerly, Mighty Oak Medical, Heartflow, ProNerve, Medtronic, GE Healthcare, and Philips North America. [Photo courtesy of Aclarion]
Ultimately, commercialization hinges on a single question: what is the tangible return on investment for patients, providers, and payers? In a system strained by unsustainable spending and value-based pressures, medtech innovators must pair scientific promise with disciplined, financially grounded strategies.
The commercialization of AI-driven solutions in medtech is about demonstrating value, building evidence, aligning with payers, and ensuring clinical ease-of-use. When science, economic clarity, and operational simplicity intersect, groundbreaking technologies have a real chance of moving from promising innovation to standard-of-care.
Drawing on lessons from scaling multiple AI-enabled decision support platforms, I’ve found three pillars that consistently determine whether a breakthrough becomes a commercially viable solution.
1) Capital efficiency and strategic payer alignment
New tools must address clinical problems where current decision-making is costly, inefficient, or lacks precision.
Cardiology and the payer community have embraced HeartFlow and Cleerly, whose FFRCT and Plaque analysis software address these questions of lack of precision and the downstream financial implications of low value care.
Spine care is another such area. Despite billions of dollars spent annually on back and neck pain, surgical success rates remain highly variable, driving unnecessary downstream costs and patient dissatisfaction. Solutions that help clinicians identify precise pain generators have the potential to reduce variation in procedures, lower surgical revision rates and improve both economic and patient-reported outcomes.
That same focus on efficiency should extend to clinical validation. Pivotal trials can be prohibitively expensive, but thoughtful study design and clear endpoints can significantly reduce costs while producing high-quality evidence. Companies that demonstrate disciplined spending and a clear plan for generating level 1 evidence such as randomized controlled trials can create a compelling value proposition for payers and investors alike.
2) Evidence, reimbursement, and market capture
Commercial traction depends on a clear reimbursement pathway. Many emerging tools begin with temporary CPT Category III codes, which give clinicians a mechanism to use the technology while collecting real-world utilization data. Moving to permanent Category I reimbursement requires rigorous evidence showing not only that the new innovation provides unique insights, but that those insights change clinical decisions and improve outcomes.
In the spine space, studies have shown that when surgeons target discs objectively identified as pain generators using MR spectroscopy, patient improvement rates can be significantly higher than when surgeries are based solely on conventional imaging or clinical judgment alone. Early coverage decisions from international payers demonstrate how real-world evidence can accelerate adoption when a technology meaningfully improves decision-making.
3) Operational scalability and IP protection
Beyond evidence, successful commercialization requires operational models that minimize workflow disruption. Clinicians gravitate toward tools that translate complex data into clear, actionable reports without adding friction to existing processes. Ease of integration often determines adoption speed more than the underlying scientific sophistication.
Intellectual property protection also shapes long-term commercial viability. Medtech companies must secure comprehensive patent coverage around core algorithms, biomarkers, and workflows to differentiate themselves in a competitive market. A diversified IP portfolio reduces the risk of encroachment and signals maturity to strategic partners and investors.
People
Executing each of the strategic imperative categories above requires extraordinary insight and guidance from true experts. Success depends on hiring the right employees and consultants and choosing the right early adopter sites.
Aligning incentives and developing a culture of transparency and respect brings people together to overcome the inherent challenges of doing difficult things.
Culture beats strategy. When both are in place, the journey can be incredibly rewarding and even fun.
Brent Ness is CEO of Aclarion and has over 25 years of healthcare technology leadership, including executive roles at Cleerly, Mighty Oak Medical, Heartflow, and ProNerve. He previously held senior leadership positions at industry giants Medtronic, GE Healthcare, and Philips North America.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
