Bringing medical innovation to market starts with understanding the clinician

Developing a medical device that performs as intended is a significant achievement. Bringing it into routine clinical practice presents a different set of challenges. Physicians and nurses must see a reason to change established practices, health care organizations need to justify the investment, and technology must fit the demands of everyday care.

Over more than three decades in medical technology, I have seen innovative products succeed, and others struggle, despite strong engineering and promising clinical performance. In my experience, the difference often comes down to a fundamental question: Does the technology solve a problem important enough for clinicians and health care organizations to change how they practice? That question needs to be addressed early in development, not after a product is ready to launch.

Start with a clinical problem that needs solving

The first step is understanding where existing approaches fall short and whether a new device can make a meaningful difference.

Physicians, nurses and other clinicians can explain which tasks consume unnecessary time, where current tools create difficulties and what improvements would help them care for patients. Asking clinicians to walk through their existing processes can also help development teams understand where a proposed solution might fit and what practical challenges it needs to address.

The frequency of a problem matters. A recurring frustration that affects a clinician's work every day is more likely to motivate interest in a new solution than a minor inconvenience encountered occasionally. Companies should consider how often the problem occurs, how it impacts patient care and what clinicians must do when existing approaches fall short.

These conversations should continue throughout development. Feedback gathered early can help teams identify missing features or usability problems before they become too expensive or difficult to address. It can also help determine whether a proposed feature solves a genuine clinical need or adds complexity without delivering a meaningful benefit.

The goal is to develop a solution around a problem clinicians actually experience, rather than expecting them to change their routines for a product that offers little practical improvement.

Demonstrate clinical, economic and practical value

Once a clinical need is established, companies must demonstrate that their proposed solution delivers meaningful benefits. Depending on the device, that evidence might involve improved clinical outcomes, shorter procedure times, simpler monitoring or more efficient use of resources. Teams should identify the outcomes they need to demonstrate before deciding how to test a device.

Clinical benefits are only part of the adoption decision. Health care organizations also need to understand the financial implications of purchasing and implementing new technology. Hospitals face high operating costs, and new equipment can require upfront spending, staff training and changes to existing workflows.

According to Kaufman Hall's February 2026 National Hospital Flash Report, the adjusted year-to-date hospital operating margin ended 2025 at 1.3%. The analysis drew on data from more than 1,300 hospitals, illustrating the financial pressures many organizations face.

One of the most common commercialization challenges is confusing clinical enthusiasm with a purchasing commitment. A physician may strongly support a new technology, but hospital administrators must evaluate its economic impact, competing priorities and implementation requirements. Successful commercialization requires building a compelling case for both the clinical user and the economic decision-maker.

Manufacturers need to explain how a device could affect patient care, staff time and resource use in the settings where it will be deployed. A technology that reduces time spent on a task, for example, may allow clinicians to focus on other responsibilities. Whether that time savings translates into financial savings depends on staffing, capacity and how the organization operates. Companies should build their economic case around realistic, measurable benefits rather than assuming every efficiency improvement will translate into direct financial savings.

Reimbursement also deserves attention early in development. A dedicated payment pathway can support adoption, while technologies without one may need to demonstrate value through existing reimbursement arrangements or operational savings. Understanding these considerations before launch gives companies time to refine their commercial approach.

Usability is equally important. Physicians and nurses work under time pressure, often managing several responsibilities at once. A device that requires complicated setup, extensive training or additional steps can make adoption more difficult, even when its clinical benefits are clear.

Companies should consider who will operate a device, what training is required and how it will fit into existing workflows. Usability testing and feedback from intended users can help identify unnecessary complexity. Training, implementation and ongoing support should also be considered as part of the adoption process, rather than treated as issues to address after a sale.

Make commercial decisions early

Even a device that addresses a meaningful clinical need and demonstrates economic value may struggle commercially if the market opportunity and resources required have not been carefully evaluated.

Companies need to understand how many potential users face the problem, what alternatives are already available and whether the proposed technology offers a meaningful advantage. They must also weigh development costs, regulatory requirements, reimbursement and the time needed to establish clinical adoption. These considerations are particularly important for emerging companies with limited resources.

Regulatory clearance is an essential milestone, but it should not be confused with commercial validation. FDA clearance or approval establishes that a device meets applicable regulatory requirements; it does not establish that clinicians will adopt it, hospitals will purchase it or reimbursement will support its use.

Prioritization is part of that process. Additional features can increase development costs and product complexity without making the device more useful to clinicians. Development teams should evaluate whether each feature addresses an identified need and whether the expected benefit justifies the investment.

Ultimately, successful medical device commercialization is not simply about developing better technology. It is about understanding clinical needs, demonstrating meaningful improvements in patient care and building a sustainable economic case for user adoption. The companies that address these questions early, listen carefully to clinicians and remain disciplined about their development priorities are better positioned to turn medical innovation into technologies that make a lasting difference.

Mike McCormick is the president and chief executive officer of Nuwellis Inc., bringing over 30 years of executive leadership experience across the medical technology and life sciences sectors. Prior to assuming the role of CEO, he served as Nuwellis' chief commercial officer and on its board of directors. Throughout his career, which includes previous CEO roles at Osprey Medical and Anulex Technologies, he has consistently scaled public and private medtech organizations focused on advancing clinical care through product commercialization and strategic execution.