Chris Kauffman, MD, NASS First Vice President, delivered one of the Summit’s most important warnings: reimbursement must be considered at the beginning of the innovation process, not after a product has been developed.

Kauffman explained how CPT codes, Relative Value Units, hospital payment systems, and site-of-service rules shape the economic viability of new technology. A procedure may be clinically valuable and FDA-cleared yet still fail because physicians, hospitals, and ambulatory surgical centers (ASCs) cannot be adequately paid for using it.

New procedures are frequently assigned Category III CPT codes, which allow emerging technologies to be tracked but often provide uncertain or inadequate payment. Even when a technology fits within an established code, claims that it makes a procedure faster can have unintended consequences. Because physician work values are influenced partly by time, greater efficiency may be interpreted as justification for reducing reimbursement.

Facilities face a similar challenge. A hospital may receive a predetermined payment through a diagnosis-related group, or DRG. If a new technology adds cost without increasing reimbursement or creating measurable savings elsewhere, the hospital must absorb that expense. ASCs, particularly those with physician ownership, may be even more sensitive to technologies that reduce already narrow margins.

Kauffman’s message was straightforward: innovators must understand who pays, who receives the payment, who incurs the cost, and who realizes the financial benefit. If those interests are not aligned, adoption will be difficult regardless of the technology’s clinical promise.

Another recurring Summit lesson was that no individual possesses all the expertise required to build a successful medical technology company.

Surgeon-founders may understand the clinical problem but lack experience in regulatory affairs, intellectual property, reimbursement, manufacturing, finance, or commercial operations. Engineers may build an elegant solution without fully appreciating operating-room workflow. Experienced business executives may understand capital markets but require strong clinical leadership to maintain focus on patient needs.

The strongest companies bring these perspectives together early. They also recognize when fractional or outside expertise is more appropriate than building a large permanent staff. In a constrained capital environment, a small and experienced team can often advance a company more effectively than rapid organizational expansion.

Leadership requires discipline. Revenue projections must be credible. Boards must receive honest assessments rather than consistently optimistic “hockey-stick” forecasts. Management teams build trust by establishing realistic goals and meeting them, not by repeatedly promising results the company cannot deliver.

Innovators also learned that “clinical evidence” is not a single universal requirement.

Regulators want evidence of safety and effectiveness. Surgeons want to know how a technology performs in appropriate patients and how it compares with existing treatment options. Payors want evidence that it improves outcomes or reduces downstream costs. Hospitals want to understand its affect on length of stay, complications, operating room efficiency, and service-line performance.

A study designed for only one of these audiences may leave the company with significant unanswered questions later. Innovators should develop an integrated evidence strategy that anticipates regulatory, clinical, reimbursement, and health-system requirements.

They must also be cautious when evaluating early physician interest. Surgeons may respond positively to a new concept out of professional courtesy without becoming actual users. Genuine demand is demonstrated through concrete actions: participation in product development, willingness to conduct clinical studies, engagement with hospital approval processes, and consistent use after launch.