Insights
References that inform the work.
US Health Strategy Group advisory draws on published clinical literature, market research, regulatory guidance, and healthcare policy. Original analysis and selected references are listed here for transparency.
Articles
The Structured Commercial Strategy Framework for Cleared Medtech
FDA clearance is a regulatory event, not a commercial one. This framework identifies the five structural components of a medtech commercial strategy that connects regulatory reality to clinical workflow and adoption.
Read article →Why 95% of Healthcare AI Deployments Fail Before Scale
Digital health and healthcare AI products are failing at the adoption stage, not the clinical validation stage. The failure is structural, predictable, and preventable. Here is what drives it.
Read article →Building a Compliant KOL Network: What Medtech Companies Get Wrong
Sunshine Act reporting, OIG fair market value guidance, and regulatory scrutiny have made KOL engagement a discipline with material legal exposure. Most medtech KOL programs are not built to manage it.
Read article →Prior Authorization Infrastructure as Physician Support
CMS-0057-F is in effect. Physicians are navigating an authorization environment that was designed without them. Device companies that build support infrastructure before launch are choosing whose problem this is.
Read article →Reference library
Peripheral Nerve Stimulation Market Report
Global PNS market projected at $780M+ in 2026, 8 to 11% CAGR through 2030. Driven by neuromodulation adoption in chronic pain and non-opioid alternatives.
Global KOL Management Market
Global KOL management market estimated at $87.4B in 2026 with a 9.8% CAGR. Driven by increasing complexity of physician engagement in medtech and pharmaceutical sectors.
Medtech Go-to-Market: Clinical vs. Commercial Alignment
Deloitte Life Sciences analysis showing companies that integrate clinical and commercial strategy in year one achieve market adoption significantly faster than those that sequence them.
Physician Engagement and Fair Market Value Compliance
OIG guidance and Sunshine Act reporting requirements for company-physician financial relationships. Applicable to speaker programs, advisory boards, and consulting agreements.
FDA AI/ML-Based Software as a Medical Device Action Plan
FDA framework for the development and oversight of AI/ML-based software as a medical device. Foundational for companies pursuing responsible adoption pathways.
VA MISSION Act Community Care Implementation
Veterans Affairs community care regulations and network adequacy requirements under the MISSION Act. Relevant to any device or digital health solution targeting the VA ecosystem.