De-Risking an AI-Enabled Medical Technology Launch
AI-Enabled Ultrasound for Point-of-Care Pregnancy Diagnostics
Challenge
A client was developing a point-of-care, AI-enabled ultrasound solution designed to support pregnancy diagnostics in primary medical settings. Through a simplified scan process requiring only six ultrasound swipes and approximately ten minutes, the technology could assess gestational age, fetal viability and presentation, umbilical blood flow, ectopic pregnancy risk, and fetal abnormalities .
While the technology had significant potential to improve access to timely pregnancy diagnostics, the path from innovation to adoption was highly complex. The client needed to understand where the solution fit within existing OB-GYN care models, how it would complement clinical workflows, what barriers could slow adoption, and whether the product should launch as a single global offering or be adapted by market.
The work also required a clear view of country-specific laws, regulatory pathways, policy requirements, and market expectations. Lessons from one launch market needed to inform the next, without assuming that the same product, messaging, or adoption strategy would translate across geographies.
Layered on top of these market-entry questions was a deeper adoption risk: trust. For emerging medical technology to gain traction, clinicians, institutions, regulators, and patients must have confidence that the technology works, fits the care environment, and delivers meaningful value. Without that trust, even promising innovations can struggle to move beyond pilot use.
Approach
Forum Solutions helped the client turn a broad set of unknowns into a disciplined strategy for product definition, policy alignment, regulatory engagement, and adoption planning. The team paired a Target Product Profile with a Target Policy Profile, ensuring that product strategy and policy strategy advanced together from the outset. This helped the client evaluate the technology not only as a clinical tool, but as a solution that would need to meet regulatory expectations, fit local health systems, and earn stakeholder confidence in each market.
The client conducted field visits to observe care environments, understand how the technology would complement existing workflows, and validate demand directly with the clinicians and communities who would use the tool. These insights helped distinguish real adoption requirements from internal assumptions. The client also engaged national regulatory bodies and government stakeholders early in the process. This engagement helped clarify approval requirements, surface market-specific considerations, and build the institutional trust needed to support real-world adoption.
Results
By connecting technical innovation with policy foresight, the client built a market-entry strategy grounded in evidence rather than assumption. Open questions about global launch sequencing, market adaptation, regulatory readiness, and customer demand were translated into a more structured, de-risked pathway for adoption. The work helped move the initiative from promising technology toward practical execution. Regulatory alignment, field-validated demand, and stakeholder trust advanced alongside the product itself, creating a stronger foundation for scalable adoption.
For emerging medical technologies, innovation alone is not enough. Adoption depends on designing for the full system around the product, including policy, regulation, clinical workflow, stakeholder trust, and market readiness. By addressing these dimensions early, the client was better positioned to move from innovation to adoption with greater confidence.
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