MedTech Commercialization
Strategic Spinouts specializes in accelerating medical device and medtech innovations from concept or early prototype to acquisition-ready status in 12 to 18 months. Our commercialization sprint is built for speed, precision, and market alignment without compromising regulatory or quality expectations.
The Challenge with MedTech Commercialization
Medtech commercialization is complex. Innovations must navigate regulatory pathways, prove technical and clinical performance, and establish a scalable commercial model before attracting serious acquisition or licensing interest. Many devices stall due to unclear go-to-market strategy, delayed regulatory planning, or insufficient market proof. We exist to solve this — to create acquisition-ready medtech assets through a disciplined, gated process.
Our Commercialization Sprint Model
Secure Rights
Confirm ownership or secure licensing rights for the device or enabling IP with clear field-of-use definitions and backend terms aligned to future transactions.
Design the Commercial Model
Define the economic model, including device pricing, consumables revenue, and potential platform or software layers, with validated unit economics.
Regulatory and Quality Scaffold
Map the correct pathway (510(k), De Novo, CLIA, LDT), stand up a lite quality system, and implement risk management to pass diligence and run pilots.
Prove It in Market
Conduct acquirer-aligned pilots or early sales to demonstrate market acceptance, price viability, and operational readiness.
Transaction Package
Prepare a complete dataroom with technical, regulatory, financial, and commercial documentation to close an acquisition or licensing deal quickly.
What Makes This Different
Acquirer-Driven Design
Every stage is aligned to the requirements of strategic acquirers and investors in medtech.
Lean and Focused
Target only what is needed to de-risk and enable go-to-market action, not multi-year R&D extensions.
Parallel Execution
Advance regulatory, commercial, and market proof tracks simultaneously for speed.
No VC Dependence
Use non-dilutive or strategic funding to reach proof before considering larger raises.
Who We Work With
MedTech Innovators
Clinicians, engineers, and founders with devices ready for market preparation.
University Spinouts
Device IP originating in academic labs with clear market applicability.
Corporate or PE Buyers
Seeking add-on technologies that are de-risked and integration-ready.
Expected Outcomes
Clean rights secured with market-specific field-of-use
Validated commercial model with recurring revenue potential
Regulatory and quality readiness to support pilots and transactions
Market proof via aligned pilots or early customer contracts
Complete dataroom for rapid diligence and close
Typical engagement: 12 to 18 months from rights secured to acquisition-ready. Timelines vary by regulatory pathway, market complexity, and pilot execution.