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Case Studies

Our ethos is that every core area of commercialization is interconnected. Decisions in one area (whether regulatory, reimbursement, clinical, or market strategy), can directly shape outcomes in another.
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The following case studies illustrate these interdependencies and the consequences of approaching them in silos.
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€1.3M Grant Raised to Launch a University-Hospital Pathology Spin-Out

Pathology
Class I - Exempt
Product Fit
Regulatory
IP
Clinical
Commercialization
“You dont always have to look at the US as your source of funding, even when it is the largest commercial market out there”
May 12, 2026
product-fit
regulatory
ip
clinical
commercialization

Avoiding a $10M+ PMA Pathway

Neurosurgery
Class II
Regulatory
IP
Commercialization
Clinical
Even with the FDA, you will need to think out of the box to optimize the pathway to commercialization”
June 5, 2025
regulatory
ip
commercialization
clinical

Reframing FDA Strategy Around Commercial Success

Post-op care
Class II
Product Fit
Regulatory
Commercialization
Insurance
Founders Beware: FDA approval is not the end goal but a stepping stone.
July 20, 2026
product-fit
regulatory
commercialization
insurance

Reframing how start-ups should think about their IP

Dentistry
Class II
IP
Product Fit
An exploration of supply chain efficiency improvements.
September 22, 2026
ip
product-fit

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