Medical Device Commercialization

Medical Innovation Meets Regulatory Excellence

Why Most Medical Device Startups Fail – and How to Avoid It

May 20, 2025 – A recent LinkedIn article from one of PASB’s partners, OVA Solutions, notes that roughly three-quarters of medical-device startups fail before even making an FDA submission. This is usually not from lack of innovation, but from overlooking regulatory compliance: teams often “build first and figure out FDA later,” a mistake that yields

What do U.S. tariffs mean for Canadian medical device companies?

Updated April 8, 2025 – The U.S. tariffs imposed on goods from Canada presents significant challenges for medical device companies. Despite lobbying by industry associations on both sides of the border, medical devices — including raw materials and parts — are not exempt. In response, Canada has implemented retaliatory tariffs on a wide range of

Hospital technologist using digital system

Integrating Real-World Evidence (RWE) into your Medical Device Commercialization Strategy

October 3, 2024 – Medical device regulators around the world have been emphasizing the uses of Real-World Evidence (RWE) to support safety and effectiveness. Real-world evidence can improve your device’s safety and effectiveness, be leveraged for future regulatory submissions, and can be used to improve your market positioning, clinical claims, and payer acceptance. If you

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