When large incumbents like Microsoft release features that seem late or inferior to startup versions, it's often not a lack of innovation. They must navigate a complex web of international regulations, accessibility rules, and compliance standards (like SOC 2 and ITAR) that inherently slow down development and deployment compared to nimble startups.

For early-stage MedTech startups, key milestones for investors are not just regulatory successes. They are fundamental proofs of concept—showing the device works in a model and demonstrating how it would function in a clinical setting. This builds an investor's vision of the product's future.

Oshkosh structures partnerships to own IP developed jointly with a startup, then licenses it back. This approach, outlined in the initial NDA, gives the large corporation control over patent defense while providing the startup with usage rights, often with market-specific limitations.

The value of a patent extends beyond simple protection. It allows a company to escape commoditization and command higher prices. For startups, patents are tangible assets that justify higher valuations. In legal disputes, they provide crucial leverage for negotiating settlements with competitors.

While patents are important, a pharmaceutical giant's most durable competitive advantage is its ability to navigate complex global regulatory systems. This 'regulatory know-how' is a massive barrier to entry that startups cannot easily replicate, forcing them into acquisition by incumbents.

The choice between a patent and a trade secret is a strategic decision based on vulnerability. If a product can be purchased and deconstructed to reveal its innovation, a patent is the necessary path. Trade secrets are only viable for innovations that are impossible to discover through reverse engineering.

To commercialize a simple mixture, the company built an IP portfolio around the timing, delivery, and indications for GIK. Crucially, they secured a 'trifecta' of FDA support: Special Protocol Assessment, Breakthrough Designation, and a Biologic License Application, which grants 12 years of market exclusivity, creating a strong competitive barrier without a traditional drug patent.

Early-stage MedTech founders should deeply study existing patents in their field. This research goes beyond ensuring freedom to operate; it provides a strategic map of the competitive landscape, revealing opportunities for iteration, new combinations, and a stronger foundation for future filings.

M&A is often framed as a win, but it can be detrimental to patients. The acquisition of an aggressive, fast-moving biotech by a large pharma company can lead to slowed development timelines and more conservative regulatory strategies, ultimately delaying access to life-saving treatments.