A Complete Response Letter (CRL) from the FDA due to manufacturing issues can destroy a biotech. CEO Ron Cooper warns leaders to invest heavily in Chemistry, Manufacturing, and Controls (CMC) early, even when the cost exceeds the clinical trial spend. This early investment in professionalizing CMC is critical to de-risk the company's future.

Unlike a biocompatibility study that can be scheduled for a specific quarter, cybersecurity cannot be treated as a one-time milestone. It must be an iterative process integrated throughout the entire product lifecycle, from initial design and software development to post-market surveillance.

MedTech companies mistakenly assign product cybersecurity to their IT teams, whose focus is data protection. Product security is about patient safety and should be owned by Quality Assurance, as all documentation must integrate into the Quality Management System (QMS) like other design files.

Retrofitting cybersecurity into a medical device near submission is a common, catastrophic error. The FDA requires security to be designed-in from the start. "Bolting it on" later leads to significant delays and costs, much like trying to add rebar to an already-poured foundation.

The primary lens for medical device cybersecurity should be patient safety, not data protection. A hacked device can directly harm a patient, making security as fundamental as sterility. This reframing changes the entire approach from a compliance checklist to a core design principle.

While Over-the-Air (OTA) updates seem to make hardware software flexible, the initial OS version that enables those updates is unchangeable once flashed onto units at the factory. This creates an early, critical point of commitment for any features included in that first boot-up experience.

In high-stakes regulated fields, documentation like FMEAs is not red tape. It's a critical tool for understanding failure modes, mitigating risks, and ensuring product viability and patient safety, especially for a startup where one recall can be fatal.

Frontline Medical chose to develop the Cobra OS not because it was their most revolutionary concept, but because it was manufacturable with limited resources. They prioritized the idea that 'checked all the boxes' for feasibility, market success, and patient impact, ensuring they could bring a product to market.

In environments with highly interconnected and fragile systems, simple prioritization frameworks like RICE are inadequate. A feature's priority must be assessed by its ripple effect across the entire value chain, where a seemingly minor internal fix can be the highest leverage point for the end user.