Medical Research and Development Using Classical Engineering Methods

Why does it take so blasted long to plan, build, test, produce, test, deploy, and mantain a new drug or medical device? It is because we use an antiquated patchwork of non engineering specific program research and development processes and procedures to develop the drug and device. Commonly praticed engineering and development methods will fix these problems. This paper defines the modernization and innovation in drug and medical device research and development. The highly efficient hybrid process is called the Medical System Development Lifecycle (MeSDLC). MeSDLC is the fusion of the very best engineering tools used in the classic engineering Software/System Development Lifecycle (SDLC) with medicine. Creating the MeSDLC concept was a sheer joy, we hope it helps.
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While drug and medical device development processes differ in technical specifics (e.g., chemical vs. mechanical testing), they share core similarities in terms of regulatory oversight, clinical trials, preclinical testing, risk management, and the requirement for post-market surveillance. Both processes aim to bring safe, effective products to the market while adhering to rigorous ethical and regulatory standards. Please read on to understand how the MeSDLC and SDLC can eloquently accelerate healing.

The author is a retired combat veteran and a cyber engineer and architect who spent years learning and implementing technical engineering and architecture methods using the classic engineering system (software) development life cycle. He has built vast global cyber solutions and designed and implement numerous combat tools such as the first drone to fly in combat since Viet Nam and the most successful Air Force flight line intelligence process in a major Middle East War.