Darci Diage, founder and CEO of TPL Consulting, provides consulting services for all facets of medical device development, manufacturing, and market approval, from concept to commercial. After more than 20 years of running complex laboratories and quality departments for medical device manufacturers, Diage decided to apply her unique contributions to the “total product lifecycle” to accelerate development timelines and launch products. Her BS in Molecular Biology from Sonoma State and MS in Biomedical Laboratory Science from San Francisco State springboarded her career in combination products, cardiovascular, peripheral vasculature, spinal, and software devices. Diage’s knowledge and expertise in feasibility testing, design control, risk management, and quality system implementation has further expanded her regulatory role, resulting in the successful submission of numerous device approvals in the U.S., EU, Canada, and Australia. With a portfolio of diverse device developments, Diage has firsthand experience in overcoming challenges within the design control process, given the continually evolving regulations and guidance documents. Having owned and operated TPL Consulting for seven successful years, Diage comprehends the intricate relationship between suppliers, service providers and contract manufacturers to get devices to the market and in the hands of users to improve patient lives.