Lean manufacturing, now common in the medical device industry, originated in the automotive industry. Companies that truly embrace lean practices dramatically reduce costs and inventory levels while improving product product quality.

Stage-gate and requirements-driven product development, pervasive due to FDA’s QSR, has roots in PRTM’s PACE process and Robert Cooper’s Winning at New Products. A well-designed product development process shortens new product development timelines and improves the likelihood of product success.

Medical device companies reap tremendous benefits from borrowing the best practices of other industries. Unfortunately, most of us spend our whole careers in medical devices with limited knowledge of other industry practices. Meanwhile, as Marc Andreesen wrote last summer, “Software is eating the world.”

It’s not just the dramatic decline in the costs of memory, processing and communications that is fueling the software revolution. Key to software success is a radically new approach to product development best summarized in Eric Ries’ fantastic book, The Lean Startup and Kent Beck’s classic Extreme Programming Explained.

While I don’t expect scalpels to be replaced with software anytime soon, we in medical devices can learn a lot from Lean Startup software practices. Today’s topic: test-driven development (TDD).

Continue reading “Lean Medical Device Startup: Test Driven Development” →