Built North: Defining the Need Before Building the Device
Many medical device startups, despite successfully building a device that works as designed, fail anyway: it was designed for the wrong need, or for one too small to support the business. Built North LLC, a consultancy founded by George Malinoff, helps device companies and their investors test that question early, while answering it is still cheap.
Malinoff brings over 20 years of engineering and corporate development experience at W. L. Gore & Associates. He developed endovascular devices (catheter-delivered stents and stent grafts) for peripheral arterial disease and aortic aneurysmal disease, from concept through commercialization. He later led M&A activity for Gore's largest global business. He also took part in multiple Lean LaunchPad and Stanford Biodesign cohorts, leading cross-functional teams through the innovation process.
Built North's core offering runs from customer discovery and needs definition through opportunity assessment. Interviews with physicians, patients, and hospitals are paired with the clinical literature and a working view of the regulatory and reimbursement landscape. The result is a defined need with early quantitative baselines (patient population, outcome targets, and cost of care) that serves as the foundation for everything from product requirements to the financial model.
The practice also supports buy-side diligence for banks, venture firms, and strategic acquirers.
Malinoff recently spoke on the "Commercialization Playbook: From Regulatory Clearance to Market Success" panel at the Michigan Medical Device Summit on September 30.
