Managing a medical device startup is not for the faint-of-heart. After moving heaven and earth to secure funding, you’re finally moving through your formal development process, sprinting towards V&V, animal studies and regulatory clearance, meaning you’ll soon be teed up for another round of fundraising! Looming just over the horizon is the question of manufacturing. Not just full scale, commercial manufacturing, but all of the fabrication and short-run requirements that you’ll need to secure in order to successfully traverse the landscape ahead.
It’s this interim set of requirements, the critical steps that get you from development to full scale, commercial manufacturing, that continue to be a challenge for startups. In examining why this continues to be a drag on commercialization, we see that there’s a fundamental disconnect between the objectives of startups and the objectives of contract manufacturers.
When it comes to identifying early fabrication and manufacturing solutions, startups need flexibility and a small number of devices, often manufactured in subsequent runs. Conversely, contract manufacturers seek forecast-ability and large, long manufacturing runs to ensure profitability. By definition, these two business entities are diametrically apart.
Having witnessed this disconnect for well over a decade, REV.1 Engineering® is introducing a solution; an approach we call Strategic Manufacturing.
Strategic Manufacturing is defined as manufacturing that directly contributes to the company’s continuous, competitive advantage. In the case of startups, this advantage immediately translates to the acceleration of your company’s valuation. In addition, Strategic Manufacturing evolves throughout the Life Cycle of your device in anticipation of the changing, strategic needs of your company.
Our proprietary approach initiates at the project planning phase, through the application of Design for Risk Management Throughout the Critical Chain. This aggressive, highly disciplined approach to de-risking your device early and often, looks over the horizon in anticipation of potential bottlenecks that can slow your road to market…and establishes documented steps to solve them. Our integrated approach also incorporates the development team that designed your device, in Design for Manufacture and Manufacturing Transfer, ensuring a seamless transition as you scale. There are strong echoes of Deming and the Taguchi Method here, where a dollar wisely invested early, in a high quality process, can save tens of thousands of corrective dollars, downstream.
As a new member of the ASAHI Filmecc family of companies, our approach also incorporates strategic sourcing, leveraging more than four decades of quality leadership in guidewires, steerable sheaths, components, coatings and custom sub-assemblies.
In support of this initiative, REV.1 is expanding its Development and Innovation operations into a new, 14,000 square foot facility and converting our current, 6,000 square foot building into a dedicated, compliant, Strategic Manufacturing facility. This dedicated facility will address the unmet needs of our development and innovation clients as they move towards commercial launch.