Our Mission
Help medical innovators quickly realize the greatest potential in their ideas
Device Start-up Business Strategy
Successfully developing medical technology has become increasingly difficult in recent years. Changes to the regulatory framework, uncertainty in the financial markets, a lack of skilled resources, and legislation that limits access to MD Opinion Leaders all create barriers to innovation. The complexity of our industry is increasing and the smart innovator exploits these complexities to their competitive advantage. New methods are needed to secure funding, define the real needs of a changing market and navigate the evolving regulatory and reimbursement pathways. Medical device CEOs may need to devote all their efforts to fundraising with little or no time remaining to run the business. Addressing fundraising at the expense of running the company, or vice versa is damaging. Let us help you focus and deliver the essentials.
First-in Human Clinical Studies
It is common for technology experts to design a product that meets defined specifications but fails to carefully address the unique environment in which the innovation will be used. Even if the user requirements are well defined, it is not enough to simply craft an Instructions for Use document, train clinicians and hand it over for use. Yes, clinicians may have good insights into key application issues, but if you allow them to sort through those without carefully facilitating the early device uses you/they will not learn the lessons quickly and patients (and your program) are exposed to unnecessary risk. Done properly, your FIH experience will provide important insights not only into device performance but also market size, market development challenges, the impact of your technology on secondary clinicians and others (like hospital administration). The first use of your device is a terrific way to learn important lessons that can shape the future of your enterprise and inform product development and other business activities.