A few members of the Centerline Biomedical team recently attended the Advanced Design & Manufacturing (AD&M) Expo at the Huntington Convention Center in downtown Cleveland. One of the most relevant sessions we attended was “Lessons Learned—Commercializing an FDA Regulated Product”. This discussion-style presentation explored the critical factors involved in planning a medical device product launch, as well as the many pitfalls to avoid.
The discussion was kicked off by Matthew Otten from Secure Surgical Corp, a medical device company in the surgical solutions area, specializing in both open and minimally-invasive procedures. He focused on what he called the “Significant 6”, or six factors that can make or break a successful medical device product launch. The topics covered included the following:
: Gather donations from interested investors who find value in your device.
2) Intellectual Property
: Make sure there is extensive due diligence done on your company.
3) Regulatory Planning & Strategy
: Get a regulatory partner involved early, often, and make sure they’re active in your process.
4) Supply Chain
: Be sure all development partners, direct materials and services are involved and integrated prior to launch.
5) Clinical Acceptance
, or factors required to make sure you conduct successful clinical studies:
- Usability studies: Gather professional and varied input.
- Beyond inventors: Ideas must be validated by other stakeholders and key opinion leaders, aside from the inventors themselves.
- Clinical sponsors: Some groups such as the NIH, DoD, and VA sponsor clinical trials that test the safety of products.
6) Market Acceptance
: Ask yourself questions like, “Who are the purchasing groups?” and “What are reimbursements like for your device?” Also, be sure to determine your selling price early in the product development cycle.
A medical device averages at about $35M in order to reach commercialization, so it’s important to make sure the above are satisfied to ensure a successful medical device product launch within budget.
We’re thrilled to be making strides toward the commercialization of our IOPS device. From completing multiple preclinical studies
to receiving funding from investors
, Centerline Biomedical is well on its way to entering the market.