What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast.
Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach to bringing a device to market, like taking advantage of reimbursement opportunities and leveraging a QMS to support all efforts along the way.
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Some highlights of this episode include:
- About 10 years ago, the startup environment was driven by regulatory strategy. There are other areas that needed to be addressed, such as reimbursement.
- Reimbursement is important to consider because it’s no longer enough for a product to receive regulatory approval. Investors want to know the business plan to get return on their investment.
- Regulatory and reimbursement go together. Know your options because not knowing your reimbursement plan is risky. To ensure a better reimbursement, you may have to alter your regulatory plan.
- Reimbursement should not be an afterthought. How are you going to get paid for it? Out of pocket or from insurance? What does that landscape look like?
- Startups must be efficient, effective, and frugal to get to market as quickly as possible to reduce the amount of capital that is spent.
- Regulatory pitfalls that impact startups include poor strategies and planning. The easiest regulatory path is not always the best path to market for your business.
- A robust and easily implemented quality management system (QMS) is critical, especially if the plan is to be acquired by one of the large strategics.
- Project Medtech Podcast is a better way for people who need to learn about other subjects, specifically startups.
Links:
Duane Mancini on LinkedIn
Project Medtech on LinkedIn
Project Medtech Podcast
Covance
FDA - Medical Devices
De Novo Pathway
Premarket Approval (PMA)
Premarket Notification 510(k)
ISO 10993
Project Medtech Podcast - Founder and President of AmSpirit Business Connections
Mike Drues of Vascular Sciences
Global Medical Device Podcast - What are the Strategic Priorities for CDRH in 2021?
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
Greenlight Guru
Memorable Quotes from Karen Schuyler:
“People go into the medical device industry to save lives. There has to be a business aspect of it. It is what it is. Investors want to know that.”
“Not knowing your reimbursement plan is really risky because it can change your regulatory plan.”
“Startups need to get to market as efficiently and in the least amount of time as possible to reduce the amount of capital that they have to spend.”
“Your easiest path to market from a regulatory standpoint, isn’t always your best path to market in general for your business.”
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