Avoid these pitfalls in early design phases

By Justin Renfrow, Contracts Director

Since 2015, MED Institute has been focused on developing its partnership with medical device and biotech companies of all shapes and sizes. We’ve been fortunate to speak to a plethora of potential partners and work with companies all over the world. We’re extremely proud of the partnerships we’ve made and the impact that we’ve had in furthering technologies developed by Indiana based startup companies. While Indiana companies may have unique challenges compared to some in other geographical locations, the same basic principles apply.

Each technology and the personalities and skill sets driving them are different. However, we do see three situations on a regular basis that can really be a hindrance to companies in their early design phases. None of these are deal killers, but I’d like to give you some food for thought in the event you find yourself in a similar situation. If you can navigate around these pitfalls, you are going to be in a much better position when you want to engage with partners.

1. You’re not sure where you want to “get off the bus.”

That’s the first question we ask the vast majority of our clients in the early development process. One commonality among experienced entrepreneurs is they know exactly where they want to exit. They may not know the path, but they know the right questions to ask to decide where to sell, license, or find a strategic partner. Just how much of the product development process do you want to fund? Are you willing to go past the phase of raising seed funding, or is your goal to find a strategic partner after you’ve done your proof of concept work? We find that those who are most successful know where they want to exit and are willing to weather the storm to get there.

2. You don’t have a working prototype, but you’ve got something (or some things) you don’t need.

We have worked with companies that have purchased a Quality Management System and full spectrum Customer Relationship Management software platform, but they do not have a working prototype. If you don’t have a working prototype and some clinical or user feedback, that should be at the top of your priority list when meeting with potential funding agents. Medical device development is an iterative process. Through these iterations you learn and de-risk the device making it more likely to succeed. Developing a prototype is one way to de-risk your concept. Overall, it is good to speak to mentors that have successfully developed devices and understand the current regulatory, funding and lifecycle of devices.

3. I have secured and been granted $X, I’ve spent $Y, what is the best thing I can do with what I’ve got left?

One of the single most common questions we get is “What can I get with $50,000 or $100,000?” Our answer; probably a lot more than you think. Just like better science doesn’t mean more testing, better device development doesn’t necessarily mean spending more of your funding. It simply means selecting the right activity at the right time to move your technology forward. This is where understanding the medical device development process, including the regulatory process and requirements, is important.  You will need to make decisions on what you want to learn yourself and what you want to rely on partners for to further your device development.

If there’s one great thing about our local start up environment, it’s that there are plenty of resources available. If you’re a university-based startup you likely have access to a skilled entrepreneur in residence. Groups like IHIF provide excellent networking and educational opportunities to meet and learn from experts not only from Indiana but from all over the world. There are several consulting companies like MED Institute that have the experience and in-house capabilities to de-risk your technology and point you toward the right regulatory pathway. There’s no better time than the present to be on the leading edge and no better place to be than in the Hoosier state.

Please visit medinstitute.com or call 855.463.1633 to learn more about how we can partner with you.