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6 Things you Need to Build a Successful Biotech or Medical Device Startup

Post By: Greg Bullock
October 24, 2015, 7:49 PM

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Not surprisingly, traditional software-as-a-service (SaaS) or app development companies are dramatically different when compared to a biotech or medical device startup. From goals to challenges to funding, the development and commercialization of bio and medical technologies requires a unique support structure in order to be successful, and these are the six ingredients that repeat across top-notch bio companies.

 A well-rounded team

One of the most common occurrences we see within our bio- and life-science community in Arizona is the prevalence of scientists masquerading as business executives. This is by no means intended to disrespect their efforts in advancing their idea, but too often they have spent months - maybe even years - developing a product, device or technology but they lack even the most basic business sense and skills to get it to market. VisionGate, a Phoenix-based bioscience firm which has commercialized its LuCED test to aid in the early detection of lung cancer, has a well-balanced team of scientists and technologists, executive-level leadership and support staff. The company learned very quickly it needed diverse skill sets and personalities to excel in their industry. Bio-related entrepreneurship studies have shown that across leading bio companies, the right management team consistently emerges among the characteristics.

Customer and scientific validation

A good technology or product is built on a foundation of customer feedback. In fact, if you can get away with testing the “concept” and value of it BEFORE you even build it, then you are incredibly well positioned. Regardless, the purpose of iterating early on in the development process not only allows you to gain valuable feedback on the benefits and features of your product, but also enables you to specifically validate the science of your technology. Ultimately, does it do what you say it will do and does the science support it? This is an adaptation of the lean methodology for medical-related technologies because those products often must meet higher standards (i.e. FDA) than those of the end users or customers.

A solid regulatory and/or go-to-market strategy

On average there is a longer road to commercialization for biotechnology startups, primarily due to FDA or other regulations. In fact, it takes between a 18 and 24 months for most medical devices to be developed and pass through regulatory certification (Improve Medical Device Time to Market, manufacturing.net). Clinical testing, regulatory filings, and cost throughout this process can all be barriers to entry, which mandates a fundamental regulatory strategy to address these issues. It is imperative to map out the timeline and finances related to it; and don’t be afraid to seek out experts in the field to help you navigate it. Furthermore, this also directly ties into how you will move your product to market. Things to consider in this phase include distribution channels, customer engagement strategy, and pricing models, all of which impact the growth and scale of your business. It's therefore important to be diligent and get it right.

Premium lab space

Many bioscience and medical device companies need premium wet lab space to develop their technologies and conduct clinical trials and testing. On the private side, you have the option to build your own (which of requires money) or, if you are affiliated with a hospital or academic university, utilize their facilities; on the public side, business incubators and accelerators are options for sourcing wet lab space.

A realistic funding strategy

We should add a disclaimer that most, if not all, of the above mentioned items require money to execute upon fully. Thus, a realistic funding model, including how much will be funded through personal, angel and/or venture capital (or other: check out MediCoventures blog post on medical device funding options) as well as the timeline for acquiring such funds, must be identified. This is where having a seasoned business executive is crucial as they can help facilitate this process; if you don’t have a business partner, you can always seek out mentorship within your startup ecosystem.

A compelling story

One thing I have learned in working with biotech startups is that most people don’t need to be sold on a company that is bringing about a life-changing product when they can SEE cool images of people in lab coats imaging cells or looking through microscopes. Biotech leader Nina Tandon of EpiBone agrees that “science is storytelling” and commands a grander scope in order to convey it properly. In the end, it really is about the impact, and yet it is often the last thing bio entrepreneurs consider. Your brand is your identity, and you need to balance the sophistication of the science and the technology with the accessibility of its impact. In other words, you need to prove you know what you’re talking about while not alienating your audience with too much technical jargon. Have a strong value proposition and a fresh brand image across all platforms, from digital formats such as your website to your in-person presentations and talking points. Check out DevicePharms ABCs of Successful Biotech Marketing Strategies for a baseline to jump start your promotional initiatives.

Want to learn more? Click below to check out another blog post about commercializing a medical technology!

I want to learn more about the basics of medical device regulation

Topics: Running a Successful Business, medtech entrepreneurs, biotech startup

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