Anchor Ventures shares resources for budding entrepreneursBioBuzz

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The BioHealth Capital Region (BHCR) continues to establish itself as the hub for startups and biotech companies. As we previously reported, BHCR startups secured significant investments in 2019, including venture capital funding and IPOs of over $ 739 million in total investment raised. To maintain the strong momentum and ensure that BHCR startups are set up for success, our region must develop and implement a robust infrastructure and network that enables innovative ideas to move from research and invention to innovation. marketing in the market.

Johns Hopkins Tech Ventures and the University of Maryland at Baltimore have collaborated to form Anchor Ventures, a conference series aimed at providing entrepreneurs and investors in Maryland with a regular gathering space to learn, network, spotlight resources and inspire enthusiasm for participating in BHCR’s robust biotechnology ecosystem.

Sponsored by TEDCO and the Maryland Department of Commerce, a recent discussion from Anchor Ventures, titled “Cleared and On the Market,” covered the ins and outs of what it takes to turn an idea into a commercial product – a topic particularly beneficial for aspiring BHCR entrepreneurs and startups.

The session was moderated by Elizabeth Good Mazhari. The panelists included three seasoned entrepreneurs who shared their recent experience in developing and selling their FDA approved medical technologies:

1. Howard Carolan, MPH, MBA Co-founder and CEO of CoapTech, the first FDA-approved ultrasound-based solution for bedside feeding tube placement.

2. Aaron Hsu, co-founder and CEO of ClearMask, the first and only fully transparent, FDA approved surgical mask optimized for maximum clarity and comfort.

3. Larry Tiffany, CEO, Medcura, FDA approved products that quickly stop bleeding regardless of the body’s coagulation cascade and work on wounds of all shapes and sizes.

FDA clearance: PMA or 510 (k)? Or De Novo?

The regulatory process for medical devices and technologies is a challenge for any business, but it is much more so for startups on their first try. With limited resources and experience, pushing a device through the door of the FDA and into the marketplace can be a frustrating multi-year validation and documentation process.

To provide an overview of the FDA regulatory process for medical devices and technologies in the United States, entrepreneurs have two main options for obtaining market approval: pre-market approval (PMA ) (which requires clinical and laboratory studies and a detailed process to determine the safety and efficacy of the medical device) or the 510 (k) approval process (does not require clinical data.

However, it must be proven that the device to be marketed is also safe and effective, i.e. substantially equivalent to a legally marketed device). For the 510 (k), bidders must compare their device to one or more similar legally marketed devices and make and support their claims of substantial equivalence. The process is generally faster and less expensive, and many companies opt for this method.

Howard, Aaron, and Larry all ended up gaining FDA approval through the 510 (k) process in 18 months. However, bedside feeding tube placement, clear surgical mask, and healing platform are very different products. As the panelist shared, they each experienced different successes and hurdles depending on their predicate device and the expectations of the FDA.

The FDA has simple guidelines for certain categories of medical devices. However, in some cases, new low to moderate risk devices that do not have a valid predicate device (as determined by the FDA) will be subject to a de novo route for the rights to market the devices. The key to a smooth and smooth process is constant communication and collaboration with the FDA. The regulator is more likely to cooperate with startups that engage in open communication from the start.

A startup could go through the regulatory process on its own and try to follow the guidelines posted on the FDA website. However, Coaptech ended up working with a consultant who offered valuable information that helped their device go through the 510 (k) process rather than the de novo route (which the FDA initially advocated). When needed, businesses and start-ups should not hesitate to tap into the region’s resources and expertise.

Beyond FDA approval

FDA approval is just a tipping point on a long, winding road for startups. Beyond FDA approval, the devices must also be adopted by clinicians and end users.

New Product Launch 101: Make sure you design a product that is 1) —needed in the market. 2). Better than the competition, if there is any. There are many programs such as iCorp that can guide entrepreneurs in customer discovery and market research. Additionally, seeking input from clinicians and end users during the product design phase will ultimately drive sales and adoption rates.

Many startups that gain FDA clearance for the product via the 510 (k) route may still need to conduct and publish clinical studies to validate its safety and efficacy in humans.

As Larry shared, “We [CoapTech] obtained our clearance from the FDA using good, high quality preclinical data. However, to be adopted by clinicians and users, we needed to show that it translates into humans.

Large-scale manufacturing and marketing of GMP medical devices requires extensive logistics. It is important for startups to recruit the right expertise in quality assurance and supply chain to help with development and commercialization. As the startup grows, hiring the right sales team can make or break the product’s commercial success.

As Howard shared, “When you make that transition [from regulatory to commercial], you have to somehow respect the discipline in the business, which is selling. Sales become a primary function as you start to grow and so figure out how to connect that with the culture you are developing. It can make a big difference.

The event attracted a lot of people and elicited positive feedback from attendees, many of whom were entrepreneurs at various stages of their product approval process. The recording of the event will soon be made public on the Anchor Ventures website.

Future event: Anchor Ventures has an upcoming event: Equitech in Baltimore | Featuring UpSurge and Techstars on October 21 from 4 p.m. to 5:30 p.m. EST.

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Nivedita is a student at the University of Maryland, Baltimore, pursuing a doctorate in biochemistry and molecular biology and a master’s degree in law (patent law). She is passionate about science writing and communications, and is actively involved in the Maryland biotech scene through her work with Women in Bio-Capital Region, AWIS (Baltimore Chapter) and BioBuzz.


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