Anchor Ventures Shares Resources for
Aspiring Entrepreneurs

The BioHealth Capital Region (BHCR) continues to establish itself as the go-to hub for biotech startups and corporations. As we previously reported, BHCR startups secured important investment in 2019, including venture funding and IPOs of more than $739M in total investment raised. To keep the momentum strong 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 progress from research and invention to market commercialization. 

Johns Hopkins Tech Ventures and the University of Maryland, Baltimore have collaborated to form Anchor Ventures- a speaker series aimed at providing entrepreneurs and investors in Maryland with a regular gathering space to learn, network, spotlight resources, as well as generate excitement about participating in the BHCR’s robust biotech ecosystem.

Sponsored by TEDCO and the Maryland Department of Commerce, a recent Anchor Ventures discussion, 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 featured three seasoned entrepreneurs who shared their recent experience with developing and selling their FDA-approved medical technologies:

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

2.  Aaron Hsu, Co-Founder and CEO, ClearMask, the first and only fully transparent, FDA-cleared surgical mask optimized for maximum clarity and comfort.

3.  Larry Tiffany, CEO, Medcura, FDA-cleared products that rapidly stop bleeding independent of the body’s clotting 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 technology is challenging for any company, but it is significantly more for startups during their first attempt. With limited resources and experience, pushing a device through the FDA’s door and onto the market can be a frustrating multi-year process of validation and documentation.

To give a bit of background into the FDA regulatory process for medical devices and technologies in the US, entrepreneurs have two main options for obtaining market approval: the Premarket Approval (PMA) (which requires clinical and laboratory studies and a detailed process to determine safety and effectiveness of the medical device) or 510(k) Approval process (does not require clinical data.

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

Howard, Aaron, and Larry all ended up securing FDA-approval through the 510(k) process within 18 months. However, a bedside feeding tube placement, transparent surgical mask, and a wound healing platform are vastly different products. As the panelist shared, they each had different successes and hurdles based on their predicate device and FDA expectations.. 

The FDA has straightforward guidelines for certain medical device categories. However, in some instances, novel devices of low to moderate risk that do not have a valid predicate device (as determined by the FDA) will undergo a de novo pathway for device marketing rights. The key to a smooth regular process is constant communication and working with the FDA. The regulatory agency is more likely to cooperate with startups that engage in open communication from the get go. 

A startup could go about the regulatory process on its own and try to follow guidelines placed on the FDA’s website. However, Coaptech ended working with a consultant who, who offered invaluable insights that helped their device go through the 510(k) process rather than the de novo pathway (which the FDA was pushing for initially). Whenever needed, early-stage companies and entrepreneurs should not hesitate to tap into resources and expertise in the region. 

Beyond FDA Approval

FDA approval is just 1 waypoint on a long, winding road for startups. Beyond FDA approval, devices also need adoption by clinicians and end-users. 

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

Many startups that obtain product FDA clearance through the 510(k) pathway, might eventually still need to carry out and publish clinical studies to validate its safety and efficiency in humans.

As Larry shared, “We [CoapTech] obtained our FDA clearance using good high-quality preclinical data. However, in order to be adopted by clinicians and users, we needed to show that this does translate in humans.”

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

As Howard shared, “When you make this transition [from regulatory to commercial], you have to sort of give respect to the discipline in the company, which is sales. Sales do become a paramount function as you start to grow and so figure out how to plug that in with the culture that you develop. It can make a big difference.” 

The event was well-attended and drew positive feedback from the attendees, many of whom were entrepreneurs in various stages of their product approval process. The recording of the event will soon be made publicly available on the Anchor Ventures website. 

Upcoming Event: Anchor Ventures has an upcoming event: Equitech in Baltimore | Featuring UpSurge and Techstars on October 21st from 4:00-5:30 pm Eastern Time.