Zero to Approved

Memphis Bioworks Foundation’s ZeroTo510 program provides “fast passes” for medical devices.



Allan Daisley, ZeroTo510 program manager

photographs by Amie Vanderford

There are few things more annoying than waiting in line for something, especially something you really want. Take it a step farther and pretend you’re at Disney World, and you’re in a sticky, miserable line for your favorite ride. The ride you’ve been dreaming and thinking about for weeks, months, even years. Then, you’re presented with a “Fast Pass,” and can now jump to the front of the line and experience the ride, in all its glory, in a reasonable amount of time.

This is what Memphis Bioworks Foundation’s ZeroTo510 program does for medical devices. No, it won’t get you to the front of the line to receive a medical device, but it will get you to the front of the line, so to speak, for registering your medical device with the Food and Drug Administration (FDA). Allan Daisley, program manager for ZeroTo510 and director of entrepreneurship and sustainability for Memphis Bioworks Foundation, explains, “Normally, if you create a brand-new medical device, it takes probably 10 years and $10 million to get it to market; it’s prohibitively expensive. However, the FDA has provided a fast path where, if you can build a better mousetrap, they will let you take it to market faster.”

Much like the metric of cars going “from zero to 60 mph,” this accelerated program takes an entrepreneur from zero knowledge about the industry to FDA 510(k) certification. “If there’s a product already on the market,” says Daisley, “and you build a better version of it so that it treats the same indications — maybe it’s a different material or slightly different design, but it’s put toward the same purpose — and you can prove it is as safe and as effective as the device already in the marketplace, the FDA will clear you to go to market with that new product.”  

The idea started from pairing two separate, but linked, matters. First, Tennessee established a grant to promote the acceleration of new businesses and the startup of new businesses across the state. Secondly, the investment firm under the Bioworks umbrella, Innova, is always looking for new companies to invest in. With money newly available, Daisley and Innova thought out a new program combining entrepreneurship training from Bioworks and investment from Innova, to create more investable companies.  

“A company that has gone through training and has shown it can be responsible with a small investment would be prime for bigger investments,” Daisley says. “It’s a courtship. We see what the entrepreneur can do and decide if it can go to the next step.” Daisley says that MB Venture Partners is the second investor in the program, giving prospective companies two investors for the initial seed money that goes into the startup.

Daisley says, “The accelerator model is not something new, but this is the first time it’s been used for medical devices. It’s been used in the high-tech arena, like with Techstars and Y Combinator. We borrowed from those models and added a medical device component to it. Medical devices are a huge industry in Memphis, with the headquarters of Wright Medical, Smith & Nephew, and Medtronic. If we were going to do anything that would have success, medical devices would be the area.”

Pairing an accelerator program with the medical device industry might seem like an easy fit, but there are added layers of red tape and difficulty when it comes to FDA certifications and getting products into hospitals. ZeroTo510 recognized the importance of mentors in the program as well as a fall-back funding plan made possible by investors. “We created a whole program that touched on everything from an overview of the healthcare system to the minutiae of ISO 13485,” says Daisley.

So far, so good when it comes to graduates of the ZeroTo510 program. For example, Better Walk crutches, which presented at the demo day in August 2013, are already being sold to hospitals and clinics. “That would be an example of Class I exempt — things that are not life-supporting or life-threatening,” says Daisley. “They redesigned a crutch. They were Georgia Tech Biomedical Engineering guys and after one of them broke his leg, he decided that being on crutches sucked, so why not make them better? They just had to get the design down, register it, and go sell.”  On the other hand, Class II, or life-supporting/ life-threatening devices generally have more hoops to jump through to gain certification. View Medical created an improved surgical light through the program and  gained Class II verification. “I didn’t expect this to be Class II, but as a surgical light, there are numerous things that can go wrong,”

Daisley explains. “You have to go through the 510 process. It has to be safe and effective, get the data, send it off, wait until the FDA analyzes the data and clears you before you can get to market.”

These are just a few of the many success stories that have come from the program in its short existence. Any scientifically minded individuals are welcome at the program, which takes six teams per term. Both Daisley and Jessica Taveau, senior manager of marketing and communications for Memphis Bioworks Foundation, agree that there are no prerequisites to becoming a ZeroTo510 certified entrepreneur. “Some [teams] are two people and an idea, and we help them form a company and birth it into an idea,” says Daisley. “[Others are] entrepreneurs who have an idea and have thought through it a little bit and maybe have a design or prototype and just don’t know where to go next. What we really look for are ideas that we can accomplish in a year, because once you go past a year you’re not really accelerating anything anymore. Good capable teams, innovative ideas, and the ability to get to significant milestones within a 12-month period.”

Aside from creative teams and ideas, Daisley gives substantial credit to willing mentors and the city of Memphis for the success of the program. “Honestly from what I’ve seen the community has really embraced it. We’re getting calls from people wanting to be involved. We’ve had tremendous success recruiting mentors; nobody says no to helping entrepreneurs.

What’s stood out has been the willingness of people to come out and be a part of making the program better, and it’s not only the medical device community but the community in general. It’s one of these ‘it takes a village,’ and the village has come together. Even more than that, it’s spread beyond the borders of Memphis because we’ve had mentors come in from California and New York and they’ve spent time doing sessions with the participants just to advance the cause.”

The program is already gaining worldwide attention for Memphis with applicants locally as well as those from top biomedical programs including Vanderbilt, Johns Hopkins, Duke, Georgia Tech, and countries such as Russia. “All entrepreneurs like barbecue, so that’s the first thing,” Daisley says with a laugh. “Seriously, it’s medical devices being a core asset that we have here. We have a big area of strength in the area of those primary companies. That means we have good mentors and good support to help validate the concepts.”

There’s also a huge entrepreneur culture that’s happening in Memphis. Daisley notes Emerge Memphis and Start Co. who are both involved in growing entrepreneurship in other areas. “We’re doing something that no one’s done before,” says Daisley. “It says a lot for ‘little ole Memphis’ that we’re pioneering something and taking a model that has never been applied to this industry before and tapping into the areas of strength we have here. Not to undersell it, but it sort of became easy because of the raw material that we have here — the device companies, the clinics, universities.”

Together with Memphis Bioworks, Innova, MB Ventures, and the aid of mentors, Daisley’s vision to make Memphis a hub for bioscience, and entrepreneurship in general, is fast becoming a reality. Daisley says, “What we’re doing here at Bioworks not just in terms of this program is substantial. We just built the lab facility for pre-clinical studies across the street — that’s a hugely important pillar that you would normally have had to go elsewhere for. Memphis is trying to fit all of the pieces of the puzzle together here so that every area where entrepreneurs need support is met.”

By investing in startups, and then providing the resources to help grow their companies locally, Memphis is keeping the creative talent it already has, while also attracting new people to come and set up shop.

 

For more info, go to zeroto510.com.

 

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