Medical Device Daily National Editor

Like lunch, helpful business advice isn't usually free.

Oh, you perhaps can get lots of opinions from friends and family and perhaps not very useful but valuable professional guidance is a whole different ball game.

Matthew Fonte, CEO of the very early-stage Massachusetts firm MX Orthopedics, says that invariably the advice that was offered him for developing a med-tech start-up usually came with a variety of pricey strings.

"You go to a symposium [to present your technology], but more often than not I was flooded by lawyers, consultants, trying to pitch me a service, so you shy away because they're trying to hook you with an expensive retainer."

In contrast is the no-retainer-attached consulting help he received and feels he is putting to good use through a entrepreneurial coaching program, MedTech IGNITE, developed by MassMedic (Boston), the Massachusetts medical device industry council.

IGNITE draws upon the volunteer expertise of med-tech veterans to coach up the region's entrepreneurs, and over the past year it has matched him with Don Freeman, former president and CEO of surgical tools manufacturer HydroCision (Billerica, Massachusetts).

Fonte told Medical Device Daily that Freeman has given him ongoing direction and a range of critical coaching help that he couldn't have gotten without paying out the financial resources that he doesn't yet have.

Fonte is one of two entrepreneurs the other being Sal Braico, CEO of another start-up, Flex Biomedical (Boston) who last week became IGNITE's first two "graduates." And both provided unqualified praise of concerning the push they believe the program will give them to reach eventual success.

MX Orthopedics is developing the Memory Alloy (SMA) Hip Implant, Fonte describing it as a self-locking device designed to improve implant stability as part of an arthroplasty procedure. The SMA Implant, once inserted and warmed by body temperature, expands and locks against the inner surface of the metaphysic.

Fonte says his father has been an entrepreneur in the aerospace and nuclear sectors, and that med-tech is all over the Massachusetts region, but these didn't give him knowledge concerning the necessary entry points to the particular sector targeted by his orthopedic device.

"You can have an idea that sounds good," Fonte says, "but nobody's going to listen unless you have orthopedic physicians who join you on a scientific board, and so prove to VCs that you really understand the space."

Fonte says that Freeman provided him a variety of important guides, citing two instances in particular: initially, helping him to hone his business plan for the med-tech eyes that will look at it from every direction, especially under a specific ortho microscope; and then emphasizing the importance of developing key industry contacts who will champion the company's technology, thus giving it important credibility.

He and Freeman then proceeded to meet with some of these contacts. Those meetings were a bit "intimidating," Fonte acknowledges, citing his not particularly high-level status as a student in graduate school and a mere tadpole in the big entrepreneurial pond.

"Here I am trying to tell them about the next best thing," Fonte says, "but Don was next to me. That was reassuring and gave me the credibility to talk to these orthopedics experts to join my team."

These conversations resulted in formation of an advisory board, consisting of four authorities in orthopedics: John Richmond, MD, chairman of the department of orthopedics at New England Baptist Hospital (Boston); Henrik Malchau, MD, PhD, co-director of Harris Orthopaedics Biomechanics & Biomaterials Laboratory, Massachusetts General Hospital (Boston); Edward Rodriguez, MD, PhD, chief of orthopaedic trauma, Beth Israel Deaconess Medical Center (Boston); and Carl Kirker-Head, director of the Orthopaedic Research Laboratory at Cummings School of Veterinary Medicine at Tufts University (Grafton, Massachusetts).

Fonte says this kind of support has "a domino effect once you get these orthopedic guys, this opens the doors to talk to the VCs."

Braico echoes Fonte's opinion of IGNITE and the mentoring that he received, also from Freeman, especially in developing important contacts.

"Don has been here years and years," he says, so able to provide valuable insights — and introductions.

Flex is developing a polymer that is being engineered to replace hyaluronic-based products currently being used as a joint lubricant for those suffering arthritis.

The clinical results and data for the hyaluronic products have not been particularly strong in treating osteoarthritis, according to Braico, while the new Flex polymer has produced superior results in preclinical testing.

Flex has received $200,000 in funding from Boston University essentially the incubator for the polymer product, since developed by one of its senior scientists and a Flex co-founder — and Braico says that the company will receive additional grant money from the National Institutes of Health later this summer.

And Braico says he currently is pursuing the additional funds needed to take the product into clinical trials, a path he believes Freeman's contacts will help smooth.

Laura Allen, executive director of the IGNITE program, says that despite the intense entrepreneurial activity and expertise in the Massachusetts med-tech community, MassMedic saw the need to provide the region's entrepreneurs a highly customized strategy.

"We really wanted to take much more of a comprehensive approach in how we were supporting entrepreneurs and use the collective expertise embedded in our membership," Allen told MDD.

The organization first "benchmarked various models around the country," that research supporting the one-on-one coaching approach at the core of IGNITE. This is then further bolstered by the more traditional seminar/symposium types of activities.

Through matching the mentoring of an experienced CEO and a new entrepreneur, Allen says the goal is "to establish all the critical early building blocks — understanding what the market opportunity is, what sort of business plan and milestone achievements to reach to successfully move forward." Important is the creation of a "value proposition" that will catch the eye of investors.

"As we were starting this process and deciding on the model, we reached out to people who had been successful and were interested in giving back, reaching back, to support up and coming entrepreneurs.

"We specifically asked if they would be willing to volunteer their time to offer as a free program."

The result: "We have terrific industry leaders who have joined us in this effort."

The effort received a boost earlier this year with a $150,000 Regional Priority Grant from the John Adams Innovation Institute, the economic development division of the Massachusetts Technology Collaborative.

Including MX Orthopedics and Flex Medical, IGNITE is currently working with a handful of start-ups, Allen says, and is currently looking at about 26 applicants to the program "vetting" them to determine the ones with the best ideas and greatest chance for success and hopes to increase participation to perhaps a maximum of 10, at any one time.

Summarizing, Allen bills IGNITE as "a one-stop-shop for all of the needs an entrepreneur would have in building their organization. It taps into an extensive network of knowledge, of expertise, both prohibitively time-consuming and expensive for them to put together for themselves."

The "graduation" from IGNITE, held last Thursday, was not the end, but just one more step in the process, with a panel listening to the value-proposition-presentations by Fonte and Braico, the two giving brief presentations of their companies and panelists in turn supplying critiquing and further coaching feedback on their ideas and presentation.

As a brief exercise, MDD asked the two to place their ventures on a scale of 10 1 indicating initial idea, 10 profitable sales.

Fonte put MX Orthopedics only at a 2, but said, "I really don't think I'd be where I'm at today I couldn't have been where I am today without this help."

Braico put Flex Biomedical at a 3, but saying there was "no question" that IGNITE has given the company a large chance to eventually reach a 10.