A Snapshot of the 10x Medical Device Conference
What do you get when you take medical device enthusiasts from across the country and abroad and place them in a scenic location for three days in sunny San Diego? The 10x Medical Device Conference. In its fourth year, 10x is the annual networking event of LinkedIn’s Medical Devices Group. The event, which took place May 2-4, 2016 at the Courtyard San Diego Airport, is the brainchild of Joe Hage, a medical device marketer with a penchant for bringing people together. On the first day of the event, conference goers were treated to workshops, a keynote speech, and the manufacturers’ showcase. In the morning, attendees heard from consultants Robert Packard, Nancy Knettell, and Maren Nelson about the intricacies of a 510(k) FDA submission. The 510(k), required for class II medical devices, shows that a medical device is safe and effective for human use. Knettell particularly spoke about software documentation requirements for a 510(k) submission. “Your software is a death dealing X-ray,” Knettell quipped, reiterating that even though software isn’t implanted in the body, its documentation is just as important as that of an implantable device.
Medical device reimbursement was another workshop topic. As insurance costs skyrocket and insurers become stricter on what they will cover, reimbursement is now more important than ever. Nicholas Anderson, an analyst at Intermountain Healthcare, explained that many product manufacturers do a poor job at showing clinical utility, which insurers require to pay for a medical procedure. Anderson explained that in the case of one product, only one in 58 patients benefits from the treatment. If the insurer pays $600/treatment, that’s almost $35000 in costs to the insurer!
During the afternoon session, attendees learned about neuro sales and marketing strategy. Mike Sperduti, the workshop’s facilitator, is a serial entrepreneur who has sold two companies. He teaches people how to approach potential customers to generate greater sales. Sperduti advised attendees to focus on customers’ communication styles. Visual, auditory, kinesthetic, and digital communicators must be approached differently to get their attention and sell to them. For instance, according to Sperduti, digital communicators want to see clinical data, independent reports, and white papers before making a sales decision. Auditory communicators are swayed by testimonials from those they trust. Sperduti even told the audience about language to use when addressing different communicators. For auditory communicators, he suggested using words that connote sound, like “I’ll talk to you later,” “Does that sound good to you?” and “I hear what you’re saying.” If you don’t know the communication style of the person you’re contacting, use all of them!
A buzz was in the air during the evening’s manufacturers’ showcase. Following a full day of workshops and a keynote by NeuroVigil’s Dr. Philip Low, attendees blew off steam by chatting amongst themselves over beer, crackers, and various cheeses. None of the latter were stinky. The products in the showcase varied from software to measure body composition to a negative pressure chronic wound treatment system to a contraption that uses laser technology to turn brown eyes blue. Didn’t know that was a thing? Me neither.
The second day of the conference started off with a bang, as David Amor of MedEngineering talked about Theranos, the now infamous medical diagnostic company whose technology is currently under scrutiny. Theranos initially promised that its technology could read over 100 blood tests with a single drop of blood in less than 15 minutes. However, a Wall Street Journal article from 2015 brought the company’s claims into question. The FDA wasn’t kind in its assessment of Theranos, either, hitting the company with two Form 483 reports, citing deficiencies in its quality systems. Amor’s talk was essentially a seminar on how a company maintains proper internal quality and regulatory policies. Another highlight of the day was the presentation by 3D Systems Healthcare’s Katie Weimer. It’s an especially exciting time for 3D-printed medical devices, as over 70 of them currently have FDA clearance. Everything from orthotic braces to seizure medication are being produced using this technology. Weimer eventually sees medical devices being printed in the hospital while the patient waits. How cool is that?
The third and final day of the conference did not disappoint. It started off with a classic David and Goliath story – Joseph Gulfo against the FDA. Gulfo’s former company, Cardima, challenged the FDA on the rejection of its flagship product’s regulatory application. Cardima eventually triumphed after years of fighting, leaving Gulfo believing that the FDA has no sense of urgency in resolving issues. According to him, the FDA is preoccupied with creating new rules instead of enforcing the old ones.
The FDA may need to formulate new policies if Liz Parrish and Bill Andrews have their way. Parrish, of BioViva Sciences, and Andrews, of Sierra Sciences, are interested in extending human life. How will they do it? They are working on lengthening cells’ telomeres, which naturally shorten with age and become senescent. People die when they have too many senescent cells. The companies’ collaborative effort involves adding a gene to a vector, with the vector being directed into cells. The cells then produce telomerase, which will lengthen telomeres. The goal is for the elderly to live longer and healthier lives. Perhaps one day 100 years old will be considered middle age!
Perhaps the highlight of the last day was the pitch presentations. Three companies, AlphaVets, NeoLight, and Conceivex got the opportunity to pitch their companies to Jeffrey Kraws of Crystal Research. An avid investor, Kraws critiqued the pitches so that the companies could improve them for future investor presentations. The audience even got in on the fun, offering its advice to the fledgling companies. Afterwards, career coach Janet Andrews gave attendees sage advice on their career paths. She implored audience members to keep their networks informed of their status, stressing that “85% of jobs found are through referral.”
It wasn’t difficult to run into people who have been attending the 10x conference since its inception. What keeps them coming back? The compliments were aplenty. “The mix of content and free time” said one attendee. The conference was “…the least stuffy conference I’ve attended” said another. One attendee “…paid attention the whole time.” For those who regularly attend conferences, that’s quite a feat!
As this was my first time attending 10x, I didn’t know what to expect. At its conclusion, I was so glad that I was there. Starting last year, the conference has been held in San Diego and will be held in San Diego for the foreseeable future. The conference is the ideal forum for networking and learning about the latest and greatest in medical devices. Want to learn more about 10x? Visit http://medicaldeviceevents.com/.
Neil Thompson is a writer, patent agent, and notary public among other things. You can read his musings on his blog “I’m not an expert. I’m just a guy who likes to think about stuff…” at neilithompson.com.