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    Columns

    Rising to the Challenge: Six Innovators Win Fast-Track Support to Market

    These six winning submissions reflect a keen awareness of patient needs during the unique and surprising circumstances of the COVID-19 pandemic.

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    Dawn A. Lissy, Founder & President, Empirical07.21.20
    You’ve lived the lockdown. You’ve seen the memes. If like me, you’re also fresh off of unscheduled homeschooling, testing employees for COVID-19, canceling gatherings crucial to building your business, and are deeply disturbed by social and political turmoil in the United States, I’m sure you could use a little good news to lift your soul. I’ll share two tidbits that give me hope:
    • The year is now half over. I make zero predictions about it getting better. But I feel confident as long as the world doesn’t run out of wine, I can survive short supplies of toilet paper.
    • I have received and reviewed compelling proof that the men and women who make up the medical device industry are not only professional badasses, but also kind, generous people who are restoring my faith in humanity.
    Point 2 stems from the results of the “For Such a Time as This – OrthoChallenge.” This was a contest launched by and for members of our professional community designed to offset the ripple effects of the pandemic, namely prolonged pain and decreased mobility for patients whose surgeries are being postponed due to COVID-19 shutdowns. Experts from across our industry donated their time and expertise to encourage new ways to improve patient experiences and outcomes in our brave new world.

    I was one of several contest sponsors, and I’m looking forward to supporting our six winners through my company, Empirical Technologies Corp., to fast-track the winning entries to the marketplace. The winners will also be featured on OREF TV and Venture Capital TV thanks to the Orthopaedic Research and Education Foundation. Also lending their professional expertise are InMotus Medical, MendMedical, KCK Group – Medical Technologies, and IntuitiveX.

    We’re all working to get these innovations to the patients who need them as quickly as possible. Each of our six champs came up with a way to safeguard patients’ health and well-being of, as did dozens of other entries that vied for fast-track support on short notice.

    Our winners include:
    • Mouhanad El-Othmani won for the Nutritional and Physical Therapy Programs for MSK Patient at Risk of Obesity and Weight Gain. This platform for nutrition and physical therapy programs is designed to help patients lose weight while awaiting surgery using a well-balanced, customized nutritional plan and exercise program guided by healthcare professionals.
    • Fred Ferlic devised the TayCo External Ankle Brace. This device provides stability and balance for ankle/hindfoot problems by fitting over the patient’s shoe or boot to enhance safe mobility for patients awaiting surgical treatment. It also helps prevent muscle deconditioning and gait changes that can occur with prolonged immobility.
    • Ryan Grabow created the Battle Born Maker Corps Stay Strong Face Shield System to reduce the risk of virus transmission before, during, and after surgery. It provides excellent protection for both patients and healthcare workers by covering the face, head, neck, and upper torso during close patient contact.
    • Thomas Myers developed the UVC-LED Viral Inactivation Protocols for Healthcare Provider Protection. This system uses specific wavelengths of LED technology to inactivate RNA viruses. It’s the source of new protocols for preventing the spread of viruses to reduce risk for patients undergoing surgery as they move through the hospital before, during, and after surgery.
    • Josh Rabinowitz submitted the Movement-Synchronous Muscle Stimulation for Out-of-Clinic Muscle Strengthening & Activation, which provides personalized, movement-synced electrical stimulation to enable patients to retain muscular function during limited physical activity as they await surgery.
    • Ronald Triolo, Stephanie Bailey, and Frank Zitko entered the Self-Leveling Walker for Safe Stair and Ramp Mobility. This device adjusts to match stair height or incline angle to help patients with limited physical capability independently navigate their environment until they can get the surgery they need.
    These innovations should make for a better patient experience, said Joseph D. Zuckerman, contest sponsor, past-president of the American Academy of Orthopaedic Surgeons, and chair of Orthopedic Surgery, NYU Langone Health.

    “I congratulate all of the winners for their creativity and ingenuity,” Zuckerman said. “This is truly an impressive group. They have all ‘risen to the challenge’ with solutions to make life better for those in need.”

    Audrey Beckman organized the selection panel. She’s a consultant whose career has spanned an impressive spread of leadership roles at Zimmer and Zimmer Biomet. Like me, she was touched and floored by the number and caliber of submissions from people who jumped on a contest with no financial prize but a shared purpose to do better by patients.

    “These six winning submissions reflect a keen awareness of patient needs during the unique and surprising circumstances of the COVID-19 pandemic,” she said. “The selection panel gave thoughtful consideration to all the submissions, but these stood out in their potential impact to patients, their novelty, and their practicality. Like any new technical advance, the path to broad commercialization is sure to be filled with bumps, but the impact to patient care will be welcome.”

    Raymond Cloutier, founder and CEO of NovApproach Spine, has worked diligently for the past several months to launch and promote the contest to get relief to patients in surgical limbo. Now he’s cheering them on to speed these products and processes to market.

    “The OrthoChallenge asked innovators to solve a problem that previously didn’t exist for patients,” he said of the hold on elective surgeries. “This was a tough assignment. Executing the development work to bring these improvements to patients will likely also be difficult for the innovators. I am very grateful for all the volunteers and donors of the OrthoChallenge.” 

    For me, this contest has been a much-needed and warmly welcomed reminder that we’re all in this together, and when we focus our collective brains on the common good, we all win. 


    Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
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