TheBridge profile: John Robert Luna
Name: John Robert Luna
Current city: Bellevue, WA
Current job: Chief Executive Officer at Nuheara
Past job: Chief Revenue Officer and President Americas at Nuheara; Chief Business Development Officer at Eargo
Q. How are you (or your company) currently bridging the gap between innovation and regulation? Innovation can sometimes function in an unregulated environment with standards guidelines for safety and effectiveness, but with regulations constantly evolving and some products, like Nuheara’s, being affected by FDA guidelines and published rules, regulation becomes the driving factor in product and commercial success. Compliance with regulations drives consumer confidence and satisfaction with a product or software in medical device solutions because complying to the standard proves reasonable assurance of product safety efficacy. I work with regulators, policymakers, lobbyists and stakeholders as an industry expert and leader to drive innovation as an active member of the Consumer Technology Association (CTA) and Consumer Healthcare Products Association (CHPA). I serve as Chair of the CHPA Medical Device Committee and also served as Chair of the CTA Technology and Standards working group for the ANSI/CTA 2051:2022 standard for Over-The-Counter Hearing Aids and Personal Sound Amplification Products. Standards and policies that provide a roadmap and guardrails for manufacturers, compliance, and regulatory issues, as well as consumer efficacy for regulated and unregulated devices and software applications (apps) will continue to evolve. It is critical to have team members and resources that can navigate the regulation to bridge the innovation available to meet compliance of the regulation to be successful. Wearable technology and digital health innovations that are inclusive of either software in a medical device (SiMD), or separate from the device, software as a medical device (SaMD), will continually require a balance between innovation and regulation to ensure public safety and efficacy. It is an exciting time to be in digital health and medical devices.
Q. Job advice in three words? Ethics, Integrity, Candor
Q. What can innovators learn from policymakers? Policymakers love innovation and out-of-the-box thinking. Innovators that involve policymakers and their constituents in the process drive support for innovation. It drives investment in time to focus on the change brought about by the innovation. Innovation matters when you participate in the process - and this is goes to the highest levels of corporate policy, local policy, and Federal government policy. Each person involved in the process has a personal connection to the technology or other innovation. We all know someone in our lives and each policymaker knows someone in their career personally or a constituent that will benefit from the innovation. That is what we have to remember when we present ideas and concepts driving to bring them to market or driving to make a change in policy to allow Americans to benefit from our innovations. Finally, policymakers have the vision beyond the innovation from a legislation or regulation standpoint which can provide the roadmap to executing on the innovation. Listen and learn, as it will help innovators gain a bigger insight.
Q. What can policymakers learn from innovators? The policymakers I've encountered and spoken with on behalf of the consumer technology and consumer medical device products industries always present as thankful to being informed and included by innovators. They want to know what is important to a constituent and new solutions available through innovation. Each has a personal story, as mentioned previously, of how Americans to benefit from our innovations. Most importantly, when we can bring change to the Senate and House members in a bipartisan manner, we all win when all Americans have the support from their representatives in D.C. up to the President of the United States. This is encouraging and what I've witnessed and experienced over the past 5 years working toward changes to access allowing affordable over-the-counter hearing aids to Americans for the first time ever in the U.S.
Q. Can you describe a skill you have carried throughout your career that has always proved to be valuable? One skill I've carried throughout my career is to lead at what you enjoy and excel at within a company, peer group, committee, or any aspect where you feel your input will provide value and incremental change. Basically, participation in the process as a leader to achieve the outcome for the team or stakeholders.
Q. Favorite spot for a coffee meeting? Roche Harbor, San Juan Island, Washington State at sunrise
Q. Do you have a favorite book you’d like to recommend to TheBridge community? Blue Ocean Strategy: How to Create Uncontested Market Space and Make the Competition Irrelevant by W. Chan Kim and Rene Mauborgne
Q. Every day is probably different, but are there certain skills that are essential to your job? C-Level Executive and Board experience, Compliance and Regulatory experience, Fundraising and Start-Up Experience, Global leadership
Q. Looking back, what advice would you give yourself in the beginning of your career? The advice I'd give myself is to enjoy every phase of your career, but to take time to decompress each day, week, month. Early in my career, like most of us, I worked nonstop, traveled on weekends to get to the next scheduled meeting, and didn’t take time for myself. On balance, I'd say "slow down and enjoy the career and the other aspects of your life that bring you happiness and wellbeing."
Q. Most underrated virtue in an employee? I think the most underrated virtue in an employee is their desire and inherent goal to do the best at the task at hand. More importantly, as employers, we need to provide the training, guidance, management and support to allow each employee to succeed and ultimately the team, projects and company will then succeed.
Q. Do you have a favorite app? My favorite app is a global time zone scheduling app called "Miranda".
Q. When was the last time you completely unplugged? The last time I completely unplugged was in August 2022 when I took a solo camping trip for kayaking and fly fishing in the Cascade Alpine Lakes Wilderness of Washington state. The beauty of the location I chose to unplug is its "No Cell Coverage" and "No Internet Access". I recommend taking time away from your mobile phone and email whenever practical to "unplug".
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