Team
Dr. Steve Levine is the founder of dB Diagnostics, inventor of Hearing Healthcare Pro™ Product Suite, and majority shareholder. He is an otolaryngologist (Ear, Nose & Throat) with more than 35 years’ experience and former Assistant Clinical Professor at Yale University School of Medicine. He has been listed by Castle Connolly as a Top Doctor for more than 20 consecutive years, and has been named such in New York Magazine, US News and World Report, and others. Levine has served on the Board of Governors of the American Academy of Otolaryngology-Head & Neck Surgery including its Executive Committee at an elected post, and has been granted both an Honor Award and Distinguished Service Award from the Academy. He has been a past president of the Connecticut Ear, Nose & Throat Society and is a Council Member of the Connecticut State Medical Society. Levine organized and created HearOPG, a consortium of independent hearing aid retail businesses connected to otolaryngology practices mostly in Connecticut. He is a founder of ATSS, a software development company formed in 1993 that created a black box interface for revenue cycle management systems and electronic medical records to generate accurate evaluation/management service CPT billing codes. He was a Director of the Connecticut Bank of Commerce, a public bank that focused business on asset-based lending and accounts receivable financing. Levine is a co-founder of the Society of Physician Entrepreneurs (www.sopenet.org) and Chapter Leader of the New York TriState Chapter of that Society. He has a BS from the Sophie Davis School of Biomedical Education at the City College of New York and MD from the University of Rochester. Levine did residency training at University of Pennsylvania.
Bob Rudolph manages all technologies at dB Diagnostics and has 35 years of experience as an IT Manager, Director, and Data Warehouse expert. He has directed software development at dB Diagnostics starting at its very beginning. His background includes working in both the public and private sectors in the IT industry including technology, infrastructure and strategic business applications. His experience includes extensive Fortune 100 IT experience which spans healthcare, insurance, Medicare/Medicaid, pharmaceutical, defense, manufacturing, banking, retail, and utilities sectors. Companies with which he has direct IT experience includes Centers for Medicare & Medicaid Services, Tenet Health Care, Hackensack Meridian Health, Amwell, Anthem Blue Cross, Aetna, Cigna, MedStar Health, Mass Mutual, Travelers, Pfizer, GM-AC Delco, Office Depot, Citigroup, GE Financial, Wells Fargo Financial, The Hartford Insurance Group and Dell Services. Bob also has start-up experience in the healthcare industry from inception thru support. He has a BS from Central Connecticut State University.
David Rothkopf has more than 35 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Founding Principal at MEDIcept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. His expertise includes technical and hands-on knowledge in a variety of regulatory, compliance management, and quality process. He has performed over 450 ISO 13485 and FDA-style audits in the past 25 years. David has submitted over sixty-five 510ks and PMAs and, with other MEDIcept personnel, has developed nearly 150 submissions. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and Hazard Mitigation throughout a product life cycle. David has also taught classes at international RAPS, ASQ, and SQA meetings. He is also an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a visiting Regulatory Affaris professor at University of Texas, Dallas, a mentor for MassChallenge Accelerator and NIH's NHLBI Catalyze Program, and now advises Doctoral students at Johns Hopkins Whiting School of Engineering on Medical Device Regulatory Affairs. In addition to being President of MEDIcept Inc., David is President of SON Medical, a medical software consulting firm, a shareholder advisor for three device companies, and a partner in two orthopaedic device companies. In the past, David was instrumental in founding and selling three medical device companies. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from Worcester Polytechnic Institute in Massachusetts and an MBA from Boston University.
Richard "RJ" Nakkula currently serves as the primary Biomedical and Acoustic Engineer at dB Diagnostic Systems, where he supports the company's technological initiatives in product R&D, device functionality, and testing. With over 7 years of experience in the highly regulated biomedical and aerospace industries, RJ brings a wealth of unique expertise and perspective to each project.
His diverse skill set includes software project management and medical device design, prioritizing patient outcomes and the ease of clinical adoption. Presently, he is collaborating with airline seat suppliers across 5 countries to ensure compliance with FAA/EASA regulations, demonstrating his adeptness in navigating complex regulatory environments.
RJ's passion lies at the intersection of engineering and business. With aspirations to drive impactful entrepreneurial innovation, he is pursuing an MBA to merge his skills and values. RJ holds both a Master's and Bachelor's degree in Biomedical and Mechanical Engineering respectively from the University of Michigan.
Michele Johnson’s 30 years’ experience includes Internal Auditor for North Carolina National Bank (Charlotte, NC), Corporate Finance for Chrysler Corporation (Detroit, MI), and General Manager of Bruce Campbell Dodge (Detroit, MI). Based in Connecticut, she has owned her own bookkeeping and financial analysis company since 2005 and published the book, “Building a Stellar Business: A Structured Guide to Financial Success”. Michele has a B.S. in Accounting from UNC-Greensboro and an MBA from Indiana University.
Scientific Advisory Board
Dr. Seilesh Babu is board certified in adult and pediatric Otology, Neurotology, Otolaryngology and Skull Base Surgery. Specializing in the medical and surgical treatment of ear and skull base disorders in both adults and children. His clinical interests include ear infections, hearing loss, dizziness, facial weakness, cochlear implants, and acoustic neuromas. Dr. Babu is currently the President and senior partner at the Michigan Ear Institute and has a joint appointment as an Assistant Professor in the Department of Otolaryngology at Wayne State University School of Medicine as well as the Oakland University/William Beaumont Medical School. He also serves as program director for Ascension Macomb Otolaryngology Residency Program. Dr. Babu is a member of the Michigan Otolaryngology Society and served as Past President and still an active board member. He is also a member of the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS), the American Neurotology Society (ANS), and the prestigious Triological Otolaryngology Society after having his research thesis accepted. He has been nominated to serve on a several national committees, including the AAO-HNS Otology/Neurotology Education Committee, the AAO-HNS Hearing Committee, the AAO-HNS Equilibrium Committee, as well as the Otosclerosis study group. He is an invited lecturer on various otology and skull base topics and collaborates with the medical industry on surgical design of instruments and devices. He has been the principal investigator for numerous clinical studies, including those involving Meniere’s disease, tinnitus, otosclerosis, cochlear implants and other implantable hearing devices. He has authored over 70 peer-reviewed journal articles, over 15 book chapters, and is the co-editor of 3 Otology and Neurotology textbooks. He serves as a reviewer for several prestigious journals, including Otology & Neurotology and Laryngoscope.
Dr. Sujana Chandrasekhar is certified by the American Board of Otolaryngology with subspecialty certification in Neurotology. She practices at ENT and Allergy Associates, LLP in New York, NY and Parsippany, NJ. She is Clinical Professor at Hofstra-Northwell School of Medicine, Clinical Associate Professor at Mount Sinai School of Medicine. She is Director of Neurotology at the J J Peters Veterans Affairs Medical Center. She is President of the American Otological Society, Past President of the American Academy of Otolaryngology-Head & Neck Surgery and Past Chair of its Board of Governors.
Dr. Hayes Wanamaker is certified by the American Board of Otolaryngology with fellowship training in Neurotology. He is retired after thirty-five years of teaching, publications in clinical and basic science research and clinical practice focusing on Neurotology in Syracuse, New York. He held academic appointments in Bioengineering and Neurosciences at the Institute for Sensory Research, Syracuse University, and SUNY Health Science Center at Syracuse, and served as Chief of the Department of Otolaryngology and medical staff president of Crouse Hospital. He also served as Chair of the Socioeconomic and Grassroots Committee of the American Academy of Otolaryngology-Head & Neck Surgery Board of Governors and president of the New York State Society of Otolaryngology.
Board of Advisors
Rich Marin is a 43-year finance, real estate, and venture capital industry executive who is currently a Managing Director at SEDA Experts, a financial services consulting boutique. He also is involved in managing private equity investments, consulting on major commercial real estate and attractions projects, and an expert in the retirement field. Within his career, he has been a senior executive at Bankers Trust Company, Deutsche Bank and Bear Stearns. His initial career spanned corporate finance, sales and trading, structured products, emerging markets, processing and several other disciplines. Later in his career he focused on building and running large asset management businesses in both the traditional and alternative spaces and in the institutional and high net worth markets. He has been a successful financial entrepreneur, involved in founding several venture capital firms (Beehive Ventures and Green Visor Capital) and a hedge fund (Ironwood Global). He has a BA in economics and government and an MBA in finance from Cornell, and is a retired Clinical Professor from the Cornell's Johnson Graduate School of Management where he taught on topics such as asset management, alternative assets, retirement and pensions and project financing, as well as a member of the faculty at University of San Diego.
Doris Nagel has more than 35 years of hands-on experience working with medical device companies. She began her career as an associate at the law firm of Sidley Austin, followed by positions at Baxter Healthcare, Allegiance Healthcare, and Cardinal Health. Since setting up her own legal services and consulting company in early 2007, she has helped mostly smaller and mid-sized device companies, including Ohio Medical, Devicor Medical, Fenwal, iRhythm, Briggs Medical, and Natus. She has worked with a number of startups, as well helped set up new start-up subsidiaries in at least 44 countries and selecting and managing distributors in more than 75 countries. She also spent 3 years at CDW as a special advisor, helping the company formulate and implement its international strategy, including its first international acquisition, Kelway. She has a wealth of transactional experience, having worked closely with international tax advisors, finance teams, and bankers on numerous cross-border acquisitions, divestitures, joint ventures, and global restructurings. As a practicing lawyer, she also assists companies with a wide variety of agreements, regulatory compliance and risk management issues. She is a former member of the board of directors of the International Trade Association of Chicago, a former SCORE Mentor, and a former adjunct professor of law at DePaul University. She currently is an instructor at the Illumeo Academy for mid-market tax, finance, and treasury executives. She is the author of a frequent blog on international expansion issues, and is also the former co-founder of startup companies MedEvolution and DocStudio, and also founded Globalocity, a consulting firm advising on indirect channels to market. She currently hosts a weekly radio talk show called “The Savvy Entrepreneur,” which features women and other diverse guest entrepreneurs and airs in the Chicago and Milwaukee areas.
Whitney K. Stearns, Jr. is a retired financial executive that is an active investor in early-stage companies. Whit has over 40 years’ experience in accounting and finance. The first decade of his career was at KPMG including being an Audit Partner. The next decade was at Schein Pharmaceutical where he became CFO, took through an IPO on the NYSE and guided the company to a sales transaction. Since 2000, he has served as CFO to a host of health care companies in both start-up and mature phases and was actively involved in multiple mergers and sale transactions. He received a BS in accounting from Lehigh University and was a CPA.
With over 35 years in the medical industry, Kevin Quilty has had a hand in building multiple organizations that launched unique medical devices and services. These products and services changed healthcare delivery in the fields of obstetrics, neonatology, cancer treatments and wound care. Kevin is currently Executive Vice President of Gentell, one of the largest vertically integrated wound care companies in the world. Kevin is responsible for product sales, distribution, and manufacturing operations at all Gentell locations across the United States and Canada. Previous roles included Senior VP Global Advanced Wound Care Marketing and Distribution at Derma Sciences Inc. a leader of Advanced and Traditional Wound Care products and Senior Vice President of Sales & Marketing for Endocare, Inc. where he developed the global strategy that successfully launched cryoablation technology for the treatment multiple types of cancer. Quilty’s solid foundation in medical sales and general management was built during these eight years at Baxter Healthcare in acute care hospital product sales and home healthcare products and services. In his community, Kevin offers his time as an active Trenton Rotary member, and volunteering time and labor with the Salvation Army Canteen that delivers food to the homeless in the Trenton, New Jersey area.