Mark Luhovy, Md Email & Phone Number

Brisbane, Qld, Au

Boston, Massachusetts, Us

Strategic digital healthcare & biotech consulting. Focus on digital health product strategy, early-stage enterprise establishment and operational strategy, medical device regulatory submissions, program management and healthcare innovation group consultation. Support via Advisory, Strategic or Operational roles.- Ghostwriter and regulatory consultant for medical software company- Regulatory consultant focused on introduction of IVD products into USA market via EUA/510(k) pre-market submission pathways- Biomedical Engineering Textbook: Medical Device Design, 1-3 chapters (pending review & publication by Springer)- Digital Health Advisory - Medtech SME consultations

Boston, Massachusetts, Us

One of two consultants responsible for driving the EU-MDR remediation of Iridex Corporation, with emphasis on the quality management system and post-market surveillance landscape of ophthalmology and ENT portfolios.

Boston, Massachusetts, Us

Responsible for designing and directing cross-functional activities for six teams (30+ personnel) in support of digital transformation and EU-MDR regulatory efforts for all J&J Hospital & Medical Device (HMD) products. Workstream Lead, driving EUDAMED UDI regulatory submission for three J&J HMD Franchises (Ethicon, Cardiovascular & Specialty Solutions, DePuy-Synthes). Harmonizing supply chain operational processes across >20 companies while coordinating the submission of >100k product codes and all associated UDI product data, per MDR EU 2017/745. Remodeling J&J HMD product data landscape via the coordinated build, validation and implementation of an automated, machine-learning digital solution.

Adelaide, South Australia, Au

Advisor to visionary technology startup combining Neuroscience, AI, and XR for increased productivity and brain flow statehttps://vimbal.ai/

Advisor to early-stage digital health startup focused on helping expectant and new mothers conquer challenges encountered during the prenatal and postnatal journeyhttps://www.getmevi.com/

Sydney, New South Wales, Au

Provide domain subject matter expertise to advise and shape national policy papers focused on Australian digital health, including Safe and Responsible AI in Australia, National Digital Health Strategy, Delivery Roadmap.The Digital Health Advisory Group (DHAG), with the support of the Medical Technology Association of Australia (MTAA) has come together to advocate for an information and communications technology (ICT) enabled health system for Australia. The DHAG vision is – “a healthcare system enabled by technology” with a purpose “to drive the implementation of an ICT enabled service delivery framework for a healthier Australia.”

Kalamazoo, Mi, Us

Drive digital health R&D efforts within a public-private research partnership comprised of industry (Stryker), government (Queensland Health), health system (Metro North Health), and academic (Queensland University of Technology, University of Queensland) stakeholders. Engage with digital health innovation ecosystem at local, regional, national and international levels. Provide insight and subject matter expertise to digital health strategy. Direct and/or contribute to multiple R&D use cases: precision health SaaS platform development, federated learning, ambient intelligence, medtech living lab.

Plasbotics pursued commercialization of the company's patented vacuum-assisted retractor for robotic assisted surgery (RAS). Our technology was invented by a 20+ year plastic surgeon who grew frustrated with the lack of quality retractor options available in breast and soft tissue surgical procedures. We actively worked to co-develop and commercialize our patented product concepts and also provided consultative services on soft tissue surgery, medical product development and advanced robotic instrumentation efforts across healthcare.

New York, New York, Us

PhenoMx, a digital health startup, developed a Personalized Digital Physical Examination platform to measure major vital organs & tissues of the whole body via quantitative imaging. Using non-invasive MRI, the company aimed to push boundaries of precision medicine, personalized wellness & human longevity, while offering healthcare systems strategic products focused on addressing social determinants of health.

Brisbane, Queensland, Au

Championed statistical review of population-based study for >1700 patients diagnosed with pancreatic cancer. Efforts aimed at correlating symptom patterns at diagnosis with TNM tumor staging and clinical outcomes.

Boston, Ma, Us

Developed, implemented and managed multiple concurrent Six Sigma Quality Improvement projects. Served as Chairman of the Quality Systems Project Steering Committee, attended by executive-level management.

Lübeck, Schleswig-Holstein, De

Maintained post-market regulatory vigilance by investigating Monitoring/IT product complaints per 21 CFR 820/822. Coordinated cross-functional team (CFT) post-market surveillance investigations and contributed to daily Scrum meetings. Designed and provided leadership on numerous Six Sigma process improvement projects.

Raynham, Ma, Us

Acted as contract project engineer for USA and Johnson & Johnson Tokyo colleagues, preparing premarket technical regulatory submissions to Japan PMDA supporting spinal implant portfolio registration (>100 products) for Asia-Pacific market.

Partner of startup design consulting group with project-based revenue model. Contracted with client organizations and provided innovative CAD deliverable and business strategy solutions.

St. Paul, Minnesota, Us

Provided technical and clinical expertise on implantable cardioverter defibrillator (ICD), pacemaker and cardiac rhythm management products. Trained engineering and sales staff by presenting in-depth product knowledge during quarterly teaching sessions.

Bozeman, Montana, Us

Conducted toothpaste prototype research on behalf of Colgate-Palmolive, regarding efficacy at removing plaque from excised human teeth. Created CAD enhancements to bioreactor model for improved performance. Presented findings at Colgate R&D headquarters.

Cleveland, Ohio, Us

Investigated bioprosthetic aortic valve durability via uniaxial mechanical testing after biochemical treatment. Drove research under the world's "leading authority on prosthetic heart valve design and tissue engineering." Created novel biochemical tissue treatment protocol.

Doctor Of Medicine - Md

Premedical Program

Bachelor Of Science - Bs, Biomedical Engineering