A TEAM WITH EXPERTISE
The MSDx team has the necessary scientific and industry expertise, and the flexibility, commitment, and passion needed to navigate the challenges and build a successful company. The company has a talented operating team, an involved board, and a thought-leading Clinical Advisory group.
Marie Wesselhoft, President and Co-Founder
Marie Wesselhoft brings extensive healthcare market experience and a successful track record in general management within large market-leading companies and new business ventures. Her early career started as a hospital laboratory director for Humana Hospitals. Marie held senior leadership positions in the diagnostics and medical surgical businesses during her twenty-year career at Cardinal/Baxter/American Hospital. In her role as general manager of the Scientific Products, Marie was responsible for the $850 million diagnostics business including the management of a 120+ sales team and a 20+ marketing organization. Throughout her career she has had multiple opportunities to launch $30-50M product lines, negotiate partnership agreements, manage key accounts, as well as in facilitate the integration of teams for acquisitions and divestitures. Most recently Marie served as the Director for the Arizona Center for Innovation, a high-tech business incubator located at the University of Arizona. She currently serves on several boards including the Academy Village Service Corporation, BIOSA, UA Tech Launch Arizona, and Allendale Home for Children.
Ramesh Nayak, PhD, Director of Research
Dr. Nayak has a 30-year career in Immunology and Neurology. He was a doctoral student in the Department of Neurochemistry, Institute of Neurology, Queens Square London. He was a Research Fellow, Harvard Medical School, Assistant Professor, Harvard Medical School and Tufts University College of Medicine and Staff Investigator, Joslin Diabetes Center in Boston and Research Associate Professor, Department of Ophthalmology, University of Arizona. He has published over 30 original publications, over 15 editorials/reviews and 50 abstracts on Immunohistochemistry, Immunocytology and autoimmunity. Dr. Nayak leads the MSDx efforts in research and the innovative biomarker technology.
Vanessa White, MS, Research Associate
Vanessa White began her career in medical diagnostics after completing a Professional Science Master’s in Applied Biosciences from the University of Arizona in 2014. She brings six years of engineering experience following a Bachelor of Science in Electrical Engineering from the University of Wisconsin-Milwaukee. Her work included design, verification and FAA certification of airborne electronics products at Astronautics Corp. of America in Wisconsin.
Melita Ball, Director of Regulatory and Quality
Ms. Ball has over 25 years’ experience in regulatory compliance and quality systems. She held Corporate Director-level leadership positions in Quality and Regulatory Compliance for Medical Device and Diagnostic companies for 17 years before she opened her consulting firm in 2006. Since then, MBCA has become well-known in the industry for helping clients tackle the most challenging compliance issues facing Medical Device and Diagnostic companies today.
Ms. Ball serves as the company’s Principal Consultant with demonstrated expertise in Regulatory & Quality Training, Remediation, Warning Letter mitigation, Quality System Development, 21 CFR Part 11, Software Validation, Supplier Qualification & Management, Supplier Quality Auditing, CAPA, Management Controls, Internal Quality Auditing, FDA Mock Inspections, and Project Management. In addition to serving as an American Society for Quality (ASQ) Auditing Body of Knowledge instructor for many years, she continues to teach public and private courses for all areas of Medical Device and IVD Quality Auditing (FDA, ISO, CMDR, MDD, JPAL, TGA, and ANVISA). Ms. Ball also continues to perform a number of quality and supplier audits worldwide on a regular basis.
Melita has worked with a number of start-up companies as well as Third Wave Technologies (now Hologic); Siemens Healthcare; Ethicon Endo Surgery (a J & J company); Varian Medical Systems; Boston Scientific; Medtronic Diabetes; Stryker; Arthrex; Nypro (a JABIL company); Intuitive Surgical, NuVasive; Ventana Medical Systems; and Life Technologies. As Director of RAQA, Melita Ball works with the company to implement our cGMP Quality System and lead our FDA pathway of a Class II, 510K cleared product. She provides regulatory oversight of the clinical studies, site audits, and regulatory adherence.
Betty Weaver, CPA, Financial Controller
Betty Weaver has over 15 years in public accounting with a regional firm in the Dallas/Fort Worth area, including several years as principal of her own accounting firms in both Arizona and Texas. She provided tax, review, and consulting to both public and private companies. Her career also includes over 11 years in industry. Industry experience includes both public and private companies in Operations Management, and as Controller or Chief Financial Officer. As Controller, Betty Weaver provides financial management of MSDx.