Who are we?

NaviDx Consulting creates unique value for the diagnostics industry through proven market-driven strategies.

OUR CORE VALUES

Collaboration

An extension of your team, we are a strategic partner committed to your business goals and commercial success.

Integrity

Everything we do has the best interest of your business in mind.

Commitment

We keep our promises and honor our commitments.

OUR TEAM

Leadership

Kim Arvanites

Co-Founder | Business & Commercial Strategy

Kim is an accomplished molecular diagnostics sales and marketing professional with over 25 years of IVD/Life Sciences experience. She has a proven track record in highly strategic positions at Beckman Coulter, Abbott Molecular, QIAGEN and Sysmex Inostics, developing and launching numerous IVD products throughout her career. Kim co-founded NaviDx in 2015 with a vision to help companies develop products that better meet market needs and improve patient care by refining the best-in-class practices from her corporate career and applying them to the NaviDx process. Kim received her BSc from DePaul University, mentors at University of Chicago Polsky Center for Innovation, co-founded AdVeritasDx and is a partner in Libertas Global.

 

Michael Reed, PhD

Product & Portfolio Development

Mike is an executive R&D leader with a diverse career of over 20-years directing product-focused life science and diagnostic research and development organizations. Mike has led the development and commercialization of over 300 products in genomic, cellular, hematology and rapid testing markets, providing him with a deep understanding of the practical requirements of commercializing products in highly regulated environments. He has leveraged this background since 2020 in support of the NIH RADx program and co-founding various start-ups, most recently joining Kim to expand the service offerings and reach of NaviDx. He has a PhD from the University of Adelaide and completed the Executive Program in Management at the UCLA Anderson School of Management.

 

Richard Creager, PhD

Co-Founder | Business & Executive Operations

Richard has more than 30 years’ experience in the in vitro diagnostics (IVD) industry. Richard has led the development and commercialization of more than 170 IVD products (assays and instruments) for infectious disease, cardiovascular disease, fertility, autoimmune disease, cancer, and women’s health in Executive roles at Seegene USA, Beckman Coulter Diagnostics, Sanofi Diagnostics and Kallestad Diagnostics. He used his deep experience in the industry to provide significant support to the NIH RADx program during the pandemic. Richard currently serves on the board of directors for the 1for2 education foundation and OnRamp Bioinformatics and has a B.S. from Muhlenberg College, a M.S. from Duquesne University, and a Ph.D. from the University of Pittsburgh School of Medicine. He also attended The Wharton School of Business for Advanced Management Program.

 

Market Intelligence & Strategy

Rachel Jones

Market Intelligence & Strategy

Rachel is a proven commercial executive with 27 years in the IVD industry leading commercialization organizations at Biofire, Karius Dx, and Co-Diagnostics.

Dave Kowalski

Market Intelligence & Strategy

Dave led strategic marketing functions at Abbott Molecular and Rapid Diagnostics for over 20 years, impacting millions of lives during the COVID pandemic.

Duane Newton, PhD

Lab Medicine & Public Health

Duane was the Clinical Micro Lab Director at Michigan Medicine for 18 years and has since leveraged that experience in Scientific Affairs roles at BioRad and NaviDx.

Carlos Merino PhD, MBA

Market Intelligence & Strategy

Carlos has had a diverse career over 15 years leading R&D, product management and strategic marketing efforts in genomics, infectious disease and microbiome markets.

Mark Boyle

Business Development & Strategy

Mark has over 35 years experience commercializing in

vitro diagnostic products for global healthcare markets in

Executive roles for Qiagen, Ellume and NAMSA.

Market Access, Quality & Compliance

Michele Schoonmaker, PhD

Market Access & Reimbursement

Michele is a recognized leader in market access strategy with 25 years of public & private experience driving reimbursement & policy strategies for IVD commercialization.

Marielle Lejcher

Regulatory Affairs

Marielle has over 20 years of IVD and related industry experience leading, developing and supporting regulatory and quality systems strategies.

Jose Rosado, MBA

Quality Management Systems

Jose is a seasoned QMS Executive with over 30 years of experience in class I, II and III IVD, RUO, Pharma and combination product environments

Bill Godfrey, PhD

Product Development & Manufacturing

Bill has over 30 years of experience leading R&D and product transfer teams in the development and commercialization of hundreds of products in many RUO and IVD markets

Dung Nguyen

Regulatory Affairs

Dung has had a diverse career leading regulatory affairs teams and strategies for 15 years. During that time she has led multiple FDA interactions and product submission.

Sonia Lecce

Regulatory Affairs

Sonia is a seasoned professional with experience in companion Dx, LDTs and a wide range of Dx devices with 513g, breakthrough, 510(k) and PMA classifications.

Commercial Operations

Ryan Chappelle

Commercial Operations

Ryan has extensive executive sales leadership experience over a 30-year career in laboratory markets selling and marketing IVD products and laboratory IT solutions 

Ed Salanga, PMP

Commercial Ops & Project Management

Ed has been leading sales and marketing teams in large IVD manufacturing companies for over 25 years and has deep expertise in marketing to the US lab market.

Jissel Fernandez, MBA

Business Ops & Project Management

Jissel has led large business operations and strategy organizations for 25 years in large global manufacturing and consulting firms across diverse industries.

Dave Flaten

Sales & Marketing

Dave has led numerous sales and marketing organizations for IVD manufacturers and clinical labs in a career spanning over 35 years.

Tracey Ray, MBA

Sales & Marketing

Tracey is a seasoned sales and marketing professional with over 25 years marketing and selling into the clinical lab market

Veronica Alloggia

OTC & Public Health Marketing

Veronica is an accomplished strategic product mgmt and marketing professional with over a decade of expertise in high-growth biotech, infectious disease Dx, and health tech.

Tony Falvo

Commercial Operations

Tony has had a diverse and distinguished career of over 20 years in public health, reference lab and IVD commercial leadership roles.

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