to promote and protect patient care by helping speed
life-saving diagnostics to routine clinical use
We leverage over 30 years of experience in the diagnostics and medical device industry, specializing in quality, regulatory, clinical research, and point-of-care training, to help innovators navigate the complex and rapidly changing requirements to achieve regulatory approval and commercial success.
We’ve achieved over 150 regulatory wins for our partners by taking a flexible, collaborative, and commercially minded approach to getting things done.
Our network of clinical influencers, commercial leaders, proven suppliers, and investors helps you get it right the first time, avoiding costly guesswork. From countless audits to more than 10,000 point-of-care training sessions, our experienced team will get you from concept to routine clinical use in the fastest, most sensible way.
to get your diagnostics to market in
the most sensible way possible
Joen T JohansenPresident & CEO
Joen T Johansen is the President and CEO at MDC Associates. Since acquiring the firm in 2019, Joen has focused on scaling infrastructure for growth, process standardization, and adding talent and expertise across its Regulatory Affairs, Quality Systems, and Point-of-Care Analyzer Training services. Joen holds a degree in Molecular Biology & Biochemistry and in Economics from Wesleyan University. Before MDC, he was Head of Strategic Marketing at Accelerate Diagnostics, responsible for strategy, product management, and marketing communications. Over 17 years of experience building diagnostic businesses from the ground up, Joen worked to define, develop, and launch more than 16 FDA cleared, CE-marked IVD products in the United States and Europe. Before joining the IVD industry, Joen was a Healthcare Investment Banker with Lehman Brothers in London.
Joanne LebrunVP, Quality Systems
Joanne Lebrun is the Vice President of Quality Systems at MDC Associates. Joanne has over 19 years of experience designing and implementing quality systems, managing clinical trials, and leading regulatory submission projects that win market access for medical device companies worldwide. She holds a Master of Business Administration degree from Carnegie Mellon University and a degree in Industrial Management and Music Performance, followed by a master’s degree in Music from Rice University. In addition to strategy and project management, Joanne also attends and leads audits on behalf of clients for Local and FDA Center inspectors and notified bodies for ISO/MDSAP certification.
Fran WhitePresident, Regulatory & Clinical Affairs
Fran White is the President, Regulatory & Clinical Affairs at MDC Associates. Fran is a highly regarded IVD FDA regulatory expert who founded MDC Associates LLC more than 30 years ago to provide her expertise to the broader IVD industry. Under her direction and leadership, the company has grown and extended service offerings to include quality systems development, managing clinical trials, and developing and supporting IVD customer training. Before MDC, Fran worked in a variety of quality, regulatory, and customer service roles for Gibco Laboratories and the clinical microbiology laboratory at New England Deaconess Hospital (now Beth Israel Deaconess Medical Center).
Michael SmithManager, Regulatory & Clinical Affairs
Michael Smith is a Regulatory & Clinical Affairs Manager at MDC Associates. Michael has over 12 years of experience working with FDA-regulated in-vitro diagnostics (IVD) devices, from development, manufacturing, and quality systems, to regulatory affairs and clinical studies. Michael holds an MBA from Southern New Hampshire University and a Biotechnology degree from Rochester Institute of Technology. Before MDC, Michael held managerial roles in both operations and manufacturing for two established immunoassay producers. Since joining MDC, Michael has worked on numerous market access projects for infectious disease, clinical chemistry, and hematology products.
Stephanie BawdenManager, Training Services
Stephanie Bawden is the Training Services Manager at MDC Associates. Stephanie has more than 20 years of experience delivering end-user and super-user training using specialized remote learning techniques and performing validation data analysis for healthcare teams bringing in new technology and tests. She holds a BS degree from Gordon College and has developed a particular affinity for creating and maintaining Access databases. Her team has provided over 10,000 remote training sessions to date and are just getting started.
Emma BinderProject Manager, Regulatory & Clinical Affairs
Emma Binder is a Regulatory & Clinical Affairs Project Manager at MDC Associates. A relative newcomer to the IVD industry, Emma works to support clients on a variety of regulatory pathways. Prior to joining the IVD industry, Emma traveled extensively and worked in the Travel Software Industry. Emma holds an MPH from The University of Edinburgh and a BA from Clark University.
Alyssa CreedenData Coordinator, Regulatory & Clinical Affairs
Alyssa Creeden is a Regulatory & Clinical Affairs Data Coordinator at MDC Associates. Alyssa has over five years of experience supporting data integrity for legal and regulatory operations from entry and capture design to database queries for statistical analysis. She is a current biotechnology student at North Shore Community College. Before joining MDC Associates, Alyssa provided data capture and record integrity support for the JA Cambece Law Office. There, she also managed the firm’s court schedule for suits across multiple state jurisdictions.
Ben CrystalSenior Clinical Scientist
Ben Crystal is a Senior Clinical Scientist at MDC Associates. Ben has over ten years of experience developing winning regulatory strategies and supporting studies to move new IVDs from concept to on-market status. He holds an MS degree in Clinical Investigations from MGH Institute of Health Professionals and a BA in Biology. Before MDC, Ben led Clinical Research and Regulatory efforts for several medical device makers, achieving market access for a variety of products, providing strategic guidance on product development plans, and creating novel study protocols to address complex sample and study challenges.
Laurie GranholmProject Manager, Regulatory & Clinical Affairs
Laurie Granholm is a Regulatory & Clinical Affairs Project Manager. Laurie has nearly a decade of hands-on experience pushing FDA submission projects and studies across the finish line, winning market access for medical devices and IVDs. Laurie holds a BS degree from Salem State University. Before joining MDC, Laurie was a laboratory technician for Salem State University’s Biology Laboratory. There she acquired extensive experience and proficiency in laboratory methods of extraction, detection, interrogation, and analysis.
Andrew HastingsQuality Systems Specialist
Andrew Hastings is a Quality Systems Specialist at MDC Associates. Andrew has more than 9 years of experience establishing and improving quality management systems across the Aerospace, Defense, Construction, Manufacturing, and Automotive industries. Andrew holds two BS degrees from Stonehill College in Business Management and Economics. Before coming to MDC, Andrew held field management, contract quality, and auditor roles. Andrew is SAE International Standard and Auditor training for ISO 9001:2015, AS9100D, AS9110C, AS9120B, 14001:2015, and 45001:2018.
Lisa KellyAccounting and HR Manager
Lisa Kelly is the Accounting and Human Resources Manager at MDC Associates. Lisa has over 18 years of experience managing accounting functions, including general ledger, payroll, receivables and payables, billing, and more. She holds a BS degree in Business Administration and Accounting from Salem State College. Before MDC, Lisa held roles of increasing responsibility for biotechnology, SaaS, real estate, and heavy equipment companies.
Joe MorencyTraining Specialist
Joe Morency is a Training Specialist at MDC Associates. Joe has conducted remote learning for end-users on IVDs and medical devices for nearly 3 years. He holds a BS degree from Salem State University. Before joining MDC, Joe was Lead Gallery Officer for the Peabody Essex Museum where he ensured the best possible experience for museum patrons.
Sarah PetersonData Coordinator, Regulatory & Clinical Affairs
Sarah Peterson is a Regulatory & Clinical Affairs Data Coordinator. Sarah has more than 10 years of experience providing technical support and training for IVDs, and coordinating data for clinical studies being submitted to the FDA. Sarah holds a BS degree in Biology. Before joining MDC, Sarah worked in the animal care/veterinary world, expanding knowledge in veterinary medicine, animal behavior, customer service, management skills and entrepreneurship.
Rob RoySenior Training Specialist
Rob Roy is a Senior Trainer at MDC Associates. Rob has over seven years of experience conducting technical training for end-users and super users on IVDs and medical devices. He holds a BS degree in Biology from Salem State University. Before joining MDC, Rob designed and implemented protocols for a security firm and held four clinical rotations as a radiologic technologist. As a technologist, he performed diagnostic nuclear medicine procedures for the Nuclear Cardiology and Medicine departments of North Shore Medical facilities.
Domenick SciolaProject Manager, Regulatory & Clinical Affairs
Domenick Sciola is a Regulatory & Clinical Affairs Project Manager at MDC Associates. Domenick has nearly 10 years of experience managing regulatory projects, their related study and submission activities, and providing IVD technical training for both super users and end-users. Prior to his current role at MDC, Domenick was an account manager for the Point of Care Analyzer Remote Training Team.
Sruthi Sundaram, PhDSpecialist, Regulatory & Clinical Affairs
Sruthi Sundaram is a Regulatory & Clinical Affairs Specialist at MDC Associates. Sruthi is a Ph.D. Pharmacologist with four years of regulatory and clinical strategy experience for investigational new drugs (IDN) or device exemptions (IDE). She received her doctoral and master’s degree from St. John’s University. Before joining MDC, Sruthi was a Senior Regulatory Scientist at Velico Medical, Inc., where she was responsible for supporting IND/IDE submissions and approvals to introduce new transfusion products to domestic and international markets.
Judy Wittenberg, MSTraining Specialist
Judy Wittenberg is a Training Specialist at MDC Associates. Judy has over 20 years of experience as a research scientist, editor, and technical educator. She holds a Masters’s degree in Biology from Northeastern University and a BA in Psychology from Columbia University. Before joining MDC, Judy’s recent research focused on the validation of a frozen plasma alternative. She also worked on developing FDA cleared and approved assays, including formulation improvement of a core detection reagent, leadership of a stability testing initiative for a point of care immunoassay, and ELISA assays for serum HER-2/neu and PSA.
We’re always looking for experienced individuals with a passion for medicine or diagnostics who seek to make a difference in the lives of patients.