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, and clinical research 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 and hundreds of regulatory submissions, our experienced team will get you from concept to routine clinical use in the fastest and 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 WhiteFounder & President Emerita
Fran White is the Founder and President Emerita of 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 SmithDirector, Regulatory & Clinical Affairs
Michael Smith is the Director, Regulatory & Clinical Affairs 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 BawdenClinical Data Manager
Stephanie Bawden is a Clinical Data 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.
Joanne BerryClinical Research Associate
Joanne Berry is a Clinical Research Associate (CRA) at MDC Associates. Joanne has over a decade of clinical and bench research experience and holds a BS degree in Biochemistry. Before MDC, Joanne coordinated clinical and research studies for both the pharmaceuticals and ophthalmic industries, as well as the Aerotek Neely Center for Clinical Cancer Research at Tufts University. Her background includes oversight of $1M+ study budgets for NIH contracts, ophthalmic surgical procedures, crosslink patient care, training, lab and technology oversight, instrument calibration, and certified medical scribing.
Emma BinderProject Manager
Emma Binder is a Project Manager at MDC Associates. In her role Emma supports MDC clients at every stage of regulatory and clinical projects to ensure on-time project execution. 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.
Malik BlackQuality Assurance Manager
Malik Black is a Quality Assurance Manager at MDC Associates. Malik holds a BS in Biology and certifications for ISO 9001:2015 Standard and Lead Auditor Training by SAE. His background in quality systems and analytical testing includes work for Abbott Laboratories and Eurofins where he was responsible for quality systems complaint processing and retains testing as well as analysis of biopharmaceuticals and raw materials to ensure GMP compliance.
Sydney CampbellClinical Research Associate
Sydney Campbell is a Clinical Research Associate (CRA) at MDC Associates. Sydney has over ten years of clinical research experience from careers at IQVIA, the Asthma & Allergy Center of Nebraska Medical Research Institute, and the University of Nebraska Medical Center. Prior to her focus on in-vitro diagnostic devices at MDC, Sydney planned, executed, and directed clinical research activities for studies of cardiothoracic medical devices as well as pharmaceutical studies in the fields of cardiology, endocrinology, and immunology.
Suzanne CheangManager, Regulatory Affairs
Suzanne Cheang is the Regulatory Affairs Manager at MDC Associates. Suzanne has over two decades of regulatory experience and a degree in Chemical Engineering. A Six Sigma Certified Green Belt, Suzanne is also certified as a Quality Auditor and Quality Improvement Associate by ASQ. Before MDC, Suzanne directed teams for Abbott Laboratories and ThermiGen where she developed and led global regulatory strategies and submissions to achieve organizational goals and obtain market access for in vitro diagnostic products and energy based medical devices.
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.
Kayla DiLorenzoProject Manager
Kayla DiLorenzo is a Project Manager at MDC Associates. Kayla has over seven years of experience moving projects from concept to completion across the medical device, e-learning, and digital marketing industries. She holds a BA in Communications and specializes in multi-year project management, organization, and nailing deadlines.
Shraddha DubalManager, Clinical Operations
Dr. Shraddha Dubal is the Manager of Clinical Operations at MDC Associates. Shraddha has over a decade of clinical trial experience across various therapeutic areas in pharmaceutical, biotech, and academic settings. Dr. Dubal received her medical degree from Saint James School of Medicine and is a certified clinical research professional. Before MDC, Shraddha led clinical operations for Accel Clinical Research, M3 Wake Research, Flatiron Health, Emory University Hospital Midtown, and Temple University Hospital, among others.
Sean FiandacaManager, Information Technology
Sean Fiandaca is the Manager of Information Technology at MDC Associates. Sean has over two decades of experience managing enterprise-level IT infrastructure, databases, user management, and security systems for life-science organizations. Sean holds a BA degree from the University of Massachusetts at Amherst and specializes in the development and implementation of IT policies and systems integration to ensure business continuity and contractual and governmental compliance.
Toni FournierVP, Business Development & Marketing
Toni Fournier is the Vice President of Business Development & Marketing at MDC Associates. Toni has over two decades of experience leading business development, product management, commercial and marketing strategy within the medical device industry. She holds a BS degree in International Business and Finance from Northeastern University and a reputation for leading teams and processes to achieve strategic aims for clients and companies. Her career spans women’s health, medical aesthetics, orthopedic and pain management products, and scientific publishing in nephrology, gastroenterology, cardiology, and rheumatology.
Alex GallantSenior Project Manager
Alex Gallant is a Senior Project Manager at MDC Associates. Alex has over five years of experience combining tools and processes with streamlined communication to bring projects across the finish line while keeping stakeholders engaged. Alex holds a BS degree in English and is a certified associate in project management (CAPM). Before MDC, Alex led production projects for a digital publisher where she oversaw a content creation team of writers and designers and built a reputation for consistently achieving deadlines for numerous simultaneous periodicals.
Katie HahnemannRegulatory Affairs Specialist
Katie Hahnemann is a Regulatory Affairs Specialist at MDC Associates. Katie is a Ph.D. Chemical Biologist with over six years of experience in IVD product development, regulatory strategy, and quality system regulations. She received her doctoral and master’s degrees from Johns Hopkins University. Before joining MDC, Katie led product development and regulatory affairs initiatives for an IVD manufacturer, recently winning clearance to market two Class II diagnostic products for the detection of pathogenic bacteria and antibiotic resistance in bloodstream infections.
Andrew HastingsQuality Systems Specialist
Andrew Hastings is a Quality Systems Specialist at MDC Associates. Andrew has more than nine 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 maintains certifications by SAE for International Standard and Auditor training for ISO 9001:2015, AS9100D, AS9110C, AS9120B, 14001:2015, and 45001:2018.
Charlie HicksChief Financial Officer
Charlie Hicks is the Chief Financial Officer of MDC Associates. Charlie holds a BS degree in Finance from Fairfield University and has a decade of finance, investment, M&A, and operations experience. He specializes in sourcing, evaluating, and expediting organic and inorganic growth opportunities while ensuring robust compliance and fiscal prudence. Before MDC, Charlie led finance, fundraising, and operations for several healthcare firms, including Ocular Science, Drake Partners, and GE.
Emily IsgurQuality System Specialist
Emily Isgur is a Quality System Specialist at MDC Associates. Emily has over a decade of experience in quality, assay development, and laboratory research. She holds a master’s degree in Molecular, Cellular, and Systemic Physiology from Southern Illinois University and certifications for Standard and Lead Auditor Training for ISO 9001:2015 and ISO 13485:2016 by SAE. Before joining MDC, Emily developed a multiplex PCR assay for an IVD company and, most recently, led material conformance, CAPA, and customer complaint systems for a contract manufacturer.
George LegnerClinical Trial Assistant
George Legner is a Clinical Trial Assistant at MDC Associates. George has nearly a decade of experience supporting integrations and coordinating projects within the pharmaceutical, security, and legal sectors. George holds a BS degree from UMass Boston. Before MDC, George designed and implemented security and life-safety programs for laboratory facilities and managed a portfolio of security and support contracts for more than a million square feet of Class A real estate.
Kammie McHughQuality Systems Specialist
Kammie McHugh is a Quality Systems Specialist at MDC Associates with more than 15 years of experience as a medical laboratory technologist, researcher, and quality systems specialist. She holds a MS degree in Regulatory Affairs of Drugs, Medical Devices, and Biologics and a BS degree in Biology. Kammie also maintains certifications for Standard and Lead Auditor Training for ISO 9001:2015 and ISO 13485:2016 by SAE. Before joining MDC, Kammie directed quality assurance for a contract manufacturing and design company serving the biotech, research, medical device, and health industries.
Angela NuñezQuality Systems Specialist
Angela Nuñez is a Quality Systems Specialist at MDC Associates with more than 20 years of experience implementing and improving quality systems in the medical device industry, specializing in complaint handling, process validations, CAPA Systems, recalls and adverse event reporting. As a certified quality auditor, Angela conducts compliance audits for Device QSRs, ISO 13485, 9001, and 14971, as well as MDSAP requirements. She holds a BS degree in Chemistry and maintains certification for Lead Auditor Training for ISO 13485:2016. Prior to joining MDC, Angela supported numerous device manufacturers with quality compliance and remediation through her independent quality systems consultancy for more than a decade.
Sarah PetersonClinical Data Manager
Sarah Peterson is a Clinical Data Manager at MDC Associates. 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.
Reshma Rajan-JoyClinical Affairs Scientist
Reshma Rajan-Joy is a Clinical Affairs Scientist at MDC Associates. Reshma is a PhD biophysicist with over a decade of experience in medical device product development in commercial, clinical, and academic settings. She received her doctoral degree in Biophysics and master’s degree in Electronics from the Vellore Institute of Technology before completing a fellowship at Temple University. Reshma specializes in in-vitro diagnostics and most recently oversaw diagnostic development, regulatory submission preparation and product life cycle management as the director for product development for a point of care diagnostics developer before joining MDC.
Michael SantinoClinical Affairs Scientist
Michael Santino is a Clinical Affairs Scientist at MDC Associates. Michael has over a decade of clinical laboratory experience and holds a BS degree in Clinical Laboratory Science from Purdue University. Certified as a Clinical Laboratory Scientist (CLS) by the Indiana University Health Pathology Laboratory, Michael’s career includes work providing clinical laboratory results, clinical instruction for students, fellows, residents and laboratory directors, and clinical study design, protocol development, and data collection for regulatory submissions and publication.
Domenick SciolaClinical Research Associate
Domenick Sciola is a Clinical Research Associate (CRA) at MDC Associates. Domenick has over 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 SundaramRegulatory Affairs Specialist
Sruthi Sundaram is a Regulatory 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.
Peter TraboldRegulatory Affairs Specialist
Peter Trabold is a Regulatory Affairs Specialist at MDC Associates. Peter holds a Ph.D. in Molecular and Cellular Biology from Roswell Park Cancer Institute, completed a post-doctoral fellowship at the University of California San Diego, and received a master’s degree in Business Administration from the University of Buffalo. Before MDC, he directed business development for diagnostic developers, where he synthesized his technical, regulatory, and business backgrounds to make science-based decisions that kept projects moving forward to achieve their commercial aims.
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.