MCRA Expands Evidence Generation Service Line to Ensure Early Stakeholder Engagement for Optimal Product Adoption

Mitali Stevens, PharmD., BCPS., joins MCRA as Director, Reimbursement Strategy & Evidence Development.


WASHINGTON, September 14, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce Mitali Stevens, PharmD., BCPS., has joined MCRA as Director, Reimbursement Strategy & Evidence Development.

With over 20 years of experience in clinical pharmacy, reimbursement and market access, Dr. Stevens has focused her career on understanding stakeholder needs and developing evidence for optimal product positioning and market adoption.  Dr. Stevens joined MCRA most recently from Edward Lifesciences, where she was responsible for developing HEOR strategies and implementing market access tactics that demonstrate clinical and economic product value for the Critical Care division. Before joining Edwards, Dr. Stevens served as a field-based liaison supporting Managed Markets, Medical Affairs and Health Economics & Outcomes Research for various pharmaceutical companies, where she executed the HEOR value proposition through research publications and formulary presentations of scientific data and economic models to key stakeholders at Managed Care Organizations, IDNs, ACOs, LTC, GPOs, PBMs and Home Health Care. 

In her role at MCRA, Dr. Stevens will support our clients in developing and executing systematic evidence generation strategies that integrate health economics, outcomes research and market access solutions across all stages of the product lifecycle, which is a critical component for new technologies to achieve broad market adoption. Specifically, Dr. Stevens will help our clients through a systematic approach in evidence development starting with an assessment of current market needs and performing gap analyses to develop a streamlined evidence plan that takes relevant stakeholder feedback into consideration, to ensure a competitive advantage and value proposition that supports commercial adoption. The evidence plan will be executed through close collaboration with MCRA’s Clinical Research Organization (CRO) and/or through real-world data analytics, followed by the development of value communication tools for stakeholder engagement that can be leveraged to gain insight for future evidence development needs as part of continued feedback.

MCRA’s Vice President, Reimbursement, Health Economics & Market Access, Tonya Dowd said “I’m thrilled to have Dr. Stevens on our team. Dr. Stevens’s role is the linchpin to achieve successful market adoption and ultimately, patient access to our clients’ valuable technologies.” 

Dr. Stevens said “The goal of evidence generation is to improve patient care by way of changing clinician mindset yet developing critical evidence that addresses multi-stakeholder concerns remains a challenge.  This requires a concerted effort across all functions within an organization to ensure that when a product is commercialized, reimbursement is established within a well-developed market.  Earlier engagement with key stakeholders allows for systematic identification of gaps and barriers, and I am honored to work with each of MCRA’s service divisions to streamline product development for a holistic market access strategy that achieves our clients’ corporate objectives.”

About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity.

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation.

For more information, please contact:

Alyssa Howard

Senior Director, Business Development

Phone: 215.870.3952