Clinical and Regulatory Affairs
Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization. He also oversees the planning and execution of the clinical studies managed by MCRA's Clinical Research Organization.
Prior to joining MCRA in February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Mr. Stiegman managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Mr. Stiegman was responsible for overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US. Furthermore, he assisted in and oversaw all integrity, compliance, and monitoring issues regarding the orthopedic industry in collaboration with the Office of Compliance.
Amanda Briscoe Tracy, MS
Global Market Development
Ms. Briscoe Tracy manages and directs the Global Market Development department for MCRA. Ms. Briscoe Tracy brings with her more than 16 years experience as an accomplished sales and marketing leader, reimbursement professional and entrepreneur. Ms. Briscoe Tracy is responsible for maximizing MCRA's US and International sales and marketing market share and profits. Work involves following global market trends and driving strategic sales and marketing initiatives to meet internal and external organizational demands. Additional responsibilities include client contract management / negotiation coupled with establishing competitive pricing and program strategies for MCRA's seven global business units: Regulatory Affairs, Reimbursement, Quality Assurance, Clinical Affairs, Biologics, Compliance and Intellectual Property.
Prior to joining MCRA in May 2007, Ms. Briscoe Tracy's executive expertise was concentrated in pharmaceutical and medical device sales , sales management and reimbursement. Ms. Briscoe Tracy's qualifications and accomplishments are exemplified through years of dedicated work experience with Eli Lilly and Company, Johnson and Johnson, and Cyberonics, Inc. Ms. Briscoe Tracy has been acknowledged for driving multi-million dollar annual revenue growth and is a recipient of multiple company reimbursement and top performer sales awards.
Christopher Gingras, FACHE CFE FHFMA
As a seasoned compliance professional with over fifteen years of experience Mr. Gingras manages and directs the compliance and business ethics practice for MCRA. Mr. Gingras is responsible for assisting clients in identifying opportunities to enhance their overall compliance efforts, thereby reducing business risk, and assuring the effectiveness of the compliance program. MCRA's compliance department helps organizations develop, implement and assess healthcare compliance programs with a particular focus on medical device companies and companies involved in clinical trials.
Prior to joining MCRA Mr. Gingras served as the Chief Compliance Officer at Baystate Health in Springfield, MA and worked as a Manager at Ernst & Young in their Health Advisory Services practice.
Mr. Gingras has extensive experience designing effective compliance programs, identifying regulatory risk areas, writing policies, assessing existing compliance programs, re-engineering business operations in response to regulatory requirements, drafting statements of business ethics and training thousands of employees on compliance.
Health Economics, Reimbursement
& Public Policy
Tim Hunter currently serves as the Vice President of Health Economics, Reimbursement & Public Policy. He has 14 years of experience helping biotechnology, pharmaceutical, and device companies understand the complex and constantly changing world of healthcare coverage and reimbursement. Mr. Hunter is responsible for assisting companies in the development and execution of strategic plans for market adoption, including preparation of coding applications, creating reimbursement pathways, preparing submissions for use by health programs (such as Medicare) and health plans (such as Blue Cross Blue Shield plans), and developing sales training materials.
Mr. Hunter joined MCRA in 2007 from Johnson & Johnson (Ortho Biotech, LLP), where he was responsible for analyzing the impact of federal legislation and regulations on company technologies and competitive markets. Mr. Hunter also has served in management functions with Covance Health Economics and Outcomes Services and the United States Department of Health and Human Services.
Mr. Biggins has over twenty years of experience in the area of Quality Systems and Manufacturing beginning as a Quality Engineering Manager. Mr. Biggins is an expert at Quality Management Systems, specifically in the areas of Corrective and Preventive Action (CAPA), Customer Complaints, Design Control (including Design Change) and Production and Process Control, including process validations based on the GHTF guidance. Mr. Biggins has assisted organizations in creating and implementing a QMS based on the FDA QSR. He has completed reviews of DMRs, process validations and instituted DHR systems at a number of small, medium and large, including multi-site and multi-national, firms. Mr. Biggins has planned and implemented systems to meet MEDDEV guidance and MDD requirements. He has implemented multi-site registrations for ISO 13485 since 2002.
David W. Lown
Mr. David W. Lown has more than 10 years of experience specific to the orthopedic industry and currently serves as General Manager for Musculoskeletal Clinical and Regulatory Advisers, LLC (MCRA). Mr. Lown is responsible for the operational execution and growth of MCRA's six service areas (regulatory, clinical, reimbursement, intellectual property, quality assurance, and healthcare compliance). Mr. Lown joined the firm in August 2006.
Prior to joining MCRA, Mr. Lown has been employed at Viscogliosi Brothers, LLC (VB), the first and premier merchant banking firm focused on the orthopedic industry. Mr. Lown has worked both for VB's merchant banking initiatives and as an operating employee within 3 of its portfolio companies.