Contributors

David Lown, General Manager, has more than 10 years of experience specific to the orthopedic industry. David is responsible for the operational execution and growth of MCRA’s six service areas (regulatory, clinical, reimbursement, intellectual property, quality assurance, and healthcare compliance). He joined the firm in August 2006. David graduated from Fordham University with a Bachelor of Science degree in finance.

Chris Gingras, Vice President, Healthcare Compliance, joined MCRA in 2011, and is responsible for assisting clients in identifying potential opportunities to enhance their overall compliance efforts, thereby reducing business risk, and assuring the effectiveness of the compliance program. Chris 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, Chris served as the chief compliance officer at Baystate Health in Springfield, Mass., and worked as a manager at Ernst & Young's health advisory services practice.

Glenn Stiegman is the Vice President, Clinical & Regulatory Affairs at MCRA. Glenn is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Glenn leads the firm’s CRO as well as its regulatory submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization. Prior to joining MCRA in February 2006, Glenn served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Glenn managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Glenn 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. Prior to joining MCRA in February 2006, Glenn served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Glenn managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Glenn 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, Vice President, Global Market Development, brings with her more than 16 years experience as an accomplished sales and marketing leader, reimbursement professional and entrepreneur. Amanda manages and directs the Global Market Development department for MCRA. She 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.

Tim Hunter, Vice President, Health Economics, Reimbursement and Public Policy, has 14 years of experience helping biotechnology, pharmaceutical, and device companies understand the complex and constantly changing world of healthcare coverage and reimbursement. Tim 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.

Clinical Affairs

Abigail Allen, Director, Clinical Affairs, is responsible for running the day-to-day activities of MCRA’s clients’ clinical trials, as well as ensuring the department’s standard operating procedures are current and maintained, following updated guidance and regulations from the FDA, CMS and other agencies. During the course of a clinical trial, Abigail is the point of contact for sponsors, sites, vendors, and monitors. In addition, she is in charge of managing the clinical project team and their activities, to ensure project timelines and client expectations are met. Abigail has extensive experience in spine IDE clinical trials, and also assisting in their PMA submissions. She has also worked on more than 35 clinical trials, as both a clinical manager and a study coordinator.

Michelle Foley has worked in the medical device research industry for more than 7 years in the roles of Clinical Monitor and Auditor. Michelle provides study monitoring services to MCRA's clients in accordance with the sponsor's requirements, to ensure that the trial is conducted and documented properly. She also conducts site and sponsor Pre-FDA audits.

Nancy Malchoff, Clinical Research Professional, has thirteen years of concrete clinical monitoring and study management experience further enhanced by seven years of clinical quality assurance knowledge and exposure to FDA and EMEA regulatory inspections. Her experience includes study management and monitoring of Phase I-IV drug trials as well as PMA, IDE and post approval device trials. She is also proficient in regulatory inspection preparedness activities, hosting FDA/EMEA regulatory inspections, conducting GCP/ICH audits, SOP writing and developing and presenting GCP/ICH training. Nancy is experienced in all facets of clinical trials, with a reputation for integrity, resourcefulness and attention to detail.

Global Market Development

Elizabeth Baldacchino, Senior Associate, Global Market Development, joined MCRA in 2007. She works closely with each of MCRA’s service departments to provide Global Market Development support. Her responsibilities include client relationship management, sales and marketing and identifying and following up on new business opportunities for MCRA.

Health Economics, Reimbursement & Public Policy

Carolyn Neumann, Senior Manager, Coding and Coverage Access, joined MCRA in 2011, and is responsible for providing coding and reimbursement support for MCRA clients in the medical device and biologics industry. Carolyn focuses on reimbursement pathways and coding solutions that are in compliance with current, correct guidelines published by the AMA and CMS. She has experience in commercial carrier and Medicare reimbursement protocol and physician and hospital revenue cycle management. Carolyn conducts research and contributes coding scenarios in support of clinical literature and manufacturer’s approved uses providing up to date coding guidance for the MCRA reimbursement team and their clients.

Daria Harlin, Senior Associate, Health Economics, Reimbursement and Public Policy, joined MCRA in 2011. She contributes to the research and analysis of clinical literature to be incorporated into Reimbursement Landscape Assessments, Strategic Reimbursement Planning and recommendations to orthopedic and cardiovascular medical device companies. Daria is responsible for the detailed review and synthesis of CMS-issued proposed and final rules, with an eye towards how companies might be affected by newly implemented regulations. She also assists with clinical trial agreement development and negotiation, as well as reimbursement protocol review. Prior to joining MCRA, Daria did policy work for a large non-profit and most recently performed regulatory analysis for a small firm in DC. She is a member in good standing of the Maryland State Bar.

Kirsten Tullia, Associate, Health Economics, Reimbursement and Public Policy, joined MCRA in 2012 after graduating cum laude from American University Washington College of Law, where she focused her studies on health law and related regulatory issues. Her responsibilities include researching factors influencing client business opportunities, analyzing payor coverage for client technologies, and tracking federal agency rulemaking. Prior to joining MCRA, Kirsten interned with a number of healthcare organizations, including the U.S. Department of Health and Human Services, Inova Health System, and the U.S. Department of Justice’s Office of Vaccine Litigation. She is currently studying for a Master of Public Health at the Johns Hopkins Bloomberg School of Public Health.

Quality Assurance

Patrick Biggins, Director, Quality Assurance, has over 20 years’ experience in the area of quality systems and manufacturing, beginning as a quality engineering manager. Patrick is an expert at quality management systems, specifically in the areas of corrective and preventive action, customer complaints, design control (including design change) and production and process control, including process validations based on the GHTF guidance. Patrick 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. Patrick has planned and implemented systems to meet MEDDEV guidance and MDD requirements. He has implemented multi-site registrations for ISO 13485 since 2002.

Regulatory Affairs

Justin Eggleton, Director, Spine Regulatory Affairs, is responsible for regulatory affairs relevant to spine devices for MCRA clients, with experience writing FDA submissions and drafting test protocols. Justin served as a lead reviewer in the FDA Orthopedic Devices Branch, and contributed to the development of guidance documents and ASTM technical committees regarding orthopedic device testing.

Holly Rhodes, Director, Orthopedic Regulatory Affairs, is responsible for regulatory affairs relevant to general orthopedic devices (hip, knee, small bone, trauma, etc.) for MCRA’s clients. Prior to joining MCRA, Holly served as a reviewer in the FDA orthopedic devices branch for more than 16 years, and advised firms and inventors as they developed clinical protocols for new orthopedic technologies.

With more than 10 years experience in orthopedics and medical devices, Kevin is a Senior Associate in the Regulatory Department at MCRA. Kevin specializes in review and analysis of pre-clinical and clinical data, design of clinical trials, development of regulatory submissions, and regulatory strategy for medical devices and biologics. Prior to joining MCRA, Kevin worked in orthopedic and medical device research, specializing in developing biological strategies to treat both traumatic injuries and degenerative joint diseases in the knee.

Erela Dana, Associate, Regulatory Affairs, is a 2010 graduate of the Johns Hopkins University, receiving a Bachelor of Science degree in biomedical engineering. With an academic background in orthopedics and biomechanics, Erela specializes in the development of regulatory submissions and regulatory pathway strategies for spine and orthopedic medical devices.

Michelle McDonough, Senior Associate, Regulatory Affairs, joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions. Prior to joining MCRA, Michelle interned for the Orthopaedic Research Foundation of the Carolinas. There she assisted the Foundation with ongoing clinical research conducted in conjunction with the Steadman-Hawkins Clinic of the Carolinas. Michelle received her Bachelor in Science at Clemson University in Biochemistry and her Master in Science at Clemson University in Bioengineering with a focus on cartilage repair procedures in the knee.

Lee Ouyang, Associate, Regulatory Affairs, joined MCRA in 2010, after graduating from the Johns Hopkins University, where he studied biomedical engineering with a concentration in cell and tissue engineering. He specializes in the development of regulatory strategy and submissions for medical devices and biologics. Prior to joining MCRA, Lee worked in a laboratory specializing in tissue repair and interned at a major international pharmaceutical company.