Regulatory Structure, Science and Compliance in a Medical Device Manufacturer. Disclaimer Statement

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1 Regulatory Structure, Science and Compliance in a Medical Device Manufacturer April Lavender, RAC Senior Vice President Regulatory Affairs May 18, 2017 Disclaimer Statement The content of this talk represents my own personal viewpoints and is not intended to represent Cook Medical company policies or procedures. 1

2 Cook Medical Organization Quality Management System for Medical Devices 12,000+ employees Manufacturing on 3 continents Distribution into over 100 countries Aerial view of our manufacturing facility and North American Distribution Center Diverse Product Portfolio 2

3 A Bit of Review Technical knowledge Excellent oral and written communication Influence and negotiation skills Collaboration skills Self motivation and Desire for Life Long Learning and Change NEVER A DULL MOMENT! Obligations of Regulatory within a Quality Management System Business Development and Research Regulatory Requirements Regulatory Strategy Regulatory Intelligence Scientific Analysis Nonclinical studies In vitro studies Clinical trials Impact Assessment 3

4 A Word on Defining Requirements Develop understanding about the device Intended Use/Indications for use Design, Materials, Users, Environment of Use, What are the target markets for commercializing the device? Determine device classification Determine reimbursement analysis Project time lines for submission and clearances/approvals Dr. Jeffrey Shuren, FDA s CDRH Leader recently reported Time Is Money Estimated Cost of FDA Decisions on a 30 Employee Company Expense to Company 8 Week Delay in Scheduling Meeting $1.8 M Additional 20 Animal Study (6 Months) Extra Year in Negotiating an IDE Additional 100 patient study with 1 year follow-up (24 Months) $5.5 M $10.8 M $24.1 M 4

5 Obligations of Regulatory within a Quality Management System Customer Service and Distribution Centers Database management (UDI, label content, project management) Submissions for Renewals, Clearances and Approvals Complaint Reporting Field Corrections Post Market Surveillance Obligations of Regulatory within a Quality Management System Global Sales and Marketing - Coordination and planning for commercialization - Advertising & Promotion - Product Restrictions - Support for Training - Scientific Data Reviews - Content of User Manuals 5

6 Obligations of Regulatory within a Quality Management System Manufacturing - Design Control - Document Control - Purchasing Control - Conformity Assessment - Product Submissions - Change Control - Post Market Surveillance - Recall Administration - Product Traceability - Labeling/Packaging Control - Audit Readiness Design Controls (21 CFR ) Design and development plans Design inputs intended use, needs of the user and patient Design outputs Design reviews Design verification testing Design validation testing Design transfer Design changes Design history file 6

7 Global Change and Governance in Health Care is Growing Exponentially International Standards Organization (ISO) International Medical Device Regulatory Forum (IMDRF) Asian Harmonization Working Party (AHWP) Latin American Working Group (MERCOSUR) East African Community New EU MDR ~80 New Pieces of Legislation! More Clinical Evidence! Product Labeling Changes Notified Body Scrutiny Processes Restrictive Substances Evaluations EU Unique Device ID Database EudaMed Database Access Many Other Changes Impact of Brexit! 7

8 Exploring a Few Questions What can we do today to stay relevant and competent with our workforce? How can we best integrate the curriculum between science, clinicians, psychology, and digital effectiveness? Are device specialization experts a necessary reality? How can we measure the soft skills of our technical folks? Basic Requirements to Interview for a Position in Regulatory Regulatory experience in the medical device field and/or 5 years Regulatory experience with Cook Medical Bachelor s degree in a life science (preferably biology or life science) or other related field; or experience of such kind and amount as to provide a comparable background Completion of Regulatory Affairs Certification (optional) 8

9 New Hires in Regulatory Science Doctorate degree in life sciences Some knowledge of Regulatory helpful Some experience helpful On the Job Training Mentoring Teamwork and Collaboration Fundamental to the translation of scientific discoveries to clinical impact is the collaboration and integration of scientists with clinicians, as well as the integration of academia, health care and industry.??? The cultural and academic identities of both clinicians and basic scientists are different. 9

10 Importance of Innovation in Regulatory Science For the good of the Public Health FDA defines regulatory science as: The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products (FDA, 2010). This requires a well-trained, scientifically engaged, and motivated workforce. IMDRF Recommendations for Competence Requirements For Technical Experts and Regulatory Agency Reviewers/Auditors March 16,

11 Foundational Competencies Personal attributes and behaviors Adaptability, attitude Diligence Critical and analytical thinking Communication Integrity, objectivity, perception Interpersonal skills Functional Competencies Skills developed through experience and required to perform regulatory reviews Time management Teamwork Effective use of IT/Digital assets 11

12 Technical Competencies Unique skills developed through experience and specific knowledge applicable to personnel depending on the scope of activities needed to address the assigned tasks Knowledge of regulatory requirements and current state-of-the-art (e.g., guidances) Risk assessment Device subject matter expertise Opportunities for Life-Long Learning Biostatistics, decision theory, and IT Fundamentals of manufacturing in pharmaceuticals and devices Scientific methodology Clinical trial methodology Discovery and development Monitoring and Quality Assurance New laws, regulations and guidelines 12

13 Words to Remember Consensus exists that an important type of competency needed by all health professionals is the capacity to collaborate across professional boundaries. Teamwork is the model for care delivery Words to Remember Leaders who are needed can grasp multiple dimensions and interconnections of the components... as well as the complex relationships between the various stakeholders. 13

14 Thank you! 14

15 References Fernandez-Moure, J.S. (2016). Lost in Translation: The Gap in Scientific Advancements and Clinical Applications. Frontiers in Bioengineering and Biotechnology. Doi: /fbioe IOM (Institute of Medicine). (2012). Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. IMDRF International Medical Device Regulators Forum. (2017). Competence, Training and Conduct Requirements for Regulatory Reviewers. IMDRF/GRRP WG/N40FINAL: