The AdvaMed MedTech Conference was an inspiring reminder that creative solutions to improving health is exactly what the medical device industry is all about. As I pursued the agenda of topics, listened to the professional exchanges and visited the many vendors, I was struck by the focus on innovation and leveraging of new scientific and technological advances. However, as a regulatory consultant, my mind drifted to concerns over losing sight of the “mundane” operational, quality and data reliability challenges that these new innovations bring.
The regulatory landscape for the evaluation, funding, manufacturing, distribution, both clinical and commercial development and commercialization of medical devices will be changing in considerable ways. For example, as the US FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways, the industry will be able to flex and grow along with industry trends. Still based in sound science and documented evidence, FDA expects companies to tighten controls over raw materials and component quality equally to internal design and production.
Likewise, FDA has extended its expectations of equally shared responsibility for quality accountabilities between the sponsor and the contract manufacturer (CMO) to guarantee safe and effective device for the patient. These innovative developments across the industry will generate increased pressure for more effective data capturing systems as well as methods to handle that data, coupled with concerns related to device accountability, source, supply/availability, and quality.
Similarly, the EU MDR is expected to come into effect in late 2019 or early 2020. This will give national regulators more control and oversight of the medical device industry. The aim of the new regulation is to ensure that products are effective and safe as well as can be freely and fairly traded throughout the EU. The impact of this regulation can alter the operations of medical device manufacturers most notably the supply chain and quality management systems of the organizations.
Regulatory health authorities around the globe are taking steps now to prepare their review and inspection approaches to be meaningful and effective. The question is “Will your company be ready to meet the next audit, clearance application or quality event with the same compliance vigor to match your innovative product design?”
Regulators are gaining more control and oversight of the medical device industry. Now, more than ever, companies must plan and prepare for not only meeting quality requirements, but ensure their quality measures are weaving the design, supporting technologies, supply chain and feedback mechanisms into one cohesive program. It is important for medical device companies to proactively prepare for these changes as their impacts could be significant. This includes impacts on cost of implementing changes to organizational prioritization and to internal processes around device accountability/supply, source, availability and quality. If industry and regulators continue to maintain their role of ensuring compliance, new innovative devices can be made available, safely and effectively for patients, providing for better health care outcomes.
At EAS Consulting Group, our expert consultants work daily with medical device innovators around the globe to develop regulatory strategies for compliance solutions. Whether the device is class I, II, or III and the submission is a 510(k), De Novo, IDE or PMA we ensure ISO 13485, QSR and FDA GMP harmonization to facilitate and expedite products through the regulatory evaluation process to obtain market approval from appropriate regulatory bodies.
As Senior Director for Pharmaceutical and Medical Device Consulting Service for EAS, I am continually inspired by this forward-thinking industry as together we proactively make for a brighter future in the healthcare realm. Countless patients, caregivers and their families benefit from not only proactive solutions but from the continually sharp focus on quality and compliance with industry and safety standards.
As we look to the future and continue to work towards creating solutions for patients, lets take a moment and return to those “mundane” challenges, reframing them as “quality benchmarks” and opportunities for guiding growth.
We look forward to working with you in the future. Please visit www.easconsultinggroup.com to learn more about our regulatory solutions to your compliance challenges.
By Bryan J. Coleman, Senior Director, Pharmaceutical and Medical Device Services
About the Author
EAS Senior Director of Pharmaceutical and Medical Device Services, Bryan J. Coleman, has 24 years of experience in FDA Investigations, OTC pharmaceuticals and tobacco quality and compliance, including various management roles with responsibility for regulatory compliance, quality assurance and multi-site audits and FDA inspections management. Immediately prior to joining EAS, he was Senior Manager of Quality Programs and Projects at Altria Client Services in Richmond, VA. Prior to Altria, he spent nearly 14 years as the Director of Quality and Compliance for Research and Development at Pfizer Consumer Healthcare. Bryan’s five years of FDA experience began as a chemist in the Buffalo District and later as a consumer safety officer (CSO/Investigator) with Baltimore District where he performed a wide variety of field inspection work, including inspections of finished pharmaceutical and API (Rx/OTC/Veterinary Medicines) firms for general GMP and PAI purposes, BIMO/GCP inspections, medicated animal feed operations, medical devices, cosmetics, food and dietary supplement manufacturing, packaging/labeling and distribution facilities, as well as product complaint and recall surveillance activities. Bryan was also a member of the FDA’s Foreign Inspection cadre for drug inspection work. He has practical industry experience with pharmaceuticals, medical devices, dietary supplements and tobacco products/processes in the areas of development, improvement, and implementation of sound Quality Systems that are efficient, sustainable, and compliant with FDA regulations. He has also performed mock FDA inspections, gap-analyses, and contractor facility audits. In addition to his professional quality and compliance experience, Bryan has over 27 years of service with the Army National Guard in both reserve and active duty tours and is currently a Colonel serving as the Director of Joint Operations for the Virginia Army National Guard.
About EAS Consulting Group, LLC
EAS Consulting Group continues 55 plus years of leadership in providing regulatory consulting to the industries regulated by FDA and other federal and state agencies. Our network of independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services to the dietary supplement, pharmaceutical, food, medical device, tobacco and cosmetic industries. Whether the need is assistance with general FDA or USDA regulatory compliance or more specific needs such as product development, New Dietary Ingredient submissions, FSMA regulation compliance, generic or customized compliance trainings, 483 responses, product market withdrawals or recalls, mock-FDA audits, expert witness services, GRAS & food additive issues, dietary supplement labeling compliance or the development of a detailed import strategy and policy, EAS, with its over 150 consultants, former FDA compliance officials and industry experts, is able to assist. With vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance in FDA and other regulatory matters. easconsultinggroup.com