Medical Device Innovations and the Evolving Regulatory Landscape

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 to learn more about our regulatory solutions to your compliance challenges.