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Kari Miller

Health Care

Achieving Better Medtech Outcomes With Proactive Post-Market Surveillance

Cross-functional collaboration and communication can lead to a competitive edge

Published: Wednesday, January 5, 2022 - 13:03

In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).

The primary goal of post-market surveillance (PMS) systems is to see improvements over time in terms of reduced adverse events in post-market environments. However, we are currently not seeing the continuous improvement in products that we should in medical devices on the market.

To combat this, the U.S. Food and Drug Administration (FDA), European Union (EU), and others are at work setting up sophisticated new monitoring requirements.

The new regulatory landscape

The growing regulatory focus on PMS can be seen around the world. The EU Medical Devices directive (MDD) had always required device manufacturers to carry out PMS and post-market clinical follow-up studies. Now with the EU Medical Device Regulation (MDR), these requirements are written as law. Under Section 522 of the Federal Food, Drug and Cosmetic Act, the FDA is similarly authorized to require manufacturers to conduct PMS for certain class II and class III medical devices. Most recently, amendments to Canada’s Medical Devices Regulations on requiring summary reports, which took effect in December 2021, mark the country’s joining with other regulators in emphasizing the importance of PMS in medical device oversight.

At the heart of these new requirements is a vision of PMS based on proactive data gathering and analysis, with close links and inter-relations with quality management and risk management systems. The goal of this action is twofold: Maintain regulatory compliance while also achieving product safety and quality. It represents a critical shift in the way we think about PMS—from only vigilance practices to a function of continuous product innovation and a means of achieving better patient outcomes.

Although these regulations ultimately support the success of medical devices, adapting to maintain compliance will not be without its challenges, especially in the midst of exponential growth in data to be culled. The focus of PMS has historically been reactive, concentrating on collating and reporting adverse events, such as device malfunctions or patient injuries, after they happen. However, as medical device complexity increases, the approach to PMS will need to enable earlier detection of potential product failures before they occur.

Medtech companies will likely struggle to keep up with extensive literature reviews under traditional manual practices. Furthermore, many medtech manufacturers have historically relied on their vigilance and field-safety corrective action (FSCA) systems to meet PMS regulatory requirements, but this approach will hinder their ability to get ahead of problems and achieve continuous improvement going forward.

In short, reactive and manual processes won’t serve these companies in this new landscape. They will instead need a proactive approach to PMS to capture potential product failures and trigger product returns, modifications, exchanges, and recalls more quickly. This will entail tools and processes that help them search, collate, and store data so they can do an effective summary on what it means for their selected device in the market and generate appropriate action plans.

A new approach to PMS

In this evolving regulatory landscape, it’s crucial that medtech companies work out their processes based on their data, as well as public data from other organizations, to ensure nothing is missed, and that they’re able to perform against post-market surveillance standards. Artificial intelligence-based tools that can capture data from a wide variety of sources such as social media and literature and synthesize those data for cohesive reporting will be important. By enabling safety teams to manage, track, and document PMS planning through data collection, analysis, and reporting, a robust and effective PMS system can reduce both costs and demands on resources, while increasing product safety and performance.

Medtech manufacturers should take two main steps when setting up a robust PMS system:
1. Scrutinize all types of activity carried out around the organization (including by distributors and others in the supply chain) to identify potential sources and assess the value of those data in terms of PMS.
2. Investigate and analyze the data to decide on necessary actions. Reactive data from vigilance reports, audits, complaints, reports and recalls should be combined with proactive data from service reports, literature, social media, real-world evidence, and possibly customer surveys.

Additionally, medtech companies must champion organizational change to effectively adopt this new system. This will require the blurring of departmental lines to promote cross-functional collaboration and communication. Having a localized source of truth about a given device across departments will help ensure consistency of work and mitigate repetitive action. The result will be an effective and efficient model for achieving product compliance and continuous improvement.

Medtech companies can achieve a competitive edge from early implementation of proactive PMS programs by heading off the tangible costs of downstream FSCA’s and the very real, yet intangible, cost of customer satisfaction. The immediate result will be more streamlined management that aids in preventing costs associated with compliance issues or recalls. However, the long-term benefit is much greater. Proactive PMS will enable the holistic oversight needed to drive innovation in the medical device industry that will spur market advantage and, above all, better health and safety for patients around the world.


About The Author

Kari Miller’s picture

Kari Miller

As Regulatory and Product Management Leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated life sciences market. She also is responsible for the Quality Compliance product road map, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in business administration and a Bachelor of Science in psychology from Marian College, Fond du Lac, Wisconsin.