Co-first authors
Contributing authors
1.0 The Changing Landscape Of Post-Market Medical Technology Risk Assessment
The U.S. Food & Drug Administration (FDA) and other global regulatory agencies provide risk classifications for approximately 1,700 categories of medical technologies/devices across 16 medical specialties. Based on intended use, indications for use, and the risk that the technology may pose to the patient/user, the FDA classifies devices as Class I (highest risk), Class II (moderate risk), or Class III (lowest risk), with these classes largely determining controls and premarket approvals required to earn regulatory approval. (Canada considers four risk classes and Europe uses three risk classes with the Class II split into IIa and IIb. While this paper most specifically addresses U.S. requirements, recommended strategies are applicable globally.)
After a medical technology enters the marketplace, companies continue to proactively and reactively predict and manage the risk of the product. The results of these risk assessments influence actions across the product lifecycle such as product recalls. The FDA provides two mechanisms for post-market risk assessment, namely Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs), though companies often use different terminologies for internal risk assessment processes and procedures, all of which we will note for the purpose of this paper with the term Health Hazard Assessment (HHA). Over the past few decades, healthcare has undergone a dramatic transformation both in how industry evaluates risk and, in the types, and sophistication of available medical technologies. Meanwhile, the stakeholder groups with whom industry communicates risk have also evolved to include patients, physicians, providers (health systems/integrated delivery networks), payors, and policymakers. Patients are now at the center of making their own healthcare decisions and are demanding data transparency, easy/convenient access, and personalized products and services. Increased need for data transparency and availability has given rise to disruptive technologies and technological advan¬¬¬ces in the form of advanced data analytics, artificial intelligence, machine learning, digitization, new social media platforms, etc. Alongside these societal and cultural changes, stricter regulations, and adjustments to healthcare policy (e.g., changing insurance landscape, use of Real-World Evidence, new European Union Medical Device Regulations (EU-MDR), increased scrutiny on pricing, as well as coverage, coding, and reimbursement, etc.) are driving new ways of thinking and compelling differential actions in the healthcare landscape.
The evolving healthcare environment presents both opportunity and challenge regarding the use of technologically advanced devices and the potential of better health outcomes that they bring reconciled against the new categories and real risks that they represent. The use of these medical devices can expose a patient/user to possible harm that can result from a faulty/defective device, errors in the use of complex devices, unforeseen interactions with comorbidities, or cybersecurity threats due to cloud-based systems (among others).
Thus begs the question:
With new stakeholders, increased product sophistication, increased data generation, new tools for data monitoring and analysis, and growing demand for data transparency, how can we – as manufacturers of these innovative devices – adapt our policies and practices to help ensure that our devices are safe? What tools can we use to understand, identify, anticipate, control, reduce, and eliminate risk to prevent patient/user harm due to these marketed technologies?
