Research

The Issue

There are many downstream challenges in relation to the repair and servicing of software-dependent medical devices. No matter how sophisticated a device or system may be, it will need to be repaired and serviced throughout its useful life. As we have seen in other industries, manufacturers and vendors of medical devices can rely on software-based controls and contractual terms to restrict or prevent third-party repair and servicing of crucial equipment. These software-based controls can prevent proper calibration of a device following a repair, or prevent access to device error logs or other technical information needed to diagnose faults.

Over 7,000 ventilators unable to be repaired or serviced in Delhi, India in April of 2021. (source: downtoearth.org.in)

Parallel to software-based restrictions, manufacturers and vendors may also rely on their exclusive intellectual property rights to deny access to replacement parts, specialized tools, and service documentation needed for technicians to effectively repair and service these devices. In situations where intellectual property rights provided only limited protection, vendors and manufacturers often resort to onerous contractual terms to limit repair options for hospitals. These restrictions may negatively impact fair competition, tie the hands of qualified local technicians, increase costs for health authorities and hospitals, and negatively impact healthcare delivery and treatment times.

This issue came to the fore during the acute phase of the COVID-19 pandemic, where supply chain disruptions and travel were severely limited or prohibited altogether. This prevented vendor-approved technicians from being able to service ventilators in hospitals and highlighted the need for local and independent technicians to have greater capabilities. This shed light on the vulnerabilities caused by medical device manufacturers’ business models that enforce exclusive distribution channels for crucial replacement parts, service information, and specialized tools. While these issues have become part of the general consciousness of right to repair advocates, there is a better need to investigate and understand the nature of these restrictions from a law and policy perspective in order to propose regulatory solutions.

Overview

Phase 1: Interviews with Biomedical Engineers and Technologists

In this first phase, we are conducting qualitative research interviews with biomedical engineers and technologists working in healthcare settings to understand the technical and practical barriers to independent medical device repair. These barriers may include difficulty accessing replacement parts, the need for specialized training and service keys to repair devices, and challenges in obtaining diagnostic error logs that are critical for identifying malfunctions. This phase will help us uncover the day-to-day issues technicians face when trying to maintain and repair essential medical equipment

Phase 2: Investigation into Contractual Barriers

The second phase of Unlocking Healthcare focuses on the contractual agreements between healthcare authorities and device manufacturers. We will analyze contracts to identify restrictions that prevent independent repair, such as exclusivity clauses, multi-year service agreements, and limitations on who can access replacement parts. This phase will highlight how these contracts can lead to hospitals relying solely on manufacturer-authorized technicians and how these agreements can increase repair costs and delays.

Phase 3: Vendor and Policy Perspectives

In the final phase, we will interview and carry out roundtable discussions with manufacturers and vendors of medical devices to understand their rationale for restricting repairs. Additionally, we will engage with federal regulators and provincial policymakers to explore potential solutions to these repair restrictions. This phase seeks to bridge the gap between healthcare providers, manufacturers, and policymakers to create more balanced repairability options that protect both patient safety and healthcare efficiency.

Through these three phases, our project aims to identify meaningful pathways for reforming repair restrictions and improving the repairability of critical medical devices in Canada.

Influence and Impact

The potential influence and outcomes of our research will be relevant to Canadian policymakers proposing reforms to medical device regulations and related intellectual property and competition laws in furtherance of the Right to Repair. It will also have direct relevance to the development of healthcare policy, industry associations, and healthcare providers, contributing to evidence-based decision-making and policy reforms.

This research also holds significant potential for broad societal impact, influencing policy and fostering social and technological innovation. The envisioned outcomes are spread across domains including policy reform and advocacy, enhancing healthcare administration and budgetary decisions, empowering independent medical device repair technicians, and raising public awareness.

By addressing critical issues at the intersection of law, technology, and healthcare, the outcomes have the potential to reshape policies, industry practices, empower healthcare providers, stimulate innovation, increase access to healthcare in Canada, and enhance public knowledge of and participation in these issues. The ultimate impacts are aimed at improving healthcare access, reducing costs, and fostering a more sustainable and innovative medical device ecosystem in Canada.