In Part 1 of this blog series, I set the stage on the debate on who owns the machine data generated by medical devices such as CT, MRI, and so on. In Part 2 of this blog, I outlined an approach and my perspective on how this debate is being resolved between Providers and OEMs.
As a concluding Part 3 in this blog series, let me tackle the “right to repair” regulation along with a 3-point action plan for Providers to consider in establishing data ownership while they make their investments, esp. in complex medical devices.
Will the "Right to Repair" regulation come to complex medical devices?
In May 2018, the FDA issued a report that focused on the quality, safety, and effectiveness of servicing of medical devices. When I read it, I got reminded of one of the famous tag lines we use in the market – “Machines Never Lie”. The ultimate truth about machine health, performance, and usage is constantly recorded by sophisticated software running inside machines such as MRI, CT, Ultrasound, X-Ray, Cathlabs, etc. The report had quite a few noteworthy findings especially in relation to not only the servicing of medical devices but also the impact of highly accurate and timely data can have in providing high-quality care to patients and efficient operation of equipment.
Most important insight that I gleaned from this report was the significance of machine data in the context of right to repair debate, and I quote – “The FDA finds, as a result of reviewing service records, that the data resulting from the maintenance and repair of medical devices provide valuable insight into the adequacy of the performance of devices.” The report notes that among its priorities for the FDA’s Center for Devices and Radiological Health (CDRH) is the establishment of “collaborative communities” composed of public and private sector members that should work together to address the challenges associated with delivering high-quality, safe and effective servicing of medical devices. Sharing of machine data and the insights solutions, such as what Glassbeam generates, are a cornerstone of these communities.
The FDA report also found that “healthcare establishments identified three leading factors that contribute to their decision to use a particular service provider: quality, cost, and timeliness.” More than ever, healthcare providers and Independent Service Organizations (ISOs) are using predictive technology to improve their cost savings and quality. The ability to confirm an issue with a medical device becomes much more difficult when it is not directly evaluated. Having the power of AI and ML in medical devices can help establish a cause-and-effect relationship that is necessary to improve the quality, cost, and timeliness of a particular medical device. As the FDA reported, “OEMs also communicated that lack of service history records can negatively impact the ability to troubleshoot or identify the root cause of device performance concerns, provide future servicing, and track device performance.” This inability to identify a potential issue with a medical device leads us to how specifically Glassbeam can play a preventive role.
Looking at this report and ensuing debate amongst industry experts over last year, it is clear that Right to Repair regulation is here to stay for the medical device industry and will provide all stakeholders the means to improve patient care, clinical outcomes and increase customer satisfaction.
A 3 point agenda for healthcare providers to act now
As industry trends are forcing healthcare systems to control costs and optimize patient care, I suggest all Providers should outline a game plan around following 3 point agenda to gain access to machine data and even manufacturer knowledge bases:
- Healthcare providers and ISOs can negotiate access to this data prior to purchasing equipment versus after when they have bargaining power. With some machines, this is possible. With other, highly specialized devices, such as the newest robot that performs a very specific task, it won't be until there is competition or someone creates a third party solution for it.
- Larger healthcare providers should leverage their size to negotiate device purchases and access to machine data for multiple facilities. Providers can negotiate longer-term device purchase contracts, using a larger purchase, even if over time, to encourage the manufacturer to provide data.
- Smaller providers can partner with other providers and negotiate group purchases of devices to gain similar bargaining power to their larger counterparts. Such providers can purchase previously-used devices on the secondary market, where manufacturers are less able to lock in providers.
Access to machine data is vital today. With immense opportunities for both manufacturers and healthcare providers to tap into insightful data from an interconnected device environment, having restrictions on the use of the data or applying a fee for more diagnostic information may lead to slower innovation, consequently a step back in striving for better healthcare outcomes.
In an environment where healthcare providers aggressively seek to improve productivity and patient care, while cutting costs, having open access to machine data and diagnostics information can result in preventive and proactive maintenance programs through AI-driven analytics. These analytics provide insights built on machine learning technology that can, for instance, increase device uptime from the current 96-97 percent to more than 99 percent. This improvement can result in recovering lost revenues of millions of dollars each year, as well as avoid costly penalties from rescheduled patient visits due to device downtime.
Reach out and share your views
Do you have suggestions on how this debate will evolve? How do you see this challenge to data ownership pan out in the coming year? I would love to hear your views. Do share your thoughts by reaching me: firstname.lastname@example.org
If you’re curious to know how our Artificial Intelligence (AI) powered machine data analytics are helping healthcare providers and manufacturers, do review these datasheets — Glassbeam Solution for the Utilization Analytics Market and Glassbeam for Healthcare Overview.