Dunstan Power, director, ByteSnap, sheds light on the challenges presented by obsolescence in the medical device industry and how companies are finding smart workarounds to overcome them.
ByteSnap IoT Medical
Obsolescence is a fact of modern technological life. Electronic devices used in healthcare may become obsolete for many reasons; for instance, outdated firmware, which poses security risks, or scarcity or unavailability of crucial components (especially evident during chip shortages). The medical device itself remains valuable and in demand. Therefore, it is in the interests of manufacturers, customers, and the environment to keep them on the shelves for as long as possible.
With the UK medtech market valued at £24.5 billion and largely made up of SMEs around the country, it is a highly lucrative industry. Nevertheless, companies producing medical products experience a distinctive set of challenges when medical devices face obsolescence, including the costs associated with developing a new medical product and the time taken to get it on the market, added to the environmental impact of discarding products in need of an upgrade.
When old medical devices become obsolete, a medical product company is left with limited options. They could start from scratch, creating a new product that could have associated costs of up to £20 million. Furthermore, devices need to be tested, certified, and pass regulations, all of which may take four to five years before they get to market.
Given the prohibitive time and cost factors associated with developing entirely new medical devices, particularly for SMEs, innovative companies have found clever solutions to extend the lifespan of their valuable innovations.
Once a company has decided to renew its medical advice, several challenges emerge. The cost of running in-house medical technology R&D departments is high. Additionally, a company may lack the in-house expertise to tackle both the hardware and software aspects of modernising the device quickly. Perhaps an electronic device needs new field programmable gate arrays (FPGAs), or integrated circuits often sold off-the-shelf, that are no longer available. Bringing in an outside engineering partner requires knowledge about the original design and any other modifications made to find a workable solution to replace the missing part.
Other devices may run on extremely outdated software, such as a previous version of Windows CE from two decades ago, which almost certainly comes with security issues. While this is a problem in itself, the number of Windows CE engineers that have the knowledge to work on such devices is scarce globally.
This specialist knowledge usually comes with no instruction manuals and is no longer taught, so it would be a case of a software engineer recalling his/her niche knowledge of that software to update the medical device, which could take the form of rewriting the software in Linux for a hospital environment, for example. Or it could be a case of upgrading the software without altering the hardware. Or finding a replacement hardware component that is compatible with the software in question. An experienced team can deploy effective solutions where the modifications are so minor that recertification may not be required. Here, expert consultancy teams collaborate with accredited in-house technicians to ensure the delivery of a functional product to market.
In addition to expert knowledge of legacy operating systems, key skills to look for in a consultancy offering software services may include porting from old to new operating systems, removing bugs, and security updates.
Outsourcing the task of repurposing a device on the verge of obsolescence to a knowledgeable or experienced consultant can result in substantial cost and time savings. A proficient team could deliver a medtech product to market in 3-4 months. Our project team worked to extend the lifespan of a healthcare company’s remote tracking of medical oxygenators that was headed for obsolescence. Previously running on 2G, it had limited coverage for the digital health product and security issues.
The company began developing a solution where data would be transmitted over Bluetooth. This would be connected to a hub system in hospitals and other environments with connectivity issues. Our engineers updated the Linux software to ensure much wider connectivity, security, and compatibility with Bluetooth. The project revived and ensured the lifespan of an otherwise legacy product.
To stay competitive and profitable in the medical technology era, it is prudent to explore the feasibility of updating and redesigning legacy products that are still useful. This is precisely what savvy companies, both large and small, are doing around the globe. The skill is finding the right team with the right expertise to rescue obsolete products and deliver to market within time and budget constraints.
