Based at the University of Sheffield’s Advanced Manufacturing Research Centre (AMRC) – a member of InnovateUK’s Catapult programme to support UK industry in certain key areas – the Medical AMRC combines cutting edge manufacturing technology, world class research, and access to clinical expertise. The Centre’s core capabilities include mechanical, electrical, and product design, design for manufacture, design verification, prototyping, materials development and virtual reality.
The Medical AMRC collaborates with clinicians, academics, the NHS, and local and multi-national healthcare companies to undertake research and development using current and emerging manufacturing technologies to improve manufacturing capabilities, reduce production time and costs and develop practical products for the healthcare sector. Samuel Rees, senior project engineer at the Medical AMRC, draws a parallel between medical design and another ‘high value’ manufacturing sector – aviation – in that both are tightly regulated and require a top level of traceability and certification. “The medical devices industry is highly regulated, which means anyone designing products and processes for the sector needs an in-depth understanding of the whole process from risk management (ISO 14971) to the Medical Device Directive 93/42/EEC. Timescales can be much more protracted, as the devices require considerable validation,” he says. “However, the principles of good design apply equally in the medical sector as they do in other areas. The creative approach and methodical application of design thinking can be applied in common.” From a research perspective, an important difference in developing products for the medical sector as opposed to other categories is the level of risk management that needs to be undertaken at the very beginning of any project. “In most cases, if there is a requirement for risk management related to the product, it can be carried out during the design process. However, the international ISO 14971 risk management standard for medical devices demands that much of the risk management associated with that device or clinical area is undertaken before even conceptualising the product,” explains Rees.
Furthermore, designers need to consider that they are producing solutions that must meet the requirements of a diverse range of end users – including clinicians, healthcare providers, and patients – each of whom has different needs and priorities. Rees admits that whilst it is the clinicians who on many occasions come up with the idea for a project, they are not necessarily in a position to fund its early development. As such, securing seed funding is challenging but is an area in which the Medical AMRC might be able to offer assistance in bringing together clinicians and device manufacturers.
An example of the Medical AMRC’s work is a new surgical screwdriver developed in collaboration with orthopaedic products specialist Harvard Healthcare. The screwdriver would offer surgeons a user-friendly alternative to the existing variety of devices used to retain screws during surgery, devices that tend to be overly complex, difficult to use, and hard to manufacture. A pre-production prototype comprises only three components – a sleeve, shaft and handle for ease of disassembly for sterilisation – manufactured from different grades of stainless steel to ensure resistance to corrosion and strength. The resulting product works better than any competitor product, yet costs less to manufacture because it requires fewer parts and is far less complex.
A patent application has been filed for the device and confidence is high that it will be extremely popular and find applications even beyond the medical sector. Based in a research organisation that works with academia and industry on innovative nextgeneration technology, Rees is perhaps as well placed as anyone to assess the emerging trends in the medical sector. He cites customisation as being especially significant. “This is particularly true in the case of implants, as part of a drive to improve the patient’s experience, speed recovery and reduce the need for revisions (the replacement of implants which have worn out or become loose over time),” he adds. “Using bespoke implants, designed for individual patients, instead of selecting the best match from a small range of established sizes, not only enhances mobility, comfort and appearance but reduces the need for replacement over time, which, in the case of a young patient, might otherwise mean they face several operations to install replacement implants during their life. This trend will also fuel the growth of the use of Additive Manufacturing (AM) technologies and the need for designers to design specifically for AM.” Additionally, Rees argues that the development of new materials that are bioresorbable (that is can be broken down by the body over time) or transparent to radiation (so they can be used in medical scanners and seen through) will have an impact on medical design. Whilst the wearable device market, although at the risk of becoming saturated, will drive demand for devices that can monitor and relay data related to health and wellbeing. “There are, obviously, many opportunities opening up for incorporating Internet of Things (IoT) technologies into medical devices.
Within manufacturing at large, the two major issues surrounding the IoT are security and connectability and that is even truer in the medical sector. You most certainly have to ensure that data transmitted to and from medical devices is secure – to ensure both patient safety and confidentiality,” Rees continues. “If you are to reap the benefits of IoT, you have to ensure that all the devices can talk to each other and that means establishing standards for formatting and exchanging data, but overlaying that with robust data security. Changing the settings for your central heating using an app is one thing, changing the settings on a Pacemaker is another. Similarly, checking the contents of your fridge to see if you need some more milk may be fine, but downloading the data from a coworker’s internet enabled health monitor most certainly isn’t.”