INDUSTRY FOCUS MEDICAL & PHARMACEUTICAL COVID-19’S LESSONS FOR


Traditional Instruments like the stethoscope must be rethought


The coronavirus crisis is a game-changer. Not only will COVID care and


treatment transform the way medicine is practiced, but it will have a transformative


effect on medical instrument design, as John Bowman, marketing director and lead: Medical Task Force


Anglia Components, explains I


n light of the COVID-19 pandemic, large established manufacturers have been


ramping up production quickly to supply the needed ventilators, infusion pumps and other systems; while smaller manufacturers have had to cope with unprecedented challenges of a massive scale-up under huge time pressure. Design of medical instruments is having to adjust quite fundamentally to address the new paradigm in treatment. It has been a steep learning curve. Medical


equipment manufacturers have quickly absorbed a lot: not just about improvements to the devices themselves, but equally important considerations are design-for-manufacture, test and compliance and, increasingly, to incorporate predictive maintenance capabilities. First, there is the issue of volume. We are


seeing instruments normally made in quantities of hundreds per week now being manufactured in thousands per day. This means that specialist medical manufacturers have had to take-in the good practice well established in the consumer electronics space. Small makers have had to rapidly take on-board the best practices for critical and time-critical designs. A further practical issue to consider is the


manufacturing process itself, given the need to protect manufacturing personnel from risk of infection or passing infection on. Such pressures extend right along the supply chain.


RAMPING-UP IS HARD TO DO For some manufacturers, availability of parts has been the greatest challenge. In addition, such a steep ramp requires the tooling-up of production lines, and the training of assemblers and testers. A major lesson has been the importance of a robust bill-of-materials for medical equipment across the board. Single-source components can be especially problematic. Future designs should make thorough use of multiple Approved Vendor Lists (AVLs) to facilitate problem-free sourcing


28 JULY/AUGUST 2020 | DESIGN SOLUTIONS


in high volume of alternative components in the quest to mitigate production risks. A key obstacle for massively increased


numbers of medical equipment like ventilators is the exponential growth in the need for test. Accelerated production requires testing and diagnostics during development and at the point of manufacture, with the issue compounded by having many more machines in service, all running for extended periods at higher duty cycles. This ‘new normal’ of medical equipment therefore dictates more emphasis on design-for-test, with orders of magnitude, more self-configuration, self-testing and self- diagnostics. Test and configuration times now need to be measured in seconds, not minutes or hours, as is the old norm. Enlarging the pool of medical devices makes


vastly increased demands on maintenance and repair. Typical COVID-19 patients in hospital have in the order of twenty pieces of medical equipment surrounding them – besides the ventilator there can be up to fourteen separate infusion pumps. This all needs monitoring and maintaining. Making the machines more modular and less


monolithic allows for more structured monitoring, with predictive maintenance built in. Ongoing needs for maintenance and (inevitably) repair can be mitigated through longer and more predictable service intervals. Further, the process can be simplified by designing-in simpler maintenance/repair procedures, for example by greater use of swap-out cards and looms for replacement subsystems. Solutions like this address another design issue highlighted by the coronavirus crisis – the need for distance.


DESIGN FOR DISTANCE Pre-COVID-19, carers and clinicians would stand close to their patients when setting up instruments and taking readings. That will become much more of an issue – especially when there is a risk of spreading or acquiring infection, so instruments will need to be designed for operation at a distance from the patient. This is a particular issue, of course, when


testing for the virus itself, and two companies – GB Electronics (UK) and Inovo Robotics – are working with Brunel University, Lancaster University and the University of Surrey to develop an inexpensive and rapid diagnostic test kit based on a battery- operated, hand-held, smartphone-linked device that is both safe and easy to use. However, distancing now needs to permeate through all aspects of medical treatment. For


example, helping clinicians listen to patients’ heart and lungs is imperative to their ability to treat all patients, including those affected by COVID-19. But, conventional stethoscopes with rubber tubing are incompatible with layers of PPE. There is a need for what is being termed Safe Distance Auscultation: the process by which doctors can listen to patients’ hearts and lungs while wearing Personal Protective Equipment (PPE) or from a safe distance. This alternative solution has a universal size


jack that can connect to speakers, headphones or a wireless output at a distance. This makes it easier for doctors in protective gear to listen to patients’ lungs – even over the noise caused by the filtration and purification systems. Alternatively, it gives clinicians the option to listen to patients in separate rooms or behind anti-infection screens. More comprehensive tele-monitoring is


possible by using wireless, wearable sensors such as a ‘smart patch’ cardiac sensor and a continuous temperature sensor to automatically collect and analyse patients’ condition. Heart rate, respiration rate, temperature, oxygen saturation levels and blood pressure can be monitored – remotely and in real time. This


Instruments need to collect sensor


data and present it to a carer standing at a distance from the patient


/ DESIGNSOLUTIONS


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