Excellent prognosis for innovation

Image courtesy Morgan IAT

In March 2020, in anticipation of the need for an immediate response to the COVID-19 pandemic and ongoing medium/long-term growth in the global requirement for medical devices, the GTMA – the lead trade association for members representing the toolmaking, additive manufacturing, prototyping, precision machinery, metrology,  and tooling technologies in technologically advanced  sectors – formed a cluster of member companies interested in working in the medical sector. Initially 40 companies joined the initiative, but the number has grown steadily to over 90.

Image courtesy Morgan IAT

Early activity of the cluster was in response to the demand generated by the UK ventilator call and specifically to provide a supply chain to make CPAP (continuous positive airway pressure) devices from UCL. Further projects have followed, and the GTMA expects growing interest in this sector to continue.

The GTMA is continuing to build up intelligence and connections into the UK medical manufacturing supply chain, identifying commercial opportunities for member companies. At the heart of this is the medical device market, which is growing at an exponential rate, but it also includes containers, hardware, fittings and fixtures, PPE, laboratory equipment, and many other componentry items. The UK is the third largest medical device market in Europe, and the sixth biggest globally. From an estimated value of £7bn in 2015 it is now reported to exceed £12bn.

A detailed report was published in 2019 by the Academic Health Science Network (AHSN). The AHSN report uses the phrase ‘MedTech’ to define the development, manufacture, and selling of medical devices. It further identifies that 84% of all companies involved in this sector are SME’s, 53 large companies with over £50m turnover are driving the UK market forwards.

According to a report from the Association of British Healthcare Industries (ABHI) in 2009 there were over 10,000 different medical devices based on mechanical, electrical and/or materials engineering. They concluded that the UK is a net exporter and the sector employed 50,000 people at that time.

As the GTMA recognises, this is a very important market now, medium and long term with the UK in a leading position globally. As demand grows for ever more complex devices the alignment and capacity of the manufacturing supply in the UK is vital, asserts the association. The exacting standards required by the medical sector are ideally suited to those companies currently operating predominantly in aerospace and other high-tech industries.

Rapid response prototyping

If there's one thing that has stood out during the last year, it's manufacturer's agility when faced with the global pandemic. In one example, additive manufacturing experts at the University of Sheffield Advanced Manufacturing Research Centre (AMRC) made crucial parts for a protective respirator prototype within a week to help a small design company develop novel PPE to keep clinicians safe while working in COVID-19 intensive care units.

The Bubble PAPR is a low-cost Powered Air-Purifying Respirator developed by Designing Science, a med-tech design consultancy, working with clinicians at Wythenshawe Hospital, part of Manchester University NHS Foundation Trust (MFT), and specialists at Manchester University, to protect frontline healthcare staff during the Covid-19 pandemic.

The simple low-cost device consists of a reusable collar that sits around the neck and a single-use plastic hood that can be easily recycled. The collar contains a fan to draw in air through a virus filter and delivers a cooling airflow around the face. It is designed to be compatible with stringent infection control practices but be comfortable to wear for the duration of a shift in ICU, or other high-risk areas. The wearer’s face is also clearly visible to improve communication between staff and patients.

Rapid polymer prototypes for critical components including the Bubble PAPR’s ventilation system, impeller and fan housing, were created by Mark Cocking, the AMRC’s polymer additive technical lead at the Design and Prototyping Group using funding from the High Value Manufacturing (HVM) Catapult to get the job done even quicker.  

Cocking said: “Designing Science approached us for assistance with Additive Manufacture (AM) design, material, and process selection. As the request was in relation to development for advanced Covid-19 PPE it was essential to provide functional components in a reduced time frame.

“To do this we implemented a custom support solution using the FormLabs SLA platform with resin suited to the required mechanical properties. Because of the urgency of the request, we used a bank of printers to speed up the production.

“We were able to deliver an optimised AM print strategy enabling challenging, first-time print components to be delivered for testing by the customer within the week.”

The Bubble PAPR is a collaboration between MFT, Designing Science and the University of Manchester to identify unmet clinical needs and work collaboratively to develop new solutions.

Patrick Hall, managing director of Designing Science, who has more than 30 years’ experience in product design and medical innovation, said: “Most current PAPRs are repurposed industrial devices not designed for clinical use and are expensive. We have taken a user-centred design approach to engineer and develop the Bubble PAPR to be as simple as possible while meeting key functional and ergonomic requirements.

“This means it can be easily and cheaply manufactured in large volumes so it can be made available right across the healthcare system, wherever clinical and support staff are interacting with patients who have confirmed or suspected Covid-19 or other serious infections.”

Linear motion

High-quality linear motion products are essential for medical imaging and MRI equipment, as uneven surfaces or inconsistent movements can produce unreliable results or information that ultimately leads to sub-standard care for patients. Designers of these systems must therefore consider every detail, including ball screw actuators and linear guides.

Linear motion systems from NSK have proven themselves well suited to the accuracy and precision that medical imaging equipment demands. In MRI scanners, for example, one of the most important components required for successful operation is the motorised ball screw. The ball screw utilises cylindrical motion to move the machine’s imaging equipment along a plane with extreme accuracy and precision. Since this equipment is large and complex, these ball screws must accommodate heavy loads and produce movement that is sufficiently smooth and consistent to generate clear, reliable results.

MRI technology also requires the use of high magnetic force, so the ball screws and other components need to function in this type of environment without affecting the machine’s energy. Ball screws from NSK are ideal for use in MRI scanners, providing both the load- bearing capabilities and smooth movement required. Smooth motion not only contributes to accurate results – thus avoiding potentially disastrous misdiagnosis – but improves patient comfort and safety during scans.

Rehabilitation technology

maxon Group and start-up Fourier Intelligence have entered into a global strategic partnership, whereby maxon's precision drive systems will be used on Fourier's Intelligence’s rehabilitation robotics. The move is expected to drive the development of new technologies for patients.

Technology plays an increasingly important role in rehabilitation services and healthcare and clinicians, engineers and companies are recognising that they need to accelerate the development of technological solutions to best meet the needs of patients. This is the main goal of the partnership between maxon and Fourier Intelligence, which specialises in exoskeletons and robotic rehabilitation. The two companies are pooling their expertise to develop industry-leading technologically products and platforms for patient treatment.

Fourier already uses BLDC motors from maxon in its ExoMotus X2 exoskeleton. In addition, maxon will become part of the Exoskeleton & Robotics Open Platform System (EXOPS), an open platform for research and development of exoskeleton and robotics systems. maxon will provide a variety of customised drive solutions with motors, gearheads, encoders and controllers to aspiring engineers who want to develop robotics solutions for rehabilitation services.

Mobile intensive care units

Siemens Smart Infrastructure has teamed up with Toutenkamion Group to jointly develop an agile container system of highly innovative mobile intensive care units, designed to take pressure off hospital infrastructure. The solution was a response to the Covid-19 pandemic, which forced nursing staff, doctors and hospital managers to urgently come up with practical solutions to ensure adequate care was provided to extremely contagious patients, while maintaining other emergency and conventional care. One of the major challenges of the epidemic has been the need to equip and increase the number of resuscitation and intensive care beds.

Toutenkamion, a French designer and manufacturer of customised mobile medical solutions for rigid lorries, semi-trailers and containers, created the skeleton of the mobile units. They selected suitable materials that are weatherproof and comply with regulatory constraints, particularly in relation to fire. The solution can be implemented quickly and moved from one location to another as needed.

Siemens supplied the technology inside the modules so they can function safely and comfortably. This includes the electrical distribution, building management system, fire detection, safety, air treatment, production and distribution of medical gases as well as the integration of dialysis solutions through specialised partner companies – ATA Médical, Novair and Baxter. The design was also supported by the construction office Intérop.

Each intensive care unit is comprised of five single rooms: a nurses’ station, a pharmacy, a technical office, a biomedical equipment store and a dirty utility area for everything that needs to be cleaned. A staff rest room or office is optional. All the rooms are at least 23m₂, which means that healthcare professionals can easily move around the patient to dispense critical care in the event of an emergency. Each room is also equipped with a patient lift for moving patients in intensive care.

One of the major benefits of the solution developed by Siemens and Toutenkamion is the speed and ease of implementation. It only takes eight months from planning to operations, including the manufacturing and assembly of the modules. French manufacturer Novair has supplied a complete system to produce and supply the medical gases used in the mobile units in total autonomy, using mobile generators. This autonomy preserves the hospital’s existing stock and network capacities. The mobile units are autonomous in the supply of normal and secured power.

Virtual reality

AMRC is involved in a further project, this time with a machine vision company, which sees Industry 4.0 technologies that once remotely guided the Mars Rover being used to create a virtual reality platform to remotely train medical students and transform how surgery is observed.

“The Covid-19 pandemic has highlighted the global need for a digitally-connected world that allows for seamless remote working conditions. The ability for senior surgeons and doctors to remotely view and be immersed in a virtual representation of an operation will have a game-changing impact,” said Dr Ben Crutchley, Senior Machine Vision Engineer at i3D robotics (i3Dr).

i3Dr worked with engineers at the AMRC on a bid for funding from Innovate UK for the Stereo Theatre project. The money, part of the Fast Start competition, is a share of a £40m government investment to advance innovative projects which tackle economic and societal issues resulting from the coronavirus crisis.

Stereo Theatre will build on the work already done by the Medical AMRC in Rotherham where an Industry 4.0 Digital Operating Theatre proof of concept has been built. The demonstrator combines a virtual reality (VR) digital twin, projection mapping and smart tools that enables the position of objects and clinicians to be accurately tracked in the theatre space, with relevant information displayed digitally using screens, projections and augmented reality (AR) devices.

Crutchley said: “Currently, the AMRC’s Digital Operating Theatre can provide a virtual representation of the real-world theatre and monitor movements with commercial off-the-shelf (COTS) sensors and smart tools but does not have the ability to produce updated 3D models of patients. Stereo Theatre will fill this gap, allow for further upscaling of the technology and offers a revolutionary approach to both the teaching of medical students and surgical procedures.”

Both i3Dr and the AMRC believe the technology could transform surgery and teaching by enhancing the way medical students can learn remotely, performing simulated surgeries on a virtual reality training platform. The Stereo Theatre project also enables senior consultants to be engaged in surgical procedures conducted by junior colleagues remotely, meaning more patients being observed by experienced surgeons.