Finance and Funding

DEVICES FOR MEDICAL TECHNOLOGY ARE ONE OF THE FASTEST PACED AREAS OF PRODUCT DEVELOPMENT. JAMES MACDONALD, TECHNICAL MANAGER AT ZLX, SHARES WHAT SUPPORT MECHANISMS ARE AVAILABLE

CASHING IN

Post-COVID, there was a huge surge in demand for respiratory care devices to meet the demands of the clinical establishments with many new players coming to the market with solutions, but the progression beyond that has been to make the devices lightweight, portable, and suitable for residential use, with the commercial constraints of being profitable in a crowded space with many constituent parts being disposable.

With the book being opened on the designs, new technology had a chance to be integrated and embed functionality into the devices which may not have previously been necessary. To capture any data for analysis, if a patient is breathing through a mask their inhale and exhale volumes can be monitored through tracking changes in the differential pressure of the patient breathing. With the patient breathing being captured as ‘data’ this can be set to trigger an alarm if there are unexpected changes, or to present a captured profile of breathing at a clinical review.

If the health indicators can truly be captured and considered as data, then it is not limited to respiratory care as similar principals and advancements are being made throughout the full industry as the level of trust in technology improves. Capturing deviations or changes can be as accurate as 60mbar, so this methodology can lend itself to extended fields like blood pressure analysis, heart rate monitoring, brain impulses for epilepsy diagnosis and negative pressure therapy wound recovery acceleration.

The technology improvement goes beyond the biometric data that a patient will generate, but it can be seen in the advancements in how care is administered. The data that a patient generates can be the ‘output’, but what about the ‘input’? Where supplementary care needs to be administered, this can also be tethered through IoT systems and loop into the symptoms the patient demonstrates.

Medical technological advancement will no doubt require multiple disciplines to deliver a robust solution for such a tightly regulated field. No unnecessary risks can be taken and a MTBF rate could be the difference between life and death. The decision to develop a new offering to the medical market can be off-putting when you consider the time, effort and expenditure that would be required to meet the guidelines within a high cost of failure environment.

Even from the example to the breathing apparatus with IoT connectivity you need a range of disciplines either from your own team or from specialist subcontractors. It needs electrical and electronic engineering for the operation and data gathering, software developers for the data connectivity and control parameters, mechanical engineering for the air flow, and most critically a medical input to ensure that the product is fit for purpose and can effectively function to support the patient. sustainable solutions. As a means of support for innovation in the United Kingdom, where development has taken place there is help through HMRC to soften the blow of that expenditure.

Where development has been applied, there are mechanisms available through tax rebate to claim back some of the outlay. This can apply to expenditure right from the beginning of the pre-planning stage through to the release and implementation to cover a portion of team wages, consumables, the cost of prototyping and for the cost of the specialist sub-contractor inputs that may have been required to give you the performance levels required.

TOM BOUCHIER, MANAGING DIRECTOR, FANUC UK, DISCUSSES CONNECTIVITY AND HOW IT’S OPTIMIZED FOR THE DIGITAL AGE

To remain competitive, manufacturers in the medical industry need to produce more goods, to higher quality, in less time. This is hard to achieve with human personnel alone, especially given the current skills shortage. The way to resolve these pressures is through automation – using robots to do the monotonous and dangerous jobs and freeing up workers to complete more valueadded tasks.

Although the UK was slow to the robotics revolution compared to many other industrialized nations, robotics and automation specialist FANUC UK is reporting an uplift in enquiries across the UK and Ireland, and especially from SMEs who have not, historically, been major users of automation. One of the factors helping to make automation a more attractive option than ever before is connectivity.

DRIVEN BY DATA Machine tools and robots are becoming more intelligent. Industry 4.0 means that all devices in the factory are interconnected. An inevitable consequence of this is a trend towards standardization of CNC applications across a range of manufacturing technologies. At the same time, availability of data from machines in operation, in real time, is helping to improve quality, reduce unscheduled stoppages and boost productivity. These things are in reach of even smaller companies.

DIGITAL TWINS Digital twinning is another trend that is proving benefi cial to larger and smaller medical manufacturers alike. Developed in conjunction with a physical system, the digital twin can help fi rms that are looking to scale up, alter or enhance their production lines. By running a virtual version of any changes through the digital twin, they can have confi dence that their automated system can handle them before investing in any new equipment, boosting uptime and eliminating the risk of ending up with a system that is not fi t for purpose.

PRIORITIZING FAT Another factor to take into consideration when integrating any new smart manufacturing solution into your production line is the Factory Acceptance Test (FAT). FANUC UK had noticed that many of their customers lacked the technical expertise to complete Factory Acceptance Testing themselves, delaying installation and commissioning. FANUC UK has therefore developed its own in-house Factory Acceptance Testing facility at its headquarters in Coventry. Launched in June 2022, the FAT unit was constructed using ultra-hygienic cleanroom materials and encompasses a total area of more than 200m.

“As a result of growing global supply chain issues, we noticed that many of our customers are bringing their manufacturing processes back to the UK, after years of relying on production capabilities in the Far East, Asia or Eastern Europe,” says Dave Raine, FANUC’s ROBOSHOT manager for the UK & Ireland.

“However, after off shoring their manufacturing for so long, many have not managed to retain members of staff with the process validation, project management, technical compliance and robotics integrations skills required to complete in-house Factory Acceptance Testing when purchasing a new, smart, injection molding machine. This is only being compounded by the post-Covid labor crisis currently facing the sector.

“Without the required skill set, plastics manufacturers run the risk of prolonged downtime and incorrectly specifi ed machinery, both of which can seriously impact their bottom line. In response, we have developed our own, dedicated on-site FAT facility specifi cally for our injection molding clients. Here, they can take advantage of our best-in-class validation and certifi cation expertise, safe in the knowledge that their machine will operate exactly as required, and to the necessary industry standards, from the moment it is delivered to their factory.”

smart, injection molding machine. This is only being compounded by the post-Covid labor crisis currently facing the sector. “Without the required skill set, plastics manufacturers run the risk of prolonged downtime and incorrectly specifi ed machinery, both of which can seriously have developed our own, dedicated on-site