A medical technology company and a University are reaping the benefits of a collaboration which has resulted in the development of an innovative piece of hospital equipment.
Following an exhaustive development process which saw biomedical test equipment specialist Rigel Medical work closely with industry professionals to ensure its new patient simulator, the PatSim200, met their needs, the company turned to Teesside University to assist with the design of the machine.
Mark Beckwith, (pictured) a senior lecturer in industrial design in the University’s School of Design, Culture & the Arts, has more than 25 years’ experience in new product development and has previously collaborated with Rigel to design a number of different medical products.
He was able to use this expertise to meet Rigel’s brief and design a product suitable for use in a hospital environment with the ability to be modified as new variants of the machine come to market.
Only a few weeks after being launched, the device is already attracting interest from markets in the Far East, USA, Germany and the UK.
Rigel, part of the Seaward Group, employs 170 people at its headquarters in Peterlee, County Durham, and is also based in Tampa, Florida.
The PatSim200 is Rigel’s simplest, fastest and most cost-effective patient simulator yet. It puts medical equipment through its paces by mimicking the most common vital signs of patients, such as body temperature, blood pressure, heart-rate and respiration.
These tests are vital for highlighting faults with medical equipment in hospitals and healthcare facilities, ensuring that the monitors are accurate in real patient situations.
Faulty or inaccurate equipment poses a large risk to healthcare managers, as problems with patients can be missed or misread and costly inquiries can ensue.
In fact, a British Medical Journal study found that one in four operating room errors are due to equipment problems – errors which could be avoided by simple device checks before surgery.
While much of the industry’s focus is on innovations in healthcare equipment, it is important to remember the test devices which interact with and safeguard this equipment.
It obviously is not practical or reliable to test the accuracy of these monitors on patients or volunteers. So a patient simulator device plugs directly into monitoring equipment and, through electrical signals, simulates various types of vital signs from ECG to IBP.
All of these tests can be performed relatively quickly by in-house engineers, independent service operators, or by the manufacturer’s own service engineers under the hospital’s contract.
To ensure that the new device met the needs of end users, Rigel took a clean-sheet approach to the development of the PatSim200. Designers and engineers spent hours shadowing biomedical engineers to understand what they wanted from a vital sign simulator.
“Human vital signs are complex signals. Particularly when we’re talking about ECG waves, they are also very small. So at the heart of a good patient simulator design is a solid low-noise analog circuit design, with independent outputs for each signal,” says Andrew Teasdale Principal Systems Engineer at Rigel Medical.
“And because human vital signs vary just as much as people do, there is an incredible array of variables and parameters to consider, which means a powerful microcontroller is needed to store, process and output the signals.
“The on-board software to make all of this work is very complex, but the product needs to be as simple as possible for the operator to use. And as any design engineer will tell you, achieving true simplicity is not a trivial task.”
The PatSim200 incorporates a large colour display, with a home menu that displays all the currently running vital sign parameters. This means that biomeds no longer need to move around multiple menus. The device also skips the traditional splash image so the user can get straight to work.
Rigel also analysed biomed workflows to optimise out unnecessary operations and button presses. As a result, the PatSim200 comes with a consistent and intuitive user interface, which speeds up the testing process – a key priority for the end users.
“Designers and engineers often don’t see their products in use on the hospital floor, but it’s important to be aware of how the device works in the real world,” adds Andrew. “Biomedical engineers perform a lot of tasks over the course of the day – our job is to streamline that process for them and save them time.
“Are there aspects of your design which could be prone to obsolescence? Will it be obvious to users if your product becomes inaccurate or faulty Does it require external testing and calibration? All of these factors can have implications for patient safety.
“We’ve listened to the feedback of our customers and built features that address their needs.
“For instance, biomeds can spend minutes scrolling through test options, whereas they might only use a handful of tests regularly. We took inspiration from everyday items like digital radios, meaning that now users can recall their five ‘favourite’ sequences at the press of a button.”
Rigel engineers also took note of compatibility needs for users. The result is that PatSim200's cable ports are compatible with most hospital legacy IBP and temperature cables, making it Rigel's most versatile simulator yet.
From agreeing the project parameters and brief with Rigel Medical, the PatSim200 project involved six months’ design, development, and prototyping work for Mark Beckwith.
Following the consultation with the biomedical engineers it was established that the device needed to be robust, ergonomic and portable. It also needed to incorporate a rechargeable battery and micro-USB connector to make recharging easier,
As well as taking into account the internal components, key to the design was the ability for the device to be modular. This would enable the PatSim to be adapted to meet the varied needs of biomedical engineers. Because it was being used in a hospital setting the device would also need to be easy to clean.
“This was a slightly more technical brief as, because of the need for the device to be modular, it meant I couldn’t use traditional clamshell moulding,” says Mark. “Once I was given the technology, I looked at the aesthetic of the design to ensure that it was saleable and good to look at.
“The second part of the project was ensuring that it could be manufactured economically and easily assembled in the factory. I looked at how many devices Rigel were planning on selling, as the manufacturing process would be very different if they were only planning for a handful to be produced. ”
Maintaining academic links with industry is a key part of Teesside University’s philosophy.
The university, based in Middlesbrough, won a Queen’s Anniversary Prize in 2014 for outstanding work in the field of enterprise and business engagement. At the heart of its strategy is working with employers to make sure its courses are relevant to the needs of industry.
The benefits of these partnerships are twofold. As well as enabling companies like Rigel to access cutting-edge academic expertise, the University’s industry partnerships also inform the teaching of academics, ensuring that students are kept abreast of the latest technology and are job-ready when they graduate.
“Doing live projects like this is a vital part of my teaching,” adds Mark. “When I first started working we were designing use a drawing board and pens. A lot of changes have occurred over the years and it’s extremely important that I’m aware of them and real-life experience is the best way to do that.
“There’s many aspects of this project with Rigel that I’ll be able to take away. It’s been quite challenging with a number of issues that I’ve had to overcome, particularly regarding modularity of the device, and these sort of details are key to how I work with students.”
Andrew adds: “Healthcare technology is becoming increasingly advanced, which makes it more important than ever to ensure patient safety by regularly testing medical equipment.
“Test equipment doesn’t save lives, but is a key part of ensuring quality patient care In the biomed field, we know that engineers and their test equipment don’t save lives. But they are a key part of ensuring quality patient care.
“Our partnership with Mark and Teesside University has been extremely fruitful over the years and the PatSim200 is the latest example of this. It marries high-quality product development with great design and we’re delighted with the end result.
“The device is already proving to be extremely popular with biomedical engineers and attracting interest from a number of new markets.”
For more information on design courses at Teesside University visit tees.ac.uk/schools/sam
