FEATURE ELECTRICAL & ELECTRONIC COMPONENTS
The key to verifying and validating medical devices
When designing medical devices, each component needs to be
tailored to meet the needs of the OEM. Here, design verification and validation are essential processes, writes Gareth Hancox, engineering and commercial support manager at Accutronics
T
he words ‘verification’ and ‘validation’ are important
practices that OEMs can’t afford to take for granted, especially in the field of medical device manufacture. After all, the possible repercussions of failing to ensure that your new device is effective, safe and fit-for- purpose in medical and healthcare applications can be severe. Whereas design verification
establishes whether you designed the device right to the specification, design validation ascertains whether you designed the right device to meet customer expectations and requirements. The distinction may be subtle, but it is significant. With medical devices there is no room for error, so verifying and validating your design proves that you’ve developed the best possible solution to a specific need and that it is safe to use. However, it’s not just the OEMs designing the machine that are going through this process – often, the smaller components within a device are bespoke designs created by another OEM, such as the all important battery. Accutronics understands how
important it is to design batteries that are both effective and safe, and by placing a high premium on the ‘two Vs’ and proving its products are up to scratch, OEMs using the batteries can verify and validate their own devices.
PLAN FOR SUCCESS Design validation and verification requires order and planning. When we first sit with any customer to establish a brief for battery design we set up both a design verification plan and a design validation plan. These documents, which are reviewed regularly throughout development, mean we stay on target and develop the very best product for our clients’ needs. A design validation plan should
include a validation strategy that covers life cycle and risk assessment, validation deliverables including design specification, operational support,
24 DEC/JAN 2016 | DESIGN SOLUTIONS
continuity plans and acceptance criteria; standard operating procedure, training, documentation management, and guidelines on maintaining the validated state. By comparison, a design
verification plan should describe in detail the tests and trials that the device needs to be put through.
TESTING TIMES For medical devices to pass validation and verification, they have to be built in the long term production
Batteries for medical devices need to be effective and safe
environment as well as put through testing - in other words on the production line and by the people that will actually manufacture the product. The US Food and Drug Administration
(FDA) guidelines on the topic stipulate that medical device verification activities must be ‘conducted at all stages and levels of device design’ and say that the ‘basis of verification is a three-pronged approach involving tests, inspections, and analyses’. In addition, the guidelines state that devices should be ‘tested in the actual or simulated use environment as a part of validation’. To ensure our customers’ devices meet
all necessary regulatory requirements, we test all of our batteries in simulated conditions. Automated testing cabinets linked to climatic chambers tirelessly test cells and batteries for applications ranging from portable instrumentation and medical devices to robotics and defence. This means the performance of rechargeable cells can be tested at different rates and temperatures and, as everything is fully programmable, we can accurately replicate customer application discharge-profiles. Our new test equipment allows us
to really put cells through their paces based on real world usage. For instance, in the field of medical devices accurate power gauging, reliable charging and storage performance are vital. As we can replicate the demands the device will place on the battery, we know the cells will perform as needed.
Accutronics T: 01782 566622
www.accutronics.co.uk
A FLEXIBLE SOLUTION FOR CAKE PORTIONING
Cake cutting machines can be time consuming to set up for different sizes, depths and portion numbers; and traditional cutting technologies can result in uneven, messy cuts and damaged product. To overcome the limitations, automation OEM Newtech decided to combine ultrasonic cutting with robotic actuation of the cutting blade, so turned to Mitsubishi Electric for a solution. The solution was built around the high speed RF13 13kg payload, six axis robot, mounted within a stainless
steel cell. The robot, which is capable of reaching all the way behind itself and also very close to its base, is controlled via the Mitsubishi Electric iQ Platform, a multi-functional automation environment which incorporates Q series PLC control and an integrated robot controller within the same rack. The benefit of this is that communication exchange between the PLC CPU and the robot controller is handled across the rack, increasing speed, data throughput and reducing robot setup times. A CC-Link network connects other machine control components, such as a Mitsubishi Electric inverter
drive and a dedicated Mitsubishi Electric WS safety controller, while a GOT2000 HMI provides the user interface where operators can select different cake recipes and set parameters such as product height, etc. As a result, the newest model in Newtech’s robo range of machines delivers the ultimate in flexibility
for cake portioning. The in-line format machine provides a compact, multi-product platform, and the high-speed ultrasonic blade offers precision, clean cutting as standard, even on detailed cake products. In operation, a through-conveyor indexes product in and out of the machine, which accommodates bakery tray sizes of 30” x 18” or 30” x 16”. Inductive sensors identify the tray size and ensure that it is in the right position in the machine cell, whereupon the tray is fixed and held in a precise position to ensure the ultrasonic blade does not have contact with the tray edges. Once the tray is in position, the robot actuates the ultrasonic blade to portion the product based on the parameters entered on the HMI. During the cutting process, another tray can be loaded onto the conveyor, and once the cutting cycle is complete the next tray is indexed into the cell. The machine, which is also capable of cutting products in smaller foil trays, features a cleaning tank to wash the ultrasonic blade.
Mitsubishi Electric
www.mitsubishielectric.co.uk
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