Med-Tech Innovation Measurement
Improving Dimensional MEASUREMENT SKILLS
Pete Moores of the National Physical Laboratory (NPL) examines why the medical device manufacturing sector is critically dependent on measurement skills and highlights ten key measurement questions manufacturers should be asking.
wrong. Parts are designed to minimise risk of failure, but if there is a problem in the manufacturing process that is not identifi ed by good measurement, then defective products could end up in circulation. A recent study on medical device recalls in the UK and the device regulation process over a fi ve year period (January 2006 to December 2010) revealed that there were approximately 2,124 Field Safety Notices and 447 Medical Device Alerts.1
T Of these devices,
44% were assessed as having a reasonable probability of causing serious adverse health consequences or death. The authors of the study, from the Centre for Evidence Based Medicine, University of Oxford, wrote to 192 manufacturers of withdrawn devices and only four provided the clinical data the authors required. The lack of response from the manufacturers means that it is impossible to predict if the failures are due to design faults, lack of testing or quality control issues. Medical device manufacturers are allowed to refuse Freedom of Information Act requests under EU medical device legislation. NPL’s experience of working with the medical device manufacturing sector highlights that having measurement skills and being able to understand and apply good
20 ¦ September/October 2013 Getting it right
One company taking a strategic approach to measurement is Owen Mumford (www.owenmumford. com), which supplies technology such as injection-based drug delivery systems and blood sampling equipment to major diagnostic and pharmaceutical companies around the world. The Oxfordshire based company has been growing for the past sixty years and now has offi ces in fi ve countries. Its ethos is that if it is not 100 % right, then it is not good enough.
Barrie Hanson, one of Owen Mumford’s metrology engineers started in 2006 in a repetitive role operating machinery, putting parts on the machine, taking them off and recording the result. Over time he developed an interest in understanding the machinery and the
www.med-techinnovation.com
he medical device manufacturing sector is highly reliant on science, engineering, technology and mathematical skills and faces severe consequences if ever things were to go
measurement practice is vital during new product development, especially in the design and scale-up process. The impact of not getting it right at the start makes it diffi cult and costly to introduce changes or design revisions later on.
Equipment choice is also important. The achievable
measurement uncertainty must be commensurate with the drawing tolerance, and rules must be defi ned for ascertaining conformance or nonconformance, for example, the rules defi ned in ISO 14253.2
should be seen as part of the overall manufacturing process and not as a process in its own right.
Owen Mumford’s Cotswold
manufacturing facilities
Measurement
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