Start early to avoid surprises

Europe’s medical device directive (MDD) is changing as a result of MDR 2017/745 published on May 5, 2017. The new regulations will come into full force in Q2 2020, after a 3 year transition period. With over 300 pages, you probably have a lot of questions about preparing for MDR 2017/745: What is new, what has changed, where to start and how this will affect you and your company.

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The value of competence and training in developing and maintaining a quality workforce is well understood. Yet, many organizations struggle with providing, documenting, and evaluating the effectiveness of their training efforts. This is often revealed in audit findings that point to deficiencies such as a lack of establishing procedures for training and identifying training needs, a lack of training evaluation, and a lack of evidence that personnel have sufficient training and can adequately perform job-related duties. As the audit findings imply, it’s not enough to verify the existence of training records. Organizations must now determine the necessary competence of personnel and assess the effectiveness of any training being provided to maintain that competency.

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MDSAPAlthough initially they may be deemed to be more expensive and complicated, MDSAP audits will provide a more efficient way of ensuring compliance with QMS and at the same time, reduce the audit/inspection burden on both medical device companies and regulatory authorities. In this blog I will provide a basic overview of the program and offer suggestions to  prepare manufacturers for MDSAP.

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Prototype Sheet Metal Parts

A cable support bracket with 2 threaded inserts and a weld, created in Solidworks 2016

Prototype Sheet Metal Parts in 4 steps

Sheet metal fabrication is an excellent method of making mechanical parts, especially support brackets. They tend to be cheap, light, strong, and easy to pack and ship. However, a major drawback to sheet metal is the setup costs in prototyping: a part might only cost $10 to make, but cost $300 to set up.
Down the road that cost is absorbed in high volumes – those 300 parts would only cost $11 each – but if you’re ordering just a couple to build a prototype, you’ll be paying $170 each for one pair of small brackets. Ouch.

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From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing from a usability document, I guess! The biggest unknown was Fig. 5.10 User Interface of Unknown Provenance (UOUP).

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simulated fluids

Author tends to cyro-preserved mammalian cell lines in our BSL2 facilities at the University of Victoria.

Designing equipment (medical or otherwise) is a complicated process. This complexity is increased when the equipment of choice must either come in contact with biological material, or function within a biological environment. In order for a device to operate as intended, it must be able to withstand the unique conditions that biological fluids impose. Depending on the site of use, the constructed parts must be able to withstand extended exposure to high or low salt concentrations, acidic or basic conditions, a range of degradative enzymes and/or microbial interactions.

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Build an Input Pyramid to support your medical device development

As a medical device designer, I see clients balancing cost and feedback in a daily struggle to decide when to get clinical feedback, from whom, and how much weight to give that input. KOLs (Key Opinion Leaders) and individual designer experience can take a product well into conceptualization, but at some point you’ll realize you need to expand the group of people who have used the device, or risk basing your entire program on a sample size made up of just a few people.

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DC Bias on capacitanceMulti-layer ceramic chip capacitors (MLCCs) are the most common capacitor found in modern electronics. MLCCs have many attractive features: low ESR, good capacitance-to-volume ratio, relatively low leakage, non-polarity, and low cost. It’s no wonder that when choosing a capacitor, an electrical engineer will usually specify a ceramic first before any other type.
However, there is one major drawback to high-capacitance ceramic capacitors that is poorly understood by even experienced engineers: the effect of DC bias on capacitance.

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medical device designComputer games and medical device design both begin conceptually in a somewhat similar space – a point where reality and science fiction meet. From there the directions they take are infinitely different but the processes are virtually identical. I recently spoke on a panel at our local Global Game Jam (the world’s largest game jam event) about User Experience and Human Factors. I went excited to tell all these budding game developers about UX from a different perspective. I didn’t expect to learn there are so many similarities between the two.

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