Medical Electronics
The evolution of experience design in Medtech
Over the last 15 years, the process of product development has made huge leaps forward in sophistication and effectiveness. The modern, connected consumer is far more savvy and demanding than they were. This has lead to huge successes in products that deliver a satisfying experience and major failures of ones that do not deliver on user friendliness. Ryan Chessar, mechanical engineer, Plexus, tells us more about the design process of medical products
T
he consumer experience led revolution has crossed over into the medical devices sector where more
and more diagnostic products are finding their way into both the local surgery and the home. This means that product managers have to match this growing demand with ever more sophisticated end user insights, marketing and product development strategies. At the same time though, increased globalisation and competition is driving the even greater focus on costs across the product lifecycle. The other major impact on medical
product development has been the evolution of medical regulations regarding usability. 15 years ago the first ever Human Factors regulatory document was released – ANSI/AAMI HE74 - and it was a guidance document and not a mandated standard to be tested against. Since then medical standards have been implemented and updated, meaning medical products cannot now be released without demonstrating a vigorous design approach to usability. As a result of these developments, the ways in which an OEM interacts with its EMS partner has seen major changes. This has become apparent with an increase in the number of medical technology development programmes being outsourced with, typically, a widening of the level of involvement required. A decade ago, an outsourced design would start with the customer issuing basic product requirements specifications and statement of work. This would define the direction to be taken during product development. Tight controls would be maintained in an effort to keep within
22 December 2016/January 2017
timescales and budgets, meaning the scope of project and design freedom was restricted. This process meant that whilst the design phase was completed quickly, the product was not always straightforward to manufacture and there were often challenges throughout the course of its lifecycle. Factors that were typically not taken into consideration, or inadequately covered in the development stage, were: • the manufacturing and product test strategy
• usability and user interface • the ease of upgrading the product when in the field
• the serviceability of the product Added to this, there could be a certain lack of focus on the product’s features as well as the end user’s experience, frequently contributing to disappointing product launches.
For example, the failure to consider a
product’s configuration in the field during development meant a medical technician might well spend too long setting up each product. This could have been rectified with a few extra lines of software code but was unlikely to have been included in the more traditional product specification. Fortunately, the whole design through to manufacture process has now evolved to a much higher level with more sophisticated interaction between stakeholders and designers, particularly at the early stages of the design process.
Design partners today have to focus on demonstrating compliance to a well- defined product realisation process that also covers the full product lifecycle.
Components in Electronics
However, the leading question is whether the design teams are able to anticipate how a product will be used and whether they comprehend the best compromise between functionality, cost, quality and the development schedule? Today’s savvy medtech design team must
approach the whole design for manufacture process as a vehicle to deliver great experiences from the moment of implementation through to end of life. The designer needs to look closely at how the end user will be utilising the medical device and work on a storyboard of interaction. The key to this process destroys that paradigm of a designer answering a fixed customer brief - that a product cannot be fully specified at the start of the process. The new paradigm is an iterative circular
process where an increasing fidelity of product confidence builds allow the design team to learn, hypothesise and test, resulting in an evolving understanding of both the end user and product. The final design cannot be specified until a prototype is available to be evaluated in situ. An early mock-up can effectively and efficiently represent the end user interaction even with low-grade materials such as cardboard and tape. The next stages could go through a simulated
graphical interface on a tablet, ‘looks-like’ visual models, ‘used-like’ interaction models, to high fidelity prototyping and finally the end product. Another key to delivering great experiences is to ensure a strong collaboration with stakeholders across the entire product lifecycle. This includes all stakeholders throughout the customer’s organisation, with engineering, sales, marketing, customer service, product maintenance and management input. At all stages the end user experience needs to be the leading factor, whether the product will be used by a medical professional or the patient. In parallel with this, the design engineer is able work through the considerations for the practical aspects of the product throughout the product lifecycle. This will include meeting manufacturing requirements, technical reliability and robustness, ease of upgradability and end of life disposal. Using this design through to manufacture process ensures that the needs of both the customer and the end user are met, at the same time as creating a product that will be delivered at the right price and on schedule.
www.plexus.com www.cieonline.co.uk
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