In general, there are no short cuts in medical device product development. It is very difficult to leapfrog the iterative design process and develop a single prototype that will hit all the checkboxes – technology, industrial design, usability, proof of concept, manufacturability, etc., all in one go.
Over the past few years, systems engineers and the role of systems engineering have all but disappeared from the medical device industry landscape. The impact on many organizations has been significant – slipped schedules, cost overruns, difficulty in component integration, limited focus on effective system risk management, numerous verification cycles due to late defect detection, and system designs that are evolutionary rather than planned.
When developing the core technology and the surrounding product, the problem is less a matter of which comes first, and more about continually balancing the assumptions we make about each.
While safety and efficacy are prime drivers, a med-tech product’s form and its function have a much deeper and stronger relation than one might assume.
What are the questions you should ask yourself, your colleagues, your customers and your networks to be at the forefront of the Connected Health transformation?
Cellular phones and smartphones are enabling a quiet revolution in the medical profession and in the field of personal health.
Creating a simple-to-use product is vital to creating a great user experience in any industry, but in the medical industry, simplification can, quite simply, save lives.
The results of usability testing and expert reviews can be inconsistent across evaluators. How can we make these more reliable?
Should you design your perfect product or begin with your minimum viable product?
This week we explore the collected knowledge of work by three research institutes (National Academy of Sciences, Seoul National University and UC Santa Barbara) to image possibles within our medical device design and development applications.