When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
As users in the field are gaining experience with EMR, usability problems have emerged that are a result of the User Interaction design of some of the many EMR software packages currently in use.
It’s not just about architecture; what are the critical systems engineering roles and responsibilities?
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.
