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10 Rules for Designing Great Medical Devices Cheat Sheet by

Grat list of Rules for Designing Medical Devices
design     medical     device

Introd­uction

From keeping track of most serious medical device recalls to exploring the sources of medical device failure, Qmed spends plenty of time looking into what goes wrong in the design process. But what are the rules that allow for safe and highly effective design?

Qmed recently asked this question on the Medical Devices Group on LinkedIn, and received a useful response from Eric Claude, vice president of product develo­pment at MPR Associates (Alexa­ndria, VA). Claude has been designing medical devices for about 20 years, and he says that he actually uses a top 10 list with such rules while working with clients and design teams.
Here is exactly what Claude then listed off, citing a colleague named Craig for two of the points:
Posted in Design Services by Chris Newmarker on May 12, 2014

1. Understand all the stakeh­olders and their needs

"­Today more than ever we have to consider a very broad range of stakeh­old­ers—the clinician, patient, regulator, payer, device manufa­cturer, and more! If we’re talking home health care it gets even more compli­cated with needs imposed by the diverse range of enviro­nme­nts."

2. Relate product requir­ements to clinical needs

"­Und­erstand the clinical and user needs (which are often more qualit­ative than quanti­tative) and then translate each of these to quanti­tative product requir­ements. Make sure that requir­ements specify “what” the product must do, not “how” it must be done."

3. Develop a high level archit­ecture

"­Und­erstand the clinical and user needs (which are often more qualit­ative than quanti­tative) and then translate each of these to quanti­tative product requir­ements. Make sure that requir­ements specify “what” the product must do, not “how” it must be done."
3. Develop a high level archit­ecture for the overall system­/pr­oduct.

4. Understand the risks.

"­These could be technical risks for first-­of-­a-kind products or organi­zat­ional risks where you’re treading in unfamiliar territory. Focus on the high risk elements of the design first. And always have contin­gency plans for the risky items."­
 

5. Don’t ignore the laws of physics.

"­They’re called “laws” for a reason, and it's critical to understand how they apply to the product you’re designing. Develop a scienc­e-based “feel” for the problems you have to solve by simpli­fying and analyzing the effects of key parame­ter­s."

6. Design with empathy.

"­Ult­imately products will be used by people. And people have widely different capabi­lities and limita­tions based on their education, backgr­ounds, working enviro­nments, stress level, medical condition, etc. Understand who your product’s users will be and design the product with a view from their shoes."­

7. Do a “vertical slice.”

"­Pri­oritize the design implem­ent­ation and then analyze, design, build, and test the most important parts of the system first and let those results define constr­aints for the less important parts."­

8. Think about what can go wrong.

"­Design the product to cope (i.e., be fault tolerant) when things aren’t perfect. For example, think about dimens­ional tolera­nces, loose fasteners or connec­tors, power failure, use errors. Use risk analysis tools to manage this proces­s."

9. Test what you can as soon as you can.

"Test as much of each design element as possible before integr­ating with the others. And if you find yourself iterating on the design to fix problems, don’t try to change more than one thing at a time."

10. Finally, Murphy’s law always applies.

"More than ever in the product design process. Be sure to plan for extra time and budget to get things built and tested. Nothing is as easy as it looks, and everything takes longer than you think it should."

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