From the most serious medical device recalls to the source of medical device failures, QMED spends a lot of time exploring what is wrong with the design process. So, what rules will ensure that the design is safe and efficient?
QMED editors raised this issue in Linkedin. Eric Claude, vice president of product development at MPR Associations, gave his answer. Claude has been designing medical devices for more than 20 years. He lists 10 applicable rules when working with clients and design teams.
1. Understand all stakeholders and their needs.
“Now we have to consider a wider range of stakeholders than ever before: clinicians, patients, regulators, payers, equipment manufacturers, etc. If we talk about family health, it will become more complicated because of the difference The environment will have different needs."
2. Link product requirements to clinical needs.
“Understand the clinical and user needs (which are often quantitative rather than qualitative) and then turn all of this into quantitative product requirements. Make sure that the product requirements specify what the product must do 'what', not 'how to.' â€
3. Develop a high-level architecture for the entire system/product.
"What are the main parts of the puzzle, how do they put together? At least determine a method, preferably a few alternatives, at the 'system' level (through brainstorming, your own experience, others' experience, similar Product) solve this problem."
4. Understand the risks.
“This may be the technical risk of the first product of its kind, or the organizational risk of getting involved in an unfamiliar area. The first step is to focus on the high-risk factors of the design, and there are always contingency plans for risky projects.â€
5. Don't ignore the laws of physics.
“They are called 'laws' for a reason, and the key is to understand how they apply to the product you are designing. When developing a 'sense' that solves problems based on science, you must simplify and analyze the role of key parameters. "
6. Design from the user's perspective.
“The final product will be used by people. And people have different abilities and limitations due to education, background, work environment, stress level, medical conditions, etc. Know who will be the user of your product and from their perspective Design the product. â€
7. Make a "vertical slice".
“Prioritize design implementation, then analyze, design, build, and test the most important parts of the system and limit these results to less important parts.â€
8. Consider the place where something goes wrong.
“Designing products to cope with (ie fault tolerance) imperfect parts. For example, think about dimensional tolerances, loose fasteners or connectors, power failures, or misuse. Use risk analysis tools to manage this process.â€
9. Do as much testing as possible.
“Test each design element as much as possible before integrating with other components. If you find yourself repeating the design to solve the problem, don't try to change more than one thing at a time.â€
10. Murphy's Law always applies.
“Compared to the past, Murphy's Law is always applied to the product design process. Be sure to plan extra time and budget to complete the build and test. Nothing is as easy as it seems, every time it takes longer than you expected Long."
Rebecca Herold, President and CEO of Rebecca Herold & Associates, added Article 11 before Claude's ten rules: ensuring effective information security and privacy controls.
Do you think this is a good list of rules? Is there anything else?
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