Well, after many years of design and development, I began to see the light. I realized the value of design controls. I saw that the use of design controls actually shortened development times and made life easier. After retiring, I began consulting with medical device companies in the application of design controls.
I will now try and explain to you, the design engineer, the value of design control. I will explain elements of design control and show how design control benefits you.
#1 - Planning
It takes a long time to write a good plan. But the plan will help you. A plan defines responsibilities – who is responsible for what and who is not. It defines the interfaces between groups – who is the interface and what gets transferred. It defines the documentation required – who creates it, who approves it. Take the time to create approved documentation in the form of a written plan that protects you. No one can say you went off on a tangent or spent too much time or money on one particular item. Your manager approved your planning.
Of course, you know what you want to develop. Who knows better than engineering professionals what is needed in the marketplace. Let manufacturing experts figure out how to make the medical device and how to make it at a reasonable price. That’s not your concern. Just start designing; we’ll fill out paperwork as we go. The above scenario is a recipe for disaster.
Perhaps, engineers don’t know the market that well. Maybe our ideas will result in a product that costs too much. Maybe that device can’t be manufactured. If we spend some time upfront defining the users and what the product should do, in consultation with marketing and other groups, you will avoid headaches downstream. A good requirements list, in addition to avoiding the above problems, will help generate an accurate cost/time/resource estimate which will help you avoid a subsequent crisis with management.
Documented and approved design outputs protect you. They confirm that you completed the design process accurately, on-time and within budget.
#4 - Design Reviews
It takes time to prepare a design review. Presenting a design review can be scary. But it’s better to learn now if you are off track than later when it will be more painful to fix the design.
#5 – Design Transfer
If you spend time early in the design process and spend time throughout the design process with manufacturing engineers, you can be certain that your design is manufacturable at a reasonable cost. Isn’t it a good feeling to know that your hard work will not be criticized or even rejected at the last minute?
#6 – Design Changes
I have seen many projects where undocumented and unapproved design changes led to several product prototypes that were different from each other, and no one remembered what the differences were. Getting design changes documented, tested and approved may slow you down, but it actually helps save time by preventing a potential disaster later in the process
#7 – Design History Profile
You accomplished all this good work. Where is it? Can anybody find it in a few months or a few years when it’s time for an upgrade? Are you relying on your memory? The time to create a numbered organized file of documents is well worth it to avoid confusion at a later time.
I hope these thoughts from an engineer will help you to appreciate the value of design controls. Use of design controls will result in a more efficient and stress free project. Development of the design will proceed on time and within budget because you planned the project and your plan was approved by management.
Edwin Waldbusser has over 27 years experience in regulated industry, including nine years as a full-time consultant. He has worked with companies from startups to Fortune 100 in the U.S., Germany, United Kingdom, Netherlands, Canada, Poland and Saudi Arabia. He specializes in design control, software validation, risk analysis, human factors studies and supplier qualification. He is also the owner of www.meddeviceadvisors.com which offers over 80 easy-to-customize medical device Quality System SOPs.
His experience includes development engineering, manufacturing and field service to the level of director. Waldbusser also has aerospace experience during which he worked on the International Space Station and intercontinental missile defense. He has a bachelor’s degree in mechanical engineering from NYU and a master's degree in business from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness Network. Waldbusser can be contacted at email@example.com.
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