Five Steps to Successfully Fail Early, Fast, and Often
The most successful innovators throughout history used a process called ideation in order to create products that make our lives better and more enjoyable. Thoughtful ideation shortens the development cycle, improves performance, and reduces cost. It aids creation of simple, elegant designs that meet user needs in the most direct way. Applying ideation during medical device design is a critical step toward creating a successful product. See MPO article:
CEO At Hwautohaus
6yRisk analysis at the early stage is the key
Physician, Surgeon, Inventor, Healthcare Leader
6yExcellent article and learning material thank you Steve. One man discovered and drew his idea on the sand (just like the early men )even he did not get the benefit of the idea which became the mostly used item in our day to day life in my opinion .
Hi Bruce, I agree that risk management is important and have written about it in other articles. In "The Human Factor" I discussed usability engineering and industrial design and folding it into risk analysis to meet FDA requirements. In "Creating Value By Design" Bruce and I discussed the design control process at length. Here, we are discussing the process of coming up with ideas and doing early analysis for feasibility. This "concept" phase is prior to any design control or risk based activity. Good to hear from you Bruce!
Owner at BAC Engineering
6yHi Steve, I think there’s one thing missing in this outline - risk management. In this context, risk management enters in the early consideration of use cases and foreseeable misuses and in later weighing of design choices. It can be applied to project, technology, economic, and user risks, but is required by regulation from the earliest stages of design for risks to patients and practitioners. I’ve seen real value emerge within designs from applying RM early on, and it makes V&V and transfer a lot easier down the road if you build a good RM foundation.