TGFR Consulting LLC Transforming Medical Device Development
Working with many large corporations and their development teams, it has become clear that the changes in meeting frequency and structure have had a significant impact on productivity. Bad meetings and their impact on the productivity are a key impediment to achieving the overall organizational goals. The refrain from many individual contributors, “I’m in back …
As organizations work to design and develop a quality management system (QMS), how to establish compliance becomes a key consideration. The choice of structure represents a continuum between two types of control Many factors influence the choice of control, and the right choice requires considering all of these factors. This choice may be a hybrid, …
Mowing the lawn, I usually listen to scholarly articles on You-Tube. It makes the effort of mowing have an additional payoff in that I can learn something. Yesterday I learned about cohesion and project execution from a very unusual source. I listened to an analysis of the Wehrmacht, (the German Army) performance in World War …
Failure to assess the status of work can result in rework, leading to project delays
This details how VOB translates into business needs.
Following the identification of the product idea, collecting the Voice of the Customer (VOC) and translating this VOC into high-level user needs begins. These user needs drive the product definition process. Simply stated, VOC (Voice of the Customer) expresses the effect that a customer would like the product to have on his life/environment. Creating good …
Medical Device development demands good system engineering and understanding the regulations, risk and clinical use that are unique to the medical device market. To get it right, the focus needs to be on a process that minimizes mistakes and maximizes success.
After task analysis has identified the failure modes, the next step is the mapping of hazards to these failure modes, identifying the sequence of events, and identifying the hazardous situation(s). The following figure illustrates the overall flow.
Medical Device Task Analysis will form the basis of future risk and workflow development
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.