-
ih37 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
Formulating a Design Input Document (DID) can require participation from every department involved on any given project. As mentioned in lecture, while marketing has a strong influence over a product’s design, it is also imperative to include a member from customer support as they have more experience with the customer’s personal needs. Researchers and engineers for example, may not take a patient’s comfort or quality of life into consideration when designing a hip stem, in which the hip stem may be functional, but makes a squeaking noise with each step the patient takes. This can be avoided by valuing the opinions provided by customer-support, which should ideally yield a more friction-less hip implant and in turn, a rise in sales.
In terms of efficiently conveying design inputs into the DID, one must take into consideration the communication between the design team and the technical writers. For example, if a user need requires a device to be portable, then the degree of its portability must be defined to the writer to add clarity to the DID such as by stating that “the pacemaker must weigh approximately 5 lbs and have a compact shape with as little bulkiness as possible.”
The DID also requires a risk management document that addresses any risks and hazards that the project may face as it progresses. What risks/hazards may result from a lack of description in the DID? What about from being overly descriptive (i.e. strictly specifying a device’s dimensions, weight, color, power consumption, etc)? Can a risk management document be constructed in a way that accounts for misinformation in the DID itself (i.e. instead of stating that a pacemaker must transmit 100 pulses per minute, a zero may get forgotten and the device was mistakenly designed to transmit 10 pulses per min.)?