Question 1 (Compulsory) a. Variation in all forms is the enemy of a validated system. Discuss this statement giving three examples. b. Designing devices for re-use poses a significant challenge to medical device designers. Give 3 examples and briefly discuss how this may impact the design process. c. A company has approached us to complete the initial design work for a new device. They have researched the need, and the problem statement they have justified is: An external device that allows limited protected movement of the thumb to aid tendon rehabilitation." i. ii. How can the company improve this problem statement? As part of the same project, you have been tasked with improving the design specification document that has been generated before it is sent to external consultants who will generate concepts. Table Q1c shows an excerpt from the design specification document. Please comment and suggest changes to the overall table and the specifications. 007 008 009 Specification Measure Device must fit By eye Device must be suitable for use Testing Device must be easy to use Table Qic: Design Specification Table