TGFR Consulting LLC
Transforming Medical Device Development
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs. The overall work flow is as shown in the following Over the next several weeks we will discuss each of the activities, starting with the use case development
Based upon the evaluation of risk, mitigation of the hazardous situations will be needed. In determining the need for risk controls, care must be taken to align with the requirements of ISO 14971:2012. The approach to risk control should be based upon the risk for a hazardous situation and can be summarized as follows This …
Identification of all the hazardous situations associated with the therapy or procedure requires the identification of all actions (both user and device) associated with the execution of the therapy or procedure. Use of functional analysis, rather than starting with the failure modes of the device and assessing risk of the linked therapy or procedure actions, …
The therapy centric risk analysis begins with the identification of the hazards and the associated harms for the therapy or procedure. Hazards, a potential source of harm, should be specific to the therapy or procedure. Mapping to the therapy or procedure makes it easier to identify the possible harms associated with the hazard. For example, …
Risk analysis based upon the clinical use of the device must be performed prior to concept elaboration (the development of design inputs). Risk Analysis establishes essential requirements, the requirements associated with safety. These essential requirements will be blended with the concept realization to form the basis of the final design inputs. The following table …
Early Concept Confirmation Concept confirmation follows identification of the final concept. In this step, the concept is realized as drawings, models or other tangible artifacts, and feedback from users and customers gathered to confirm that the concept developed truly meets the user and customer needs. Throughout the concept development process, user and customer needs have …
Concept Development using QFDs and Super Concepts The process of concept development requires two integrated activities The identification of CTQs using the QFD. CTQs consist of those performance parameters that drive customer satisfaction. The QFD activity identifies the CTQs The evaluation and selection of concepts using the Super Concept process. Success iterations create and evaluate …
Feature Development and Performance Parameters Feature Deployment maps the VOC statements to a set of device features to be used as part of the QFD process. An effective mapping effort creates a minimum set of performance parameters, sufficient to allow the QFD to be effective. Developing the minimum set of performance parameters drives more …
Creating the Requirements – VOB (Voice of the Business) VOB (voice of the business) represents the commercial and other business considerations for the medical device. VOB development must be kept distinct from the activities associated with user needs in order to prevent the corruption of the true user needs. In developing these distinct needs, every …
Building VOC (Voice of the Customer) VOC (voice of the customer) is an expression of the effect that a customer would like to have on his life/environment for him to best perform his desired tasks. The process of developing VOC includes Gathering, understanding, targeting, and verifying the needs of non-business ‘actors’ directly affiliated with the …