TGFR Consulting LLC Transforming Medical Device Development
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 …
Over the next several months, this blog will explore the process of developing a medical device. We will explore in detail the steps that transform a great idea into a great product, quickly and compliantly. The process of developing a great medical device can be subdivided into two high level activities Creating the Requirements – …
Welcome to TGFRconsulting. This site is dedicated to the exploring process improvements in the area of medical device development. By changing the way that organizations approach development we change development. Throughout this process we will stress that by embracing change we can move to the next level of development. Specific topics will include Determining the …