Lucy Malby Business Development Manager eg technology Ltd

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1 Lucy Malby Business Development Manager eg technology Ltd Design review, engineering prototype and design freeze Pre- clinical unit verification, clinical unit validation

2 Engineering Prototype What is an engineering prototype? A prototype designed to meet a need within the development pathway. It might answer specific questions about usability, functionality, ergonomics or technical challenges A prototype designed to meet a business plan requirement. It might provide specific input to goals for funding, investment or marketing Kinds of engineering prototype - the importance of language. Alpha prototype primary, functional, not like the final design Beta prototype more like the final product, rapid prototyped Pre-production prototype using production methods

3 Engineering Prototype Where does an Engineering Prototype fit into the process? Prototypes for market evaluation Models Mock-ups Conviction kits Prototypes for technology evaluation Breadboards Proof of principle units Risk reduction units Prototypes for proof of manufacturability Pre-production units Units for regulatory approval Pilot manufacture

4 Design review What s the purpose of Design review? Keeping development on track Accommodating change Communication design evolution Proving QA controlled design processes Requirements of the MDD and FDA (documentation of input and outputs for a design review) Where does it fit into the process? Design review at each stage as closure on a phase Acts as a gateway and trigger point to the next phase of a project

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6 Design review Who does it involve? Stakeholders as appropriate Developer, Client, User, Marketer, Investor, QA Roles required for compliance to ISO 13485, and MDD Those who can consult and review when they have expertise and input regarding the stage of design An individual who does not have direct responsibility for the design stage and can provide an independent voice Peer review and the importance of multidisciplinary input How do you know it meets purpose as a process? Output should be auditable Output should be credible

7 Design freeze When to stop developing and start commercialising? Is the design fit for purpose, what value is there in further development? Risk evaluation and mitigation. Is the design sufficient to generate revenue with low risk? At what point does the the ROI (in value and non-monetary factors) dictate a move to market? What constitutes a freeze? A stake in the ground in the design process The point at which all further change becomes a further product iteration The point at which an engineering change control process is needed

8 Design freeze When is design frozen in the process? Triggered by specific development deliverables Software release Deliverable prototype First manufactured product Triggered by specific development events On achievement of specific goal results On submission to regulatory testing Necessary before release to clinical validation to avoid revalidation

9 Design freeze How is a frozen design then allowed to evolve? Accommodation of feedback from a frozen design into a further defined development phase Use of a change control process By resubmission to regulatory testing and notified body etc Tools for design freeze and evolution Specification management tools e.g. Visure Corrective action request (CAR) / Engineering Change Order (CEO) process

10 Pre- clinical verification What is verification? Wikipedia says "Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process. Contrast with validation. Formal testing of a design against the full specification Testing agreed between the client and the developer. What is a pre-clinical unit as opposed to a clinical unit The verification unit A unit used for initial trials at friendly beta sites A unit which does not have full regulatory approval (note requirements for Medical ethics and MHRA) Pre-regulatory units marked for research use only

11 Pre- clinical verification What are the requirements for verification? ISO process requirements Regulatory requirements, Software development requirements traceability and the MDD Applicable standards requirements Proof of the pudding Testing against specification (Visure ) Compliance to specification by design by type testing by QA test on an each and every basis Testing must be against agreed test protocols for functionality, where the test has been rationalised and is to traceable standards where necessary

12 Clinical unit validation What is validation Wikipedia says "Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Contrast with verification. Formal supervised testing of the final product under defined operating conditions Who is responsible? Determine and agree who is completing this in advance of the hand over of deliverables Independent testing, client testing and developer involvement Where will this be completed and have the right approvals been obtained? Witnessing testing, is this required or desired?

13 Clinical unit validation Proof of the pudding Testing should cover the user requirements for performance and prove that the product meets the defined market requirements Additional information may be gained by consideration of exceptional use and missuse in order to satisfy consideration of Human Factors outside of validation testing Validation test protocols should be in accordance with the output needed for the regulatory requirements such as CE or FDA submissions

14 SOME factors that contribute to successful prototype design and development Defining and understanding Engineering prototypes, their uses and roles in the development process Knowing when to freeze design, defining specific gateways and goals to enable design freeze and managing evolution of a frozen design to the next iteration Knowing the difference between Validation and Verification Pre-clinical verification of a design using process, methodology, rationale and testing in line with the requirements of the regulatory environment under which the development took place Clinical unit validation on production batch with the correct stakeholders, using accepted and agreed methodology in line with the use conditions

15 Lucy Malby Business Development Manager eg technology Ltd Cambridge, UK

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