Lucy Malby Business Development Manager eg technology Ltd

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Copyright eg technology ltd 2014

Lucy Malby

Business Development Manager eg technology Ltd

• Design review, engineering prototype and design freeze

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• 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

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• 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

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• 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

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• Design review

• Who does it involve?

– Stakeholders as appropriate

• Developer, Client, User, Marketer, Investor, QA

– Roles required for compliance to ISO 13485, 62304 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

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• Design freeze

• 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

• 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?

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• 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

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• 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

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• 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)

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• Pre- clinical verification

• What are the requirements for verification? – ISO process requirements

– Regulatory requirements, 62304 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

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• 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?

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• 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 miss-use 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

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• 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

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Lucy Malby

Business Development Manager eg technology Ltd

Cambridge, UK

www.egtechnology.co.uk hello@egtechnology.co.uk