Stage 1 marks the beginning of the device development process and is characterised by an evaluation of, and verification of, an identified clinical need. Other stage 1 considerations include a preliminary market analysis, financial review and competitive product assessment. In addition, a initial review of the proposed product’s IP landscape should be made and potential regulatory pathways as well as initial reimbursement strategies identified.

Functional groups include: Management, Marketing, R&D, Legal, Regulatory and Reimbursement

Examples of stage 1 related considerations include: Is there market opportunity? Is the technological, regulatory, QMS, IP approach feasible? Is there basis for competition? Are identified risks and executional gaps manageable? What funding streams are available to us? Will we need to undertake clinical trials?

Examples of stage 1 related deliverables include: needs assessment validation, competitive analysis, SWOT, business opportunity report, financial and cannibalisation analysis, early technical risk assessment and design inputs, prelim IP landscape review, regulatory plan and clinical path identified, early reimbursement strategy and a device business strategy. QMS strategy initiated.

Stage 2 concerns design concept formulation and feasibility. It is driven by a ‘cross-functional’ core development team and results in a general project plan and timeline. Often R&D lead stage 2 activities as they are responsible for initiating the design plan and design history file which are important requisites of a company’s design control strategy. This stage is also important for collecting the ‘voice of the customer’ which often determines early design inputs and can help to establish the competitive landscape.

Functional groups include: Management, Marketing, R&D, Legal, Regulatory and Reimbursement

Examples of stage 2 related deliverables include: Cross functional core development team is identified, project timelines are established and signed off, design inputs are approved and target specifications identified, project concept clearly defined, concept documentation ready and concept evaluation methods established (testing methods), prelim legal review and regulatory plan to include QMS considerations established, initial design risk assessment complete, design for manufacturing initiated.

Stage 3 involves in-depth product design verification and validation which will determine whether the proposed product will perform consistently and as intended in ‘real world’ scenarios – successful verification and validation requires strict acceptance or qualification criteria to ensure that product testing is pertinent, stringent and the results empirically and statistically robust.

Functional groups include: Management, Marketing, R&D, Legal, Regulatory and Reimbursement, Manufacturing and Operations.

Examples of stage 3 related considerations include: Does our product prototype match real world expectations i.e. are we satisfied that our design outputs meet verification and validation targets (i.e. the design inputs) and can the device design be ‘frozen’? Are we adequately commercially ready? Are our QMS system and risk management strategies in place and operational, are we wholly convinced they’re adequate? Have we established that we can meet the regulatory requirements of our proposed market? If we need clinical trials are they underway and using appropriate ‘design frozen’ product?

Examples of stage 3 related deliverables include: Parts and component drawings, assembly drawings, packaging drawings; well defined material specifications; design risk assessment completed; verification and validation test matrix and protocols created; verification testing and reports complete; quality and process validation plan delivered; clinical investigation plan created; regulatory submission completed; manufacturing strategy progressed.

Stage 4 should see the production of finalised design and manufacturing prints, final product verification and validation, closure of recommended risk mitigating actions, sales launch preparation and regulatory approval. Functional groups include: Marketing, R&D, Legal, Regulatory and Reimbursement, Manufacturing and Operations, Quality, Clinical and Sales.

Examples of stage 4 related considerations include: Can our marketing strategy / product claims be backed up by sufficient evidence? Have we satisfied all verification and validation criteria? Have we gathered all testing outcomes, data and evidence from this process e.g. biocompatibility data, electrical safety etc.? Is our manufacturing process established and stable? Is all our technical documentation complete, accounted for and audit (regulatory / quality) ready?

Examples of stage 4 related deliverables include: Design validation completed; scaling of manufacturing and operations activities for launch underway; process risk analysis and plan finalized; Design risk analysis and risk management plan reviewed and complete; legal clearance obtained; working QMS in place; product branding and sales and marketing preparation for launch underway; supplier qualification; reimbursement strategy finalized.

Stage 5 involves final product launch and post market surveillance (PMS). PMS activities in addition to ensuring the ongoing safety and performance of a product post launch can also include clinical trials to support claims for reimbursement, expand a product’s indications for use (requires regulatory approval) or bolster the company’s marketing strategy.

Functional groups include: Marketing, R&D, Regulatory and Reimbursement, Manufacturing and Operations, Quality, Clinical and Sales.

Examples of stage 5 related considerations include: Does our technical documentation need updating? Have we an appropriate system in place for dealing with, processing and assessing the potential impact of complaints / user feedback? How do we feed this back into the risk management system? How will we handle required changes to design documentation, re-testing and contact with the regulatory agencies if required. How will we handle product recalls if required? Are we adequately resource to support out post market obligations?

Examples of stage 5 related deliverables include: design change control system in place; QMS compliant post market surveillance system in place.