It used to be that product design and product development were two distinctly different things. Not anymore. In the inextricably interconnected world of “smart” devices where design and development (D&D) occur as tandem processes, they are now an integrated process.
In the case of medical devices and the stringent regulatory criteria with which all stakeholders must comply (designers and developers, technical and non-technical professionals alike with diverse backgrounds in business administration, life science, business administration, computer science, engineering, and the arts), this poses an additional layer of complexity that demands a highly coordinated, transparent, iterative approach to communication, execution, and review processes at all scales.
With this in mind, mapping the medical device product design and development lifecycle into a manageable workflow is critical, and can be simplified into the following 7 phases:
1. D&D planning. Create a plan that articulates D&D in terms of action items and those responsible for them, especially factoring path dependencies between different teams of designers and developers. Review, revise, and approve this plan with all relevant parties till the plan is finalized and validated.
2. D&D input. Use regulatory, safety, performance, safety, risk management, business economics, and consumer feedback (for example, from healthcare professionals and patients) to inform D&D such that the “what,” “why,” “how,” and “for whom” are clear to all parties towards production that delivers on all fronts.
3. D&D output. Design output procedures involve technical specifications for D&D that are collaboratively identified by D&D teams in the input phase. These articulate critical measures/outputs for the function of the device, and include measures used to test alignment between D&D input protocols and actual output performance.
4. D&D review. Iterative review is critically important at all phases but this phase calls for hazard analysis and failure mode and effect analysis across D&D teams as well as review by an objective party. As with review at all phases, document the D&D review results by date, D&D designation, by those performing the review, and by design history file (DHF).
5. D&D verification. This is the phase during which to confirm the device design with objective examination verifying that alignment has been successfully achieved between input protocols and device output. Protocols for examination must be created, adhered to, and results must be documented in DHF records that verify the proper function of outputs (for example, software verification, test method validations, risk analysis and management results, biocompatibility results, and third-party certifications).
Ultimately you will need a control process comprised of mutually informing practices and procedures that are documented and implemented during medical device D&D. A business can successfully identify customers’ needs in relation to competitors’ offerings, calibrate requirements for end to end execution, detect discrepancies between concept, redesign, and design improvement, engineer a repeatable design-development process, and accurately predict alignment between the concept and end product. Good luck!
Mark Dohnalek is President & CEO of Pivot International, the Kansas-based global product design & development, engineering and manufacturing firm with success in medical device, fitness and healthcare technology products. He can be reached at [email protected]
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