Developing drug delivery platforms and medical devices can be a labour intensive and frustratingly lengthy process, even for the simplest of devices.
Here at Haughton Design, we have worked hard on optimising our procedures, systems and tools to compress design development activity and keep projects ‘lean’. We regularly surprise new clients with our team’s impressive pace, depth of thinking and thoroughness in very short timescales.
Phase 1 Rapid Conceptual Research
Phase 1 allows for a structured approach to design immersion, concept development and feasibility studies. The first step, Discovery and Immersion; affords our team to absorb the information and frame the challenge. We invest time in planning with the end in mind and use planning tools developed by ourselves to minimise administration duties yet are still flexible to suit the nature of early-stage development work. We have found that off-the-shelf software packages don’t provide the level of detail required to handle the many strands of activity without becoming overly cumbersome.
Phase 1 concludes with a feasibility study to ensure the designs are tested and evaluated, whilst being technically and commercially viable to progress further into phase 2. Potential manufacturers are typically engaged at this point with their thoughts and cost estimates feeding into the summary reports. This close working relationship with manufacturers means we can benefit from their invaluable hands-on industry experience. This results in smarter, more informed decisions, thus de-risking the manufacturing transfer activities further down the line. With all these checks complete and any residual risks deemed acceptable for this point in the project, it’s time to move into the final phase.
Phase 2 Controlled Design & Development
Phase 2 is when things become much more formal to comply with our ISO 13485 design control system along with ISO 14971 safety risk management activities. It is critical to enter this stage with a well developed and tested concept as well as a thorough and documented plan. We plan the whole project with a keen focus on the end deliverables, detailing precisely how we intend to conduct verification and validation, and how we will complete the technical file required for submission.