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.

The Workflow and Responsibilities

By working with industry experts and regulatory consultants, we have identified many efficiency gains and developed an ISO 13485 certified workflow document that de-mystifies the overall device development process. Our WorkFlow plan explicitly details the responsibilities of HD, our clients, manufacturers and other collaborators. This preliminary formality helps the team understand expectations and ultimately avoid any awkward discussions later-on, but more importantly de-risks their development programs. The workflow is split into;

  • Phase 1 Rapid Conceptual Research
  • Phase 2 Controlled Design & Development

The workflow forms part of our formal Development Plan, guiding the overall project through a tried and tested path to product readiness.

Banner of HD's design workflow

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.

 

Our systematic approach & structured process may sound a bit restrictive. However, we have been careful to provide sufficient breathing space for free-flow design thinking. The concept stage kicks off with creative innovation workshops, enjoyed by our team and clients alike. Design Sprints are launched, and mock-up low fidelity prototypes are built to test early ideas in the fail-fast philosophy. Draft versions of the design input requirements help to steer creativity, and our intelligent idea judgement tools ensure time and budget go against the most promising of ideas.

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.

This concentrated focus on the project requirements, from start to finish, cuts out any unnecessary R&D activities which can sap time and effort. We map out the framework for our technical files upfront, using dedicated software to maintain links and traceability between initial requirements and outputs. This software will also draw attention to any missing activities, so there are no surprises or missed opportunities that could impact timeframes and budgets. With the right approach and systems, our team can focus on the tasks at hand, knowing the regulatory administration, product safety, and efficacy controlled in real-time, giving us the confidence to work at pace.

As experienced medical device development teams understand, there needs to be some level of flexibility in the stage-gate/FDA waterfall approach.  Sometimes, to meet project requirements, we need to test early, evaluate, and iterate. This means crossing over some workflow stages which is particularly useful if you have a critical function/essential requirement requiring early verification work. Our system is flexible and adaptable enough to suit most project requirements while remaining compliant.

What are Design Controls and why do they matter in Medical Device Development?

We continuously look out for risks, potentially arising from many angles, such as;

  • Product safety risks
  • Product failure risks (user, design, process)
  • Foreseeable misuse (deliberate and unintentional)
  • Commercial feasibility (manufacturing cost monitoring)
  • Project management risks (delivery schedule, budget, commercials)
  • Industrialisation risks
  • Intellectual Property Risks
  • 3rd Party contributor Risks (manufacturers, subject matter experts etc)
  • Confidentiality

Any critical high risks identified spin out for further investigation, rather than being left to languish to align with any pre-planned future testing.

 

Early phase 2 designs will undergo a preliminary design review (PDR), followed by a detailed analysis of the design(s); identifying sensitive areas using FMEA and Fault Tree Analysis (FTA) tools. P-Diagrams and Fishbone-Diagrams also help us critique factors which contribute to device functionality, reassuring us that significant interactions and functions are genuinely understood, so any future changes or optimisation happens efficiently.

This approach helps remove the endless proliferation of prototype creation in the hope of solving challenging problems. With Solid Works Motion, FEA and Design for Experiments, we can solve the inevitable stubborn design issues and understand more complex compounding factors to optimise designs.

inhalation device

Design engineer giving a project status update to a client with a Gannt chart in the background

 

Having frequent status updates with clients and manufacturers helps keep project momentum and accountability. The frequency often changes to suit the stage we are in, to remain efficient in our use of time.

We often call upon industry and subject matter experts to provide helpful contribution and oversight, so projects benefit from an even deeper pool of experience and expertise. This additional support helps our design team and client build confidence in the design direction, leading to quicker decisions and significant progress.

 

The final engineered design(s) will undergo a significant amount of self-checking, firstly using our CAD systems’ power to identify geometry weakness before committing the design to our senior team for a detailed critique. We follow checklists created from many years of experience and continuous updates in line with our CAPA  (Corrective and Preventative Action) QMS system. This intense checking program helps us identify issues early on that can, if unspotted, prove detrimental if left until the later stages of a project, i.e. upon tooling completion.

Once in the verification stage of a project, the critical parameter work we mentioned earlier in the process, may be called upon to solve any issues arising in the tooling/sample approval process. As the toolmakers will have been made aware of these critical areas prior to tool manufacture; tool modifications will be quick and cost-effective if required.

A medical device designers reviewing the engineering drawings of a blood sampling diagnostic device

Two design engineers packaging up soft tooled, injection moulded autoinjector trainers

 

Labelling, packaging, and sterilisation requirements will also be considered very early in the development program, preventing last-minute panics and timeframe spoilers.

In fact, there is an incredible amount of foresight and contingency planning required to ensure the smooth running of any project. A certain level of positivity, tenacity and agility is required to tackle the unforeseen issues as they present themselves, although our systems filter a lot of known risks there’s always going to be new challenges, that’s the nature of developing innovative devices. That’s why you need a design team with the right mindset; one of ownership and an eagerness to get things done!

We appreciate that all projects are different. Therefore, we tailor and optimise our approach to add value to your individual project’s needs. Please get in touch to learn more about our approach or discuss how we can help you with your design and engineering challenges.

 

Amber Davies, Human Centred Designer & Digital Marketer Amber Davies 21 May 2021

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Get in Touch with Amber Davies

Human Centred Designer & Digital Marketer

Amber graduated from Cardiff Metropolitan University with a degree in Product Design. She has a particular interest in the medical field stemming from her personal experience of using a medical device. She pairs her design background with her personal experiences to apply empathy and develop improved user experiences. Amber also combines this understanding to liaise with customers and create digital content at HD.

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