Correct planning should be carried out to control the design & development of your medical device however, many companies fall short when it comes to their documentation and overall approach to planning. In the first of this two-part blog, Senior Design Engineer, John and Human Centred Designer, Amber address some frequent questions regarding writing a design & development plan as well as the typical activities involved.

A development plan can be created for individual project phases for example, a Phase 1 project where a pharmaceutical company might have an inkling about a technology and would like to explore the area to determine the value of investing in it or, a full device development project.

Occasionally at HD, we’re asked to write a project development plan for our clients as a singular activity so, we have tried to address some frequently asked questions to guide you through some of the steps and tools involved:

Is a medical device development plan a regulatory requirement?

It’s a regulatory requirement to follow a certain set of audited development procedures – our development workflows at Haughton Design follow these. At HD, we can’t compromise on our procedures therefore, occasionally we have to please both our own and the client’s systems/procedures depending on their specific requirements.

ISO 13485 outlines some loose guidelines for the development plan. The standard dictates that you need procedures in place and, to a certain extent, they dictate the requirements of those procedures. However, it doesn’t necessarily tell you what the procedure needs to be. This is one of the reasons that there is often a lot of confusion surrounding the topic. Therefore, you’re required to write your own procedure. At HD, we have our own design development procedure for medical device projects that we created internally through utilising the experience of our network of industry consultants. It’s important to note that design planning isn’t a ‘one size fits all’ neither for specific projects nor companies.

The key regulatory requirements of medical device design and development planning can be found in section 7.3.2 of ISO 13485, the international quality management system standard for medical devices, and FDA 21 CFR Part 820.30 (b), the quality system regulation for medical devices.

Is the development plan a singular document?

There are a number of documents and activities that form a high-level design development plan. For example, there are various project planning documents such as Gannt charts, flow charts, a risk management plan, a human factors engineering (HFE) plan and various others that are completed to inform the overall design development plan.

Where to start and what are the typical steps involved?

The first thing to do is to block out the major milestones in the project – the obvious first one being the completion date of the project as well as what exactly all stakeholders intend to receive from it.

Typically, we’ll have a good understanding of our clients’ expectations which are usually driven by factors such as cost and time. Usually, clients have a window of time to gain market share for example, on a recent drug-delivery project we have worked on for a pharmaceutical client where a technology has come off patent – A number of our client’s competitors will be working under time pressures to include benefits of the newly available technology into their own devices and then launch into other markets to take advantage of the opportunity.

As do various locations, the U.S. market has its own exclusivity clause meaning that the first to enter the market has exclusive rights for 6 months. Often the volume of sales within those 6 months and the market advantage alone would warrant undertaking this kind of project.

Calculating and understanding these various parameters, such as time and cost to market, typically determines whether the project is or isn’t feasible. This then allows a projected date for project completion with an allocated budget for all associated activities – this isn’t to say that all activity has to be overly condensed to meet this date, the time available must be used to determine whether the project is possible or not within the time frame of ‘X’ to the budget of ‘X’ to meet ‘X’ deliverables.

From here, you should block out the major milestones and activities that need to happen to achieve your goal;

Once the major milestones are determined and set you would then begin exploring each of them in more depth. It can help to do this using tools such as flowcharts. For example, if your identified milestone is a proof of principle (POP) prototype, you should then work backwards from this point to identify the steps, inputs and activities required to reach that milestone.

These activities are likely to include verification of prototypes. So you should identify what will be required to complete that, starting by creating a verification plan. It will also be necessary to manufacture prototypes so you should consider what is needed to manufacture those prototypes? Perhaps soft tooling; This will need to be designed, procured and manufactured. It then might be necessary to trial the tools, manufacture and assemble the components. If that activity was to be undertaken overseas then there may be time required for transport. All of these things should be considered and built into the plan.

You should continue to work backwords in this way for each of the major milestones. You’ll then review this diagram on a weekly basis to monitor your design & development plan.

Treat your development plan as a living document;

The plan isn’t something that you’ll do once and complete, it is something that will be continually tweaked as more information is gathered throughout a project and as you discuss it with the client, your team and other stakeholders. It will continue to evolve until it’s a fairly mature block diagram.

As stated, it’s incredibly important to review and update the plan on a regular basis, such as in weekly meetings with your client or with other stakeholders where you should share the plan, talk through it in some detail and if required, agree on any changes to reflect what is actually happening in the project. Things always change unexpectedly so careful monitoring and management will ensure time isn’t lost and will allow adjustments without jeopardising key milestone dates.

 

We hope this insight has been useful – In the next blog, we will continue to address some of the frequent questions regarding writing a design & development plan as well as the typical activities involved. In the meantime, please reach out if you would like to learn more about how we could help form your medical device development plan.

Amber Davies, Human Centred Designer & Digital Marketer Amber Davies 5 April 2022

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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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