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. But, what structure should the top-level plan follow?

In a previous post, we answered if a medical device design and development plan is a regulatory requirement? As a continuation of that post, this week we are exploring what structure the top-level plan should follow. Alongside the flowchart and other documentation, you will be writing the top-level plan. This too will be a live document that you will be writing alongside your flow chart, Gantt chart, and other supporting documentation. Essentially, this is the launchpad to those other documents and so you would list them as external references.

So, this is the high-level master document that executives can read to understand how much the project is going to cost, how long it’s going to take, and ultimately, if it will be feasible. Typically, a pharmaceutical company will take this document and process it through its financial system to govern the financials, understand the return on investment and market share before deciding whether to progress and plan it into the budget for the next financial year.

There’s an art to writing these documents and remaining concise…

The design & development plan is not limited to but should follow a loose structure of;

1. Overview:
An overview of the project and its purpose.

2. Scope:
The intended use of the device.

3. Major deliverables
The outputs and deliverables for the project.

4. Exclusions:
These are important to outline from the offset.

5. Assumptions:
It’s fine to make assumptions if everybody involved knows what areas your assumptions lie in. This allows you to evaluate what assumptions were incorrect and spot deviations to recoup some budget when problems arise.

6. Project team/structure:
This gives an idea of who’s working on the project, how big the team is and how the team works together. This is crucial in multi-disciplinary teams or where external subcontractors are involved.

The plan needs to clearly demonstrate who is responsible for what as well as the relationships between stakeholders. This will help prevent finger-pointing when challenges arise.

7. Required resources:
These include the external resources you will require such as your test houses, manufacturers, and validation Partners.

8. Accreditation, documentation, procedures & necessary competencies:
This will demonstrate that you have the right certifications, procedures and a robust QMS system in place.

9. Flow Chart Outputs:
These get migrated into a Gantt chart where you will list all line items and start assigning time and cost to each item. This is where the research as well as discussions with your identified resources will happen to gain costs, timeframes, and other parameters to build into the Gantt chart. The results from the flow and Gantt chart work will usually be distilled into a list of major milestones including information such as who’s responsible for these milestones and, when these milestones will be delivered.

We hope this post has given some insight into the structure of the top-level design & development plan. Please visit our resources page to learn more and download a copy of our full free guide on How to Plan the Design & Development of a Medical Device.

John Harverson - Senior Medical Device Design Development Engineer & Quality Manager at Haughton Design John Harverson 17 March 2023


Get in Touch with John Harverson

Technical Director

Holding a Bachelor’s degree in Industrial and Product Design as well as certificates in Project Management and UX Design, John is an advocate of user-centred design and finding innovative solutions within regulated fields. With over a decade’s experience in the medical device industry from working as a Consultant helping companies develop innovative medical devices, to head of an Industrial Design company developing imaging equipment for early detection of breast cancer, John also manages our ISO 13485 & ISO 9001 QMS.

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