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…
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.
Ash brings over 25 years of experience in leadership, board advisory roles and hands-on development within the health tech and medical device sectors. He has successfully guided numerous national and international companies through the complete product lifecycle from ideation to full-scale commercialisation and scale-up.
As our Founder and Chairman retires, he reflects on building the company, the milestones along the way, and the future ahead....
Explore inside a sustainable inhaler - do reusable designs really offer an eco-friendly solution, or is there more to consider than reusability....
HD CEO Ash Ghadar shares drug delivery development insights from PDA Vienna....
Discover how Haughton Design's diverse team leverages their extensive experience to drive innovation in device development. Learn about our expertise and unique insights that ensure successful project...
Explore how commercial constraints influence innovation in businesses. Discover whether budget limits, regulations, and market pressures drive creativity or stifle progress in today's competitive land...
HD strive to foster effective collaboration on all projects to push boundaries in innovation. We discuss how collaboration with the NHS can provide unique insight....
Why do we trust the accuracy of digital devices more than their non-digital counterparts? HD discuss the 'why' and how this improves device development....
We discuss the whether the medical device industry can embrace paper as a viable alternative to plastic as we advance towards Net Zero....
What is the impact of emerging technologies on medical device and product development? Design Engineer, Dan Kirkham, discusses their applications....
We discuss transforming medical device development through the utilisation of interdisciplinary, and cross industry teams....
