We’ve now reached the conclusion of our journey around the route map for developing a medical technology, visiting each of the key disciplines in turn.

Having watched other videos in this series, you’ll appreciate that developing a medical device is a complex business, with many opportunities to experience pain. We’re here to help you avoid as many of those painful moments as we can. That’s why we’ve put together a series of 4 videos to examine each of the 4 phases every medical device project goes through – covering all the things you’ll need to take care of in each phase, in one short session.

 

How would it be, if you had a straightforward route to get you from here to there, what would you do, armed with that?

In this bite-sized video, we’ll continue our exploration of the map of medical device development.

Effort and costs rise significantly as you progress, whilst the risks of failure are mitigated – you go from high risk and uncertainty in the early phases through to a defined risk profile.

This time, we’re taking a look at the first of four phases that every project goes through – Define.

Project Management

Project Definition – every successful project begins with the end in mind. Understand who has influence over its success and create with them a clear, shared view of what the end point looks, sounds and feels like. Think about the risks you might face and get everyone on the same page about what you’re doing together.

Work on agreeing shared objectives, project roles and responsibilities.

You should create a Project Plan to capture shared understanding and use as a reference throughout the actual work. Outline the big chunks of activities that you’ve defined together. The rule of thumb here is to plan for the “big picture”, resisting the urge to delve into detail until the next phases. This’ll be tough as we feel a strong pull to “get on with doing”.

How long should this take? It depends upon the size, complexity and novelty of the project, however we’ve found it invariably is done in less than 1 day!

As your project progresses, you start to put flesh on the bones of this plan, phase by phase, buttoning tasks down so there’s less opportunity for scope creep. Learn from what did, and didn’t, work for previous projects, incorporating this knowledge within your evolving plan.

Click here to view the complete video explainer for this key discipline.

 

Regulatory + Quality

Quality Planning – identifying the requirements you will need to satisfy, including regulations, standards, involvement of notified bodies, verification and validation, and making sure they’re there in your project plan.

Quality Management System – is your QMS up to scratch, if you have one, how will the project respect SOPs and processes.

Document Controls – checking that you have adequate and robust control of documentation (both project and routine), as “if it isn’t written down, it didn’t happen”.

Design inputs – this is the starting point for device design, these requirements are the basis for activities through to validation. That’s why having a solid foundation here is the single most important design activity. It’s tempting to move over this quickly, to get on with making something – yet quality time spent here pays off magnificently later on.

Click here and here to view the complete video explainers for this key discipline.

Intellectual Property

Checking for what’s known as “Prior Art” – this is looking to see if your invention is already known.

It doesn’t need to exist physically or be on sale. It is enough that someone, has described or shown or made something that includes a use of technology that is very similar to your invention.

An existing product is the most obvious example here. But, just because you can’t find a product containing your invention, don’t make the mistake of assuming that it must be novel.

You should also look for what’s known as competing art. These are ideas that may not be at all like yours but do the same job. If you find some, all is not lost, as you can learn a lot from other solutions.

A major risk, particularly in sectors like healthcare, is that an innovation can be blocked by a competitor who holds a patent for something that’s incorporated within your product. That’s why you really should ensure that you have “freedom to operate” before embarking on costly development activities.

Click here to view the complete video explainer for this key discipline.

 

Design Development

Market research – this is finding out what the unmet medical need actually is, what it is not, constraints and the considerations. All this to make sure you’re developing technology to fit a need, instead of the other way around. This step may well be linked to the first stop of the “Market Research and Access” track, however that often comes once you have identified the unmet need and have a concept(s) to set out to address that.

Concept design (assuming that you’re free to operate) – developing a set of creative responses to address the unmet medical need that could be turned into a product.

Design Feasibility – looks at the concepts you’ve created, with clear eyes, exploring how or whether they could be developed into practical designs, that can be made, assembled, disposed of and, very importantly, be used by your intended users.

Click here to view the complete video explainer for this key discipline.

 

Human Factors

User Research – Kick start your project with a clear understanding of who your users are and what they really need, using a range of research tools.

Concept Design – Give your design the best possible chance of success by removing potential use errors at the start. Use errors that you’ve already uncovered.

Usability Plan – Turn the complex into a straightforward, achievable plan. A plan that ensures you satisfy the regulatory authorities, especially the FDA and EU.

Click here to view the complete video explainer for this key discipline.

 

Risk Management

First off, you’ll need to define your approach to Managing Risk, throughout the life cycle of your medical device. In our experience, good Risk Plans are updated throughout the life cycle, they’re not left in a cupboard to gather dust.

To objectively assess each potential risk, it’s helpful to pull together a list of the Hazards and Harms for use of your device. Hazards are potential sources of harms to people, property or the environment. Risk is the combination of the probability of a harm happening and its severity.

Click here to view the complete video explainer for this key discipline.

 

Market Research & Access

You’ll want to ensure that there is actually a market for the product you want to develop! It’s helpful to have at least an idea of which countries you plan to sell the product in.

So, it’s a good idea to perform a Market Assessment, to check the market exists, its size, complexity and what competition is already out there (which may include other ways of addressing the same, or similar, unmet clinical needs). The assessment should also look at the options for a route to the market, for your product.

Click here to view the complete video explainer for this key discipline.

 

Clinical

Get started with Clinical Planning, to set out the broad brushstrokes of activities that you’ll need to do, to ensure your development project addresses the requirements of regulations (particularly the Medical Device Regulation) and ISO 14155 for Clinical Investigation.

At this stage, you’ll probably get started with Literature Research, so you have a clear picture of any gaps in research that you may need to plug later on.

Click here to view the complete video explainer for this key discipline.

 

As you watched this video, you’ll have started to think about how you can go about addressing each of these steps properly, making the best of each part of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.

Now that we’re coming to the close of this video, subscribe to our YouTube channel, sign up to our website, or follow us on social media, so you’re the first to know when new content is available.

Thanks for watching, remember to send us your feedback and comments.