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 second of four phases that every project goes through – Develop.

 

Project Management

Manage Project – You’ll want to be clear about how you, the project team, work together, procedures you’ll follow in day-to-day execution of your project plan. Many project teams schedule regular reviews, to check they’re on course, that the data supports continuing along that path. Pause, take stock of where you’ve got to.

Issue Resolution – consider how you’ll deal with changes and issues, how will they be described, decisions made and actions implemented? Issues won’t just be design related, things like changes in the skills, people and resources you’ve got, will also impact upon project delivery. It typically looks something like this:

  • Understand what the issue/change really means

  • Assess its scope, and drivers

  • Examine the impact upon your end-point and planned activities

  • Identify any additional things that will need to be done as a consequence

  • Decide whether to accept the change or reject it, as well as if it results in returning to an early project phase.

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

 

Regulatory + Quality

You’ll notice that the track divides at the start of this phase, into Design Controls and Quality Management lines.

The Design Controls track includes:

Design Documentation – As you embark on developing concepts, document what’s being done, when it happens – this benefits you in so many ways, not least in proving the birth of your IP and giving you solid, reliable information on which to make decisions. It really doesn’t stifle creativity, despite what some may tell you.

Design Outputs – essentially these describe your frozen device design, and let you go ahead with Design Verification and Validation. It’s things like assembly drawings, specifications, test results, risk analyses.

Alongside these activities, you’ll be ensuring appropriate control of purchasing and suppliers to the project (be they suppliers of goods or services).

Purchasing Controls – it’s required by FDA, and others, that you have control over what is bought, from whom and to what requirement. That’s what this is about, having a process to do all that, especially the more critical the thing or service you’re buying.

Supplier Evaluation – again, particularly for the more critical things, you need to demonstrate you’ve followed a process to identify, evaluate, select and manage your suppliers.

Design Qualification – sets out to answer “does the design I’ve come up (as Design Outputs) with meet the Design Inputs we’ve written down”.

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

Intellectual Property

At some point you must legally protect your IP, or you won’t be able to:

  • Disclose it safely,

  • Be recognised in law as its owner,

  • Profit from its commercialising it,

  • Prevent or discourage its unauthorised use by others.

Protection could be in the form of a patent, copyright, design or brand protection.

This is a very complex legal area, that’s rightly the domain of Patent Attorneys. However, to get you started, the European Patent Office have some very useful materials.

https://www.epo.org/learning-events/materials/inventors-handbook.html

It’s often the case with medical devices, that what they look like can be covered by “Design Protection”. As long as it is really “new” and has individual character (that is, it doesn’t mimic something already in existence), then you can assert a “Design Right”. There are two choices here:

  • You can seek formal registration, or

  • Rely upon rights provided by it simply being in use. – a bit like Copyright.

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

 

Design Development

The Design & Process Risk Analysisstophas you identifyingand evaluating risks related to the device design, as well as it’s likely manufacture, assembly, distribution, recycling or disposal processes – identifying ways to mitigate risks.

One of the difficult things here is balancing these requirements with the needs of the User (as you might expect, this stop is intimately linked to the Risk Management and Human Factors tracks.

Design Iteration – sees your device design evolving to incorporate risk mitigations, firstly because of the risk analysis, then to respond to the results of …

Design Evaluation – bench testing and usability testing of design iterations, to see how well they deliver against specific requirements and risk mitigations. Again, this stop is intimately linked to Risk Management, Human Factors and IP tracks. They all have a part to play.

It is usual to go through this loop a number of times, as you learn more about how your design performs, especially in the hands of real users.

Consideration of Manufacturing & Assembly Processes should start at the very early stops, however here is where these processes will become concrete, with the knowledge that they can be used to build devices for the upcoming verification and validation stops

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

 

Human Factors

Use Related Risk Analysis – Reduce project risk by identifying and mitigating Use Related risks before they arise. This stop is intimately linked with Design Development and IP Tracks.

Usability Evaluation – Uncover strengths and errors in your design, with real users, before it becomes fixed. This activity is often a series of short usability and readability tests, the results of which are gold dust for the designers.

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

 

Risk Management

Risk Analysis – has two parts; firstly identifying potential risks for the design, manufacture, assembly, distribution, use and disposal of the product. The second part is evaluating each of these against the Hazards and Harms we mentioned above.

You’ll prioritise these risks based on their probability and the severity of the harm that could result. This allows you to focus onaddressing the most important ones first.

Risk Mitigation – now that you understand the risks, you’ll need to develop ways to mitigate them as far as possible.

Far too often, people jump straight to putting a warning or legal wording in the user manual. This isn’t good enough! Regulators in the US and EU expect you to look at design changes first, then protective measures such as alarms, limits. Only if neither of these can be done, should information in a manual be considered.

These mitigations must be tested, to see if they work and whether they introduce new risks or Use Errors into the device design. The results should feed back into design controls and Human Factors evaluation.

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

 

Market Research & Access

Building on the information you gathered earlier, Competitor Benchmarking assesses the position of your product’s competitors, their market access, opportunities for your product and threats to it’s success.

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

 

Clinical

Clinical Design sets out the details of your plan for Clinical Investigations that are required to plug gaps you identified during your Literature Research.

You will need to ensure that you plan for regulatory authority and ethics approval of your Clinical study(ies), as well as the set up, execution, analysis and reporting of study results.

During this phase, you execute your planned Clinical Programme, which may include several Clinical Investigations, across a range of countries – all designed to answer the scientific questions required to demonstrate your product’s clinical safety and efficacy.

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.

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