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 third of four phases that every project goes through – Industrialise.
Project Management
Transfer of Design – At some point, you’ll take your device design forward to production. That transfer is what this stop is all about. In reality, it starts at an early stage in development, but comes to its conclusion at this point in your journey. It takes your design outputs and turns them into a product. That’s why you will have involved people from production from project definition onwards.
Issue Resolution – we spoke about this stop earlier, the principles continue to apply throughout your project.
Click here to view the complete video explainer for this key discipline.
The Design Control track continues with:
Design Verification – answers the question “have I built my device right”, does it meet the specification.
Design Validation – however, answers a different question, “have I built the right device”, by comparing your device with the needs and intended use you set out to fulfill. Checking if these needs can be fulfilled consistently.
Design Transfer – as discussed above in Project Management; at some point, you’ll take your device design forward to production. That transfer takes your design outputs and turns them them into production specifications.
Design Changes – from the stop on your journey where you decide to start design controls, you’ll be taking care to identify, document, assess and manage changes to the design as you go, usually in line with a procedure or process.
The Quality Management track, on the other hand continues with these parallel and linked activities:
Test Methods – it’s no good testing devices without using a documented method, as how else can you have confidence in the results? That’s what this stop is all about, creating, refining and validating test methods – they can be for incoming materials, in-process checks, product release, development tests.
Installation Qualification (IQ) – when you’re putting in new or changed equipment, its installation needs to be qualified, to confirm what you’ve put in is what you wanted it to be.
Operational Qualification (OQ) – then, you’ll confirm that the new or changed equipment actually functions like you wanted it to
Process Verification (PV) – going a step further, you need to demonstrate that the process that uses this equipment works as you expected
Performance Qualification (PQ) – then, you will check that this process really does perform as you wanted, over time, reliably and consistently
Validation Reporting – all of these activities are wrapped up in reporting, which also concludes on whether you have really made the right device.
Supplier Quality – builds upon the purchasing controls and supplier evaluation to make sure that you continue to get what you need for the devices you produce to be safe and effective in use.
Click here and here to view the complete video explainers for this key discipline.
Your brand is the part of your company that the outside world sees. People buy into that brand and recognise it. So, it may well make sense to protect both it, and your medical device, from others attempting to either undermine it, or pass their products off as yours.
Click here to view the complete video explainer for this key discipline.
You undertake the activities we discussed above for the Quality Management branch of Regulatory + Quality.
Click here to view the complete video explainer for this key discipline.
Design Validation – Confirm that User Needs have been met and the device is safe & effective in use – basically “Have I built the right device”.
HF Summary Report – Assures regulatory authorities that you’ve conducted an effective Human Factors programme. It tells the story of how you understood users’ needs and created a device that spoke to them.
Click here to view the complete video explainer for this key discipline.
Mitigation Verification – once it looks like the mitigations are effective, you’ll want to generate test data that verifies their effectiveness. This it usually done as part of Design Verification and Design Validation stops on other tracks.
Residual Risk Assessment – having hopefully verified that mitigations do work, update your risk analysis to reflect it. You’ll need to consider whether the residual risk (what’s left after all the mitigations) is acceptable against criteria you’ve put in your Risk Plan. This step can flag up the need to put in place more mitigations, and that’s ok.
The final step in development is to document what you’ve done in a Risk Management Report that also concludes on the safety of your medical device.
Click here to view the complete video explainer for this key discipline.
Market Research & Access
Building on your earlier research, you firm up on the most effective Route to Market for your product, in its launch market and subsequent launches that build on that initial success.
Developing a Marketing Strategy is an important part of preparing to launch your product. As part of this, you’ll work with key opinion leaders (hopefully you’ll have started working with them much earlier in development to support Clinical activities and Market Assessment activities).
Click here to view the complete video explainer for this key discipline.
Clinical
The results of your Clinical Programme are reported during this phase of development, leading to the production of a Clinical Evaluation report, that documents the fruits of your Clinical Evaluation Plan, the Investigations undertaken and how their results support the safety and efficacy of your medical device. As we mentioned earlier, you’ll be taking care to ensure that the Medical Device Regulation requirements for Clinical Evaluation are comprehensively demonstrated.
There’s a close link here with Risk Management reporting, particularly to support the verification of risk mitigations.
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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