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

Launch Preparation – everything involved with completing your regulatory submission, manufacturing, assembling, packing finished product, ready for distribution and sale once you get the green light.

Of course, Issue Resolution – continues to be relevant.

Project Closure – the evaluation of what led to your project being successful is often overlooked. Yet, this is how people, teams and organisations learn, so it should be an integral part of how you do business.

Look back over the project to recap on how well you achieved what you set out to do, what worked well,what you achieved, would be done differently. A couple of the things we’ve found work well here; knowledge cafes, case studies,

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

 

Regulatory + Quality

Regulatory Authority (RA) Approval – before you can sell your shiny new product, you’ll need to get approval from national authority. As we mentioned before, this is where you set out the story of your medical device for regulators to review, ask questions, and hopefully approve for sale. Don’t underestimate the time this can take.

Change Management – doesn’t stop just because you’re on the market, keep on identifying, documenting, assessing and managing changes, particularly in light of post-market surveillance data.

QMS Update – alongside this, your QMS should evolve to respond to changes in regulations, the way you work as a business and what your competitors are doing.

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

Intellectual Property

Confirm IP Protection – Having done all these things, you’ll want to get started with the process of securing Patents, Design Rights and brand protection. Each of these probably takes longer than you’d like, so get to grips with them early in development,and certainly before Industrialisation. By this stop, you’ll be putting the finishing touches to applications, and hopefully awaiting award of protections.

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

 

Design Development

Design Development doesn’t stop once your product is on the market. Here’s where it loops back, to develop the next generation of your medical device, or address issues that arise from complaints, and, more seriously, adverse event reports.

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

 

Human Factors

Post – Market Surveillance feeds back into the next version of your device, identifies design changes. This activity also enables you to know what to avoid and gain valuable intelligence on competitor products.

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

 

Risk Management

You must undertake Post-Market Surveillance when your product is on the market. You’re expected to keep tabs on similar devices, not just your own. Regular review of the risk management file for your product is expected, as well as taking action when this information changes existing risk estimations.

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

 

Market Research & Access

During Launch, you start to execute your Marketing Strategy for the product, including the delivery of Tactical Communications to your target market(s). Clinical and product performance data can be very useful here in allowing you to make claims about the product.

Alongside this, you’ll be keeping abreast of opportunities for Business Development – whether into new countries, additional market segments, with new distributors.

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

 

Clinical

A significant aspect of your Post-Market Surveillance activities will be the planning, execution and reporting of Clinical Follow-up studies. These will typically look at things like;

  • Safety and performance of the device

  • Previously unknown side effects

  • Emerging risks

  • Acceptability of the Benefit/Risk conclusion

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.