News and Insights

We need to talk about Brexit and medical devices

We need to talk about Brexit and medical devices

On 31 January 2020, the UK left the European Union. For the rest of the year at least, there's a transition period during which existing arrangements apply. You may well be wondering what this all means for you, now and afterwards. Here's the situation in a nutshell:...

5 Things You Need To Know About Medical Device Risk Management

5 Things You Need To Know About Medical Device Risk Management

It may have escaped your notice, in the run up to Christmas and year end, that there have been some substantial changes to the way we manage risks when we develop or manufacture medical devices. As you read that sentence, you may have sighed. It’s an understandable...

How to Launch and Market Your Medical Device

How to Launch and Market Your Medical Device

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...

How to Finish Developing Your Medical Device

How to Finish Developing Your Medical Device

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...

How to Develop Your Medical Device Innovation

How to Develop Your Medical Device Innovation

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...

How To Get Started With Your Medical Device Innovation

How To Get Started With Your Medical Device Innovation

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...

Is There a Market For Your Medical Device?

Is There a Market For Your Medical Device?

https://youtu.be/aHjLlu0HxGs Why would you spend time, effort and money developing a medical device without checking that there’s actually a viable market for it? That would be crazy, wouldn’t it? Yet, all too often, we focus on the technology, the engineering, at the...

Ensuring Your Medical Device Is Both Safe and Effective

Ensuring Your Medical Device Is Both Safe and Effective

https://youtu.be/Plwrhzc9wYE It’s a major part of getting your medical device approved. It’s also vital to show that your device is safe and effective in use. Clinical Evaluation requirements have become larger and more complex, with the advent of the Medical Device...

How To Get a CE Mark For Your Medical Device

How To Get a CE Mark For Your Medical Device

https://youtu.be/MDH6FC3P0LI As you’re watching this video, it’s safe to say that you’re at least curious about how to get your medical device approved for sale in the European Union. Still with me? Then we’ll begin.   If you had a sense of what you needed to do,...

Something a bit different…

Something a bit different…

You may already be familiar with Business Bridge, providing EU funded support to healthcare businesses in Staffordshire. To mark a significant milestone in the Business Bridge journey, we were asked to share out experience of the programme, as an Expert Panel member...

Protecting Your Innovation

Protecting Your Innovation

https://youtu.be/eXy_6o_5fnQ However great your device design and technology may be, to maximise the return on your time, energy and money, you need to protect the innovation. Without that, your idea is basically worth so much less! Worse still, you may find that your...

Balancing Risk and Reward

Balancing Risk and Reward

https://youtu.be/XaCdbrgN4QY It doesn’t matter how sexy, high tech or innovative your medical device is. You must, and regulatory authorities demand this, understand and mitigate risks for the user if you want to get approval to sell your product.   If you had a...

How To Manage a Medical Device Project

How To Manage a Medical Device Project

https://youtu.be/eq4JUA0dHYY It’s a complex, challenging thing, developing a medical device. And it’s littered with opportunities for pain. Opportunities that good project management helps minimise. But, what does good look like? If you had a sense of what you needed...

So, you want the NHS to buy your medical device?

So, you want the NHS to buy your medical device?

https://youtu.be/P9FgWVOCMe0 In many of the conversations we’re having this year, one of the top things people tell us that they struggle with is the challenge of getting their medical device into the NHS. Perhaps that looks familiar, strikes a chord, feels like...

It’s All About The User

It’s All About The User

https://youtu.be/dDdPn8k0xXo However great your device design and technology may be, it still needs to work for the users, answer their needs, accommodate their constraints and expectations If you had a sense of what you needed to do, to take care of this, what would...

Getting Your Design Right

Getting Your Design Right

https://youtu.be/yYofOOBrc_s Coming up with a design for your medical device that can be manufactured, assembled at a low cost, whilst ensuring it does what users need it to do, safely and repeatedly, is one of the big challenges you’ll need to overcome If you could...

A route to Regulatory Compliance: Part 2 – Quality Management

A route to Regulatory Compliance: Part 2 – Quality Management

https://youtu.be/nZQkE7wxD2c Compliance with regulations and quality requirements is a key component of success when you’re developing a medical device. If you had a good feel for what you need to take care of for this, what would you do?   In this bite-size...

A Route to Regulatory Compliance: Part 1: Design Controls

A Route to Regulatory Compliance: Part 1: Design Controls

https://youtu.be/0CPgz39sCso Developing a medical device is a complex business, and compliance with regulations and quality requirements is a key component of success.   How would it be, if you had a clear picture of what you need to take care of for these...

4 W’s of Design Review

4 W’s of Design Review

https://youtu.be/0ivYXoeOfHY Developing a medical device is a complex business, with many opportunities to experience pain. And one of those moments that keeps cropping up is Design Reviews – they’re a requirement for the US, covered in ISO 13485 and you know what?...

4 steps to create a medical device

4 steps to create a medical device

https://youtu.be/9whDcxJXSsI 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. If...