News and Insights

How to navigate complexities of medical device development

How to navigate complexities of medical device development

https://youtu.be/pHmvnJoRlIQ It’s a complex business, developing an idea into a medical device. And it’s complicated by the myriad of important things you need to address, to get approval to sell your product in markets around the world. So, it’s understandable that...

How to make sure your project doesn’t fail

How to make sure your project doesn’t fail

https://youtu.be/y8r-pZXb3NE You’ll probably remember our discussion about 5 key things that successful device development projects take care of, to minimise the risk of failure and the harm and expense that results? I’d like to share with you an approach to looking...

Failure is expensive, very expensive!

Failure is expensive, very expensive!

https://youtu.be/WVjnX8D2DeU Failure is expensive, very expensive And it gets even more expensive when you’re developing a medical device. Like me, you’d probably like to avoid the pitfalls where you can, avoid the pain. Abut 10 years ago, being naturally curious...

ISO 13485:2016 – time has run out!

ISO 13485:2016 – time has run out!

You'll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don't fail? If you've reached the conclusion that it would be advantageous to show customers, regulators or investors that you're working in an appropriate way, then you'll see the...

Another week, another funding opportunity

Another week, another funding opportunity

Hot on the heels of last week’s article, there’s a further opportunity to get some funding to support your development project. This time, the criteria are slightly different, but rest assured, we can walk you through the process. SMEs in West Midlands, Yorkshire and...

Funded regulatory and development support for SMEs

Funded regulatory and development support for SMEs

Would £5,000 of fully funded product development or quality + regulatory support sound good to you? Are you working in a Staffordshire based business? Does your business want to access (or increase your sales in) the healthcare / medical devices market? If you said...

You can’t afford to fail!

You can’t afford to fail!

Failure is expensive.  Very expensive. Particularly when you’re developing a medical device. There are 5 things you should know about, to avoid the painful bite of failure; 7 steps you'll want to take. At the heart of every successful project are 5 key things: "Begin...

To conference, or not to conference, that is the question

To conference, or not to conference, that is the question

You’ve probably attended your share of industry conference over the years.  You may have found some of them pedestrian, perhaps boring? So have we! Until last January. Our team were invited to the 19th Regulanet Conference, in Badenweiler, Germany. As new partners to...

Human Factors & Design Controls

Human Factors & Design Controls

Human Factors is key to your success in Medical Device Development.  As a recognised device development discipline, Human Factors should follow a clearly defined methodology.   If you are struggling to get to grips with incorporating Human Factors processes into your...

Successful medical devices have great Project Management!

Successful medical devices have great Project Management!

Significant project delays are often experienced when activities fall out of sync and people become blinkered, rushing to finish their goals first and missing sight of the big picture. Having a Device Development Strategy with a clear Plan matters, a lot. When setting...

Why  Quality Management matters more today than ever before

Why Quality Management matters more today than ever before

The importance of quality in medical device development is set to rise because: More complex and innovative devices are being created, and user environments are evolving, with increasing emphasis for use of devices and therapies in the home; there is a high potential...

Medical Device Risk Management

Medical Device Risk Management

Risk occurs in all our lives, it’s a part of our everyday living. To minimise the threats from risk and maximise their potential we need to manage our risks; this equally applies to the field of medical device development.  By implementing a risk management process,...

Which option would you choose?

Which option would you choose?

You’re running late, you’re hungry and won’t have another chance to pick up something to eat before your journey.   There’s a busy food retailer nearby, and you go in to find something to tide you over, scanning the sandwiches, wraps and salads. A couple of the...

9 changes to FDA goalposts for medical devices

9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 "21st Century Cures Act", with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and...

FDA Quality System Regulation and ISO 13485

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories. Often, manufacturers wrestle with ensuring that their development process, activities and documentation aligns with both ISO 13485 and...

Getting your medical device into the NHS

Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a "dark art", a mysterious journey into the unknown.  Having a map for this journey would be an attractive proposition. To flesh out our map for the journey, we joined around 30 other industry...

Involving patients and the public in medical device development

Involving patients and the public in medical device development

There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK). An aspect that was revealed to those attending a recent Medilink East Midlands conference in Nottingham. An aspect known as “Patient Public Involvement”...

Recruiting complex user groups

Recruiting complex user groups

Medical devices, and combination products, are typically targetted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. The usual state of affairs for Usability studies is to recruit participants from relatively...

9 Steps to right first time regulatory compliance

9 Steps to right first time regulatory compliance

It can be a scary thought, regulatory compliance.  So much to get your head around, so much to make sure is done right, and what is "right" anyway. Wouldn't it be handy to have a "crib sheet" to help you get there with less pain, in a shorter time, whilst...