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Behind the scenes – creating new medical devices

Create a medical device

Behind the scenes – creating new medical devices

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Feb 11, 2020

Create a medical device

The US celebrates National Inventors Day on the 11th Feb every year. In 2014 BT launched a campaign to celebrate this day in the UK as well, a campaign which unfortunately did not gain momentum – which seems like a real shame. So we are taking on the mantle to help shine a light on the people behind pioneering new inventions. 

 

We fired a few questions at James Carpenter, CEO of SurePulse Medical, a medical device company based at MediCity Nottingham advancing newborn care, to find out more about the reality of creating new medical devices.

 

TELL US ABOUT THE INVENTION.

“SurePulse VS is the first vital signs monitoring device created specifically for newborns, designed to provide clinicians with the accurate information they need to make the best decisions for their patients.

 

About one in ten babies need some form of help in the first few minutes after birth to stimulate breathing and to ensure the heart is beating properly (80,000 babies in the UK, more than 200 each day, and 14 million worldwide each year). The heart rate of the baby is critical for guiding the stabilisation or resuscitation process; however current monitoring methods do not always provide an early enough or sometimes accurate enough heart rate; which can lead to uncertainty in the management of the baby’s care.

 

Consisting of a sensor fitted into a single-use T shaped cap and a display unit (which houses two wireless modules), SurePulse VS provides accurate and non-invasive vital signs monitoring of newborns.

 

Using wireless technology, SurePulse VS allows accurate and continual monitoring, even throughout other medical interventions and supports modern delivery room practices like skin-to-skin contact, delayed cord clamping and early breastfeeds.”

 

 

WAS THERE A EUREKA MOMENT?

“It’s very gradual so I wouldn’t say there was any one moment.

 

The company, SurePulse, is five years old, but the technology was in development for around eight years before that. A collaboration between the School of Electrical and Electronic Engineering and the Department of Academic Child Health at the University of Nottingham, researchers realised that vital sign technology being developed within the University could be applied to monitor newborn babies who need help at birth.

 

Because things change bit by bit, it’s a constant process of refining prototypes as you go along.

 

I couldn’t guess how many versions of the prototype we made. Each part needs countless iterations in trials and in the field, you are constantly looking for little niggles, things that might be a factor with extended usage that couldn’t be predicted until clinicians are actually using the device. And it’s a process that never stops; we’re always questioning what the next version will be.”

 

 

WHAT ARE THE BIGGEST CHALLENGES YOU’VE FACED TRYING TO TURN YOUR IDEA INTO A REALITY?

“There are so many challenges in creating a new medical device. Finding good people to join the team is crucial. Small ventures are dependent on their team because there are few of you; every person matters and finding people who are really good and really know what they are doing can make all the difference.

Because the process is so long, keeping the money coming in is a real challenge, luckily, we have supportive shareholders and grants are available.”

 

 

IS IT TOUGH TO MAINTAIN MOMENTUM?

“Even though it’s a slow process, it’s still satisfying, and you learn to take the rough with the smooth. It can be frustrating at times but you learn how to work through it and ultimately it’s for the benefit of our most vulnerable – that keeps the focus.

 

The most validating phase is actually getting out into the marketplace, being out in the field getting validation from all over the world that there is a real clinical need for your device. Having clinicians say it’s a great product that worked on these babies – that’s brilliant.”

 

 

WHAT ADVICE WOULD YOU GIVE TO OTHERS CURRENTLY DEVELOPING OR THINKING ABOUT DEVELOPING A NEW MEDICAL DEVICE?

“Validate your concepts. Talk to as many clinicians as possible, both within the UK and internationally. Get their feedback and take it into account in your design. There are so many stakeholders and all of their perspectives are essential, from the clinician using it to the person cleaning it to the department paying the bills, – they all have different priorities and requirements. Your device has to tick everyone’s boxes.”

 

 

WHAT ARE YOUR HOPES FOR YOUR DEVICE?

“Our aim is to be the go-to monitoring solution for any baby that needs help at birth. We want to give clinicians the information they need to make the right decisions to help every baby in a way that is accurate, unobtrusive and easy to use; to be something that makes a real difference.

 

At the moment, we are focusing on the delivery room, but there is a real need for wireless vital signs monitoring in intensive care, to allow parents and babies to have physical contact without wires getting in the way.”

 

 

 

Dr James Carpenter

Dr James Carpenter

James Carpenter has served as CEO of SurePulse Medical since its incorporation in mid-2014, having worked to secure considerable grant funding for early development and trials. He has spent 7 years working in medical device engineering and development, particularly focussed on blood flow analysis in the field of Laser Doppler Blood Flowmetry. More recently his work has been centred on high reliability heart rate estimation. He holds a PhD in Electronic Engineering from the University of Nottingham.

 

Find out more about SurePulse VS

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