futures❵ENTREPRENEURIAL SPECIAL
Louise Burns monitors the progress of product development in the complex world of healthcare
Baby love W
hen it comes to childbirth, there is simply
no room for mistakes or failures. As a result, launching a new business or product into the highly regulated healthcare industry can be a significant challenge in itself, setting aside the usual business issues that affect entrepreneurs. This steep learning curve is something that Betina Korshoj Andersen (BSc Midwifery,
2011) is still tackling as she develops her innovative new product for expectant mothers, the fetofit. Currently foetal monitoring is done using a transducer, monitoring the baby’s heart rate and movement, which is attached to the mother’s stomach via a fabric strap. It is this fabric strap that Betina wants to revolutionise: “There are a range of issues with the existing strap which makes its use difficult for
I can really see the big benefits that it will have – it’s really worth it
both women and their midwives. The strap means that when a woman moves the transducer can lose contact, making it hard to pick up the foetal heartbeat. As a result, women have to lie still, and given that movement is encouraged during labour to help with the pain, this often isn’t very comfortable.” Betina also cites issues around hygiene and
different body shapes which led her to look into an alternative. The fetofit is unique through its use of adhesive straps which can be reattached to the skin without discomfort. It is designed for single patient use but its re-attachable properties mean that women
can move around and experience greater comfort, at a time when they really need it. Betina’s passion for her product really shines through
and it’s clear that she really cares about making a difference in the lives, and labours, of pregnant women. “I’ve had to learn the business side as I’ve gone along and so have been doing everything from scratch. However, I can really see the big benefits that it will have and how it will help – it’s really worth it.” The next few months seem to be a pivotal point for the future of the fetofit – Betina hopes to start a full clinical trial later this year, and is currently collecting pilot evaluations from obstetricians and pregnant women. After that it’s full speed ahead for conversations with the NHS and private clinics, in the UK and abroad. “It has been tough balancing developing the fetofit with studying and family life, but I have real passion for this product. I just have to believe and keep going!” f❵
TOP TIPS FOR SUCCESS WHEN DESIGNING A MEDICAL PRODUCT
Ensure that your product is CE marked and has received approval from the MHRA – the authority that regulates and insures medical products.
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Patent your idea as soon as possible and consider the different regions where you might want to sell it – this will affect whether your patent is for the UK or worldwide.
Ensure that you have a robust protocol in place for a trial.
Make sure that you have ethics approval, as this is required for any NHS clinical
trial.
You must be persistent and believe in your product, especially in industries such as heath which are so heavily regulated, as there will be obstacles.
Ask for help – I received support and advice from the research team in the The Centre for Lifespan and Chronic Illness Research (CLiCIR) and won Proof of Concept funding which made an enormous difference.
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