How to make an award-winning femtech device

UK firm Femeda recently scooped Product of the Year at the Bionow Awards for Pelviva - a pelvic floor muscle re-trainer with ‘reactive pulse technology’ (RPT). Dave Gray caught up with Julia Herbert, clinical director, Femeda, and Andrew Tasker, CEO to find out about the design principles behind femtech products.

Pelviva is a new pelvic floor re-training device which works using a pattern of neuromuscular electrical stimulation via a programme developed by Professor Jackie Oldham at The University of Manchester. Each device contains a microprocessor that delivers RPT to the pelvic floor muscles. The pulse mimics the way the body works naturally, causing the pelvic floor muscles to contract. This helps restore speed and strength to the fibres, to help prevent bladder leakage when women cough, laugh, sneeze or exercise. It also re-trains the endurance fibres to hold on when a woman urgently needs the toilet, giving back control over urgency bladder leakage.

Pelviva is made of a body responsive foam, which adapts to individual shapes. The Pelviva RPT delivers a series of intensive reactive pulses every alternate ten seconds, to stimulate the pelvic floor muscles. Each thirty-minute treatment using the Pelviva innovative stimulation programme delivers up to 25% greater penetration of the deep pelvic muscle than conventional stimulation, according to the company.

In a twelve-week randomised single-blind clinical study involving 123 women, 84% of women using Pelviva reported improvement in bladder control. The Pelviva women reported a four times greater improvement in quality of life versus women who only followed an unsupervised pelvic floor muscle exercise programme.

The UK’s National Institute for Health and Care Excellence (NICE) recommends a three-month programme of supervised pelvic floor muscle exercises. However, research shows that up to 50% of women have problems correctly contracting their pelvic floor muscles, many fail to adhere to an effective exercise programme and only 25% of women with UI seek professional help.

Designing an award winning product for the female health market is not without its challenges. Tasker explains: “The overall design consideration is to react to the real needs of the female consumer. To do this in-depth, market research is required, starting with the end female user to understand their condition from multiple angles. Market research is then required with all health professionals who can be, or may in the future be involved in the care pathway.

“All our design and development work is based on consumer and health professional insights. Having women in the development team is important – though its our end consumers and patients who drive our strategy.

“Our research confirms that women need a product that is discrete, effective, easy to use, and increasingly, able to meet the needs of busy lifestyles.

Female health is such a major area where innovative solutions are required meaning from a design perspective we need to look at both devices for use in primary and secondary care, and which can be sold both over the counter via the pharmacist and direct to the consumer. Therefore route to market needs consideration at design and development stage to ensure the appropriate level of advice and support can be matched at point of recommendation or point of sale.”

Herbert added: “I am so pleased to have been able to work with Femeda to develop Pelviva. I believe Pelviva will really improve the lives of women whose quality of life is negatively impacted by the symptoms of urinary incontinence. Over my many years as a pelvic health physiotherapist I have met many women, who although they know pelvic floor muscle exercises will help them, they have really struggled with doing them; many don’t know how to use these muscles correctly and others simply don’t remember to fit them into their busy days. Pelviva has been specifically developed to fit into busy lives, it’s easy to use and has been designed so that women can continue with their everyday activities whilst having their Pelviva treatment.”

Materials choice and processing options were limited by the unique requirements of the product, according to Herbert and Tasker.

“PU foam was selected for the main body of the device as no other materials have been found to possess all the characteristics required to satisfy the product’s design requirements. These materials require significant additional processing and a high level of R&D input from our teams to tailor some of the characteristics to ensure ease and comfort during use”, said Tasker.

He added: “Materials that can satisfy the stringent biocompatibility requirements are difficult to process in discreet mouldings of the size required for Pelviva. This challenge is compounded by the highly specific physical characteristics required from the foam to ensure optimal performance of the device in terms of its weight and compressibility.

“Consequently, it has been necessary to establish a specialised foam manufacturing facility in the North East of England. This has been a substantial investment and required significant product and process design effort over a 3-year period, after the initial 5 year R&D development phase.”

Herbert agrees that without investing in the manufacturing was crucial to the success of the product.

“Establishing the manufacturing facility in Cramlington has been a primary focus for the company over the past three years to finalise the development the product. We have worked closely with a range supply partners and academic groups to optimise the chemical formulations of materials and to develop additional processes to modify the moulded products’ final characteristics”, she said.

“The equipment that is employed has been developed to provide process control is the latest technology, combined with pharmaceutical standard clean environments. Building a highly skilled internal team has also been fundamental to delivering a highly consistent product that satisfies all design requirements.”

Innovating in a regional hub has been another one of the keys to success for Femeda. Tasker said: “In recognition of the major support the business has received from clinicians and academics in the Manchester area to bring Pelviva to the market, Femeda would like to invest back in the Greater Manchester community. The business is committing to provide up to £50k of Pelviva product to women with urinary incontinence in the region, via the appropriate clinicians and hospital trusts. Femeda is looking to work with primary and secondary care providers to make this product available to women who as yet have had limited alternatives, and will be seeking advice from Health Innovation Manchester and Manchester Foundation Trust how they can best recommend this product is allocated.”