Pericoach is an amazing device that looks like it will be of genuine help to women around the world suffering from Urinary Stress Incontinence, and who are told to do pelvic floor exercises to strengthen the relevant muscles to alleviate the problem.
The thing is, these exercises can be hard to do in the sense of knowing if you’re doing the right thing, and without proper feedback, many women turn to incontinence pads and a diminished lifestyle to deal with the problem, rather than confidently doing the exercises to enjoy the strengthened muscle results.
We last looked at the Pericoach on 12 January 2015 when it launched, and I marvelled how it is designed to work, how it is designed and made in Australia, and I embedded a Pericoach-provided video on how the device worked and connected to iOS and Android smartphones and tablets with a coaching element to help women overcome the Urinary Stress Incontinence problem.
That original article and Pericoach video can be seen here and is definitely worth reading if you’re interested in the device for yourself or the women in your life that could use it.
I was also interested in the device because my mother has had to endure two operations for prolapsing organs, first her uterus and then her bladder, and given the fact my mother needed to do these pelvic floor muscle exercises, this seemed like a device that would not only help her, but hundreds of millions if not billions of women worldwide.
So, I decided to talk to the company behind Pericoach, Analytica Ltd, and its CEO, Mr Geoff Daly. I asked Daly a series of questions and slipped up saying he was a doctor part way through the interview as his grasp of all the medical terms was so incredibly solid, but as Daly immediately corrected me, he was an engineer - so apologies for the stereotypical mistake and to Geoff Daly for the error.
The video is embedded after the next paragraph, but Daly also provided me with written answers to my questions before we did the interview, as background, and after doing the interview and reading the background material. I thought it was great material and worth printing, so I asked Daly if I was able to print the written answers he gave me in addition to embedding the video.
Daly readily agreed, so what follows below is not a transcript of the video but the answers in print and on video are naturally very much intertwined as they came from the same person, and as I felt it made sense to print them and got permission to do so, they are below - please enjoy the video and read on!
So, the video is above, with the written answers to my questions below.
Q1. Geoff, can you please tell us a bit about yourself, Analytica, and both how and why you came up with the PeriCoach?
Analytica is an ASX-listed medical device commercialisation company based in Brisbane. I am a Chartered Biomedical and Mechanical Engineer with 20 years of experience in the medical device industry, and have been with Analytica Limited for 9 years. We have recently launched the PeriCoach product in Australia and New Zealand which is designed to manage, monitor and motivate women doing their pelvic floor exercises.
Pelvic floor exercises are the front line treatment for urinary incontinence, and are also known to assist with other conditions such as pelvic organ prolapse and sexual function.
The idea for the PeriCoach was first raised with our company chairman, Dr Michael Monsour, by his neighbour one afternoon while having a beer on the verandah. The neighbour is a Brisbane-based electrical engineer and had developed the concept, but understood that to get to market it needed resources and expertise that he couldn't provide.
I did a business case and the first thing that jumped out at me was the massive size of the market. 1 in 3 women. That's 1/6th of the planet. We did some preliminary market research with 1500 women, and whilst a lot of respondents didn't think they needed a device or didn't want to use anything invasive, (which is fair enough to some degree) the number of women who said they needed something like this made an overwhelming case for the project. This result was even without having a product to show them.
Q2. How long did it take to create the Pericoach, what was the process involved in creating prototypes, etc?
In 2008 we licensed the idea and started development using a university engineering student to develop the idea into a working concept for his final year thesis. This type of device is called a perineometer and was first developed by Arnold Kegel in the US in the 1940's and Americans call pelvic floor exercises "Kegels".
The problem with traditional perineometers is that they measure the pressure inside the vagina. That's an indirect and often misleading indicator of whether the pelvic floor muscles are being exercised. That's fine for 1940's, but we were able to adapt modern technology to measure the force exerted by the pelvic floor muscles themselves.
So we have a patented advantage being able to measure the muscles that matter. At the same time we identified that smartphones were on the rise, so we didn't need a separate, custom display module. People had extremely powerful processors (for the time) with great displays and touchscreens in their pockets. We could just use a program (App!) and we could ditch the wires using Bluetooth.
The rise in smartphone internet connectivity and the ability to upload exercise session data for later analysis was not lost on us either. When speaking with the physios we asked them what information they would like to see, and we were met with blank looks. They had never considered it possible that they could see their patients exercise activity once they had left the clinic.
So we had some immediate converts straight away when they saw the enormous potential for remote monitoring. Clinicians’ involvement has been central to our strategy throughout the commercialisation process. We worked on the product part-time for a couple of years with the assistance of local (Brisbane) physiotherapists and gynaecologists.
Once the shape and size were settled on (2013) and we had design registrations lodged we were able to really tell our shareholders about it. From there we produced production equivalent prototypes, and developed the app and database software, and in May last year we did a limited pilot release. We used that release to iron out any major bugs (hopefully!) and launched publicly late last year for Android and [in January 2015] for Apple.
Perineometers are regulated medical devices and we have Australian TGA clearance, CE Marking, and we're pending clearance from the US FDA. During the development process we've had a lot of suggestions from users and clinicians and we've taken them on board. We have ideas in development to make the system a diagnostic tool unlike anything out there.
These range from small usability improvements (like gamification), to data mining projects, to new product families for related disease states. We also have other devices unrelated to pelvic floor health that we would like to develop which use the data gathering and analysis capabilities we've developed, but we're concentrating our efforts on the PeriCoach for now.
Q3. What does PeriCoach cost, and how long are women expected to use it - over a period of months or the rest of their lives?
It depends on the severity of the incontinence when the patient starts and, where she feels comfortable ending. Patients might see improvement in a matter of weeks with regular use, and they could even consider themselves “fixed” in a few months. There’s no objective endpoint – it’s what the patient feels that matters. If they’re not improved within a couple of months and they have been doing their exercises they should probably go to see a clinician.
Chances are they just need help to do their exercises properly, because they are not an intuitive exercise to do, but it could also be some other condition causing the incontinence. So once a woman considers herself better, she may put the device away. But like any muscle, if you don’t keep exercising it, the pelvic floor will get weaker.
Hopefully by using the PeriCoach, the woman will have developed the habit of doing her exercises even without the device. But if she needs that bit of extra motivation and feedback she can always pick it up where she left off.
Q4. What has the reaction been from the public since launch, along with the media, the medical world in Australia and worldwide?
Social media has played a large part of our PR campaign, and the response from women has been very encouraging with evidence of engagement through "likes", comments and sharing of blog posts. There has been a high level of excitement and interest from online, print and digital media here in Australia, which is currently the only country (as well as NZ) where the PeriCoach is available.
Pelvic health specialists are responding favourably and we are starting to see referrals to women from these sources. International interest is growing, particularly in the US as we begin our pre-launch activities, with a number of women's health physiotherapists taking part in an early adopter program. We have displayed the system at a number of clinical events in Australia and overseas, and the overall reaction from clinicians has been incredible.
We’ve just been to the American Physical Therapy conference in Indianapolis and the physios there can’t wait for us to get FDA clearance so that they
Q5. How are you able to make PeriCoach in Australia when everything seems to be made in China these days?
There’s a couple of reasons. First – the product isn’t mature enough yet to do that. Over the next couple of years we have a number of iterations planned with new features and capabilities. In my experience, and this is a generalisation of course, those factories are not very good at design iterations. They prefer a stable design from which they can manufacture large quantities.
And secondly, The device itself is not particularly labour-intensive to make so the advantages of going offshore are not great. You may get the labour costs down but the overheads, especially Quality Assurance oversight increases enormously. And the PeriCoach is a medical device so quality matters.
Q6. How long do you think before other companies in the US or Chinese factories try cloning the product?
Perineometers have been around since Arnold Kegel invented them in the 1940's. Essentially these are just fluid or air-filled sacks that measure pressure. A number of more sophisticated devices have been showing up recently which connect to your smartphone, but these all have a significant problem: Measuring pressure in the vagina is at best only an indirect indicator of pelvic floor muscle strength.
The PeriCoach has sensors that are activated by the pubococcygeus and puborectalis muscles. These are the muscles that matter with pelvic floor health and Analytica has patents on this.
We will not be shy about enforcing our intellectual property rights. It is also important to realise that perineometers are medical devices and subject to onerous regulations enforced by agencies such as the TGA in Australia and the FDA in the US.
Copying a widget is one thing. Selling them legally with regulatory approvals is another.
Q7. What other kinds of app-connected medical devices is Analytica thinking of creating (without giving away specific ideas to competitors)?
The technology we have created can be extended to a wide range of health devices. But there's also a lot of innovation still in the pelvic floor health space. We have a long product development pipeline that will improve the PeriCoach over the next few years. Usability improvements, diagnostic capability, data mining and reporting are all areas we're already working on.
Q8. What other app-connected medical devices are out there that you know of and are impressed by?
I've seen app-connected toothbrushes, with are also quite personal, but not quite as personal as the PeriCoach Well a toothbrush is pretty personal too. You don’t really want to share it do you?
I’m not sure whether it needs an app, but a connected toothbrush isn’t a bad idea for monitoring kids brushing habits.
I haven’t quite yet bought a wearable for myself yet – I’m waiting for the next-gen when they blend the smartwatch and the health monitoring properly.
My favourite health device is the AliveCor ECG monitor. I have paroxysmal Atrial Fibrillation, and it’s brilliant what these guys can achieve with such a tiny device and a phone.
And whilst they’re not really App-connected, Simavita’s system allowing aged-care homes to manage their patient’s continence issues with dignity is also a great product, and ResMed’s sleep monitors look pretty cool.
Q9. Do you think PeriCoach data will ever be incorporated into the Apple Health app / S Health / Google Fit, or ported to Windows Phone / Apple TV / etc?
Linking to other systems is a “later” project, and we wouldn’t want to tie ourselves to any particular OS or manufacturer. We’re trying to get market penetration so Android and iPhones are all we’re aiming at for now. In the short we don’t need to – we have our own proprietary cloud database and we can do a lot of what these systems do anyway.
The next step is to be able to not only analyse our own pelvic floor health data, but cross-analyse that with the sort of general health data that these common health systems provide. For example, being able to monitor pelvic floor improvement against a woman’s medications, or diet or general fitness is important.
Anti-depressants, a big night out, or a big gym session are all going to have an effect on that day’s pelvic floor workout. We’re currently investigating a partnership with a Brisbane-based company SportsMed who have the analytical and statistical capabilities to help us do that.
Q10. What will the app-connected medical device market look like over the next 5 to 10 years?
The phone and OS manufacturers have obviously cottoned on to the size of the mobile health market, and I hope the needs of small developers like ourselves will be given a lot of thought. I think uptake for the consumer wearables like smartwatches and Google glass-like UIs will increase, and more specialised medical and entertainment wearables will start becoming more common.
Maybe to accommodate this the personal area network might take off. The mobile data needs for the devices will play a big part. There’s a tradeoff between the sort of analysis you can or need to do locally ‘on-body’ to display real-time feedback to the consumer and what needs to be done in the cloud.
Q11. How many women worldwide suffer with incontinence?
1 in 3. In Australia, 4.2 million.
Q12. Where can I find out more information about the problem of incontinence and the treatment options available?
Visit your GP, or a website such as the Continence Foundation of Australia.
Q13. How effective are Pelvic Floor Exercises in treating incontinence?
Strong clinical evidence suggests that pelvic floor exercises performed regularly under supervision can help improve incontinence. Studies have shown up to 70% improvement in symptoms of stress incontinence following appropriately performed pelvic floor exercise. This improvement is evident across all age groups.
There is evidence that women perform better with exercise regimes supervised by specialist physiotherapists or continence nurses, as opposed to unsupervised or leaflet-based care" (Pelvic floor exercise for urinary incontinence: A systematic literature review Natalia Price, Rehana Dawood, Simon R. Jackson Department of Obstetrics and Gynaecology, John Radcliffe Hospital, Oxford OX3 9DU, UK)
Q14. Any final messages for iTWire readers, for upcoming PeriCoach users/customers and the medical community?
If you’re one of the 1 in 3 women out there bravely suffering incontinence in silence, you’re not alone, and there is something you can do about it. Talk to your GP or women’s health specialist. Visit the continence Foundation of Australia or the Women’s Health Foundation in the US, and go to the Pericoach website.