Urinary Catheters - $2 billion problem waiting to be solved

Patients may be recommended to use Urinary Catheters if they are suffering from Urinary incontinence (leaking urine or being unable to control when they urinate) or Urinary retention (being unable to empty their bladder when they need to).

If we look at the big picture, and try to see this from a problem (urinary incontinence & retention) and solution (urinary catheters) perspective, we should strongly ask this question - Is this solution (Urinary Catheters in current form) a good solution? Are the patients completely satisfied? At the end of the day, a business is created and sustained as long as a better solution is provided to the customers.

There are mainly two types of urinary catheters – Indwelling and Intermittent. An indwelling catheter is the one that is left in the bladder and is for long term use (4-6 weeks). The catheter has a small balloon inflated on the end of it. This prevents the catheter from sliding out of the patient’s body. When the catheter needs to be removed, the balloon is deflated. First prototype of an Indwelling catheter was designed by a US based surgeon, Fredrick Foley, in 1930s and the catheter was named in his honour – Foley Catheter (see image of the basic design below). 

Foley catheters have been in use from last EIGHT decades now. According to a data, around 90 million Foley catheters are being used worldwide. It would have been fine if these catheters were a good solution and patients were happy and comfortable using it, which is not the case. Patients using these catheters report many problems the worst being urinary tract infections (UTI). Some of the additional ones are following –

•          Higher rate of stones
•          significantly increased risk of bladder cancer
•          odour, leakage
•          urethral damage

One could see a major attempt to solve this problem with a complete new solution in 1997, when a multidisciplinary partnership between academia and industry was set up to design and develop suprapubic catheters. The product however, is not prevalently used and it can be safely said that this solution failed to impress the patients/caregivers.

Intermittent catheters on the other hand are used when one needs to use a catheter sometimes. These catheters are removed after the flow of urine has stopped. Although, these catheters do offer a better solution compared to indwelling, it is still not a very comfortable solution as patients

•          have to monitor fluid intake
•          have to remember to catherize on time and adjust to fluid intake
•          may have to wake up at night to catherize
•          problems for those with limited hand function (elderly patients)

Despite of such problems, over 100 million intermittent catheters are used each year and they have been eating market share of indwelling catheters (which will still be used by the patients who cannot self catherize themselves).

If we look back in last eight decades, this space has seen very few innovations most of them are incremental (improvement in material, adding anti-infective agents, coating etc.). It seems that these are not enough. The patients have still lot of issues as they are still unhappy or uncomfortable with the current solutions (products). The big players should bring either breakthrough or disruptive innovations (What I mean by this) otherwise they are leaving a door open for small players & new entrants and the open door is unsolved problem and unsatisfied patients.

Urinary catheter market is around $2 billion. Small players/new entrants must have in their minds that it will be hard to capture a significant market share with “me too” products. If they can develop a good solution (probably a non-invasive one) then the opportunity is HUGE. 

Create your innovation ecosystem the iWay

Everybody in the technology and the business world has been astounded to see the growth Apple has seen in the last decade. Some say it is marketing, some say it the design brilliance, and a lot of people say it is the brilliance and vision of Steve Jobs. One of his brilliance was to create an innovation ecosystem around Apple’s products. He wasn’t content with only changing the music industry. He went on to change the mobile and computing industry as well. 

The graphic below will help us understand the innovation ecosystem better.

If we look closely, Apple did not start everything from scratch. They evolved iPod with flash memory and touch screen technology which were developed outside. Now, add a mobile phone and an internet communications device to iPod, you have an iPhone. Widen the screen of iPhone and increase computing capacity, you have an iPad. Usually, companies add features to their products, Apple added products (phone, tablets) to their existing features/technologies. Strange, isn’t it? Next in the ecosystem would be widely rumoured iTV? Very smartly, they created an innovation ecosystem and developed products that were disruptive for mobile and computing industry. Next in line is $100 billion TV industry.

May be some innovative organizations can take out some lessons from the Apple way (or iWay). First of all, the organizations need to have a vision, a vision that is not restricted by the existing limitations. The vision should be of an ideal product or solution in their domain. Once the vision is there, solutions should be looked both inside and outside the organization. One should be ready to go beyond their expertise and technology domain to bring the outside solutions and integrating them into their products. It might be a new product altogether.

Also, the organizations should think about creating an ecosystem around their existing products or solutions. If they modify their products a bit, can they solve some other customer need which is not their existing focus? For e.g. an insulin delivery device, if it is modified a bit, can it be used for diagnosis as well? Can it be used for delivering fluids during surgery? Can it be used for fluid extraction instead of delivery or both? Can it be used for delivering fluids in aerospace or auto industries where precision is the key? Possible I guess. If you could do that, you could create an altogether different market and create disruptive products.  

Start thinking about creating your own innovation ecosystem, the iWay.

J&J exists stent business - Lessons to be learnt

A  very nice article on how J&J missed the first mover advantage in stent business...twice!

http://www.medcitynews.com/2011/06/end-of-jj-stent-business-carries-lessons-for-medical-device-innovators/

Innovation Strategy – Are you ready for all types of innovations?

These are my initial thoughts on the points which should be taken into account when an organization is preparing their innovation strategy. I am sure with your discussions and inputs, these thoughts will get fine tuned over time.

I would like to define or classify different types of innovations as following :

As organizations increase in size, they should prepare themselves for all three types of innovations.  

Internal R&D team can focus on incremental innovations. Innovation managers, with broader outlook and diverse technical skills, should be responsible for breakthrough innovations. The managers should go beyond their technical domain and look for technologies which can be integrated with the existing product line. If we look at Apple products, they brought flash memory created by Toshiba for their iconic iPod. Then they integrated the touch screen technology and lot more. An organization should always try to make their product better and in addition to the internal R&D, they should keep on looking for technologies developed outside. The technologies which are difficult to integrate can be used to get inspiration for the product development by internal R&D team.

The job of innovation manager should also include tracking the alternative solutions that are being developed to cater the same need as of their products. Disruptive Innovations come as a real threat and can take you out of business. They are also generally not tracked much. However, they should be monitored on a frequent basis and their progress should be reported to the Strategy team for decision making. The key to success lies in identifying the successful innovations early and acquiring such companies.

This is just an overview. My next articles will discuss these thoughts in details with case studies. I welcome all the suggestions and inputs. 

Disruptive Innovations in Ostomy Care - Time we look at it?

Ostomy care market is currently estimated at $2 billion with about 1.5 million patients worldwide. Currently, about 90% of the market share is captured by three key players – Coloplast, Convatec and Hollister.

Ostomy care products revolve around ostomy bags/pouches and skin barriers. The products come with the features such as odour control, leakage, bag cleaning, adhesions and many more. This has been working well for the industry for quite some time and I wonder if this is the right time to think about alternative solutions as well.

One such solution has come from an Israel based startup, Stimatix GI. The company has developed a device named Artificial Ostomy Sphincter (AOS-1000™) that provides continence and bowel control to the patient without the need to wear a traditional ostomy pouch. This device is currently under clinical trials and expected to be launched in the market in mid 2012. The company claims to bag 15% of the market share within the first few years of commercialization.

This concept itself is not new. Artificial sphincters have been successfully used for fecal incontinence. However, it was difficult to replicate the same with stoma as there was the risk of ischemia and necrosis of the intestinal wall because of excess pressure. Stimatix’s device solves this problem by controlling the pressure exerted on the intestinal wall using pressure gradients.

Stimatix is not the only one. Another small firm, Zassi Medical (now Leto Medical) has been working on restoring bowel evacuation control by artificial stoma sealing devices. Alternatively, they are also looking at electrical and chemical stimulation of the intestinal musculature for temporary continence.

Interestingly, one of the key players, ConvaTec, also has a product in market which is on similar lines. The product, Vitalla Continence Control device, enables the patients to be continent for around 8 hours. The device uses pressurized chambers to avoid excess pressure on intestinal wall.

These disruptive innovations are knocking on the doors in Ostomy Care domain. It will be interesting to watch this space in next 2-3 years.  Will the big players be interested at this stage or they will be in wait ‘n’ watch mode?