Removing a cork stuck inside a wine bottle without damaging either the cork or bottle may seem like an impossible task.
In fact, all you need is a plastic bag, which you feed into the bottle, inflate and use to pull out the enveloped cork.
That simple trick is well known to bar flies the world over, who have long used it to win bets and impress their friends. But it also inspired Argentinean car mechanic Jorge Odon to invent a lifesaving medical device.
Mr Odon realised the same idea could be applied to address one of the biggest problems of childbirth: babies becoming stuck in the birth canal. Taking the cork and bottle trick as his inspiration, the inventive mechanic built a workable prototype in his kitchen in south Buenos Aires using a glass jar for a womb, his daughter’s doll for the baby, a plastic bag and a fabric sleeve.
In developing countries the need for a cheap, safe and easy-to-use birth assistant tool is huge.
From this eureka moment back in 2006, the Odon Device™ as it is now known has attracted hundreds of thousands of dollars of investment from global health donors and the private sector and is undergoing clinical trials all over the world ahead of its launch. And, as with all the stories in Innovate4Health, intellectual property has been central to the lengthy process of turning an interesting idea into a useful, marketable product that has the potential to address a major global health challenge.
The problem
Prolonged or complicated second stage of labour can give rise to potentially serious maternal complications and deaths as well as stillbirths and new born mortality. Worldwide, more than 13 million births each year face serious complications, and every year 300,000 women die from preventable causes related to pregnancy and childbirth
Mothers in high-income countries with complicated deliveries are generally able to benefit from obstetrician-led use of forceps or vacuum extractors; or caesarean sections. But the use of forceps and other mechanical devices in the extraction of a baby in a difficult delivery can cause internal bleeding in the mother or may result in injuries to the baby’s head or spine.
These options are rarely on the table in lower-income countries, where only 1–5% of complicated births are assisted in this way. Lack of staff, training and equipment all play their part.
“In developing countries the need for a cheap, safe and easy-to-use birth assistant tool is huge. In the Democratic Republic of Congo, where I used to work, I saw mothers stuck in labour for hours, if not days,” according to Sam Jennings, a midwife with Médecins Sans Frontières
“Often this resulted in the baby dying and the mother developing a hole known as a fistula, which causes permanent incontinence. A cheap and easy-to-use device like the Odon could be a gamechanger for millions of mums and babies around the world.”
The solution
The Odon Device™ essentially works along the same principle as the wine bottle and cork trick. It is a very simple invention that consists of a special tool to allow insertion into the birth canal, a hand pump and a plastic sleeve that allows the midwife to safely extract the baby.
The Odon Device is a simple, low cost and low risk solution to a significant health challenge that impacts millions of women and babies all over the world.
A significant advantage of the Odon device is that it can be used by a midwife and does not require operation by an obstetrician or other highly-skilled medical practitioner. The device also reduces the risk of infecting the baby or mother with HIV or hepatitis, a significant risk in many low-income settings. And perhaps most importantly, the device is cheap to manufacture at an expected cost of USD50 per unit, so can be made widely available.
The innovation process
Mr. Odon’s first step was to apply for and receive a patent for his invention, upon which he began to create a functioning prototype. Discussions with a local obstetrician led to refinements of the prototype, including a glass model of the uterus and two fully insertable sleeves. It was then suggested that the device be improved further to envelope only the baby’s head, rather than the entire body.
Around this time, the World Health Organization (WHO) became interested in the invention, at which point the prototype was transferred to the University of Iowa for further clinical studies, under the auspices of WHO. This led to the invention winning a grant of USD250,000 from the Canadian government’s Grand Challenges Canada programme, for further refinement and testing of the prototype.
It was at this point that clinical trials on real patients began. The first patient was a thirty-five year old Argentinean music teacher, undergoing her second birth. The device functioned successfully, apart from the initial insertion with a spatula, which was painful and difficult. This caused Mr. Odon to consider a further refinement to the device: a specially designed insertion device, the intellectual property rights of which were secured with another patent.
In total, the first trials in Argentina were conducted on 30 women with normal pregnancies, during which period Mr. Odon applied for another three patents as he further refined his insertion device.
From prototype to commercialisation
The Odon Device is a simple, low cost and low risk solution to a significant health challenge that impacts millions of women and babies all over the world. But even with significant work on the prototype and initial clinical trials, it was not yet ready to be launched onto the market. Partners were needed to test the effectiveness of the design through large-scale international clinical trials with thousands of patients; to get feedback on the design from obstetric leaders; and to build the significant capacity necessary to manufacture the product at scale and ship it all over the world.
To this end, the team behind the Odon Device decided to grant a license to Becton Dickinson, a U.S.-based medical device manufacturer, for further development and commercialisation. In return, the company would have exclusive rights to manufacture and distribute the product.
“When they gave the prototype to us, they actually thought it was almost a complete product. But we told them sorry, no. We need to go back and get it configured based on proper scientific procedures so as to lower any potential risks,” say Ms Lim Wan Leng, Core Team Leader at BD’s Research and Development unit.
Any small innovator or entrepreneur will testify to the importance of protecting inventions with patents.
Over the past three years, the team has been making multiple connections with doctors in the UK, hospitals in Europe as well as academics in Singapore to improve the device to get it ‘market-ready’.
Trials have been run examining how practitioners interact with the device in real-world settings, the results of which have led to improvements to the device and its accompanying written instructions. The next step is to run large clinical trials which will be held in Europe and Africa. When these are successfully completed, manufacture at scale will begin and the Odon Device™ will finally be launched onto the market.
As part of the license conditions, Becton Dickinson will offer the device at “access” pricing to lower-income countries that have the highest rates of maternal and newborn mortality.
The importance of intellectual property rights
It is telling that one of Mr. Odon’s first actions upon hitting upon his new idea was to secure a patent, which he followed up with a series of related patent applications as he created and refined the insertion device.
Any small innovator or entrepreneur will testify to the importance of protecting inventions with patents.
At the most fundamental level, holding the exclusive rights to the invention is crucial to attracting the investment necessary to develop and refine a product to get it ready for market. Evidence shows that start-up companies with a robust patent portfolio are far likelier to receive successful venture capital investment than those without. The existence of a patent acts a signal that the inventor is serious about his or her invention and has full control of its rights. This gives investors more certainty, as the patent prevents competitors from duplicating the invention before a return on their investment can be made.
Often small companies and inventors do not have the resources or expertise to develop an invention from concept to market launch. In this case, the patent holder can sell or license its rights to another enterprise for commercialisation. This allows the invention to go through the process of commercialisation and eventually come to the market, providing a source of income to the inventor in the form of royalties while benefitting society at large through introducing an innovative product.
For an invention with obvious social benefits such as the Odon Device™, the ability to retain ownership of intellectual property via licensing gives the inventor control over how the product is distributed. For instance, licenses can be structured in such a way to ensure pricing is set at a level to maximise access, as is the case with the Odon Device and indeed many medicines in the HIV and Hepatitis disease areas.
Finally, research and development today, particularly in the health sphere, typically involves a large number of organisations and individuals, often located in different countries. This is certainly true of the Odon Device.™ Intellectual property rights such as patents provide certainty that proprietary knowledge can be safely shared across borders and across organisations during the research and development process. The existence of global intellectual property treaties (notably the WTO TRIPS Agreement) has created a minimum standard of patent protection and harmonisation of IP rules amongst every WTO member country, enabling international research projects and partnerships to flourish.
Conclusion
The Odon Device™ will shortly complete its journey from a crude prototype assembled in a suburban Buenos Aires workshop, to a fully tested, safe birthing tool that will benefit millions of mothers and babies all over the world. Mr Odon’s imagination allowed him to look at an old problem in new way. But the long road to commercialisation has required cooperation, investment and perspiration — and that is where intellectual property rights have been key.
