Innovations, inventions and Dr Archie Brain
“He that will not apply new remedies must expect new evils; for time is the greatest innovator.”
– Sir Francis Bacon (1561–1626)
The main theme of the opening ceremony of the 2012 London Olympics was a celebration of the British spirit of innovation and progress featuring the inventions of Watt, Stephenson and Brunel. In the same year, the innovations of Dr Archie Brain are celebrated in recognition of the 30th anniversary of the first pilot study of the laryngeal mask airway (LMA) and its registration for a patent. His design revolutionised the practice of anaesthesia and along with the symbiotic advent of propofol, routine oximetry and capnography, made a unique contribution to simplifying airway management, thereby greatly enhancing patient safety. In this issue of Anaesthesia, van Zundert et al.  pay a well-deserved tribute to Archie Brain and his development of the LMA.
The history of anaesthesia is, in essence, a continuum of innovations and inventions. Anaesthesia itself is hailed as one of the ten most significant inventions and milestones in the history of medicine . Innovation (Latin: innovare – to change) relates to different, usually better, usage of an existing product or technology, while invention (invenire – to find) relates to a completely new idea or concept. Britain used to be renowned worldwide for its high rate of inventions compared with other countries but in recent years this gap has closed. The UK is now in 20th place for patents granted per million population (69.5), with Taiwan (356), Japan (353), the USA (340) and Israel (250) now leading . It is of interest to note that some major international companies such as Panasonic, Apple and Google were granted 3132, 566 and 283 patents, respectively, in 2010 alone .
The difficult road to success
The road to success for any invention or innovation, medical or not, is plagued with obstacles. Once an idea is conceived, there are a number of crucial and arduous steps that every inventor or innovator must take to see his/her idea translated into a finished and marketable product. The whole process involves up to ten stages before the product is in use ; the main steps are outlined below.
Protecting your idea
To safeguard the idea requires a ‘patent’ or a ‘registered design’ that will protect the shape and form of a novel device. This process secures the intellectual property of the idea. It requires a simple application that outlines the idea and its novelty, and prevents anyone else from copying or stealing the idea for one year. This one-year period should provide enough time to establish whether the idea is really patentable, is worth protecting and has the potential for further development and ultimately, marketing.
Next, an application for a proper patent must be filed. For a patent to be granted it has to show novelty, an inventive step and potential industrial applicability. Patent attorneys specialise in performing thorough patent searches and, most importantly, in writing patent claims in a way that it is impossible for third parties to plagiarise. Patents are accompanied by references to all previous patents relating to this new idea. This process is not cheap and can amount to several thousands of pounds. Once granted, the patent is usually valid for 20 years as long as the annual patent fees in each and every relevant country are paid.
Patents are intellectual properties and some can carry enormous value. For this reason, many are contested by inventors who claim either ‘prior art’ (information that has been made available to the public in any form before patent application) or ‘infringement’ (manufacturing, using, selling or importing a patented product or process without the patent owner's permission). Highly publicised legal cases include Dyson's dual cyclone technology versus Hoover on the basis of similar design (6] and recently, Apple versus Samsung regarding touch-screen technology . These cases often involve millions of pounds in compensation if a patent is found to be infringed.
A little known fact is that in the healthcare environment, the intellectual property of ideas (if related to or created at work) may be legitimately viewed as belonging to the employer, so that one has to be very clear about the ownership of the patent before embarking on commercialisation of the product.
If the concept is a new object or apparatus, often the most difficult part of the invention process is to create a prototype. This may be a hurdle too high, for example through time constraints or the need for financial or industrial support. In medicine, if the inventor or a friendly engineer in a hospital workshop cannot produce a prototype, it may need to be developed by a medical equipment company. To do this one has to disclose the nature of the invention to the company. This is usually done under a so-called ‘non-disclosure agreement’ that guarantees confidentiality, prohibiting the company from sharing information with others and restricting duplication and further development if the owner does not want to proceed any further.
Prototypes can be prohibitively expensive to produce as they may involve the cost of high-quality tooling, manpower and company overheads. The company, if interested in the product, may forfeit the fee for manufacturing a prototype, otherwise the inventor will need to cover the costs. This is another frequently insurmountable obstacle at which many good ideas fail, as inventors run out of money and their projects are shelved. In this situation there are various ways in which to raise the required sums, either by finding suitable investors or by using licensing agreements or joint ventures and partnerships.
The numbers involved can be awe-inspiring. Archie Brain produced over 1000 prototypes of his device in the space of 30 years (Brain A, personal communication, Sept 2012). James Dyson produced over 5000 prototypes before his bagless vacuum cleaner went into production .
Testing of a prototype or a new product
Once made, a prototype needs to be tested to see whether it works as intended before going to mass production. In stark contrast to pharmaceuticals, the evaluation pathway for new medical devices is not well defined and this has recently been a source of considerable criticism. A spate of highly publicised failures of new products, for example metal-on-metal hip replacements, coronary stents and breast implants, has increased awareness that the medical equipment industry is not properly regulated and it has been described as unsatisfactory, unscientific and in need of a major overhaul . Once a medical device is granted a CE mark (Conformité Européenne – conforming to European requirements), it can be sold on the open market without any clear evidence of functionality and safety. The CE mark only guarantees technical quality of a product but says nothing about its application and more importantly, clinical efficacy. In anaesthesia, this can pose dilemmas and concerns, for example when new supraglottic airways come on the market or when new non-Luer lock spinal and epidural needles are introduced .
In the 1980s, Archie Brain and his associates carried out the original testing of LMAs on cadavers and then humans, following which there were several hundred publications confirming its virtues . It has to be admitted that the criteria for clinical testing and obtaining patients’ consent were much less stringent then they are now, and it would probably be difficult to conduct some of those studies today.
The success of the LMA ensured that as the patent expired, several companies started manufacturing a variety of devices, some of variable quality, and many were possibly brought to the market without proper evaluation or comparison with the existing, well-functioning, original designs .
To address the problem of testing airway devices, the Difficult Airway Society recently started an initiative called ADEPT (The Airway Device Evaluation Project Team). The remit of ADEPT is to evaluate new airway products under simulated and clinical conditions, coordinate multicentre studies, identify a minimum of level-3b supporting evidence and thereby derive objective recommendations to the profession about this type of equipment .
The problem is not confined to airways. Testing the new, non-Luer lock spinal needles sparked controversy as there were no firm guidelines relating to the evaluation of such equipment and trialling on humans presented ethical dilemmas with the inherent potential for more harm than good . While the equipment has all attained a CE mark, there is no substantial proof of either efficacy or safety, although there have been attempts to assess these clinically . This has proved frustrating both to the medical equipment industry, which has invested considerable capital in this new venture, and to its potential users.
The final product
Once initial tests are satisfactory and the product is ready for mass production, the stage of commercialisation begins, with a view to reaching as large a market as possible. There are three ways of doing this: transferring technology to an interested company; licensing the same technology and the intellectual property to a company; or forming a specific company to manufacture the product. The full description of these options is beyond the confines of this editorial and can be found elsewhere .
Can I be an innovator or inventor?
It is well recognised that anaesthetists and intensivists, by nature, tend to be both practical and often inventive individuals. The job is hands-on and involves constantly working with equipment and new medical developments. I suspect that nearly every practitioner, whether involved in research or not, has had at least one or two inventive or innovative ideas during his/her career. Although the old saying that ‘necessity is a mother of invention’ may be a cliché, it is certainly true that in both the operating theatre and the intensive care environments, numerous situations are encountered in which conventional equipment is suboptimal, and this is the driver that can foster either improvements or new ideas. The original Macintosh and Magill designs, that are still used today, were essentially solutions to problems encountered in practice while developing and perfecting tracheal anaesthesia. One only needs to look at the now vast array of surgical instruments and in particular, laparoscopic devices, to understand how this also applies to other practical specialties such as surgery. These represent both perceived improvements on existing instruments and completely novel approaches and technology.
Innovation in medicine comes in various forms and is not limited to creating new products only. It may be improvement in the way we work (e.g. productive operating theatre), enhanced safety or advances in information technology, whether it be easy access to emergency information, drug regimens, laboratory ranges, videos of important procedures on mobile devices or limitless other applications [15, 16].
To nurture those in the anaesthetic fraternity with bright ideas, and to help them navigate the convoluted process described above, the Association of Anaesthetists of Great Britain & Ireland (AAGBI) has recently formed a new Section of Innovation and created an annual Innovation Prize (see http://www.aagbi.org/research/innovation). The aim of this Section is to enable individuals to seek advice on how to develop an idea, obtain intellectual property, produce prototypes, test them, and make contact with potential manufacturers among the medical equipment companies. The inaugural AAGBI Innovation Prize in Anaesthesia and Critical Care was very well contested by 21 applicants. It was very fitting that it was Archie Brain who presented the first winners with the prize during the AAGBI's Winter Scientific Meeting (WSM) in January 2012.
Archie Brain has shown us all that a good idea is only the start of creating an innovative product and the hard work follows. Not only are perseverance and a steadfast belief in the idea required to overcome the obstacles, so too is an ability to absorb and use criticism constructively whilst keeping an open mind and listening to others, to achieve continual improvement of the product and eventually, success. At the time of writing this editorial, Archie was making yet another new prototype, 30 years on (Brain A, personal communication, Sept 2012)!
Archie Brain, a great inventor with many accolades, the Medicalfutures Lifetime Achievement Award amongst them, is a very humble man. He has been a source of great inspiration to many of his contemporaries and is an inspiring role model for the generations that follow. His example has, and will, inspire a whole new generation of young anaesthetists to innovate and to come up with solutions to the many unsolved problems in anaesthesia and critical care that still exist today.
Archie – the profession and I salute you!
All mention of LMA in this paper referes to LMA® airways, a product of Intavent.
I am AAGBI Innovation Section Lead. I have held patents for anaesthetic equipment devices in the past. I am not supported or receiving royalties from any medical equipment company. No external funding declared.