Abstract
Information Points
- You can protect a new idea / intellectual property for a clinical product by not telling anyone about it (secrecy), copyright, patents, design rights or trademarks.
- In general terms, two models exist for getting a product into clinical use. These options include licensing the idea out to a company, or starting a company yourself to make and sell the product(s).
- A new product then has to be proved to be clinically effective and safe and approved by a regulatory body before it is marketed and sold.
- The benefits of a new product have to be demonstrated to colleagues and hospital managers and it has to be competitively priced to get it into clinical use.
Objectives
- To provide a guide to the process of converting an innovative idea to a clinical product.
- Intellectual property protection, evaluation and transfer into clinical practice, in medical devices.
Ethical issues raised
- Should a potentially life-saving idea should be kept secret or commercially exploited?
- Will a potentially life-saving idea not get into clinical use and benefit patients because of an absence of intellectual property protection and a promise of commercial benefit?
Keywords
Intellectual, Property, Patent, Copyright, Licensing.
Introduction
In early 2005, during the process of performing a laparoscopy and dye test for infertilty, I found that on using a certain cannula, there was a lot of leakage of dye from the cervix back into the vagina because of a poor cervical seal. It was therefore not possible to accurately assess the patency of the patient’s fallopian tubes. This caused a delay in the operation because I had to use a Leech Wilkinson cannula to ensure that I made an accurate diagnosis. A less experienced or hasty surgeon may have made a wrong diagnosis.
My experience was not unique. Almost every gynaecological surgeon I had, and have since, spoken to shared that same frustration. On this occasion however, I did something different because I was a Medici Fellow at the time, learning about intellectual property exploitation in relation to my research program developing new biomarkers in Polycystic Ovary Syndrome. I drew a rough draft of a device that I thought would solve the problem. That simple sketch evolved into a prototype, patent application and finally a clinical product, the Atiomo-DyeSeal™ Uterine Manipulator which provides a better cervical seal during laparoscpy and dye test miniming the chances of a false diagnosis of blocked fallopian tubes. Because of my experience in creating and successfully licensing the device to a manufacturing and distribution company, I have formed a gynaecological devices company . This has led to the invention of other gynaecological devices for example the “Atiomo Laparoscopic Assistant™” which enables one surgeon manipulate the laparoscope as well as the uterine manipulator during laparoscopic surgery, potentially saving manpower costs as an assistant sitting between the patients legs during laparoscopic surgery is no longer required.
Using my experience as the framework, this article begins by exploring some approaches to generating an idea for a new product. It then provides a guide to ways of carrying out an initial evaluation to check the viability of the idea. Next, important ways of protecting these ideas are considered, followed by the process of making a prototype, licensing the idea to another company or forming a new company to manufacture and sell the device. Regulatory issues are also discussed. The process of launching a new product into clinical use, product sales, marketing and distribution are briefly outlined. Finally, some of the important personal attributes for success are highlighted.
The Best Ideas Start from a Problem
At an innovation networking day organed by Medilink East Midlands in 2008, I heard the after dinner speaker say that the perfect way of developing an idea was to look for the pain in people’s lives and find a solution to it. “How appropriate”, I thought. It is important to position your ideas for new products around the solution of a problem because it is more likely to be in demand and it makes it easier to find a commercial partner to help with product development. In obstetrics and gynaecology, several opportunities arise, for the generation of new solutions to existing problems. These situations may arise in the context of trying to solve a common clinical or surgical problem, developing innovative ways of teaching / learning or it may arise from novel research findings.
However, not all new ideas will survive the journey from a concept in your mind(s) to a viable clinical product. The next section offers some quick first steps you can take to evaluate the viability of your new idea.
Will This Work? Initial Evaluation
The first step in establishing if an idea will be viable is determining whether it has already been made or patented. There are easily accessible online patent databases such as those of the European patent office and the US patent office where a quick search using the right keywords can establish whether or not your idea is unique. A search on any commercially available search engine such as “Google®”, “Yahoo®” or “MSN®” is also useful. A discreet enquiry from colleagues and experts in the field is also useful. It is however important to note that not all innovations will be visible on these sites as some patents may have not been published. Others may require a detailed search using unique keywords or a search of other national patent databases through a patent agent. However, if you have been working in a particular field and you and other experts in your discipline have not come across a similar product and you haven’t found a similar device by searching the above patent databases and websites, there is a very good chance that you have got an innovation that is unique.
Having established the uniqueness of your product, the next step is to obtain an initial assessment of the commercial potential of the product. This information will be useful in convincing a medical device manufacturer to work with you on developing the product or in deciding if you want to form a company to manufacture and sell your products. The important bits of information required at this point are how often the product will be used in a geographical territory (say a country, continent or globally) in a year and how much you estimate each unit will sell for based on the price of similar products. With specific regard to medical devices, I often find the United Kingdom Hospital Episode Statistics website an excellent resource. The section on hospital episode statistics provides the number of times a particular operation is performed in a given year within the National Health Service.
Having convinced yourself that the product is unique and that there