How to turn your ideas into clinical products: A guide to the innovation process in medical devices

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 is a stable market for it, you must take the necessary steps to formally protect the idea (your intellectual property).

Protecting Your Intellectual Property
You can protect your idea by not telling anyone about it (secrecy), copyright, patents, design rights and trademarks. In developing your idea for a clinical product it is important that you keep the idea secret, only disclosing it after you have some sort of intellectual property protection. Until then, it is advisable to have anyone you discuss the idea with to sign and date a confidentiality non-disclosure agreement. This is extremely important as any public disclosure (including research presentations and publications) can jeopardise the chances of a successful subsequent patent claim.

Copyright protects material such as literature, art, music, sound recordings, films, software and broadcasts. In developing a clinical product, the initial concept drawings of your idea are often your first tangible intellectual property (copyright) and are of commercial value. This means they can be licensed or sold. Taking a simple step such as signing and dating the drawings is therefore very important. Always have back-up copies should you lose your original document. It is amazing how often in discussions; people draw sketches of potentially new products and discard the piece of paper unaware of the potential commercial value of that piece of paper.

Patents, on the other hand, protects the technical and functional aspects of products and processes. For a patent to be granted, the patent examiner must be satisfied that the invention is new, has an inventive step that is not obvious to someone with knowledge and experience in the subject, and it must be applicable in some kind of industry. It is advisable to seek the services of a patent attorney. However, the UK patent office has very useful information on the patent application process.

Other ways of protecting your idea are through trademarks and registered designs. Once you have protected your intellectual property, your idea now has commercial value and it is possible to sell the idea to a commercial partner. However, in my experience, it is easier to sell the idea to others if you also have a tangible physical product to show (prototype).

From an Idea to a Product – Prototypes
A prototype is a preliminary model of your final product. You can either choose to make a prototype yourself or form a partnership with a local medical engineering unit or manufacturer. The costs of a prototype can vary ranging from a couple of hundred pounds to thousands depending on the nature of the device you want to build. To keep expenses down, a shared risk model can be used where the engineer builds your prototypes at no up-front costs but gets a proportion of the royalties due back from the device once it is fully commercialised. However it is important to agree upfront, revenue sharing arrangements that will apply if you choose to go down this route. Changes to the original design arising from the intellectual input of your collaborator may warrant a co-inventor status on any future patents. Government grants may fund the costs of building a prototype for a promising product and it is worth investigating the prospects with your local commercialisation agency, business link or technology transfer office.

Having gotten an idea, carried out an initial evaluation, protected the intellectual property and developed a prototype, the next key decision an inventor has to make is how the product into clinical use and generate revenue. In general terms, two models exist although some variants of each model occur. These options include licensing the idea out to a company, or starting a company yourself to make and sell the product(s).

Licensing & Company Formation
Licensing involves giving the rights to your intellectual property to a commercial partner who will take on the tasks of manufacturing and selling the product for you in return for a royalty. The advantage of licensing is that you do not have to create your own manufacturing facilities and develop your own sales force. However, the down side is that royalty payments are not always as profitable as creating your own company for making and selling your product. Licensing is a very attractive option if you want to limit your risks and if time is an issue. Potential licensees can be found from a variety of sources. These include trade shows, conferences, personal contacts, internet web listings, local university or NHS technology transfer officers, business directories, business links and local chambers of commerce. Government-operated business support agencies can also help to match inventors with potential licensees. Some large companies also advertise for new ideas on their websites. It is advisable to have a legal/licensing expert go through the process and look over the contracts with you.

The alternative to licensing your idea to another company is to consider forming your own company to make and sell the product. The potential commercial returns of forming a company can be higher than a licensing deal. Forming and running a company can be time consuming, require a significant upfront financial investment and involve a significant amount of administrative burden. The process of forming a company should start with writing a detailed business plan to help you clarify the process you want to embark on in your own mind and communicate the plan to partners and potential investors.

This should include the goals and vision of the business, the products or services that will be sold, the commercial potential, the proposed legal structure of the business (including directors and shareholders), how the business will be managed and run on a daily basis (including a Gantt chart), which employees are required, the marketing plan, projected costs of starting the business, a financial forecast of the running costs and the anticipated exit strategy (when and how you intend to sell your business) .

What Next; Clinical Testing, Regulatory Approval, Product Launch, Marketing and Sales
Regardless of whether you have licensed your idea or formed a company, to actually get your product into clinical use it has to be clinically tested, approved by the relevant regulatory body, launched, marketed and sold.

Clinical Testing
This is required to show that your product is safe and the intended benefits are proven. Depending on the regulatory structures in your hospital / work place, you need to have the clinical test approved by the local research and development and ethics committees. Initially, a simple proof of concept study to demonstrate that the device is safe is useful. The study can also determine the best design for the product because changes may be needed after it is tested.

Regulatory Approval
The national regulatory approval process in the UK involves getting the product CE marked. This provides some reassurance that the safety aspects of the product have been evaluated and defined and that there is ongoing monitoring of the product whist in clinical use. This process is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. In general medical devices are classified as Class I, II or III. Class I devices are low risk, Class II are moderate and Class III are high risk. The Food and Drug Administration (FDA) regulates the US market . Similar regulatory bodies exist for most countries and geographical regions where you want your device to be used. To ensure acceptance of your device, guidelines for each country and region will need to be followed. Again, regulatory consultants are helpful in providing important guidance on these issues. However in the UK/Europe further information can be found on the MHRA website.

Product Launch, Marketing and Sales
Launching, marketing and sales are the key to the successful translation of your idea into a clinical product. You may have invented the best life saving device on the planet, but I am afraid it still has to be marketed and sold. You still have to convince colleagues to use it instead of sticking with what they are used to even if the existing device is slow and painful. Careful planning, implementation and long-term sustainability are required. The exact nature of the launch, marketing and implementation will vary from product to product. Its success will depend on several factors including the benefits of the product, the nature of the marketing campaign, and the response of the competition, pricing and ultimately, the wider environmental / economic climate.

Conclusion
This article was written to provide an outline guide to colleagues in obstetrics and gynaecology on the innovation process based on my personal experience. More details can be found in an e-book I have written on the topic . I have found that some generic attributes are also important in the process. These include skilled people management, persistence, patience, focus and determination. There are also ethical issues which you may need to deal with such as whether a potentially lifesaving idea should be kept secret or commercially exploited.

Focus is important because things don’t always go as planned and new challenges arise. It’s like a game of chess. You make an opening move and think a few moves ahead. You do not know how your opponent is going to respond so you change your strategy in response to the moves of your opponents. The key is to remain focused on the outcome. Even if you do not win that specific game, you just shake hands and start a new game (or in the innovation process, “new idea”). The important thing is that you enjoy it.

References

1. Simon Mosey, Andy Lockett, Paul Westhead, Building the Foundations for Academic EnterpriseSimon Mosey et al. In New Technology-Based Firms in the New Millenium Emerald Group Publishing Limited. 2008. 6;69-83.
2. Nottingham Gynaecological Devices. N.G.D. Limited. www.ngd.uk.com. The Sir Colin Campbell Building University of Nottingham Innovation Park (UNIP) Triumph Road Nottingham, UK.
3. Medilink East Midlands. www.medilinkem.com
4. European Patent Office. http://ep.espacenet.com
5. United States Patent and Trade Mark Office. http://www.uspto.gov
6. Hospital Episode Statistics. www.hesonline.nhs.uk
7. UK Intellectual Property Office. http://www.ipo.gov.uk.
8. Business Link. Prepare a Business Plan. Available at https://www.gov.uk/browse/business USA Food and Drug Administration Agency http://www.fda.gov
9. Medicines and Healthcare products Regulatory Agency www.mhra.gov.uk
10. William Atiomo. 2008. How to turn your idea into clinical products. E-book. Available at http://store.payloadz.com/go?id=193498
11. Digital.com publishes reviews by real people to help you find the best tools for your small business website, including web hosting, website builders and ecommerce platforms.  https://digital.com/#ixzz5Da09el2n

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