Medical Device Innovation

Intellectual Property and Health Care

How many times have you been taking care of a patient when you’ve been suddenly struck with an idea for a better medical device? Why isn’t there a better catheter, or surgical retractor, or I.V. infusion pump, or endotracheal tube? My usual work environment is a large neonatal intensive care unit. My colleagues, including physicians, nurses, and respiratory therapists, are constantly coming up with new ideas to improve patient care.

How do new medical devices get to the bedside? Who is responsible for the original idea? What is involved with the development process? Are there opportunities for healthcare providers to assist in the development of new devices? If you are the inventive type, you’ve likely asked yourself these questions.

Back when I was in medical school (it seems like 200 years ago), a friend and I tried to develop a new product. It seemed like it was a pretty good idea. We spent some time and some money. We paid for a patent search, and then we got too busy and never pursued the idea further. A few years later, “our idea” was at the bedside. Someone with more time, money, motivation, contacts (or something) followed through with the idea. We were glad to see that the device was available to help patients, but we were a little disappointed that we didn’t have the resources to develop the product ourselves.

A series of articles will be appearing over the next several months. These articles will address the various challenges facing the health care inventor. The article this month will deal with some introductory themes. Future topics will include confidentiality, engineering, device design, prototyping, patent protection, marketing, funding, and licensing.

So, you’ve got an idea for a new medical device. The device needs to be designed, built, refined, protected and sold. All of this must be accomplished with a certain degree of confidentiality, or you may find that others are trying to market “your idea”. The development process can be long and arduous. However, the rewards can be substantial. Not only is there the potential to improve the lives of our patients, but there is also the opportunity for inventors to receive substantial monetary gains from their ideas.

WHAT IS INTELLECTUAL PROPERTY?

Intellectual Property includes inventions, expressions, ideas, secrets, and other creations of the human intellect. Intellectual property is similar to other types of property, except that intellectual property is largely based on your thoughts and ideas. We’ll learn more about intellectual property in the coming months. For now, the reader should appreciate that intellectual property is “property”, and it can be protected, assigned, sold, stolen, etc…

WHERE DO NEW IDEAS COME FROM?

As one would expect, new ideas come from a variety of sources. However, bedside clinicians are the source of many innovative products. Most of us are familiar with the Mayo stand, Debakey pick-ups, Foley catheter, Kelly clamps, and the Swann-Ganz catheter. Who is better situated to solve clinical problems than those individuals who spend countless hours at the bedside? The overriding challenge, of course, is following through on one’s idea. Many physicians have told me that they’ve had new product ideas for 10-20 years, and they’ve never pursued the invention. How many people may have derived benefit from these devices that are never developed? How many lives could have been saved? How much suffering could be alleviated?

Many ideas are developed internally by medical device companies. Even in these cases, clinical input is generally critical to the success of new products. If a nurse doesn’t see the need, or the physician doesn’t ask to use the new device, then the new product may never be used. Therefore, medical device companies understand the need to gather clinician’s input as part of the development process.

So, the answer to the question, “where do new ideas come from?”, quite often is you, the bedside clinician.

GETTING STARTED: THREE EASY STEPS

1. DO A PRELIMINARY PATENT SEARCH

Is your idea truly new? Has someone else already patented “your” invention or a similar invention? You can certainly save yourself a great deal of time and money by taking a look at official website of the United States Patent and Trademark Office uspto.gov. This website has a tremendous amount of information, and you can perform a patent search from your home computer. Patent searching takes some practice, but searching this website can be similar to using other search engines. Your local library may have information about patent searching classes as well. Prior to committing substantial resources to prototype development or filing a patent, it is common to pay for a professional patent search. You may also engage the services of a patent agent or patent attorney.

2. KEEP AN INVENTOR’S NOTEBOOK

If your patent search yields encouraging results, it’s an important step to record your ideas in a bound notebook. There is often great benefit in just putting your ideas down on paper. If you’ve made any preliminary drawings, they should be included.  When do you first think of your idea? Whom, if anyone did you tell? Have you built a prototype? Did anyone help you build the prototype? 

 Remember to make all your entries in pen. Time, date, and sign all entries. Some inventors choose to have all entries witnessed by another competent adult. It can be extremely important to keep an accurate record of your invention. If there is ever a dispute concerning the ownership of the invention, your Invention Notebook could make the difference.

Entries should be legible. Who are we kidding? Telling doctors to write legibly….the gall. However, your Invention Notebook may be the only evidence you have that a multimillion dollar device was based on your intellectual property

3. MAINTAIN CONFIDENTIALITY

One of the major topics we’ll discuss next month is confidentiality. Healthcare workers are accustomed to maintaining confidentiality for our patients. However, it is also in our nature to openly discuss issues with colleagues, so that we can all work together to provide the best possible care for our patients. Until you’ve secured some degree of intellectual property protection, your idea is “vulnerable”. It is generally a good idea to maintain complete secrecy about your idea/invention until your idea is protected.

About the author:

Robert Turbow, M.D., J.D. is the CEO of PatientPatents, Inc. (PPI). PPI develops ideas for health care inventors. www.patientpatents.com

DISCLAIMER

These thoughts are general observations on medical device development. The previous statements should not be viewed as substantive legal advice. This article does not create an attorney-client relationship between Dr. Turbow and the reader.