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Medical Device Inventing
1. The Surgeon Inventor: From a Napkin to Sand Hill Road.
By W. Thomas McClellan, M.D.
As young plastic surgeons we are bombarded with information and endless tasks from the
moment of graduation. Building a practice, business 101, coding, and collecting cases for Oral
Boards. All of this, while trying not to kill a free flap, or answering that daily question, “How the
heck am I going to fix that?, while maintaining a completely straight face.
Many of us seek refuge from these stressors by playing sports, painting, or other avocations. One
that is often overlooked is inventing. The basics of inventing and plastic surgery often go hand in
hand. Plastic surgeons are creative, outside the box thinkers who are challenged to get from A to
Z 100 different ways on a daily basis. This type of challenging and complex problem solving
often leads to innovation within our broad field. Examples of these innovations by surgeons
include the subcutaneous stapler, venous coupler, or a sternal closure system to name a few.
How many times during training did you say to yourself, “we could do it better this way…” or “I
wish there was an instrument or tool to perform this task better.” As Tom Fogarty, one of the
most famous surgical inventors (balloon catheter) told me, “one day the light just goes on”. I bet
most of you reading this article have at least thought of one alternative way to solve a problem.
I believe one of the great barriers to developing these ideas is how easily they are brushed off as
being too simple, too difficult, or an assuming “someone has already thought of that” attitude.
My challenge to you is to get those ideas out of your drawer, take the leap of faith and get to
work! Show it to a colleague, your spouse, or engineer friend. Work on it in your garage, draw it
on napkins, and dream about it when you’re asleep. As a specialty we are creative individuals
that typically have to make a square peg fit into a round hole like Apollo 13 engineers. Plus
inventing is a great way to forget that your insurance collection rate is 25% and that the local
“cosmetic surgeon” (family doctor) just started offering the Quick Lift™.
Do your research.
It’s difficult to come up with a completely novel idea or invention. Most of the time it has
already been invented, protected, and didn’t make it to market for various reasons. Not all of
those reasons are because it was a bad idea but more likely it had no direction, no money, no
market, or no elbow grease.
However your invention may still be patent protected by someone else and could obstruct your
patentability. One of the best ways to search for patentability is to simply use Google Patents.
It’s by far the easiest to navigate and understand. If you’re like me, and have to see a picture of
the idea to fully understand it, Google is the only service to utilize. You could also search the
USPTO web site, www.uspto.gov, for information which has a little tougher Boolean format to
navigate but is complete.
A patent attorney could perform a more formal search but would cost you a significant amount of
money. Although an attorney patent search is expensive it may be in your best interest if you are
2. pursuing an expensive patent in a field with significant prior art on record. It’s better to find out
in advance that your idea has already been invented before you pay the expense for a non-
provisional patent and get denied.
Whatever method you chose, a good understanding of the prior art and its relation to your idea is
necessary before spending too much money or time.
Protect thy self
Protecting your best new widget is an important first step in the inventing process. It’s also
where many surgeons get stuck and the idea goes back into the drawer. Most don’t want to
absorb the cost or do the research for prior art that is necessary. To protect your idea may cost
upward of $25,000 per patent, take years to defend, and even then may be out engineered.
Start the process by getting a bound notebook to carry around and collect the evolution of your
idea. Many times the various nuances of an invention can be lost or fragmented between 10
napkins and scraps of paper. An organized chronological notebook demonstrating your thought
process and idea development is a good first line defense.
Baseline protection may be as simple as emailing a description, photo, sketch to yourself.
Obviously this is not a patent but does set an admissible point in time and serve as a paper trail
back to your brain. It’s best to have your notes and drawings notarized as well. Usually there is a
notary in your office, or in someone in your building that won’t charge you $29.95 for every
signature.
Getting a basic non-disclosure agreement (NDA) or confidentiality agreement is critical if you
intend to discuss your idea with other people. The best NDA’s are designed specifically for you
by your attorney but skeleton agreements are often available on the web for free. Anytime you
discuss the secret sauce of your idea with anyone, you should consider having a mutual NDA on
record.
The next simplest form of protection is called a provisional patent. A provisional patent is a
cheaper way for you to have limited protection of your idea. It serves to create a placeholder in
time of when you dreamt up your invention and will be valid for 12 months. You can create
these documents on your own and simply submit handwritten notes or sketches to the US Patent
office. Provisional patents are valuable because of their cheap cost, simplicity, and time they
give you to organize your thoughts. In the 12 months following provisional submission you
could work out kinks in your idea, modify aspects, and even safely approach other people to help
with development.
Eventually you’ll need a patent attorney who can give you the basic information and lay of the
land. For the best advice you should search for one with experience specific to your invention.
There are advantages to having a patent attorney write provisional patent descriptions. It may
lower the cost of your non-provisional, be better written with broader claims, and organized
better. However, attorney costs to write a provisional patent may be anywhere from $3-8,000,
depending on complexity of the idea.
3. Finally a non-provisional patent that is written by a patent attorney is best method of protection.
It’s submitted to the USPTO and generally takes 18 to 24 months to be approved or rejected.
Submitting a non-provisional can be an expensive process and many cost $10-25,000 depending
on developments during the patent prosecution. This type of patent offers protection only in the
United States and will last for 20 years before becoming public domain. Specific details on non-
provisional patents and EU protection are beyond the scope of this article but should be
discussed at length with your attorney.
Patentability standards have recently been challenged in the Supreme Court with the KSR vs.
Teleflex ruling. This ruling is very important to note and may change your strategic approach for
filing. It has become more difficult to obtain a new or defend an existing patent based on its
“obviousness” in relation to the prior art. Basically the Supreme Court made is harder to get a
patent because your invention must not be just an obvious, to the educated observer,
improvement to an existing invention. It’s important to ask your patent attorney how this
landmark decision may affect your patent application.
Build a Great Team
Team building is difficult for inventors because most are concerned about idea theft, being left
out, or relinquishing control. However building a great team is the most important part of
developing an idea or building a startup. Very few inventors can bring an idea to life by
themselves, particularly the more technically complex. Remember, it’s not what you know or
who you know, but who knows you, that separates you from the herd of other inventors.
Therefore I must encourage you all to be “Inclusive not Exclusive”. Sharing your ideas with
others is beneficial for reasons beyond how they might help you. Getting other people to believe
and emotionally invest in your idea is one of the true joys with inventing. When the person
across the table says, “ahh haa I get it, and that’s a great idea”, is when the thrill of inventing
comes to life. Their addition often has a synergistic and energetic effect on the team. In reality
very few people will hi-jack your idea and if you have taken even rudimentary protection steps
you should be ok even without a non-disclosure.
At a minimum your team should include a corporate attorney, patent attorney, engineer and a
business partner. Of all of these potential team members, I believe the business partner is the
critical cog in the wheel of success. You can easily look the other three up in the yellow pages
and likely be ok, but the proper business partner is where the rubber meets the road. I often refer
to this person as the “Face man” from the A-Team show of the 1980’s. As all of the young
plastic surgeons reading this will remember the Face man gets the team what it needs to
accomplish the task at hand. He is the champion of all problems, the networker, with a “can do”
swagger. While you may be the dreamer and see the great benefit your invention may provide to
patients, the Face gets things done and brushes aside the hundred obstacles you never saw. A true
Face is hard to come by but must be an early addition to the team.
One way to get an intact team from the start is to utilize an accelerator. An accelerator is a small
company that provides the services of your team all in one place. They make introductions to
money, give advice, and guide you to other potential team members. Their most valued asset is
4. the experience gained from traveling the startup road before. This experience will save you
untold heartache, money and time.
Raising Capital
Unless you recently won the Power Ball you will likely need to raise money at some point in
time in order to move your idea forward. Most start-up’s Bootstrap; i.e. bankroll yourself until
you can convince someone else to give up their hard earned cash. In simplest terms you beg,
barrow, or steal what you can to make your prototype and fill in the holes with your own money.
Trust me, if you don’t believe in your idea enough to spend your own money no one else will
either. Bootstrapping your new idea will work initially but at some point in time you will have to
go out and beat the proverbial bushes for additional capital.
Initial investors are usually the 3 F’s; friends, family, and fools. These are usually the first
suckers…., I mean investors, because they are the only people willing to come over to your
house and view your small font, hundred-slide PowerPoint lecture. However getting these
individuals invested in your idea will force you to hone the message, boost confidence, increase
opportunity, and gain experience. Most importantly it will enable your idea to survive until the
next funding round.
Angel funding may be the next logical step along your funding route. An “Angel” is a general
term for wealthy individuals investing their own money to provide seed capital for startups, in
return for founder’s equity. Angel investors have a more altruistic approach to start-up’s and
want to benefit society. They can provide valuable mentorship, open doors, and more
importantly open their Rolodex. They may know the perfect engineer to design you out of a
corner or alter your prototype to open up potential markets. One drawback to Angel investors is
that their checkbooks are often limited to below 1 million dollars. Therefore if your invention
likely needs 10 million to get to market they are not your last funding stop.
Eventually you may end up seeking Series A funding at the door of a Venture Capitalist (VC).
There are VC all over the country with the pinnacle being a non-descript road in Menlo Park
named Sand Hill Road.
You might get introduced to a local VC through your corporate attorney, Face man, or Angel.
Many allow submission of ideas online however I would steer against this method. Meeting with
VC is interesting because they approach your idea from a completely different vantage point.
You have come wanting to help your patients and make the world a better place, while they
assess whether you’re a 5X ROI (return on investment). If you’re lucky enough to even pitch to a
VC be prepared and bring your hard hat and lunch pale, it’s not easy. Rejection is common and
patience is thin. Although the preparation for VC funding is time consuming and complex it’s
worth it. Very few other people can make your vision a reality more than the slick haired Gordon
Gekko’s of venture capital. They have the money and savvy to deliver most good ideas to the
market however the heavy price you pay is direction and ownership.
Resources
5. Absolute required reading is The Art of the Start by Guy Kawasaki. It’s is a bare bones guide to
everything you’ll need to know, from developing Mantra to achieving Menchhood. You’ll end
up reading it four times and still mine useful information from it.
If you have the time, the Stanford Biodesign Fellowship is worth a look. This one year
experience integrates physicians, engineers and business minds to solve challenging medical
problems.
Get Going!
Inventing the next great widget or medical device is an ideal pursuit for the young plastic
surgeon. We are naïve, used to eating instant Ramen noodles, willing to take risks, and have our
whole professional career ahead of us.
Your idea may help our patients heal, ease suffering, improve outcomes, or prevent
complications. As a hobby (or second job) it’s fun and uses all the brain cells that you haven’t
exercised over the last 10 years. Plus when in your lifetime can you ever learn about burn rates,
pre-money valuation, and capitalization tables outside of a B-school.
But to get started you have to take that leap of faith, believe in yourself, and get that idea out of
your drawer. To paraphrase Guy, Think big, Make Meaning, Believe in Yourself, and Get
Going!
About the Author:
W. Thomas McClellan, MD is a plastic surgeon, serial entrepreneur, inventor, and founder of
Intermed Partners.
He is in private solo practice in Morgantown WV. www.intermedpartners.com