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Medical Device Inventing
 

Medical Device Inventing

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An article I wrote on Inventing for Physicians. From conception of an idea until funding.

An article I wrote on Inventing for Physicians. From conception of an idea until funding.

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    Medical Device Inventing Medical Device Inventing Document Transcript

    • 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 themoment of graduation. Building a practice, business 101, coding, and collecting cases for OralBoards. All of this, while trying not to kill a free flap, or answering that daily question, “How theheck 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. Onethat is often overlooked is inventing. The basics of inventing and plastic surgery often go hand inhand. Plastic surgeons are creative, outside the box thinkers who are challenged to get from A toZ 100 different ways on a daily basis. This type of challenging and complex problem solvingoften leads to innovation within our broad field. Examples of these innovations by surgeonsinclude 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 “Iwish there was an instrument or tool to perform this task better.” As Tom Fogarty, one of themost famous surgical inventors (balloon catheter) told me, “one day the light just goes on”. I betmost 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 asbeing 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 towork! Show it to a colleague, your spouse, or engineer friend. Work on it in your garage, draw iton napkins, and dream about it when you’re asleep. As a specialty we are creative individualsthat typically have to make a square peg fit into a round hole like Apollo 13 engineers. Plusinventing 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 hasalready been invented, protected, and didn’t make it to market for various reasons. Not all ofthose reasons are because it was a bad idea but more likely it had no direction, no money, nomarket, or no elbow grease.However your invention may still be patent protected by someone else and could obstruct yourpatentability. 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 ofthe idea to fully understand it, Google is the only service to utilize. You could also search theUSPTO web site, www.uspto.gov, for information which has a little tougher Boolean format tonavigate but is complete.A patent attorney could perform a more formal search but would cost you a significant amount ofmoney. Although an attorney patent search is expensive it may be in your best interest if you are
    • pursuing an expensive patent in a field with significant prior art on record. It’s better to find outin 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 isnecessary before spending too much money or time.Protect thy selfProtecting your best new widget is an important first step in the inventing process. It’s alsowhere many surgeons get stuck and the idea goes back into the drawer. Most don’t want toabsorb the cost or do the research for prior art that is necessary. To protect your idea may costupward 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 youridea. Many times the various nuances of an invention can be lost or fragmented between 10napkins and scraps of paper. An organized chronological notebook demonstrating your thoughtprocess 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 trailback to your brain. It’s best to have your notes and drawings notarized as well. Usually there is anotary in your office, or in someone in your building that won’t charge you $29.95 for everysignature.Getting a basic non-disclosure agreement (NDA) or confidentiality agreement is critical if youintend to discuss your idea with other people. The best NDA’s are designed specifically for youby your attorney but skeleton agreements are often available on the web for free. Anytime youdiscuss the secret sauce of your idea with anyone, you should consider having a mutual NDA onrecord.The next simplest form of protection is called a provisional patent. A provisional patent is acheaper way for you to have limited protection of your idea. It serves to create a placeholder intime of when you dreamt up your invention and will be valid for 12 months. You can createthese documents on your own and simply submit handwritten notes or sketches to the US Patentoffice. Provisional patents are valuable because of their cheap cost, simplicity, and time theygive you to organize your thoughts. In the 12 months following provisional submission youcould work out kinks in your idea, modify aspects, and even safely approach other people to helpwith development.Eventually you’ll need a patent attorney who can give you the basic information and lay of theland. 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 maylower the cost of your non-provisional, be better written with broader claims, and organizedbetter. However, attorney costs to write a provisional patent may be anywhere from $3-8,000,depending on complexity of the idea.
    • 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 dependingon developments during the patent prosecution. This type of patent offers protection only in theUnited 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 bediscussed 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 forfiling. 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 apatent 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 thislandmark decision may affect your patent application.Build a Great TeamTeam building is difficult for inventors because most are concerned about idea theft, being leftout, or relinquishing control. However building a great team is the most important part ofdeveloping an idea or building a startup. Very few inventors can bring an idea to life bythemselves, particularly the more technically complex. Remember, it’s not what you know orwho 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 withothers is beneficial for reasons beyond how they might help you. Getting other people to believeand emotionally invest in your idea is one of the true joys with inventing. When the personacross the table says, “ahh haa I get it, and that’s a great idea”, is when the thrill of inventingcomes to life. Their addition often has a synergistic and energetic effect on the team. In realityvery few people will hi-jack your idea and if you have taken even rudimentary protection stepsyou should be ok even without a non-disclosure.At a minimum your team should include a corporate attorney, patent attorney, engineer and abusiness partner. Of all of these potential team members, I believe the business partner is thecritical cog in the wheel of success. You can easily look the other three up in the yellow pagesand likely be ok, but the proper business partner is where the rubber meets the road. I often referto this person as the “Face man” from the A-Team show of the 1980’s. As all of the youngplastic surgeons reading this will remember the Face man gets the team what it needs toaccomplish 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 topatients, the Face gets things done and brushes aside the hundred obstacles you never saw. A trueFace 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 smallcompany that provides the services of your team all in one place. They make introductions tomoney, give advice, and guide you to other potential team members. Their most valued asset is
    • the experience gained from traveling the startup road before. This experience will save youuntold heartache, money and time.Raising CapitalUnless you recently won the Power Ball you will likely need to raise money at some point intime in order to move your idea forward. Most start-up’s Bootstrap; i.e. bankroll yourself untilyou 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 willeither. Bootstrapping your new idea will work initially but at some point in time you will have togo 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 firstsuckers…., I mean investors, because they are the only people willing to come over to yourhouse and view your small font, hundred-slide PowerPoint lecture. However getting theseindividuals invested in your idea will force you to hone the message, boost confidence, increaseopportunity, and gain experience. Most importantly it will enable your idea to survive until thenext funding round.Angel funding may be the next logical step along your funding route. An “Angel” is a generalterm for wealthy individuals investing their own money to provide seed capital for startups, inreturn for founder’s equity. Angel investors have a more altruistic approach to start-up’s andwant to benefit society. They can provide valuable mentorship, open doors, and moreimportantly open their Rolodex. They may know the perfect engineer to design you out of acorner or alter your prototype to open up potential markets. One drawback to Angel investors isthat their checkbooks are often limited to below 1 million dollars. Therefore if your inventionlikely 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 Parknamed 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 withVC 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 theyassess whether you’re a 5X ROI (return on investment). If you’re lucky enough to even pitch to aVC be prepared and bring your hard hat and lunch pale, it’s not easy. Rejection is common andpatience is thin. Although the preparation for VC funding is time consuming and complex it’sworth it. Very few other people can make your vision a reality more than the slick haired GordonGekko’s of venture capital. They have the money and savvy to deliver most good ideas to themarket however the heavy price you pay is direction and ownership.Resources
    • Absolute required reading is The Art of the Start by Guy Kawasaki. It’s is a bare bones guide toeverything you’ll need to know, from developing Mantra to achieving Menchhood. You’ll endup 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 yearexperience integrates physicians, engineers and business minds to solve challenging medicalproblems.Get Going!Inventing the next great widget or medical device is an ideal pursuit for the young plasticsurgeon. We are naïve, used to eating instant Ramen noodles, willing to take risks, and have ourwhole professional career ahead of us.Your idea may help our patients heal, ease suffering, improve outcomes, or preventcomplications. As a hobby (or second job) it’s fun and uses all the brain cells that you haven’texercised 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 ofyour drawer. To paraphrase Guy, Think big, Make Meaning, Believe in Yourself, and GetGoing!About the Author:W. Thomas McClellan, MD is a plastic surgeon, serial entrepreneur, inventor, and founder ofIntermed Partners.He is in private solo practice in Morgantown WV. www.intermedpartners.com