DR. K. ON ADVANCED INNOVATION TASKS
(This section is to provide advanced information for anyone involved in ocular innovation, but potential patients are welcome to read it.)
The topics covered are:
- Performing a hospital Institutional Review Board (IRB) study;
- Submitting an application to the U.S. Food and Drug Administration (FDA);
- Giving away or selling your concepts;
- Writing medical articles;
- Writing a book;
- Having your book published;
- Starting your publishing company;
- Developing a website.
PERFORMING A HOSPITAL INSTITUTIONAL REVIEW BOARD (IRB) CLINICAL STUDY
AND SUBMITTING AN APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION
If your innovation is invasive to humans, is unknown to your peers, deviates significantly from the State of the Art, or from the Procedure of Choice, you may wish or be compelled to do an I.R.B. clinical study. These Boards are located in hospitals and have the purpose of allowing some innovation but in a controlled atmosphere of proper ethics, of known and decreased physical risk for participating subjects, and for decreased liability risk for the hospital. These Boards are typically made up of physicians, hospital administrators, and lay people such as religious leaders.
Prior to starting the study, the Principal Investigator (P.I.) submits to the Board a detailed written application of his training and of the study. Careful attention is given to the extensive operative permit to be signed by the subjects. The PI must take an on-line course in ethics and proper treatment of subjects and receive a passing grade and have a refresher course every three years. Included is the PI's conflict of interest status and financial disclosure. The PI also appears before the Board to answer any questions on the study including patient treatment. The Board will then decide if the proposed study will get a 1) a review exception, 2) an expedited review, or 3) a full board review. Frequently there is input, coordination, and submission of data to the National Institute of Health if they are to supply any funding, and with the U. S. Food and Drug Administration if it is anticipated there will be an application to them. The length of the study is usually jointly determined by the PI and the Board.
In my case I was doing an unknown procedure called laser treatment of eye floaters. Some doctors could not envision that such a simple approach could be both safe and effective. I had done under my sole supervision a pilot study of 17 patients in which there were zero complications and the procedure was effective in 92 per cent of the patients. The only alternative treatment to using a laser was vitrectomy, which is sucking out the floaters along with all the fluid of the posterior 3/4ths of the eye. Vitrectomy has a rate of significant complication of about 65 per cent. About 65 per cent of these patients get a cataract that has to be removed within two years, and there is about a 1 to 3 per cent rate of retinal tear of retinal detachment. In spite of this comparison, it was suggested I do an IRB study.
During the last phase of my application for my Institutional Review Board Study of laser treatment of eye floaters, someone casually asked if lasers had been approved for this procedure by the FDA. After a search, it was found that the FDA had never been asked to make a judgment on this particular use of lasers. The IRB felt that it was necessary to get approval from the Food and Drug Administration for an Investigational Device Exemption before we could start an IRB study. Since I was the only interested party and the only person whose livelihood was threatened, the job of applying to the FDA fell to me.
Such an application is almost always submitted by the manufacturer using their research, secretarial staff, and funding. For one person, such as me, to do all the clinical research and writing of an application is rare.
There is a widely held misconception about the FDA, which is that they approve or disapprove of surgical operations. They don't do this; they leave it to medical doctors. What the FDA does is approve or disapprove of devices and machines for use on humans.
At this point I found myself in a very difficult situation. That is, (a) I could give up on laser treatment of eye floaters, losing my income, and medicine losing this beautiful procedure, or (b) apply for an Investigational Device Exemption from the FDA. Getting such an Exemption typically took many months and was extremely laborious. I decided to abandon laser treatment of eye floaters. However, I soon learned that just a few months previously, Congress had passed a law that required the FDA to make a ruling on such exemptions within 90 days of receiving such an application. That piece of information encouraged me, and I applied to the FDA.
My application for this new use of YAG lasers was submitted to:
Food and Drug Administration
Center for Devices and Radiological Health
IDE Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, MD 20850.
The Application with its copies was 7 inches tall.
It included, for example:
REPORT OF PRIOR INVESTIGATIONS: CLINICAL STUDIES: here I submitted all peer review literature; non-peer review literature; non-published studies; and articles somewhat related to the proposed study. INVESTIGATIONAL PLAN; PROTOCOL; STUDY DESIGN AND METHODS; INCLUSION AND EXCLUSION CRITERIA; RISK ANALYSIS; JUSTIFICATION OF THE STUDY; THE EXPERTISE OF THE INVESTIGATOR; STATISTICAL METHODS; etc.
On March 20, 2002 (twenty days after the FDA received my application) I was notified by the FDA that my investigation of laser treatment of eye floaters represented a non-significant risk device study and that previously approved ophthalmic YAG lasers could be used for my study without an Investigational Device Exemption from the FDA. With that ruling, my IRB study commenced. This 200 consecutive patient study with pre- and post-operative photographs and 16 items followed for one year was finished after two years. The results were that the procedure was effective in 92% of patients and there were zero complications.
GIVING AWAY OR SELLING YOUR CONCEPTS
- Dr. Karickhoff gave almost all of his innovative concepts to the medical profession. Many were given by simply writing a journal article that revealed the concept. An example of this was my Two Direction Radial Keratotomy Incision Technique. Another doctor saw this article and designed a new diamond knife for my technique. His knife became the most popular in the world for radial keratotomy incisions.
- Giving your innovations to industry: There is not enough profit in many simple surgical instruments to warrant the expense of getting a patent and many of them are not patentable. Several of these were given to manufacturers of surgical instrument with the stipulation that my name be placed on or with the product. My most widely used was a double barreled device for removal of cortical material after removing the cataract nucleus.
- Selling a device outright: This involves some marketing of the device to a manufacturer. Usually this is done with a letter and pictures. You offer to sell: the device; the expertise on the details of the final produce; I usually offered to write their advertising of it; if I had a trademark, I sold it; and I sold my standing by their booth at the Academy explaining it to customers. Of this category, my most profitable was a macula function test called the Flying Corpuscle Viewer.
- Selling the assignment of a patent to a manufacturer plus receiving royalties: The Karickhoff Keratoscope was held over the eye after extracapsular cataract extraction. This produced a round image or an oval depending on the amount of astigmatism. The sutures were then tightened or loosened to reduce the astigmatism. Its patent was sold for a fixed sum and I received 12% of sales continually for several years.
WRITING MEDICAL ARTICLES
In the last few years it has become increasing more difficult to publish articles in medical journals. This is because of decreasing advertising and resultant shortening length of journals. My suggestion is, before writing an article, write to the editor about your subject, telling the editor what is new that you want to present, and ask him if his journal might be interested, and if so, what length of article might they accept. If they encourage you, study well the form they desire and write the article exactly that way.
WRITING A BOOK
The book should be written with the word processing software most familiar to you. In my case that was Microsoft Word. The only problem I had was that captions would not stay with their picture when the text above the picture was changed. When finished, the book needs to be changed to the PDF format before it is placed on a CD and mailed to a printer. If the text is sent to a printer in Microsoft Word, the page lengths, photographs, and spacing can shift. Alternately, one can write it in Microsoft Word, then immediately convert it to some publishing software, and then the captions will stay with the pictures.
A proofreader is essential both for correctness and for what sections may be too long or too short. Place everything new you learn on the subject of the book in a separate notebook. Then yearly revise your book from the notes.
HAVING YOUR BOOK PUBLISHED
Major book publishers are reluctant to accept a book about an innovation. For example, my book on Laser Treatment of Eye Floaters was rejected by a major book company because “there was lack of interest in the subject.” They had sent the text to their “experts” who had probably never heard of such a treatment. Of course there would be lack of interest in a subject unknown to experts. Another problem is a book company will keep about 94 percent of the sale price of the book and give the author about 6 per cent. After all, the book company has to accept it, get it a Library of Congress number, print it, market it, sell it, ship it, and do the bookkeeping.
Another very significant problem is the publisher may not market your book well, and if it sells poorly, they may decide to discontinue the book, meaning your innovation may remain unknown.
Therefore, if you have written the whole book yourself and it is an innovation, it is probably better not to place it with a major book publisher. However, if you have written only a chapter in a broader book written by others, placing it with a major book publisher may be the only choice.
STARTING YOUR PUBLISHING COMPANY
Your publishing company will be assigned the copyright of your book and it would be in charge of printing, marketing, selling, dispersements, and bookkeeping.
The main advantage of self-publishing is you keep all profits (about 90%) while 10% is spent on printing and shipping of the books.
Another advantage is you have no problem having the book accepted for publishing by your own company.
And the most important advantage is you can continue the printing and selling of the book even if it makes no profit.
Let's take the tasks in starting your book publishing company in the order they arise:
- Choose a name. To give mine a legitimate sound, I chose Washington Medical Publishing, LLC. Then go to the internet and see if that name exists as a book publisher. It did not, but I called Washington University Medical School in St. Louis to be sure they did not use that name for publishing purposes.
Establish a checking account at a local bank for Washington Medical Publishing, LLC separate from your medical practice account.
- For sales tax purposes you need to register on-line your company with your State Corporation Commission (Virginia) and with your local tax authority (Falls Church). You will see there that you need to decide whether to be a Stock Corporation, a Limited Liability Company, Limited Partnership, Partnership, etc. I chose, mainly for simplicity, to be a Limited Liability Company (LLC). In my state the sales tax is collected monthly on line by the State only and the State forwards the local tax to Falls Church. In Virginia the taxes are paid by me on-line and the money is taken automatically from my Washington Medical Publishing, LLC checking account.
Contact the United States Copyright Office to receive a Library of Congress Control Number for your book. Fill out the forms and send them a copy of your book when requested. This number is placed on the Copyright page of your book.
- Obtain an International Standard Book Number for your book. That is obtained in the United States from R. R. Bowker, a private company. Their website is www.myidentifiers.com. The cost for one book is $125. This number is placed on the Copyright page of your book. If you like, also get a bar code from them.
- Have your book printed. There are thousands of book printers and their prices vary enormously. Mine varied for a hard color cover with 232 pages and four pages of color illustrations with one insertion from $12.50 to $150 per book. I use Brandt Doubleday, 1515 E. Kimberly Road, Davenport, IA 52807. Phone 800-248-0888.
- Set up a Paypal account so that customers can buy your book securely on-line. This allows the customer to give their credit card information to your website order blank and their cost for the book will be transferred from their credit card to your publishing company's bank account.
- Place an order blank for the book on your website.
- Consider publisher's insurance. The premium of these policies is paid yearly. Rarely the policies are for life if the book is unchanged, except for purely cosmetic changes. I used the Argo Insurance Group.
- Have the mailing service come to your office for pick-up, not you go to their office. We use UPS since they deliver world-wide. The U.S. Postal Service contracts out foreign shipping.
- If you include postage in the price, set it so you make a profit even if the order is from rural Japan (about $150 in shipping). Most books cost $14 to be delivered within the U.S. We charge the same price for each book regardless of its destination.
- Another way to charge for postage is to include postage domestically and not include it internationally. When an international order arrives, you calculate the cost of postage on UPS's website and e-mail that to the customer. If they then buy the book, you again have the postage before shipping.
I have sold 362 of my books to eye surgeons without advertising except this website.
DEVELOPING A WEBSITE
A website can be essential to draw attention to an innovation, to sell it, or to attract patients to the doctor using the innovation. My website, www.EyeFloaters.com converted my local practice in Falls Church to one with patients coming from every state and 35 foreign countries.
The first step is choosing a domain name. I chose EyeFloaters. Go to www.NameSecure.com or a similar organization. Click on Domain Names and type in the blank your desired domain name. They will immediately tell you if that domain name is available and will tell you what extensions are taken or available. For example “.com” may be taken, “.edu” is not allowed unless you are with an educational institution, but “.net” you find is available. If you find a domain name you like, it can be yours for a year for $14.95 and for every year thereafter as long as you pay the fee.
Normally for a website you would write the text and supply any pictures, but a webmaster would organize it, probably supply any artwork, and connect it to the internet for a housing fee. The webmaster will work on the website for an hourly fee. A website is usually being enlarged or improved almost monthly.