Nurses can turn their ideas into life-saving health care inventions
Introduction - The Importance of Nursing Innovation
by Sandy Summers, Executive Director, The Truth About Nursing
"Launching Your Idea, Balancing Pain and Gain,"
by Steve Schmutzer, Co-Founder, Firefly Medical Inc.
Introduction - The Importance of Nursing Innovation
By Sandy Summers, executive director, The Truth About Nursing
Nurse and inventor Steve Schmutzer called me a couple months ago and told me about his invention, the IVEA -- an IV pole / rolling walker / cart to hold the patient's equipment. So I checked out a video of it online. I was just thrilled that a nurse had created this kind of equipment to improve nursing work and patient care. Many nurses have great ideas about new technology or practices that would make health care easier, safer, quicker, or better. A recent program of the American Association of Critical Care Nurses has encouraged teams of nurses across the U.S. to develop clinical initiatives within existing structures that have shown great promise in improving care and saving money. But seldom do nurses have access to what they need to turn their ideas into entirely new products to deliver better health care.
It shouldn't be that way. Too much of the health care environment is designed by people other than those who actually take care of patients. Nurses are the ones who work on the front lines to bring patients back to good health, and we think a lot about the best ways to do that. So the health care industry is missing a lot by not having more of our ideas for new technology put into action. That is why I was excited to learn how Steve had managed to design (with others, including many nurses), patent, finance, build, and produce a piece of equipment that seems so promising.
I asked Steve to tell us the steps he took in creating the IVEA so other nurses could get ideas on how they might make it happen for their ideas. Neither I nor the Truth About Nursing have received anything of value for our comments about the IVEA or Steve; we are not endorsing the product. We are simply presenting Steve's story to help other nurses consider how they might move their ideas forward and improve patient care.
Below is Steve's description of his path from idea to marketplace. We hope it helps you. And we're looking forward to your inventions!
Launching Your Idea, Balancing Pain and Gain
By Steve Schmutzer, Co-Founder, Firefly Medical Inc.
So, you've got a great idea for a business. You've thought of a product, something you feel people need but don't have. How do you know? What are you supposed to do? Can you develop it and get it to market? My hope is that this article helps answer those questions and others like them.
Raising a successful startup is as much an art as it is a science, so it's not reasonable to seek out prescriptive approaches. If it were simply plug and play, everyone would jump in and be successful. Most entrepreneurs I know had to venture uncomfortably far from traditional bounds and conventional advice in order to achieve success.
But if you're a nurse, I believe you have an advantage.
You see, I'm an entrepreneur, and I'm also a nurse. I practiced nursing for 12 years in the ICU, telemetry, orthopedics, long-term care, and ER. I even had a brief stint flying with a helicopter team as a flight nurse, before I learned that I like helicopters even less than I like planes.
As a nurse, I endured long hours on night shifts, fighting to stay awake as patients tried to get some sleep. I maintained professional poise despite the stench of upper GI bleeds. I led a team of nurses to overcome incredible odds. I changed six lives in twelve hours, drew ABG's with right and left hands, showed a resident how to put in an IV, comforted a frightened patient at death's door, and ate a sandwich moments after a messy Code Blue. Many times I felt overworked and underpaid.
As an entrepreneur, I've endured long financial droughts, fighting to stay in the game as others were trying to get out. I've maintained professional poise as investors doubted everything that was not in the rear view mirror. I've led a team of employees to accomplish incredible goals. I've changed an Executive Summary six times in twelve months, drawn up contingency plans for multiple go-to-market strategies, shown an MBA graduate how to develop a budget, counseled a nervous businessman on the verge of bankruptcy, and eaten my words moments after a messy mistake. Many times I've felt overworked and underpaid.
Nursing and entrepreneurship both require leadership, tenacity, patience, and superior multitasking and communication skills. If you can't quickly prioritize and make decisions, it can get really bad really fast. Nurses and entrepreneurs both must understand that it's more important to be respected than liked. They know they must effectively collaborate with others and bravely face steep learning curves. It's a tall order for both, but having endured the challenges of both professions, I'm convinced the professional nursing population is fertile ground for new ideas, new leaders, and new startups.
In fact, my life as a nurse and entrepreneur led me to develop the IVEA, a new product to replace the outdated IV pole. The IVEA holds all the patient's gear: IVs, oxygen, chest tubes, foley, and the like. The IVEA is designed to be a safe mobility device that helps nurses ambulate patients more easily and helps patients to stand up, sit down, and move about more independently, thereby aiming to improve health, safety, handling, and efficiency.
I'd like to share a few thoughts with nurses who are thinking of developing a new product. As much as I consider advice a dangerous thing to give, The Truth About Nursing's executive director asked me to try, so other nurses could learn a little about how I did it and how they might make their innovative ideas a reality. Towards that end, I'll offer some suggestions for navigating the stages of this journey, followed by some general considerations to keep in mind throughout. Here we go . . .
Know what you want
Ask yourself a question before you get in too deep with your idea: "What do you really want from this?" Do you want to be a multimillionaire, drive an expensive sports car, be the envy of all your friends, and have vacation property in Monaco? Personally, I think goals like these are out of touch with reality.
Far more reasonable ambitions include making the lives of nurses and patients better with your innovation, improving the healthcare system, gaining a greater degree of independence, learning new skills, developing diverse revenue streams, and enjoying additional career opportunities. Any and all of these goals can be the outcome of a well-run startup.
And that's the key issue here. Your focus should be on raising a successful business. Size is no real concern; plenty of excellent businesses have annual revenues of less than $150K. But when your venture conforms to the conventional measures of a business--overhead, cost of goods, profit margins, revenue growth, market share, and dull-sounding things like that--you can attract attention and really expand your options.
You should also ask yourself whether you want to sell your product to a larger company. Do you want to license it and get royalties? Do you want to set up your own manufacturing, build your own sales force, and displace an established competitor? Frankly, there isn't a right or wrong answer here, although in today's business climate, it's wise to acknowledge Murphy's Law. The broader your goals, the more challenges you will experience. Be honest with yourself about your capacities.
Crawl before you walk, and walk before you run. If you do that well in your startup, you will have the luxury of various options. You can then make the right decision for yourself at the right time. Otherwise, obsession with a particular outcome before there is demonstration of commercial viability is both premature and foolish.
"Never miss a good chance to shut up."
This is a great quote from Will Rogers, and I use it here to reinforce the importance of confidentiality. Too many people mean well in freely talking about their idea with others, but this habit can bury a good idea before it's even born. Speaking in general terms here, patent law--which gives inventors certain rights to benefit from their work--has changed. It used to be that if one could prove they had an idea first, then the weight of the law was on their side. Not anymore. Now the emphasis may be given to whoever filed the patent first. You might be tempted to run your idea by others, but except as I explain below, it's best to keep your thoughts to yourself and preserve your opportunity.
Speak up the right way
A good patent attorney will help you determine if you've disclosed your idea prematurely before he or she files your patents. If you have, you may have undermined the integrity of your intellectual property. Someone might show up later and claim your patent is faulty because you made your idea public knowledge before you filed. You don't need those risks.
Of course, you may need to discuss your idea with people who can help you. But whenever you talk to someone about your idea, first get their name, signature, and date on a standard Non-Disclosure Agreement, also called a Confidentiality Agreement. While generic templates of these forms are common, a better course is to have your patent attorney draft one that's specific to your product and suitable for the laws of the state in which you live.
Get legal representation
I'll admit I'm not a big fan of trying to do everything yourself. I've done that, and I think it's too easy to blur lines and round corners. While just about everything you need to tackle the basics of a startup can be found online, you'll have to be incredibly diligent—and available!—to anticipate the myriad details that may come back to haunt you. In my world, peace of mind is priceless. Few things give me more peace than knowing something was done right the first time.
You'll need two types of legal representation to raise a product-oriented startup: patent counsel and corporate counsel. Patent counsel will help you figure out if you have an idea that can be patented. They'll also guide you through the intellectual property strategy best-suited to protect your idea and give it maximum opportunity. Corporate counsel will help you form and operate a legal entity within which you can responsibly raise investments, build a business, and address taxation matters.
There is one last comment about legal counsel I need to make here: Manage your attorneys. Don't let them manage you. Attorneys fixate on problems. As there's no end to potential problems, this can easily translate to no end of legal bills! Use common sense and professional assertiveness to keep your plan focused and your attorneys productive.
Make a prototype
You should move your idea beyond a verbal concept or drawing as soon as possible. Having your product in tangible form will yield the most returns for you. The best way to do this is to make a prototype.
Remember, "prototype" is a verb as much as it's a noun; it's a process as well as a product. Start with whatever form of your product you can manage and work your way to more advanced versions as resources permit. My product, the IVEA, began as a cardboard cutout, evolved to a crude wooden item, and then graduated to one made of aluminum tubes and fittings. Eventually, it morphed into a sleek preproduction unit, with machined parts, polymer components, and state-of-the-art hardware. The final prototype was virtually indistinguishable from the commercial version, and we were able to test it with patients. We went through a total of eight IVEA prototypes before we felt we'd learned enough to proceed with commercial manufacturing.
Now, it took a lot of money to get through this whole process, and that's part of the reason prototypes are important. If you need to raise money to fund your idea, investors will understand something they can touch and see more than something they are simply told about. Depending on the idea, the cost for a prototype can range from a few bucks to thousands of dollars. The IVEA became progressively more expensive to prototype, because we had more to prove with each phase. The stakes were higher. But with further refinements and additional industry knowledge, the bigger dollars also came in.
Tell your story
Unless you have a large reservoir of personal funds to tap, chances are you'll need to raise some money. When it comes to getting investments, the clichéd advice is to stick to the basic facts because that's all "sophisticated investors" want to hear. The notion is that numbers and bullet points communicate the essential message.
I have a problem with this. Based on my own experience and that of other entrepreneurs I know, this approach is counterproductive. First, "sophisticated investor" might be one of the great oxymorons, since these investors tend to invest after the bulk of risk and hard work is eliminated and there's relatively little left to prove. Second, most investors I know have a safety-in-numbers mentality. They would rather leap over a cliff with the lemmings than stand alone. Call this what you will, but "sophisticated" seems a stretch.
I've had my best luck raising funds when I told my story with the detail and human elements needed to convey my passion for the product. And the investors who backed me the most were the ones who connected with that story. Of course, I did not bury them in unnecessary detail or anecdotes; they filled in whatever gaps or questions that remained with their own experience and sense of vision. It's natural to want to be part of something exciting, and the right investors will get a kick out of this as much as any potential for return.
On the other hand, sticking to basics may be the right approach when it comes to financial projections. Investors who pressure you to deliver sales forecasts for five years and then grill you mercilessly on the hows and whys of your second quarter projections in the fifth year are a waste of your time. The right kind of investors know it's unreasonable to try to peer beyond the reach of the headlights with any certainty.
You may think your idea is the best thing since sliced bread, but some people prefer their bread unsliced. It's important to find out whether others perceive your concept as you do, and if they don't, then why not? The best way to evaluate your idea is to get your prototype in front of its end users and ask them to critique it. This is called a Voice of Customer exercise. Remember to use those Non-Disclosure Agreements!
Here are a few pointers about this informal but important feedback process. Take copious notes. Try to develop a thick skin. Listen. Let them speak their minds. Ask questions to clarify what's being said. Don't defend decisions you've already made. Show respect for all comments (no matter how ridiculous they may seem). Implement whatever reasonable suggestions this process has recommended for your product. Produce an updated prototype. Repeat. It's a cycle not unlike the nursing process.
You should replicate this process as many times as you can with various end users. When you're no longer hearing significant new suggestions (a gauge that amounts to a wet thumb in the wind) you can be reasonably sure your concept has been adequately vetted for this stage. For the IVEA, this was several years and several hundred thousand dollars later. Hopefully, it won't be like that for you!
Test your product with customers
This is a delicate matter because if your idea is for a medical product that is highly-regulated by the FDA (like a medication or an invasive device) you are in for a long and costly ordeal. If that's your situation, you will need much more advice than I can offer in this article. If however, your idea is a Class 1 device with a 510(k) exemption (like a simple cart or basin), or if it has nothing to do with the medical market, testing your product with customers may be much easier.
The bottom line is you will gain valuable and unexpected insights on your product by having potential customers actually use it in a more formal testing program. If your product rids rings in a bathtub, then find some dirty people to test it. If you've invented the best adult diapers ever, then locate some leaky folks to try them out! You should make an effort to test a version of your product that is as close to the commercial one as you can achieve, and then do this again and again. If you need to change something about your product, this is the time to do it.
If you stay faithful to the steps above, you will give your idea the best possible chance for success. I don't believe any of these elements can be eliminated or compromised without adversely affecting your startup's opportunities.
All that said, there are other equally demanding general considerations to pay attention to as you raise your startup. These are ongoing personal disciplines that will be as important at the end of your journey as they are at the beginning. In truth, they are more a measure of one's character than checkboxes on a to-do list. Here they are:
Stay above reproach
It's easy to bend the rules. It's arduous to take the high road, especially if the masses seem to be OK with ethically dubious decisions. In the years I've been developing startups, I've seen many entrepreneurs succumb to the appeal of easier paths. Such decisions often mean regrets down the road.
There's a fine line between having integrity and being "above reproach." I believe the latter is the more responsible of the two. Here's a personal example: Early in the IVEA's development, I hit a wall. I'd proven what I could with the funds we had, but the distance between the prototype then and the version I needed was great. Surrounded by high-net-worth people who were happy to cheer me on from the sidelines, I ran out of options.
I was advised to do a "down round." The idea was to offer a fixed number of shares in my company for less than the prior share price. I was told, "It's a deal! Folks will jump in." It was legal, and as such, it had integrity—down rounds are not uncommon. Yet, I was troubled. It didn't seem right to sell new shares to new investors for less than earlier shares had been sold to folks who had accepted a higher risk.
I decided instead to sell some of my own stock at a low price and reinvest the money into the company. It wasn't long before I'd funded the new prototype. My decision burdened me with significant personal taxes, and I didn't get paid while others did. I also owned less of my company than before. In the long run, though, it was a turning point for my startup. It was the right decision, and it was above reproach.
Recognize stupid and stay away from it
The path from product concept to commercial triumph is inherently fraught with obstacles. To be honest, the odds are against success. So, don't make it harder. Disentangle yourself from any person, situation, or decision that introduces unnecessary challenges. Your time and resources are valuable; they need to be allocated wisely.
I remember a time I was asked to present my startup to a large regional event comprised of so-called "angel investors." The application form was five pages of densely-packed questions. The instructions to me were to provide clear and comprehensive answers to all of the questions in " . . . .three pages or less." It simply wasn't possible to do that, and as such, it was stupid!
I pointed out to the event organizers that this approach was myopic. They seemed aghast that I would challenge them and elected to leave the process as it was. I chose not to participate; my time and energy were too valuable, and I didn't need to waste either by chasing specters. I learned a few months later that this group of investors had dissolved without funding any startups.
Follow the law
Perhaps this point seems obvious; nobody wants to be a law-breaker. But I include it to call attention to the many opportunities to get away with things you think nobody will notice.
A great example here concerns accredited investors. You should raise funds only from these folks. The SEC can get nasty if you opt to take funds from your friendly next-door neighbor, just because you've known and liked each other for years. You may have plenty of people who want to help fund your idea, but if they are non-accredited by SEC standards, then resist the temptation to take their money.
Yes, "practice" it! Do it over and over. You might be born with natural athletic talent, but nobody is born with a talent in perseverance. Perseverance is learned.
The ability to put one foot in front of the other when conventional wisdom declares the journey to be fruitless is a vital measure of one's capacity to succeed. The best ideas, without perseverance, generally fail. Conversely, average ideas plus incredible perseverance often yield great returns.
Starters are a dime a dozen, but finishers are rare. There is nothing appealing about hard work, about pain and trials, or about getting up each time you fall down. But it's these things that bring results. Perseverance is the key to realizing a dream.
Well, I've said a mouthful. But to be honest, I've only scratched the surface. Let me wrap things up by encouraging you in this entrepreneurial process, wherever you find yourself in it. Developing a new product and bringing it to market isn't easy, but nothing good and worthwhile ever is! It's wise to hope for the best and plan for the worst.
If you keep this realistic perspective, you'll preserve your emotional strength and your positive attitude. Both are essential for the journey you may already be on, or the one that may still be in front of you. Travel safe!
Steve Schmutzer is the Co-Founder and Director of Clinical Programs for Colorado-based Firefly Medical Inc., makers of the award-winning IVEA. Visit their website at www.iveamobility.com or call 970-472-5323 to learn more about the IVEA.
None of the views expressed above constitutes legal advice or any other type of professional advice.
Copyright © 2015 Steve Schmutzer. All Rights Reserved.
The views expressed herein do not necessarily reflect those of the Board Members or Advisory Panel of The Truth About Nursing.