12 Bringing Novel Spine Devices to the Marketplace Abstract Unsatisfactory surgical outcomes and frustration with available techniques and instrumentation often lead surgeons to develop novel improvements and solutions. The surgeon then faces a difficult decision regarding what to do with that solution. In addition to the typical intellectual property, production, and distribution concerns associated with any new product, there are unique regulatory, marketing, and reimbursement issues that must be considered when developing novel medical technology. This chapter discusses points to consider throughout the entire product realization process. Crucial first steps require introspection on the part of the surgeon, who must gauge his level of interest in becoming an entrepreneur. An entrepreneur must be willing to make a significant investment in time and money for the project to be successful. An alternative is to partner with an existing commercial concern to develop the product. The surgeon must also have some basis for believing the technology can be shown to provide value. This includes an evaluation of cost/benefit from the market’s perspective, without bias due to the developer’s personal beliefs and preferences. Additional topics covered in this chapter include determining ownership of the technology, creating and protecting intellectual property, sources of capital, design and development including quality management, regulatory considerations, manufacturing options, and distribution. While the topics are treated discretely, it must be remembered these factors are interrelated. A single change in the user requirements can have a ripple effect that spreads through all facets of the development program. Keywords: entrepreneur, commercialization, medical device, product development, medical technology, product realization The invention and development of novel medical devices has been a critical component in the improvement of surgical techniques and patient outcomes for as long as surgery has been performed on humans. The role of the surgeon/inventor in that advancement cannot be understated. It was true in the early days of spine surgery and even more so today, especially given the complexity of minimally invasive spine (MIS) procedures, devices, and implants. Some surgeons have been content to scratch out an initial concept on a napkin and rely on a company to do the development. Others have taken on the complete project, from designing the initial concept to patents, prototyping, U.S. Food and Drug Administration (FDA) approval, starting companies, sales and marketing, and everything in between. If you have developed products and commercialized products, this brief chapter is probably not going to be of significant value. It is geared more toward novice inventors. No matter how you decide to approach getting your concept to market, there are critical steps you will need to take to protect your idea, maximize its patient benefit, and ensure your financial rewards are commensurate with the amount of time and money you spend. Bringing a novel device or implant to market can be a complex, expensive, and daunting task even for the most business savvy surgeon. Depending on the device and how it is approached, the process can be fairly straightforward or very complicated and expensive. Making the right decisions early can insure the process goes smoothly. For our purposes, we are going to focus generally on products that can be brought to market via the FDA 510(k) process, which allows for clearance of devices equivalent to previously marketed devices. Any other processes, such as a PMA (Pre-Market Approval) and IDE (Investigational Device Exemption), require time-consuming and expensive clinical studies, and in many instances can be difficult for an individual surgeon to manage. Our goal in this chapter is to give you a broad overview, advice, and tools you can use to avoid making costly mistakes. It is not meant to be an exhaustive step-by-step manual. We plan to discuss some of the critical topics that should help you decide the best approach to navigate the complexities of product development. Probably the best advice for any surgeon thinking about turning their device concept into a commercial product is to “know thy self.” Bringing a device to market requires hundreds of hours, multiple layers of experienced people, and usually lots of money. Honestly addressing some basic questions will help determine if you want to go it alone, hire someone and start a company, or work with an established corporation. Are you risk averse? How much time and money do you really have to devote to the project? Do you have practical experience and expertise on the business/engineering side? What is your motivation? A good analogy is your overall approach to the practice of spine surgery. Are you most interested in being a medical center employee so you can concentrate more on patient care and surgery, or do you feel the need to strike out on your own and open a surgery center? The decision on the best way to bring your product to market really comes down to who you are. One of the first things to think about is exactly how your product idea improves a procedure and ultimately patient outcomes. Determining how a device or implant will improve patient outcomes has always been the most important factor in bringing a new product to market. It is always the best place to start and should be primary in your thinking. If, for example, you come up with a surgical instrument that makes a particular procedure easier and faster for you and your colleagues, then you have indirectly improved patient outcomes even though you may not be able to immediately quantify it. The same holds true for novel implants. Once you have determined that your idea has the potential to improve patient outcomes, the next step is to investigate whether or not there is a market for your device. This process is sometimes called determining your value proposition and it is the collection of reasons why a customer would buy your device. Does it fill an unmet need? Are there enough potential procedures or usage to make it financially worthwhile to spend the time and money bringing the device to market? Is there a reimbursement code for the procedure and device? Who is going to pay for it? Can the product be manufactured and delivered to the end user at a competitive price? How do you protect your position? Surgical instruments, such as a new MIS retractor, are usually capital expenditures paid by hospitals or brought in by implant companies if they are proprietary and part of their implant system. Most hospitals do not buy implant sets currently, so this needs to be taken into consideration during the planning and budgeting phase of the project. There are also legal considerations depending on if you are working alone in private practice or in a group, hospital employed, or work for a university. Make sure you fully understand your employment contracts since a partner or institution may have claims to your invention. One other important question to consider is the financial outcome you want to achieve. Do you want to build a company around your invention or sell it off at the appropriate time? If it is a new implant, a brief investigation into reimbursement codes is fairly easy. The best source for both Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS), which codes for products, is www.cms.gov. Most companies also offer coding advice or services for their products. The days of having the next generation of implant and expecting to be paid a premium are over. Even truly novel devices and implants need to show a proven cost/benefit to avoid commodity pricing, so this is an important consideration. Finally, investigate the patent landscape to see if your device is truly unique and what barriers there may be to actually designing it and getting it made. It is critical that you take all the necessary steps to protect your novel idea, and the best place to start is to document everything. When you start thinking about a new device and write down anything, date and sign it, even though it will probably evolve as you start to think about it in more detail. The obvious reason is to file your patent application at the earliest date possible and document when you first thought of the idea. The best source for patent and trademark information is actually our government, and it is available online at no charge. The U.S. Patent and Trademark Office (USPTO) website (www.uspto.gov) is easy to use and provides all the basics and the ability to search other patents. Searching patents for products in the same category as your invention will probably turn up a lot of devices that seem similar, but do not get discouraged too quickly. The devil is in the details and patents need to be interpreted very carefully. Even though your idea may be truly novel and unique, you will certainly find devices that have similar characteristics. You will learn a lot and it is less expensive to do the initial searches yourself. Ultimately, you will need a good patent attorney who will help you protect your business and insure the freedom to practice. However, be aware that a patent is only as good as your willingness and resources available to defend it. Choosing the right patent attorney is critical, and you should ask for recommendations from medical professionals in the business. Your patent attorney should be very familiar with devices such as yours, which will reduce the learning curve and save you time and money. There are different types of patents and you can find the details on the USPTO website. However, in most cases, for first-time inventors, you will be considering either a provisional patent or a nonprovisional patent, usually a utility patent. The benefit of filing a provisional patent is to establish the first inventor to file. Provisional patents are only good for 1 year and then a nonprovisional patent needs to be filed or it expires without being published. The other benefits are that the provisional patent will not be examined by the USPTO, and you do not need to disclose any prior art or make claims. Provisional patents are especially beneficial when you do not have all the details of your invention worked out but are far enough along that you want some protection and an early filing date. They are also much less expensive to file and you can even do it yourself. You will also need to decide if you want to file only in the United States or in other countries, which can get expensive. If there is going to be a large market for your invention, you should consider at the very least filing in the major European Union countries and critical countries in Asia and South America. If you already have a design, it is important to have a Freedom to Practice Opinion. This is a legal opinion prepared by your patent attorney that provides a well-reasoned determination as to whether your device infringes any other patents. It is no guarantee that you will not be sued, but offers some protection if you are ( Before revealing your proprietary information to anyone, whether you have an issued or pending patent, always have them sign a nondisclosure agreement (NDA). They are fairly standard and most have basically the same language. However, we have seen some that are one-sided and leave too much wiggle room on important issues. Make sure you have an attorney review before signing or disclosing anything. If possible, have the recipient of your information sign your NDA or obtain an attorney review before signing theirs. It is important to manage your expectations. Commercial concerns are in business to make money and no one is going to highly compensate you for a “concept on a napkin,” no matter how good it is. They will, however, generously compensate for a well thought out, novel, and patented or pending product idea that they can sell, or better yet is already generating revenue. If you have decided that you just do not have the time, money, or inclination to take the product from concept to the market, partnering with an established company is a good option. Your choices range from multibillion dollar international firms to local start-ups.
12.1 Introduction
12.2 First Steps
12.2.1 Value Proposition
12.2.2 Legalities
12.2.3 Patents
Fig. 12.1).
12.3 Partnering, Going It Alone, and Funding Your Device
12.3.1 Partnering
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