Spinal Surgery, Cement Systems - Orthoworld

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SURGEON AS ENTREPRENEUR A Roadmap to Success for Surgeon Inventors, Part 3: Technologies for Development of Your Ideas Author: John Kapitan Traditionally, as a surgeon inventor, you may have waited for one of the large implant companies to recognize the value of your new product idea. Then the game began by negotiating timelines, team structure and ultimately, your royalty agreement. While this process has been rewarding for some, it has proven to be disappointing for others. Is there a better way? What would it look like to maintain control of your design, timeline and budgets while hitting milestones and advancing your idea? And what if you could do this while creating intellectual property along the way to build exponential value? There is a different paradigm to consider, and that is to do it yourself with the help of an independent engineering partner. In most cases you would not consider taking an idea all the way to the market yourself, of course (especially for product ideas that will eventually require costly and time consuming clinical studies), but taking it from a concept to prototype is well within the realm of possibility on a limited budget and compressed time schedule. There is of late a strong interest in avoiding the type of government and media scrutiny on industry/surgeon relationships that is rampant today. Although industry/surgeon collaboration has proven to be, and will remain, a fundamental piece of new product innovation fueling the advancement of patient care, that fact doesn’t seem to satisfy those who are bent on keeping it front page news. Considering this current climate on industry/surgeon relationships, I have noticed that surgeon inventors increasingly find that carrying their new product ideas further on their own is proving beneficial if for nothing else than it distances them from the companies whose products they are using in the OR. As the logic goes, selective industry collaboration means minimal government meddling, which means that your friends and neighbors won’t be reading about you over their morning coffee. This is an oversimplification, of course, but nonetheless the message is clear – hold on to your ideas and create as much value as you can before you begin shopping it around. It will pay off in multiple ways. How can you produce a prototype of your idea quickly given the many constraints on your time? And, just as importantly, how can this be done cost effectively, especially with lots of iterations in mind? Rapid prototyping helps to address these issues. Additive Rapid Prototyping During the course of product development few things are as exciting as when rapid design-build cycles allow a surgeon inventor and his design team to see iterations of physical prototypes real-time. Team members (especially inventors!) love to hold a prototype in their hands. Perhaps it is the tangible evidence of all of the late nights spent thinking about, shaping and reshaping a spark of an idea. With state of the art computer processing power, software modeling capabilities and rapid prototyping technology, engineers can turn a sketch into a plastic or even metal prototype model in a couple of days or less. Multiple iterations are easily produced. This gives unprecedented speed and insight into the nuances of a design and allows you, the owner of the idea, to make decisions quickly based on what you see. Recent advances, especially in the rapid metal prototyping arena, have allowed engineers to start building surgical instruments and even implants using this technology with remarkable speed and flexibility. This opens up a whole new realm of possibilities for the inventor because previously hard to manufacture designs from the standpoint of traditional machining may now be possible (and in a fraction of the time it would normally take). In addition, what was once relegated to making simple “show and tell” prototypes is beginning to gain more widespread acceptance for real parts. What is additive rapid prototyping? How does it differ from traditional machining? Growing Parts At the core, you can think of additive rapid prototyping as a way to “grow” a prototype rather than cut it away from stock material as is the case for subtractive processes like machining. Why the focus? Why does this matter? There are four distinct benefits of additive rapid prototyping. 1. Speed – Your prototypes can be made in days rather than weeks or months. Rapid changes can be made quickly so that the design team can visualize the idea. Other team members, including patent attorneys, supplier partners and marketing and sales professionals may also benefit. This is one way to jumpstart the marketing process early in the development cycle before you sink a lot of money into production and testing. 2. Complexity –Designs can be made using additive prototyping that simply cannot be made with traditional machining. continued on page 13 12 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
SURGEON AS ENTREPRENEUR continued from page 12 As an example, note the porous structure in Exhibit 1. This part would be very difficult, if not impossible, to make with conventional means. Additive prototyping really shines where there are complex internal cavities and features or freeform shapes. In the words of one industry professional, you can get “complexity for free” due to the fact that there are no additional expenses incurred for very complex geometry. Exhibit 1 - Porous lattice structure made with additive manufacturing. 3. Cost – Because there is no expensive tooling or fixtures involved, startup costs are minimized with additive processes. Overall cost varies with the type of process and materials used, but generally I have found a cost improvement over conventional manufacturing due to the minimization of nonrecurring startup expenses. For example, many plastic models can be made for $200 or less. Added to that is the benefit of producing a series of parts all at the same time in the same build. 4. Customization – Parts can be made to match a specific patient’s anatomy if desired. These parts may be produced quickly and cost effectively, at least when compared to traditional machining technology. Or customization could mean producing variations of parts on the fly, as needed. Additive rapid prototyping is not a cure-all for your development pains. It will not be applicable for all projects and as a whole is not always a better way to go than subtractive processes like machining. Instead, think of additive rapid prototyping as a suite of complementary processes in the arsenal of development tools at your disposal. Weighing the Options One of the first questions your team should ask when considering this option should be, “For what will my prototype be used?” While some parts are useful for concept visualization only, others can be used for mechanical testing while some may be used for a cadaver training session or during live surgery. The range of possibilities is quite large. Your application will in part drive the type of technology employed to make your part. Other key considerations are budget and lead time requirements. Rapid prototyping in plastic has been around for some time, dating back to the 1980s. At last count, there were over seven different core technologies for producing rapid plastic parts and dozens of material choices for several of these methods. In general, the size of a part made from plastic prototyping is no larger than ten to 20” per dimension. Parts can be made in color to help demonstrate a concept. More recently, additive metal rapid prototyping has garnered significant focus for its ability to offer a very good material property match to “real” orthopaedic materials like stainless steel, cobalt chrome and titanium alloys. Although the field is relatively new and a limited number of materials are available, new materials are coming out regularly and the knowledge base is growing. Two key areas of interest with metal revolve around the ability to create complex porous structures, both integrated porous coated implants and fully porous structures. By creating the porous coating at the time of part build, typical problems seen with existing porous coating technology are eliminated. Design boundaries are expanded at the same time. Considering the part shown in Exhibit 1 above, what other types of porous lattice structures could one create in the pursuit of the optimal implant design? According to one publication, “In the medical area, lattices can replace material in implants. The resulting structures cost less as well as help facilitate bone in-growth. In general, lattice structures can reduce weight, transfer heat, absorb impact, dampen vibration and be engineered to a specific stiffness.” 1 Direct Metal Laser Sintering (DMLS) The idea of using additive processes is intriguing and the benefits are certainly compelling. But you’re not sure where to start. With so many choices in the additive rapid prototyping field, which one will best fit your needs? A comprehensive review of the entire field is outside of the scope of this article. Thankfully, the engineering partner you choose for your team should be able to help you select the right technology for a given purpose. Shop around and ask about their experience and knowledge of the area. For sake of brevity, let’s focus on one particular technology which is making significant strides in the medical device industry. One of the more promising additive metal prototyping technologies out today is called Direct Metal Laser Sintering. The process is just as it sounds – metal powder is melted together into a specific shape using a laser. Using this process, designers can achieve direct production of functional metal parts by utilizing a laser to sinter very fine layers of metal powder layer-bylayer from the bottom up. This produces 100 percent dense parts that exhibit material properties as good as, and in some cases better than, traditional machined parts. Examples of medical continued on page 14 1. Machine Design, “New from the Fab Labs: Lightweight but Superstrong Parts,” Aug 2008. September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 13
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