The PuzzleCast 1 Erin McCafferty, Hillary Herstin, Smita Gupta Section 2 EIS Mini Project October 8, 2012 1 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf Executive Summary The PuzzleCast is a prospective innovation that hopes to improve upon the traditional fiberglass cast. The main value proposition of the product is the reduced effect of atrophy and thus the reduced recovery time and cost of care. Many players across the ecosystem derive value from the PuzzleCast, but concerns of the manufacturer and doctors need to be addressed before the product can be successfully deployed in market. With the adoption challenge in mind, we examined the benefits of being a first mover and the potential to create additional value for the manufacturer and doctors through the possibility of a higher insurance payment for the PuzzleCast and the possibility of targeting elite athletes to create premium price and demand for the product. Innovation Overview The PuzzleCast is a modular plastic cast invented by four biomedical engineering students at the University of Virginia. When assigned the task of identifying and solving a biomedical problem for one of their courses, the team found inspiration in their personal histories of multiple broken limbs. They studied the current treatment of broken bones and realized that the muscle atrophy associated with immobilization was a costly outcome upon which they could improve.2 Although still in the initial patenting stage, the PuzzleCast represents a promising advancement over traditional treatment for broken limbs. bvTraditional Fiberglass Cast (L) versus PuzzleCast Prototype(R) Today when someone breaks a limb, they are fitted with a plaster or fiberglass cast that immobilizes the site of the injury for a period of 6-12 weeks (depending on the type of injury) to allow for the bone to heal. The first three weeks are the most critical to make sure adequate alignment is maintained. During this time, patients are seen weekly. Following the initial three weeks after the injury, doctors will see patients every 3-4 weeks. On average people are in 2-3 casts per injury, but the entire area remains immobilized.3 A common side effect of this immobilization is that the otherwise healthy muscles and joints surrounding the injury atrophy from lack of use. An additional 8-12 months of physical therapy is 2 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf 3 Interview with Dr. Melissa Christino, resident in Orthopedics, Brown University, October 3, 2012. thus required for the patient to regain muscle mass and range of motion, more than tripling recovery time and putting the patient at risk for re-injury. 4 The PuzzleCast team’s research revealed that only 2-3 weeks are required for a broken bone to regenerate a stable structure, and therefore the entire injured area does not need be immobile for the full healing process. The team thus sought a way to progressively free up areas of the injured limb to allow the patient to gradually regain range of motion, increasing blood flow and reducing muscle atrophy, while keeping the injured area immobilized and protected.5 The result of their efforts was the PuzzleCast, a modular arm cast made of interlocking thermoplastic components that are shaped to the patient’s arm and held in place with rivets. In subsequent office visits, the treating physician can remove the rivets and associated pieces, like a puzzle, as the injured area heals. Initial testing showed that the PuzzleCast “can successfully immobilize a forearm as well as a traditional fiberglass cast, and can open up individual degrees of freedom while keeping others constrained.”6 The time to apply the cast is the same as for a standard cast and the costs are comparable to a fiberglass cast.7 The PuzzleCast’s main value proposition is the reduced effects of atrophy and thus the reduced cost of care. The main saving is in physical therapy, which may be reduced by as much as half, resulting in saved time and money for the injured patient. With the average American facing at least two immobilizations in their lifetime8 and 6.8 million Americans incurring immobilization-induced muscle atrophy each year9, the addressable market for an innovation that reduces the need for physical therapy following immobilization is significant. In 2011 the team won a $10,000 grant from the National Collegiate Inventors and Innovators Alliance and in 2012 was one of ten 2012 PopSci Invention Awards. The team has filed for a provisional patent and is working with the University of Virginia Patent Foundation to identify companies to whom they can license the technology. The licensee would need to perform clinical trials, develop additional sizes and a cast for the legs; ideally, the PuzzleCast could be brought to market in three years.10 4 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf 5 PuzzleCast, University of Virginia 2010. NCIIA (National Collegiate Inventors and Innovators Alliance). www.nciia.org 6 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf 7 Delesline III, Nate. “Puzzlecast breaks the mold.” The Richmond Times Dispatch. July 2, 2012. 8 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf 9 PuzzleCast, University of Virginia 2010. NCIIA (National Collegiate Inventors and Innovators Alliance). www.nciia.org 10 Fang, Janet. “PuzzleCast: speed up healing by removing modular cast piece by piece.” www.smartplanet.com. June 12, 2012. Understanding the PuzzleCast Ecosystem The innovators of the PuzzleCast need to examine their entire ecosystem in order to understand: Who are key players? Where does the value lie? Which players need to be incentivized to use the PuzzleCast? Exhibit 1: PuzzleCast Ecosystem Map Between the patent owners of the innovation (the innovators themselves) and the end patient, there are a variety of players. The value proposition of each participant must be considered, including the level of co-innovation and adoption risk that must be overcome for each party to come on board. For each of the players in the value map ecosystem that are not a clear green, the innovators need to understand the cause of the problem and identify possible solutions (see Exhibit 1: Puzzle Case Ecosystem Map). In examining the ecosystem into which the PuzzleCast will launch, the most important players are the doctors. The innovators of the PuzzleCast must get doctors to recommend the PuzzleCast during diagnosis. Additionally, if doctors will not adopt it, the manufacturer will see negative results from its efforts during clinical trials and will most likely never bring the product into the manufacturing process. If by chance they do start manufacturing it, once doctors choose not to purchase it, manufacturers will quickly stop and divert their resources elsewhere. In order to gain adoption by doctors, the PuzzleCast needs to offer a more advanced form of cast therapy that provides the doctors with a benefit – either decreased time or increased revenue. Furthermore, it has to be easy for these doctors and their technicians to learn how to create the cast and provide treatment. Value Creation of the PuzzleCast Patent Owners Value creation for patent owners is clearly positive (green light). These individuals hold a safeguard on the engineering specifications of the PuzzleCast and have the ability to license it to manufacturers. For a small investment in terms of money and time, these individuals will have the ability to make a royalty from their product, contingent on adoption by the medical industry. Over time, if the cast receives widespread adoption, the innovators have the potential to receive an unlimited amount of revenue through royalties as the average American faces at least two immobilizations in their lifetime.11 A small monetary investment is required by the patent owners. According to the 2012 Invention Awards, the total cost to develop the puzzle cast was $10,300. Looking to the future, no significant investment will be required to license the product to a manufacturer. The manufacturer will then be responsible for creating the cast, running clinical trials, and marketing the product to doctors. Patent owners will only bear the costs of hiring a patent attorney to write and file the paperwork and possibly an accountant to collect and pay taxes on the royalties received once the cast is in production. Post-development, the additional time investment required by the patent owners is relatively low. The patent owners will need to spend time initially marketing the product to manufacturers. However, the patent owners then benefit via royalties from the time and investment put in by the manufacturers to get FDA approval, go to market, and sell to doctors. Innovation risks have already been overcome by the innovators and there is no adoption risk as the owners are eager to move their product to market – green light. Manufacturer The value proposition for the manufacturers exists, but requires some convincing from doctors through clinical trials (yellow light). The PuzzleCast does not pose co-innovation risk for manufacturers. Large medical device companies have the resources and technical know-how to undertake the development and selling of new products, such as the PuzzleCast. However, the cast does present some adoption risk for the manufacturers. The innovators need to address adoption risk by clearly articulating the benefits of the cast to the manufacturer, which will induce them to manufacture and sell the product. Although the innovators 11 Amante, Daniel; Kelly Anderson; Amanda Harton; Clara Tran (BME ’12). “PuzzleCast: Design Project Becomes Framework for Business Idea.” University of Virginia School of Engineering & Applied Science. Fall 2010 Newsletter. http://seas.virginia.edu/students/rodmans/newsletters/fall2010/page_7.pdf have a prototype, investment will be required from the manufacturer to develop a mainstream product in a variety of different sizes and versions. The manufacturer must also invest time and energy into performing clinical trials and gaining approval from the FDA. In order to take on this investment in time and resources, the innovators of the PuzzleCast need to provide some sort of profit motivation for the manufacturer – yellow light. FDA The FDA is not in a position to gain or lose anything from the invention and adoption of the PuzzleCast. Its role is to review the product and results from clinical trials and make a judgment on the safety of the product. The PuzzleCast will be reviewed in its normal course of business and will not entail any coinnovation or adoption risk for the FDA. The FDA will be an objective third party who will follow a standard set of criteria that cannot be altered or changed. Insurance Company The insurance company stands to benefit from the innovation of the PuzzleCast and requires no coinnovation and adoption risk (green light). In terms of co-innovation, no new payment method will need to be developed on behalf of the insurance company. Instead, funds will just be redirected between parties. During treatment for a traditional cast, insurance companies pay doctors a one-time fee for treatment. The same will be true for the PuzzleCast, thus no adoption risk will be present. Additionally, because post-treatment physical therapy visits are greatly reduced, insurance companies will pay the therapists a smaller sum or less frequently. This will allow them to reduce the overall costs of the treatment, while maintaining the same fees from their customers – green light. Doctors The value proposition for the doctor is of concern (yellow light). There are reasons why a doctor would be interested in this technology, but there are additional reasons that would limit the ease of adoption for this stakeholder. In terms of co-innovation, the doctor needs to ensure his or her technician knows how to create the PuzzleCast, and personally needs to learn how to properly remove the pieces of the cast and when to do so. The cast technician will be able to quickly learn how to make the cast as it is likely that the process will be the same – molding pieces to a patient’s limb in the same amount of time as the traditional cast – even if the materials used may change slightly. From the doctor’s side, the removal of pieces will be easy for the doctor as she or he will have experience with common medical bolts from medical school and other medical procedures. Understanding when to remove each piece of the cast will require time and possibly additional x-rays. The PuzzleCast has six pieces, which implies at least six visits; during each one a piece would be removed if the bone has healed sufficiently. At this time, it is unclear whether the average number of patient visits will change; since a traditional cast requires weekly visits for three weeks and subsequent visits roughly every three weeks, we expect the number of visits to be equal. Since a doctor receives a onetime fee for the treatment, the PuzzleCast does not offer additional revenue streams or time savings, thus the doctors have no incentive to adopt the new technology. In terms of cost, the PuzzleCast may reduce some of the doctors’ cost versus a traditional cast. With a traditional cast, a patient must still make frequent visits for x-rays and MRIs. This requires numerous casts on the doctor’s part as a traditional cast must be removed for these procedures that help determine how the bones are healing. A PuzzleCast would reduce the number of casts required as the pieces can be unscrewed for easy on and off, resulting in less money spent during a patient’s treatment. Thus, more of the insurance money can be retained by the doctors, rather than spending time and resources on additional casts. The PuzzleCast offers the doctors a potential advantage in terms of cost savings; however, since time with patients is not reduced and the cost savings are small, adoption risk exists. However, if a time advantage or further cost savings can be achieved, this adoption risk will be lowered – yellow light. Patients The PuzzleCast provides many advantages to the patient and requires no co-innovation or adoption risk (green light). The patient is ready to adopt the product as they can easily understand the benefits it will provide. The PuzzleCast reduces the patient’s amount of recovery time by increasing mobility, and also increases convenience. First, recovery time is reduced because less time is required for physical therapy post treatment. The six removable pieces of the cast allow the patient to regain movement in healed parts quicker than the traditional cast. Now, doctors can deliver more localized treatment that helps the patient build flexibility, increase blood flow to muscles, and ultimately reduce muscle atrophy. These benefits are significant to the patient as it cuts the amount of physical therapy required after the cast by about half. For the patient, the PuzzleCast is also much more convenient than a traditional plaster cast. Although the initial process of molding a cast is similar – cast is molded to limbs and both processes take about the same amount of time - the daily convenience of the PuzzleCast is much greater. Provided that the cast is made out of plastic as opposed to plaster or fiberglass, it may have the ability to get wet, allowing the patient to easily shower and wash his or her hands. Additionally, plastic may prevent odor build up, which many customers claim is one of the biggest drawbacks of having a cast. Additionally, there is no indication that the cast will cost more for the patient. It is likely that the patient will pay the same copay for the initial doctor’s visit, but then the insurance company will cover the cost of the new cast as it is expected to be the same as a traditional cast. If anything, the patient may experience less cost if they pay the physical therapist on a per-visit basis. With no downside and only benefits to gain, patients will accept the PuzzleCast – green light. Physical Therapists There is a clear red light for physical therapists. The adoption of the PuzzleCast will significantly reduce their relevance in the patient’s treatment. By reducing muscle atrophy, the PuzzleCast reduces the amount of physical therapy required by the patient by almost half when compared to a traditional cast. Thus, the number of physical therapy visits drop, greatly reducing the insurance payments received by the therapist. It is likely that physical therapists will not need to be fully retrained in order to see patients after their PuzzleCast treatment. They will likely be able to carry out some of the same treatment as is used with patients with the traditional cast with some modifications. However, with the adoption of this innovation and subsequent improvements, therapists face the risk of getting phased out of the process. This will result in a loss of patients and reduce or end their revenue stream. Thus, physical therapists have a clear reason to prefer the status quo and reject this innovation – red light. Altering the Ecosystem In order to launch a successful innovation, the innovators of the PuzzleCast need to make all players green by removing some of the co-innovation or adoption risk that currently keeps them yellow or red. Each player needs be ready and eager to participate in the innovation by seeing a clear surplus from the product (see Exhibit 2: Modified PuzzleCast Ecosystem). Exhibit 2: Modified PuzzleCast Ecosystem Map In order for the PuzzleCast to be successful, the risks faced by manufacturers and doctors need to be overcome. Physical therapists are less critical to the innovation as they are at the mercy of doctors and patients – doctors must refer physical therapy treatment in order for a patient to consider it and patients must deem it necessary before they choose to schedule an appointment. Adjusting the Value Proposition Manufacturers In order to motivate manufacturers to invest time and energy into holding clinical trials and gaining approval from the FDA, the innovators need to convince the manufacturers that there is a viable, profitable market opportunity. The student innovators could possibly apply for grants to potentially offset some of the manufacturer’s costs. Another way to secure profit for manufacturers would be to target the PuzzleCast to a market niche that is not cost-sensitive. The PuzzleCast could mitigate the adoption risk that the product faces from the manufacturers by targeting a niche that would have a high demand for a cast which allows a quicker recovery time – professional athletes – thus guaranteeing a market. Professional athletes would pay a premium to have access to a product that will allow them to recover faster from a broken bone injury because they lose money for every game they miss. Doctors would capture this premium, creating demand for the product, guaranteeing a viable market and allowing manufacturers to also charge a premium. The ability to get back on the field to make money is a great incentive and thus a premium could be charged for the PuzzleCast. Gaining a patient base of professional athletes would establish two things: 1. Provide a secure base of customers that are willing to pay for something even if insurance doesn’t cover it. 2. Create demand by establishing itself as a “cool” product that the casual athlete will want, having seen in on professional athletes and understood its benefits. By creating this demand and secure patient base, you are able to create incentives for the manufacturers and the doctors. Both will then turn to “green” and create an ecosystem that is a go. Doctors As previously mentioned, doctor’s initially are likely to be hesitant to adopt the PuzzleCast because proper incentives do not exist. The doctors and their cast technicians will require upfront training for the PuzzleCast. In the current ecosystem, doctors do not save time in patient visits or receive sufficient cost savings. However, they would likely adopt the cast if they could make a higher proportion of money or reduce patient visit time compared to the traditional cast. In terms of time, if the innovators were able to identify and have the manufacturer make the cast out of a radiolucent material, the patient visit time would be greatly decreased. During visits, the doctor would have the ability to x-ray the patient with the cast on to determine if the bone had healed and would not have to spend the time and energy removing the cast during each visit. This would significantly enhance the value proposition of the PuzzleCast. In terms of money, incentivizing insurance companies to pay a portion of the money they recouped from decreased physical therapy visits to doctors. Thus, a physical therapist loss now becomes a doctors’ gain, switching the doctors’ yellow light to green. While the physical therapists remain red, they are hired by patients post-cast treatment and have no influence on treatment technology (type of cast used). First Mover Advantage of the PuzzleCast To determine whether the PuzzleCast innovators and licensees should move forward with the innovation at this time, we looked at the advantage of being first to market. Exhibit 3: First Mover Advantage In looking at the first mover matrix for PuzzleCast (see Exhibit 3: First Mover Advantage), we believe that there is a high first mover advantage as a result of high execution risk and low co-innovation risk. There are no aspects of the PuzzleCast that require co-innovation by other parties as the product requires no complementing products. There are executional challenges to bring the product to market, but the innovators have already created the prototype and the eventual manufacturers will have the technical know-how and resources to execute the PuzzleCast. The PuzzleCast needs to be brought to market by promising to heal bones safely while allowing for increased movement, which will cut down on the amount of physical therapy needed by a patient. Managing this execution risk – providing a better way to heal bones – is the most essential element to make the product a success. Because the PuzzleCast will be patented and licensed, the licensee and innovators will initially capture all the potential profits. However, once competition enters, there will are no distinguishable features about the product that will keep costumers from switching to the lowest cost option. Therefore, it is essential to enter first and gain profits while there is no competition. Conclusion There are issues with the PuzzleCast becoming a viable product – it is easy to copy and hard to come up with a sustainable competitive advantage. There is little to no technology that can be leveraged during the life of the patent that will provide an advantage over competitors. However, the PuzzleCast can create an ecosystem to allow it to become a successful product. While the doctors and the manufacturers are the two players to cause concern within the initial ecosystem, there are ways to turn these “yellows” to “greens”. First, if profits can be gained by the doctors either through higher insurance payments or charging a premium for a better product, doctors may be influenced to choose and offer the PuzzleCast over the traditional cast and future competitors. If the demand is established by the doctors, manufactures will be incentivized to provide this product. Finally, the first mover matrix illustrates that being first to the game can come with high profits initially, especially if the PuzzleCast establishes itself with elite athletes.