MECHANICAL PROPERTIES OF CARBON HYBRID BRAIDED STRUCTURE FOR LOWER LIMB PROSTHESIS

A Project Report Presented to

The Faculty of the Department of General Engineering

San Jos State University

In Partial Fulfillment of the Requirements for the Degree Master of Science in Engineering

by Bhavana Shekhar Salma Riazi Shirin Rahmanian December 2009

 2009 Bhavana Shekhar Salma Riazi Shirin Rahmanian ALL RIGHTS RESERVED

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SAN JOS STATE UNIVERSITY

The Undersigned Project Committee Approves the Masters Project Titled MECHANICAL PROPERTIES OF CARBON HYBRID BRAIDED STRUCTURE FOR LOWER LIMB PROSTHESIS by Bhavana Shekhar Salma Riazi Shirin Rahmanian

APPROVED FOR THE DEPARTMENT OF GENERAL ENGINEERING

Dr. Arthur Diaz, Department of Chemical & Materials Engineering

Date

Dr. Richard Chung, Department of Chemical & Materials Engineering Date

Dr. Leonard Wesley, MSE Director, General Engineering

Date

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ABSTRACT MECHANICAL PROPERTIES OF CARBON HYBRID BRAIDED STRUCTURE FOR LOWER LIMB PROSTHESIS by Bhavana Shekhar Salma Riazi Shirin Rahmanian The aim of this project was to test and evaluate different types of materials for lower limb prosthesis in order to choose the most appropriate material in terms of performance and cost. Breakey Prosthetics Inc. has provided the materials chosen for this project, which include Carbon-Carbon, Spectra-Carbon, and Spectra-Nylon fiber composites. The tests conducted on these materials consisted of Instron tensile test, hardness test, and SEM failure analysis. The tensile and hardness results indicate that Carbon-Carbon fibers have the highest tensile strength and hardness. The SEM results showed that Carbon-Carbon has poor bonding to the resin, while the Spectra-nylon has the best bonding. SpectraCarbon had an average bonding. Economic analysis was also conducted to determine the viability of this project and justify its completion.

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Acknowledgements

We would like to express our gratitude to Dr. Richard Chung, Professor, Chemical and Materials Engineering, SJSU, for giving us an opportunity to work with him. This project would not have been possible without his support. We would like to thank Mike Gidding and Chris Pimental of Breakey Prosthetics for sponsoring our project. We would like to thank Dr. Arthur Diaz, Professor, Chemical and Materials Engineering, SJSU, for his guidance. We would like to thank Dr. Leonard Wesley, Associate Professor, Computer Engineering, and Dr. Micheal Jennings, Department Chair, Chemical and Materials Engineering, for their advice and support. We are thankful to Jaron Nimori, SEM lab; Neil Peters, Materials lab; and Craig, Machine shop, SJSU for their assistance. Lastly, we are grateful to our family and friends for their support throughout the project.

Table of Contents 1.0 Introduction ..................................................................................................................1 2.0 Literature Review ........................................................................................................3 2.1 Introduction to Literature Review ..............................................................................3 2.2 Background ................................................................................................................3 2.3 Pre-amputation and Post-amputation Procedures ......................................................4 2.4 Components of a Below Knee Prosthesis ..................................................................7 2.5 Manufacturing Process of Prosthetic Limbs ............................................................10 2.6 Materials ..................................................................................................................12 2.6.1Historical Development of Composites for Orthopedics ...................................17 2.6.2 Properties of Spectra .........................................................................................18 2.7 Experimental Methods .............................................................................................19 3.0 Materials and Methods ..............................................................................................20 3.1 Tensile Testing .........................................................................................................20 3.2 Hardness Test ...........................................................................................................27 3.3 SEM Analysis ..........................................................................................................30 3.4 Discussion of Results ...............................................................................................35 4.0 Economic Justification...............................................................................................37 4.1 Executive Summary .................................................................................................37 4.2 Problem Statement ...................................................................................................38 4.3 Solution and Value Proposition ...............................................................................38 4.4 Market size ...............................................................................................................39 4.5 Competitors ..............................................................................................................40 4.6 Customers ................................................................................................................41 4.7 Cost ..........................................................................................................................42 4.7.1 Fixed Cost .........................................................................................................43 4.7.2 Variable Cost ....................................................................................................45 4.8 Price Point ................................................................................................................46 4.9 SWOT Assessment ..................................................................................................46 4.10 Investment Capital Requirements ..........................................................................47 4.10.1 Norden-Rayleigh Financial Profile .................................................................50 4.11 Personnel ................................................................................................................53 4.12 Business and Revenue Model ................................................................................55 4.13Strategic Alliances and Partners .............................................................................56 4.14 Exit Strategy...........................................................................................................56 5.0 Project Schedule .........................................................................................................58 6.0 Conclusion ..................................................................................................................60 7.0 References.....................................................................................................................61

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List of Figures Figure 1: Components of transtibial prosthesis Figure 2: Sample specifications Figure 3: Stress-Strain curve of Carbon-Carbon sample 1 Figure 4: Stress-Strain curve of Carbon-Carbon sample 2 Figure 5: Stress-Strain curve of Carbon-Carbon sample 3 Figure 6: Stress-Strain curve of Spectra-Carbon sample 1 Figure 7: Stress-Strain curve of Spectra-Carbon sample 2 Figure 8: Stress-Strain curve of Spectra-Carbon sample 3 Figure 9: Stress-Strain curve of Spectra-nylon sample 1 Figure 10: Stress-Strain curve of Spectra-nylon sample 2 Figure 11: Stress-Strain curve of Spectra-nylon sample 3 Figure 12: Box plot for Hardness test Data Figure 13: SEM images of Carbon samples. (a) Crack area at 50x magnification (b) at 400x magnification (c) at 6000x magnification Figure 14: SEM images of Spectra-Carbon samples. (a) Crack area at 6000x magnification (b) at 2400x magnification (c) and (d) at 10000x magnification Figure 15: SEM images of Spectra-Nylon samples at 3000x magnification (a) top surface (b) fiber pull-out Figure 16: Percent concentration of limb prosthesis companies in the U.S. Figure 17: Profit and Loss chart Figure 18: Break-even chart

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Figure 19: Cumulative Distribution Function for Norden Rayleigh Figure 20: Probability Density Function curve for Norden-Rayleigh Figure 21: ROI Chart

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List of Tables Table 1: Mechanical properties of some materials used for prosthesis fabrication Table 2: Comparison of Mechanical Properties of different fibers
Table 3: Mechanical Properties of Carbon-Carbon Table 4: Mechanical Properties of Spectra-Carbon Table 5: Mechanical Properties of Spectra-Nylon Table 6: Hardness test results for Spectra-Nylon, Spectra-Carbon and Carbon composites

Table 7: Major Competitors Table 8: Fixed Cost Break Down Table 9: The Variable Cost Break Down Table 10: Price Point Analysis Table 11: SWOT analysis Table 12: Expected Profit and Loss Table 13: Funding Break Down Table 14: Cost Drivers Table 15: Probability density function and Cumulative distribution function for NordenRayleigh Table 16: Return on Investment for Prosthetics Labs

1.0 INTRODUCTION There are about 1.7 million people in the United States alone who have lost at least one limb. Need to be fitted with a prosthetic limb to enable them to carry out normal daily activities. Currently, only one type of fiber (for e.g. Carbon fiber) is used in the fabrication of below knee prosthesis for all different kinds of patients. Athletes for instance would require stronger sockets than would an average person. Hence different socket materials can be chosen based on usage.

Although the first prosthetic leg was a wood stump, we have come a long way since then. Some of the materials used for the fabrication of sockets include: Carbon fibers, Kevlar fibers, glass fibers, and thermoplastic polymers. We have tested three different composite materials that are used to make the socket of below-knee prosthesis. The materials tested are braided carbon fiber, spectra-carbon, and spectra-nylon composites which were provided by Breakey Prosthetics Inc., San Jose, CA. To characterize and compare the mechanical properties of these materials, tensile test, hardness test, and failure analysis were used. The samples were then cut into dog-bone shapes in the SJSU machine shop to conduct the tests. All of the tests were conducted in SJSU Materials Engineering laboratories. For the tensile testing, three samples of each material were tested using the Instron Machine. The Rockwell hardness machine was used to measure the hardness of the samples. Twenty test values for each composite were obtained. Finally, for failure analysis, a Scanning Electron Microscope was used to view the images of the failed samples to discover the cause of failure in each composite.

To further justify the completion of this project, it is important to economically evaluate it. The work done in this project can be viewed as a service provided by a small start-up company offered to limb prosthetic companies to test their materials and also give them consultations. Prosthetic Labs, Inc., is a Limited Liability Company (LLC) which provides testing and consulting services specific to prosthetic limb manufacturers. For tax purposes, Prosthetic Labs files as a sole proprietorship. Prosthetic Labs Inc. will initially consist of about 9 employees, including technicians to the test, expert analysts, marketing consultant, and the CEO. What sets this company apart from other material testing companies is that this company will be the only company that offer tests and consultation exclusive to limb prosthetic companies and meet tailored needs. The economical analysis conducted has shown that the market size is large enough for starting such service and considerable profit can be made in a short period with a relatively low budget.

2.0 LITERATURE REVIEW

2.1 Introduction to Literature Review Prosthetics allow people with limb amputation to resume normal daily activities. Developments in limb prosthesis have significantly improved over the last few years that even in patients being able to participate in extreme sports. For instance, in the 2000 Paralympic Games, Sydney, a new world record was set for the 100m sprint for belowknee amputees at 11.09 seconds (Gutfleisch, 2003). The 2008 record for fit and healthy athletes was 9.69 seconds. This astounding result was due to the superior performance of lower limb prosthesis along with the determination and talent of the athlete. This chapter includes a literature review of materials used in lower limb prosthesis.

2.2 Background The word prosthesis comes from the Greek word prostithenai which means to add to. A prosthetic device is an artificial device which mimics the function of a missing body part. The use of Peg legs, carved out of wood, as early as 3000-1800 B.C. has been documented in Indian literature (Cochrane, Orsi, & P., 2001). James Potts constructed The Anglesea leg in 1800. The socket and shank were made of wood; the knee joint was made of steel, and it had an articulated foot. The shank was attached to a leather thigh corset with the help of metal hinges and side bars (Bannister, 1978). Even in the 1940s sockets for below knee prosthesis was made out of either blocks of wood or leather (Verrall, 1940). The basic design of the prosthetic limb remained unchanged till 1950.

Research on improving the design of the lower limb prosthesis was going on at the University of California, Berkeley; and in 1958, they made their design public. It was called Patellar Tendon Bearing (PTB) prosthesis. The socket was made of plastic and lined with rubber and soft leather. The hollow wooden shank was reinforced with a plastic laminate, and the articulated foot was replaced with a rubber solid ankle cushion heel (SACH) foot. Leather straps were used above the patella to provide suspension. Though it had a huge advantage of being much lighter than the older version and fit properly to the residual limb; the drawback limited knee flexion, skin abrasions, and dermatitis. In 1964, the PTB prosthesis was further modified such that the sides of the socket extended beyond the femoral condyles. The liner was built-in with one or two wedges to provide suspension. This design was called the PTS (patellar tendon supracondylar) prosthesis (Bannister, 1978). The Botta prosthesis was an adaptation of the PTS prosthesis. The socket was light in weight and was fabricated with polyester or other synthetic resin strengthened with carbon fiber (Marquardt & J., 1984).

2.3 Pre-Amputation and Post Amputation Procedures Some amputations of the lower limb, which are due to some diseases, can be predicted. In this preamputation phase, before the surgery, the patients will attend certain meetings to learn about how this surgery will affect their lives and how to deal with it. They will also get emotional support by meeting with an amputee in the same situation as they are. Providing information to individuals might also prevent some traumatic and nontraumatic amputations. For example, an amputation care facility program held by the

Department of Veterans Affairs, has decreased the number of non-traumatic amputations by forty percent each year (Pasquina, Bryant, et al. 2006).

Different surgical techniques must be used for each amputee. Using a general technique will not work for all individuals. In order to attach the remaining muscles two different techniques are used which are called myodesis, and myoplasty. In myoplasty the opposite muscles of the amputated limb are sewn to each other, whereas in myodesis the muscles are attached to the periosteum of the amputated bone (Pasquina, Bryant, et al. 2006).

After the surgery is done, there are certain issues to have in mind and precautions to take. The amputated part has to be taken care of properly, in order to be able to attach the prosthetic to it without encountering any problems in the future. The cut limb has to undergo a skin desensitization program which involves massaging the severed section of the limb. This is done to heal the scar and not let it adhere to the bone underneath. Also, edema should be prevented by using a residual limb stump. The cut end of the limb is then introduced to increasing amounts of pressure so that it adapts to the forces that it will undergo after the prosthetic is placed and utilized (Kelly, Spires and Restrepo, 2007).

A study done by Moore, Hall et al., has proved the advantages of immediate postoperative techniques which has been done about 30 days after the amputation, in comparison to a later post operative action. The advantages include a quicker rehabilitation, lower number in mortality and healing rate. Therefore, the time from the

amputation to the fitting of the prosthesis is critical and can affect the procedure directly (Moore, Hall, et al. 1972).

For a prosthetic surgery to be successful and make it as comfortable as possible to the recipient of the prosthetic limb many factors must be considered. Some of these include proper diagnosis, to begin with, the patients weight and other physical characteristics, and also their activity level (Kelly, Spires and Restrepo, 2007). It should also be noted that for children extra consideration must be taken because they are constantly growing. This is why adjustments to the prosthesis must be made more regularly than those of adults (Pasquina, Bryant, et al. 2006). On average the life expectancy of the prosthetic devices is approximately three to five years depending on the patients physical activity, and the materials with which the prosthetics are made of. Also, the location where the socket of the prosthesis and the limb are in contact with each other is of great importance. The socket must not cause any damage, irritation, or allergic reactions to the skin, since the skin at the severed end of the limb is very sensitive. The most important issue which has to be considered is the amputated tissues response to the applied load, after the prosthesis has been placed. Depending on the individual and their body type the tissue will get more susceptible to pain after the amputation (Kelly, Spires and Restrepo, 2007). Other than pain, some temperature changes might be observed in the area which load is more. When the tissue undergoes an amount of load, due to decrease in blood circulation, the temperature of the tissue will drop. After unloading the tissue however, the temperature will rise (Mak, Zhang & Boone, 2001). The skin in the contacting region of the prosthesis and the tissue might get abraded as a result of rubbing

against the device. This might lead to some skin problems, such as skin thickening and blisters (Mak, Zhang & Boone, 2001). 2.4 Components of a Below Knee Prosthesis

Socket

Socket Adapter

Tube Clamp Adapter Pylon Endoskeletal finish Ankle Foot

Figure 1. Components of transtibial prosthesis Source: Below Knee (Transtibial) Prosthesis. (n.d.). Retrieved March 12, 2009, from Prosthetic
Concepts Web site: http://www.prostheticconcepts.ca/belowknee.pdf

The components of a transtibial prosthesis are shown in Figure 1. The main components of the prosthesis include:

1. The Socket connects the amputated limb to the prosthesis. It transfers the body weight to the prosthesis and may contain liners that act like padding. It protects the amputated limb and enables the user to stand, walk, and move freely. Mostly in transtibial amputation, patellar-tendon bearing socket (PTB) is used (Carroll, 2006,

Kelly et al. 2007). Before this socket was introduced, some open-ended plug-fit sockets were used which had some disadvantages such as skin irritation and chronic choke syndromes (Kelly, Spires and Restrepo, 2007).

However, the socket fit and comfort depends on the individual and has to be chosen by them and the help of the prosthetist. Some common sockets are: PTB, Totalsurface bearing (TSB), PTB-supracondylar, and joint and corset (Kelly, Spires and Restrepo, 2007). All these sockets have their own pros and cons due to their mechanism of load bearing, pressure transmission to the amputated area, and comfort. As technology advances, recent and more applicable materials are being introduced for this purpose. Sockets are now being manufactured with computer-aided designs and are custom fitted for the patients. Some carbon graphite sockets that are now being used are light weight and last longer. The linings of these sockets are also more flexible and comfortable. By being custom made, the socket manufacturing will not only be cheaper, it will also save time and accelerate the delivery time to patients (Carroll, 2006).

2. The Ankle joins the foot and prosthesis. This part is made of some joints which allow axial rotation. This part should also be capable of energy storing and absorption (Kelly, Spires and Restrepo, 2007). The ankle is made from different material depending on its use and the socket its connecting to. There are ankle joints made of wood with a laminated outer shell. Some other ankle joints are made out of metal, plastic or carbon fiber. There are different types of prosthetic ankles with different

movement axes. A study done by Rita, Mason, et al. has shown that these ankles show different results in shock absorption. Although it has to be taken into consideration that stride length, age, weight and some other factors are involved as well (Witra, Mason, et al. 1991). It is common for this part to be available together with the socket; however, it is also available separately for use in sports and heavy physical activity (Kelly, Spires and Restrepo, 2007). 3. The Foot acts as a base support. Not only this part must be able to bear all the weight acted on it, it must also transfer the body weight to ground, act as a shock absorber, and replace lost muscle function and biomechanics of the foot ( Kelly, Spires and Restrepo, 2007). It must also provide cosmetic appearance and should fit in normal shoes. The recent artificial feet are now being made to reproduce a healthy foots function. They have energy absorption mechanism in multiple planes, as well as being able to absorb vertical and torsional shocks which are acted upon them ( Kelly, Spires and Restrepo, 2007). 4. Suspension systems are used to hold the prosthesis on the body (Below Knee Prosthesis). The socket must have some suspension mechanism in order to not to fall off. Different mechanisms are used for this purpose such as suction, harness, belt, and gel suspension. A combination of them is also available (Moore, Hall, & Lim, 1972). By using a gel elastomer, the gel suspension system provides cushioning to the residual limb. It also provides an acceptable cosmesis to the amputee. Using a thin gel can improve the sense of propioception in the patients, allowing them to function

better in their activities (Carroll, 2006). Another common suspension system is using sleeves. Sleeves have their own drawbacks, since the material can get punctured easily; it has to be replaced quite often. They can also have ventilation problems as well as getting hot in warm and humid regions (Carroll, 2006). This problem however, has recently been solved by putting a valve on the sleeve to provide air transfer.

The transtibial prosthesis is also comprised of some other components which are mainly used for connecting the major parts to each other. They consist of a socket adaptor which connects the socket to the rest of the prosthesis and aligns the prosthesis; a tube clamp adaptor, which is used to connect the pipe to the socket; a pylon, which is used to transfer the body weight and should be adjusted to achieve proper height of the prosthetic; and finally an endoskeletal finish which envelopes the whole prosthesis and hence protects the internal parts from dust, dirt, and moisture (Osbourne, 2009).

2.5 Manufacturing Process of Prosthetic Limbs After amputation, a medical doctor has to prescribe prosthesis to the patient. This device cannot be bought in stores and is not mass produced. Following the prescription, the patient must consult with the prosthetist and physical therapist in order to choose the best prosthesis for his use. Some parts of the prosthesis are manufactured in factories, and some other parts like the socket, can be custom made for each patient.

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The procedure starts with the prosthetist studying the amputees residual limb, taking an impression of it and measuring some body segments of the patient. The impression and the measurements are used to make a plaster cast of the stump, which is then used to make the stump itself. Afterwards, a clear sheet of heated thermoplastic is placed onto the mold and put into a vacuum chamber. When the air is taken out of the chamber the thermoplastic sheet smoothly presses against the mold taking its shape without having any air bubbles trapped between the sheet and the mold. The product of this process is the test socket. The reason why it is clear is so that it will be easier for the prosthetist to check the fit of the prosthesis.

The penultimate process involves the prosthetist to check and confirm that the test socket that was just constructed properly fits the patient. After the patient puts it on he or she walks while the prosthetist analyzes the gait. Adjustments are made both in response to the appearance of the gait and the comfort of the patient. Only after this is done and both patient and prosthetist are satisfied do they move on to the final procedure. Finally, the permanent socket is formed usually using polypropylene, again, using vacuum forming as the production or shaping process. Over time, if any anatomical changes occur to the appendage changes to the prosthesis are made accordingly.

The manufacture of prosthetic limbs involves a wide variety of materials and methods. Many are made using different types of plastics which are formed using vacuum-forming, extruding, or injection molding. Those that are made of metallic

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components usually use titanium and aluminum parts which are die cast and then finished by drilling, sanding, polishing, and other finalizing processes.

After the different parts and components that make up the prosthesis are manufactured the assembly is done by the prosthetist technician using various tools such as wrenches, screwdrivers and other such hand or power tools. The patient is fitted with the assembled by the prosthetist. (Stacey, Blachford, & Cengage, 2002)

2.6 Materials Metal, leather, and wood were used as prosthetic materials before mid 19th century. Lower limb prostheses made before 1984 were rigid and were manufactured from metal, leather, or plastic laminate with a foam toe filler (Lange, 1992). Although these devices did not restore function lost by amputation, they maintained rollover in the toe section. Since these devices were rigid, a lot of effort was put in to make partially rigid devices which integrated foam toe fillers with clear and flesh-tone plastics that were flexible. Cosmesis was an issue although the function and fit was satisfactory. During 1984-1986, thermoplastics were used to fabricate custom prosthetic sockets. Flexible Surlyn below-knee (BK) sockets which were supported within semi-rigid polypropylene socket retainers were made at the University of Virginia Medical Center (Schuch, 1991). Polyethylene was used to make flexible sockets, and polypropylene was used for making socket retainers. The advantages of prosthetic sockets made of thermoplastics were flexibility, light weight, quick and simple fabrication (Schuch,

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1991). The drawback of this material was that it was not durable, i.e., it would split or tear. Also, thermoplastics shrink and this would loosen the fit. Shrinkage of the material was found to be greatest, if it was stretched at the time of fabrication. Hence, it must be carefully draped and vacuum-formed rapidly to optimize the results (Rothschild, Fox, Michael, Rothschild, & Playfair, 1991). Next, laminated silicone sockets were attached to hollow foot shells with silicone sealant (Lange, 1992). To improve cosmesis, another layer of lamination was put above the socket and the foot shell to join them permanently and a zipper was used at the back of the socket (Lange, 1992). Langes silicone partial foot prosthesis had two laminations and incorporated the foot shell between the two. The result was that the foot shell was permanently bound to the socket thereby producing an elastic, resistive toe lever. The hollow toe in the foot shell was filled with room temperature vulcanized (RTV) foam to attain more natural ankle motion (Lange, 1992). This design also had a zipper closure behind the socket. Instead of adding pigments to the silicone, a nylon stockinette matching the skin tone of the patient was coated on the foot shell to provide better cosmesis (Lange, 1992). Fiber reinforced plastics are laminated composites made by applying resin to one or more layers of fibers. The material properties of the resin and the fiber, the extent of bonding between the two and the resulting structural architecture determines the strength of the laminate (Phillips & Craelius, 2005). The tensile and flexural strengths of the fiber reinforced plastics were found to be high along the fiber axis. From Table 1, it

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can be noted that the Youngs modulus of nylon fiber is slightly lesser than that of the SPT (SPT Technology, Inc., Minneapolis) resin. Although the nylon fibers are supposed to increase the strength since they are the reinforcing materials, they do not do so because of their low modulus of elasticity when compared to that of the resin (Phillips & Craelius, 2005). Hence it is important to choose a fiber whose modulus of elasticity is greater than that of the resin else the material properties will be completely controlled by the resin.

Table 1 Mechanical properties of some materials used for prosthesis fabrication Source: Phillips, S. L., & Craelius, W. (2005). Material Properties of Selected Prosthetic Laminates. Journal of Prosthetics & Orthotics , 27-32.

While glass and carbon fibers have high strengths, the main drawback is that they are brittle; during post-fabrication modification, instead of stretching, they break (Phillips & Craelius, 2005). A strut was designed by Madden using Kevlar-49, carbon, and S-2 glass fibers. Carbon fiber was used to make the inner core, Kevlar-49 was used to fabricate the outer layer, and S-2 glass was used in the middle layer. The S-2 glass acts as a transition layer for the stress changes which is an intrinsic to the strut design. Carbon fibers and Kevlar-

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49 are comparatively weak under tensile and compressive loads respectively, S-2 glass acts as a balance between the two, facilitating stress transfer between the layers. This design has been used successfully for fabricating rigid frames for flexible socket systems in prosthetics (Madden, 1991). As discussed previously the initial material made of wood and metals for artificial legs had major drawbacks, since they were limited by their weight, and had poor durability to corrosion and moisture induced swelling (Ramakrishna et al., 2001). These limitations resulted in restricting the user to slow and non-strenuous activities due to poor elastic response during stance (Ramakrishna et al., 2001). Due to these limitations, polymer composites were introduced for material of choice for limb systems, because of their lightweight, corrosion resistance, fatigue resistance, aesthetics, and ease of fabrication (Ramakrishna et al., 2001). Polymer composites can be either thermosetting or thermoplastics composites that are reinforced with glass, carbon, or Kevlar fibers (Ramakrishna et al., 2001). Thermoplastic polymers have the advantage of having strong intermolecular bonds that result in good biocompatibility and resistance to moisture damage (Evans, & Gregson, 1998). Polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyethylene, and polysulfone have been widely used for orthopedic use (Evans, & Gregson, 1998). While these materials have excellent biocompatibility and good durability in the physiological environment, they are difficult in fabrication of long fiberreinforced composites, and thus difficult for prosthetics with sufficient strength for highly loaded applications (Evans, & Gregson, 1998).

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Thermosetting polymers such as epoxy resins have not been so common in orthopedics because of variable biocompatibility and durability characteristics (Evans, & Gregson, 1998). However studies have shown that properly processed and selected epoxy resins can have excellent biocompatibility, and these materials can have much better processing characteristics than the thermoplastics, allowing the fabrication of more sophisticated composite structures (Evans, & Gregson, 1998). During the past 10 years the most notable reinforcing materials for orthopedic use have been carbon fibers (Evans, & Gregson, 1998). Especially for lower limb prosthesis carbon composite lay-ups are very popular (Strike & Hillery, 2000). These composites are chosen or their flexibility and energy storage and release properties (Strike & Hillery, 2000). The fibers can be fabricated in different ways such as being braided, woven, knitted, or laminated. According to a lower limb design by Strike & Hillery, the lamination would allow them to have specific tensile strength and stiffness by changing the resin and controlling the angles between successive layers (Strike & Hillery, 2000). There are also other reinforcing materials that have been used for prosthetic use. One of the most recent ones are Aramid fibers such as Kevlar, which have excellent tensile properties (Evans, & Gregson, 1998). However, these fibers have poor compressive strength and stiffness and thus have limitation during bending loads (Evans, & Gregson, 1998). Morever, according to Ramakrishna et al., the sockets currently in the market, are made using a combination of knitted or braided carbon or glass fiber fabrics and watercurable (water-activated) resins (Ramakrishna et al., 2001). The braided fabric

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reinforced sockets have the advantage of being stiff and strong, whereas the knitted fabric reinforced sockets have the advantage of being flexible and more conformable to the patient's stump (Ramakrishna et al., 2001).

2.6.1 Historical Development of Composites for Orthopedics

While composites have been used throughout history, the emergence of composite materials as we know today is fairly recent, becoming most popular during the early 1950s due to extensive research done in aerospace industry. Development of fiberglass in the 1930s has led to using these materials as reinforcement for polymers, and thus improving composite technology (Erwin, 1947). As it has previously referred to, polymer composites can be reinforced with glass, carbon, or Kevlar fibers (Ramakrishna et al., 2001). Major breakthrough in the composite development was the use of reinforcing fibers. In 1961, the first carbon fiber was produced by Shindo et al. (Shindo, 1969). Carbon fibers have the advantage of having a low density, high elastic modulus, and high tensile strength. Also, due to their high specific strength and good fatigue resistance (when used as a reinforcing polymer) makes them a good candidate for orthopedic use (Pigott & Harris, 1980). The major drawbacks of carbon reinforced thermosetting composites are their brittleness yielding low fracture toughness and poor impact resistance. The next major emergence of reinforcing fibers in composite development was the production of Kevlar by DuPont in 1971. Thermoset resins that are reinforced by Kevlar fibers display high fracture toughness and good resistance to tensile loading (Pigott &

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Harris, 1980). However they have the disadvantage of being weak under compression and they are also hard to fabricate because they are difficult to shape, cut, and saturate with resins (Berry, 1987)

2.6.2 Properties of Spectra Spectra fiber is a polyethylene fiber that is produced from a gel-spinning process by Honeywell, Inc. (Honeywell). Spectra Fibers are available in three different series: Spectra 900, Spectra 1000, and Spectra 2000. Spectra fibers have tensile strength that is higher than aramid fibers at temperatures below ~ 1000C and above this temperature their tensile strength will decrease (Lewin, Sello, & Preston, 1996). Spectra fibers can withstand twisting without losing their strength. These fibers also have very good abrasion resistance, can creep well under static load, and have a good impact resistance, when compared to aramids. The mechanical properties of Spectra fibers are shown in Table 2 and are compared to other composite materials (Lewin, Sello, & Preston, 1996). Table 2 Comparison of Mechanical Properties of different fibers Source: Lewin, M., Sello, S. B., & Preston, J. (1996). Handbook of fiber science and technology (Vol. III). New York: Marcel Dekker, Inc.

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2.7 Experimental Methods

Samples of braided carbon fiber, spectra-nylon, and spectra-carbon have been provided by Breakey Prosthetics. At least three tensile (dog bone shape) samples of these fiber composites will be made for mechanical testing. The dimension of the samples will be as shown in Figure 2. The samples will be tested for their tensile strength, hardness and bending. Fractured samples will be analyzed using a Scanning Electron Microscope. The results will be compared to the values required by ISO standards to see if they meet the minimum requirements.

Figure 2. Sample specifications Source: (2008). Quality and testing. In B. A. Strong, Fundamentals of Composites Manufacturing: Materials, Methods and Application (p. 277). SME.

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3.0 MATERIALS &METHODS

3.1 Tensile Testing Tensile test is a mechanical test in which a machine is used to deform a specimen under gradually increasing tension load. Tension test can be used to plot a stress-strain curve and several mechanical properties can be obtained from this curve. Some of the most important mechanical properties that can be obtained from the stress-strain curve include yield strength, modulus of elasticity (Youngs modulus), ultimate tensile strength, ductility, and toughness.

The yield strength measure the stress level at which a material starts to plastically deform. This means that up to yield strength, the material can return to its original length after deformation. Beyond yield strength, the material will undergo plastic deformation, in which the deformation is permanent. During elastic deformation (before reaching yield strength), stress and strain are proportional to each other. This relationship is known as Hooks law and the constant of proportionality is called Youngs modulus, or modulus of elasticity. The modulus can be obtained by measuring the slope of linear portion of a stress-strain curve. The greater the modulus, the more brittle the material is, meaning it will go under less strain before yielding.

Another important mechanical property is the tensile strength (UTS), which is the maximum strength in the stress-strain curve. UTS corresponds to the strain that a material

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can sustain under tension. If such stress is applied and maintained, the material will start to non-uniformly deform and fracture will occur.

Ductility and toughness are another mechanical properties that can be obtained from the stress-strain curve. Ductility is a measure of the amount of plastic deformation at fracture. It can be expressed as percent elongation or percent of reduction in area the fracture. Toughness is a measure of the ability of the material to sustain energy up to the fracture point. Toughness can be measured by calculating the entire area under the stressstrain curve.

Tensile test was conducted on the three different types of composite samples under study, which were carbon-carbon, Spectra-carbon, and Spectra-nylon. The tensile done test was done using the Instron machine on dog-bone shaped sample. For each material several tensile tests were conducted and the three most consist results were selected for each type of material for analysis. The strain rate used for all the samples was 8.0 mm/min.

The stress-strain curves of the samples are shown in Figures 3-11. Figures 3, 4 and 5 show the stress-strain curve of three different carbon-carbon samples. Figures 6, 7 and 8 show the stress-strain curve of three different spectra-carbon samples. Similarly, Figures 9, 10 and 11 show the stress-strain curve of three different spectra-nylon samples.

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Figure 3. Stress-Strain curve of Carbon-Carbon sample 1.

Figure 4. Stress-Strain curve of Carbon-Carbon sample 2.

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Figure 5. Stress-Strain curve of Carbon-Carbon sample 3.

Figure 6. Stress-Strain curve of Spectra-Carbon sample 1.

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Figure 7. Stress-Strain curve of Spectra-Carbon sample 2.

Figure 8. Stress-Strain curve of Spectra-Carbon sample 3.

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Figure 9. Stress-Strain curve of Spectra-nylon sample 1.

Figure 10. Stress-Strain curve of Spectra-nylon sample 2.

Figure 11. Stress-Strain curve of Spectra-nylon sample 3.

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From above curves the important mechanical properties were calculated, including yield strength, yield strain, tensile strength (UTS), ductility, strain at failure, E modulus, and toughness. Tables 3, 4, and 5 show the results of these measurements along with mean and standard deviation of each property for carbon-carbon, Spectra-carbon, and Spectra-nylon respectively.
Table 3 Tensile Properties of Carbon-Carbon composites

Table 4 Tensile Properties of Spectra-Carbon Composites

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Table 5 Tensile Properties of Spectra-Nylon Composites

3.2 Hardness Test Hardness is the ability of a material to resist plastic deformation. The Rockwell hardness tester uses an indenter to press against the surface of the material under study. There is a minor load (10 grams) which constantly presses on the indenter; a major load will be applied to the material gradually until equilibrium has been reached. Then the major load will be removed and some of the penetration it caused will recover. At this point the residual penetration is measured which is the hardness. The three studied samples, which were Spectra-Nylon, Spectra-Carbon, and Carbon composites were tested for their hardness. The hardness test was done using a Rockwell machine on an M scale with minor load being 10 kgf and the major load 100 kgf. As Table 6 shows, the hardness of spectra-nylon and spectra carbon are very similar, being tenths different, whereas Carbons hardness is twice as much as the other two. This result shows that carbon can withstand plastic deformation much more than the other two samples. Therefore in case of hardness and plastic deformation, carbon would be the most suitable for lower limb prostheses application. Evidently lower limb

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prostheses are constantly under load during the time they are being used, therefore it is crucial that they do not fail and deform plastically. From the Box-Whisker plot, we can see that the hardness value of 75.6 in Carbon sample is an outlier.
Table 6 Hardness test results for Spectra-Nylon, Spectra-Carbon and Carbon composites

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Figure 12. Box plot for Hardness test Data

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3.3 SEM Analysis A Scanning Electron Microscopic analysis on the tensile test samples were done in the SEM lab at San Jose State University. The samples were placed in a low vacuum, slightly humid environment inside the SEM. The fractured area was at the (0, 0) coordinates of the mount so as to focus on the crack area. Figure 13 shows the SEM pictures of the carbon fiber samples at different magnifications. Figure 13(c) shows that the fiber surface at the crack is smooth which indicates that the bonding between the resin and fibers is poor. We can conclude that the resin broke first which was followed by fiber pullout.

Fiber pullout

(a)

(b)

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(c) Figure 13. SEM images of Carbon-Carbon samples. (a) Crack area at 50x magnification (b) at 400x magnification (c) at 6000x magnification Figure 14 are SEM images of Spectra-Carbon samples. Figure 14(a) indicates that the failure mechanism was de-lamination. It can be seen in Figures 14(b) and 14(c) that the resin is still attached to the fiber. Figure 14(d) shows the breakage of resin. These images indicate that although the bonding between resin and fibers in the Spectra-Carbon samples were poor, it was better than in Carbon fibers. Since Spectra-Carbon is a hybrid of polyethylene (spectra) and carbon fibers, it is difficult to tell which of these fibers caused this failure mode. An Energy Dispersive X-ray analysis could be done to differentiate between the fibers by identifying their composition.

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(a)

Matrix

Fiber

(b)

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(c)

Resin breakage

(d) Figure 14. SEM images of Spectra-Carbon samples. (a) Crack area at 6000x magnification (b) at 2400x magnification (c) and (d) at 10000x magnification Figure 15 shows SEM images related to Spectra-Nylon samples. Figure 15(a) shows the resin crack and 15(b) shows the fiber breakage. The fiber has good adhesion

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with the resin but they are not strong enough. As such, the fiber was pulled out with resin still attached to it.

Cracks in the resin

(a)

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Resin

Fiber

(b) Figure 15. SEM images of Spectra-Nylon samples at 3000x magnification (a) top surface (b) fiber pull-out 3.4 Discussion of Results The hardness and tensile tests were done in accordance to ASTM D 3039 standard. The results of the tensile test show that the tensile strength of carbon samples to be in the range of 83-89 MPa spectra-carbon - 27 to 36 MPa, and spectra-nylon to be in the range of 28 to 30 MPa. According to the literature review, the tensile strength of Carbon fiber/Epoxy resin composite was 76.8 MPa, while that of spectralon, which is a hybrid of spectra and nylon, was 25MPa. The findings of this project are close to those in the literature review. The ultimate tensile strength (UTS) of cortical bone is between 80 and 115 MPa (Mechanical Properties of Bone). The mean UTS of carbon sample is 92 MPa, which is in the range of that of the cortical bone. From stress-strain curves of spectracarbon, and spectra-nylon, it can be seen that the UTS is very close to the point of

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fracture. This indicates that the samples are very brittle. The fact that Spectra containing composites have no yielding and the Carbon-Carbon does have plastic deformation can be due to the bonding strength of resin. That is the Carbon-Carbon sample continues to plastically deform after yield strength because the resin is no longer bound to the carbon fiber while the Carbon fibers by themselves have not failed completely. On the other hand, Spectra-Carbon and Spectra-Nylon had good bonding with resins, therefore making them brittle and failing without plastic deformation.

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4.0 ECONOMIC JUSTIFICATION 4.1 Executive Summary Limb prosthetics need to have certain mechanical properties to perform well and meet different requirements and regulations. Prosthetic companies need to test their material to optimize the performance and cost. Prosthetic Labs offers material testing and consulting services to prosthetic limb manufacturers in order to evaluate their materials. What sets Prosthetics Labs apart from other material testing companies is that the services are exclusive to limb prosthetic companies. Hence, the customers can get specialized and tailored tastings from experts in their field to choose the best and cheapest material.

The prosthetic market was about 1.45 billion in 2006, with an estimated growth rate of 3.9 %, which makes the testing market potentially lucrative. With more than 500 limb prosthetic companies in the U.S, the current market for material testing of these companies is estimated to be $3,500,000. The goal of Prosthetics Lab is to gain 30% of the market share amounting to $1,050,000. The main competitors in this market are testing companies that offer services to a wide variety of industries, therefore being exclusive to limb prosthetics, Prosthetic Labs has a major competitive advantage. However, the major weakness is the limited number of potential customers.

The average price point of the different services is $7000, which was calculated from number of test and the costs incurred. The company will start in year 2010 with an estimated budget required is $415,816. The company will break even in the second

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quarter of 2012. The required capital will be funded from bank loans, family and friends contribution, and venture capitals. These investments will be returned starting from 2013.

Prosthetics Labs will offer its service by using web cataloguing. The revenue will be generated through customer referrals and advertisement in biomedical journals and magazines. Also, advertisement space will be sold in the companys website to material manufactures for prosthetics.

4.2 Problem Statement In 2007, there were nearly 185,000 amputees in the United States. Due to the large number of amputees, the prosthetic limb market is quite large. In order for the prostheses to perform well and not fail, their material must be tested for its mechanical properties and failure. Therefore Prosthetics Labs is offering its services to test these materials for this purpose. The customers of Prosthetics Labs are companies which are manufacturers of prosthetic limbs. These manufacturing companies also need consultation in order to reduce their material cost. Also, FDA requires the prostheses limbs to possess certain qualities for safety and efficacy.

4.3 Solution and Value Proposition Prosthetic Labs is the only company which offers testing and consulting services exclusive to prosthetic limb market. Working with only prosthetic limbs, makes Prosthetic Labs an expert in this field. The company offers material selection and tailored tests for the customers. Other companies offering testing are not aimed at prostheses.

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They offer a wide range of device testing in the biomedical field, which makes them not as specialized as Prosthetic Labs in prostheses area.

Consulting services offered by this company will result in choosing the best and cheapest material which has the required properties for its use. The prostheses manufacturing companies often use unnecessary amount of expensive materials in order to improve the performance of the prosthesis. Also, there are different prostheses for various uses; prostheses for athletes must be much stronger and much more flexible than prostheses for the elderly. Therefore a consulting service is required to understand these differences and make changes to the material amount to save cost and improve performance.

4.4 Market Size According to a study by Frost & Sullivan, the U.S. market for prosthetics was about $1.45 billion in 2006, and this value is estimated to reach $1.85 billion by 2013 (Prosthetics Market Growing, 2007). Based on Frost & Sullivan study the average annual growth rate will be 3.9 % which equates to annual revenue of $56.5 million. This means that the estimated revenue of $1,135,000 will be 2.38 % of the total market growth. This is important because the growth rate of Prosthetics Labs completely depends on the prostheses market. Hence, there is a great potential in the prosthetics industry which creates a good opportunity for Prosthetics Lab Company.

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To calculate the market size for limb prosthesis testing services, the number of limb prostheses manufacturing companies needs to be found. . There are about 500 limb prosthesis companies in the U.S. Some of the companies in the United States that manufacture limb prostheses are: Ossur, Becker Orthopedic Appliance Company, Hanger Orthopedic Group Inc (Prosthetics and Orthotics, 2009).

The entire market size of material testing and consulting for prosthesis companies can be estimated by multiplying the number of all potential customers by the average service charge of $7000. Therefore, the estimated current market size is $3,500,000. The goal of Prosthetics Lab is to attract 150 customers or more of these possible 500 companies by year 2013. This means that Prosthetics Lab will gain 30% of the prosthetic limb testing market share which amounts to $1,050,000.

4.5 Competitors

Table 7 shows the major competitors for Prosthetic Labs including their annual revenue, geographic location and the industries they serve. As it can be seen in Table 7, most of these competitors serve wide variety of industries and located throughout the country and worldwide. The companies that only serve Medical Device have much smaller revenues. Furthermore, there are no competitors that are exclusive to prosthesis companies, thus most of the competitors will be large corporate companies.

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Table 7 Major Competitors

4.6 Customers The customers for Prosthetics labs are the companies that manufacture limb prosthesis. The principal manufacturing or R&D engineers of these companies will be the targets for sale. There are currently about 500 limb prosthesis companies located in the United States. The population distribution of these companies is show in Figure 16. The states with highest percentage of the potential customers are New York, Ohio, Florida, Pennsylvania, and California, each having 6-7.5 % of the prosthetic companies. Since Florida has one of the highest potential customer bases, and corporate income is not taxable in Florida for a single-member LLC, Prosthetic Labs will be located in

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Florida.

Figure 16. Percent concentration of limb prosthesis companies in the U.S.

4.7 Cost The cost for starting the company and providing the services for the years 20102011 can be broken down into two different categories. These costs include fixed cost and variable cost which will be discussed in detail in this section.

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4.7.1 Fixed Cost Fixed cost is the cost needed to provide the service that does not change with the amount of service. The fixed cost break down of Prosthetics Labs Inc. is shown in Table 8 for two years. The fixed cost of the company includes: Startup Cost, which is the initial cost needed to set up the office including the business license fees, lease deposit, rent, furniture, computers, printers, fax machine, and etc. Office rent Stationary, telephone and internet services, website, insurance Equipment rental, which includes Instron tensile test machine, SEM machine, Rockwell hardness test machine, and three point bending test. Salaries, which include salaries of seven permanent employees. The three of the employees including the CEO, the senior consultant and the senior analyst have been assumed to work for free for the first three months. They will start getting paid from the first quarter, although with no benefits until the end of the first year. From the other four employees, two of them are testing technicians. The first year only one testing technician will be hired; however from the beginning of the second year another testing technician will be added. SEM analyst is another employee who will be working part-time for the first year, and full time in the second year. The last employee would be the janitor, working 10 hours a week. Benefits have also been included in the salaries for the full time employees in the cost break down.

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Since Prosthetics Labs Inc. only provides research and consulting services, there are no manufacturing and material costs. There will also be no patent and intellectual property costs. Table 8 Fixed Cost Break Down

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4.7.2 Variable Cost The variable costs of Prosthetics Labs include the costs which are for hiring contract professionals and advertising. The two contract employees are one marketing analyst and another scientific analyst. Due to the low number of customers in the first quarters, the scientific analyst is only needed a few hours a week. However, as the company progresses and attracts more customers, the scientific analyst will be hired for longer hours per week.

As oppose to the scientific analyst, the marketing analyst will be needed more in the initial quarters. As the company grows and settles, the need for marketing as well as advertising will decrease. Other variable costs are incurred by packaging, shipping, equipment calibration and maintenance. The variable cost break down is shown in Table 9. Table 9 The Variable Cost Break Down

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4.8 Price Point

Based on the amount of effort and time required to test and analyze the material provided by the customer, the price point will vary as shown in Table 10.

Table 10 Price Point Analysis

The price point has been calculated according to the number of sample types received and services requested by the customer. For one and two types of samples the service charge is a flat rate of $5000, while for three to four types of samples the rate would be $7000. Finally for five or more samples the price point would be $9000. The mean of the distribution for the price point was calculated and found to be $7000, which will be used in the next section for calculating the revenue and breakeven.

4.9 SWOT Assessment As a part of their planning process, any successful business needs assess their strengths and weaknesses to explore potential threats and future opportunities. Table 11 provides a list of strengths, weaknesses, opportunities, and threats (SWOT) for Prosthetic Labs.

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Table 11 SWOT analysis

4.10 Investment Capital Requirements In order to calculate the budget needed to start the company and make a profit, the total income and losses of company need to be calculated. The income is the revenue that the company will be generating based on the number of customers. The expected number of customers has been calculated based on quantitative forecasting.

The profit/loss then is calculated by subtracting the total cost (the sum of fixed and variable costs) from the total income. Table 12 and Figure 17 show the expected profit and loss (P&L) of the company for years 2010 to 2012.

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Table 12 Expected Profit and Loss

Figure 17. Profit and Loss Chart

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The time at which a company starts to make a profit is called the break-even point. Figure 18 shows the break-even graph. As can be seen from this figure, Prosthetics Lab will be break-even from losses and start making profit of $36,450 in the second quarter of 2012. The total capital required will be the sum of all the losses before break-even. Therefore, the expected budget for Prosthetics will be $415,816.

Figure 18. Break-even chart To fund the budget three different sources will be used which are bank loans, venture capital and money borrowed from family and friends. The break down of the funding is shown in Table 13.

Table 13 Funding Break Down

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4.10.1 Norden-Rayleigh Financial Profile The Norden Rayleigh cost profile indicates the total budget spent until breakeven. Table 15 shows the calculations of cumulative distribution function and probability density for the curve.

Cumulative distribution function is given by (Wesley, 2009):

Where, t-time to breakeven V(t) total amount spent d- estimated budget a-cost drivers Cost drivers are those that cost money to a company. Assuming the cost drivers to be as in Table 14, a will be equal to 0.55.

Table 14 Cost Drivers

Number of cost drivers, N=6 Hence, a=Total/N=0.008

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The probability density function is given by (Wesley, 2009):

From Figure 19, it can be seen that maximum budget is spent at the end of three months. Table 15 Probability density function and Cumulative distribution function for Norden-Rayleigh

Figure 19. Cumulative Distribution Function for Norden Rayleigh

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Figure 20. Probability Density Function curve for Norden-Rayleigh

4.11 Personnel As a start-up company, Prosthetics Lab will only need a few employees to start the business. There are three founders of the company who will occupy the top positions. All three of the founders will share the same set of technical and scientific skills. The skills include having at least an M.S. degree in materials or biomedical engineering. They must have the knowledge of material science, especially in composites and biomaterials and experience in mechanical testing of material and analysis. They must also have a good understanding of the prosthetics industry.

The first of these three positions is the CEO. The CEO will be responsible for management of the employees and financial resources of the company. She will also be

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responsible for legal matters and hiring. The second position would be the senior analyst whose responsibility is to analyze the data gathered from the material testing. Subsequently the third top position is the senior consultant. She will be in charge of consulting the costumers based on the analysis of the results and coming up with the most effective material for the intended purpose.

There will also be three other permanent full time positions in the Prosthetic Labs. The positions are two material testing technicians and one SEM technician. All three positions must have 2 years or more experience relevant to the tasks. The material testing technicians must have a high school diploma or higher. They must be trained to perform the tests offered by the company including Instron tensile test, bending, and Rockwell hardness test. The testing technicians will also be responsible for cutting the samples in order to fit in the test machines. They must also be computer literate and have the knowledge of operating specific software used for the tests. The SEM technician must have at least a B.S degree in material science or material engineering. He must be experienced to operate the SEM machine and have basic knowledge of failure analysis. There will also be another permanent janitorial position which will only be ten hours a week.

The rest of the employees are contract employees which are the marketing analyst and contract scientific analyst. Since the company is a start-up the marketing analyst will be extensively needed in the beginning phases. The marketing analyst must have five years or more experience working with start-ups in the biomedical field, preferably

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prosthetics and have at least an M.B.A degree. The scientific analyst must have a Ph.D. degree in material or biomedical engineering. The skills required for this position is to give professional advice to the consultant and the scientific analyst. Due to low number of customers in the starting period the contract scientific analyst will only be hired for two to six hours a week depending on work load. As the company develops, the need for the scientific analyst will increase and he will be hired for longer hours per week.

4.12 Business and Revenue Model

Any business needs a strategy to sell its product and also generate revenue, which is called business and revenue model. In addition to on location order processing, Prosthetics Lab will use web cataloguing to enable its customers to choose the required testing services for their product. Web cataloguing has the advantage of being easier for those customers who find it hard to commute to the office location. The customers will also have all the information about the services and the amount of samples needed online. The samples can be shipped to the testing location, after which they will be tested and analyzed. The consultation services can either be offered by email, fax or in person as desired by the customer.

The strategy that Prosthetics Lab plans to make revenue is by advertising and customer referrals. Advertising will be done in several ways. One way is to advertise Prosthetics Lab in journals related to materials and medical devices. Prosthetics Labs will also be advertised on the internet, on different prosthesis manufacturers websites.

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Another way is to sell advertising space of the companys website to materials suppliers for medical devices.

4.13 Strategic Alliances and Partners

Prosthetic Labs will be a sole operator and will have no strategic alliances or partners.

4.14 Exit Strategy Return on Investment is calculated by dividing the profit by the total cost of investment. It signifies how profitable an investment is at each time period. Table 16 and Figure 21 show the ROI for Prosthetic Labs. Table 16 Return on Investment for Prosthetics Labs

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ROI 40.00 20.00 0.00 %ROI -20.00 -40.00 -60.00 -80.00 -100.00 Time
Q 1, 20 10 Q 2, 20 10 Q 3, 20 10 Q 4, 20 10 Q 1, 20 11 Q 2, 20 11 Q 3, 20 11 Q 4, 20 11 Q 1, 20 12 Q 2, 20 12 Q 3, 20 12 Q 4, 20 12

ROI

Figure 21. ROI Chart The ROI is negative in the first nine quarters which shows that the company is not making any profit. The rate of increase in the ROI is maximal between the first and third quarter of 2012. It is by the second quarter of year 2012 that Prosthetics Labs will be able to return the capital investments. Assuming a ten fold return for the venture capital, Prosthetics Labs will repay about 35% of the profit starting from year 2013 for the next 20 years. The bank loans will be repaid based on their interest rate.

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5.0 PROJECT SCHEDULE The schedule for the entire project has been split in to two charts: one for ENGR 281 and the other for ENGR 298 Gantt Chart for ENGR 281

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Gantt Chart for ENGR 281

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6.0 CONCLUSION AND FUTURE DIRECTION In this project the mechanical properties of Carbon-Carbon, Spectra-Carbon, and Spectra-Nylon composites has been tested and assessed for the specific application of lower limb prosthesis. According to the results the Carbon-Carbon composite sample had the highest tensile strength of 92 11 and hardness of 93.5 5.8. The SEM results show that the binding of carbon fibers and resin for Carbon-Carbon composites is poor compared to the other samples. This result is consistent with the results from stress-strain diagrams from which the brittleness of spectra-carbon is seen, indicating strong binding. While it is assumed that Spectra-carbon can be a cost-effective alternative to carbon composites, Carbon-Carbon composite is still the best material of choice for this application because of superior mechanical properties. Future research could be done on carbon fiber and resin binding in order to make stronger binding between the two. Furthermore, in future more types of samples and tests could be used for testing and analyzing for this purpose.

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