$$Company Name$$



MedTraction, Inc.

Executive Summary

The purpose of this business plan is to raise funding from an investor. MedTraction, Inc. is dedicated to the development and marketing of a superior traction splint for the use of pre-hospital emergency care providers.

The Product

QAT Splint - A traction splint for EMS pre-hospital care

The QAT Splint (Quick Action Traction Splint) provides optimal traction for mid-shaft and proximal femur fractures. Intuitive in its use, the QAT Splint can provide a trauma patient with rapid care of a painful and dangerous femur fracture. In addition, the QAT Splint stands above most competitors through its unique design allowing it to be easily used in smaller ambulatory vehicles such as van and air ambulances.

Major Benefits

• Delivers stable traction

• Permits movement of patient without fear of losing traction

• Minimizes space problems due to minimal extension beyond patient’s foot

• Minimal interference with important spine immobilization devices

• Facilitates rapid application due to intuitive tensioning mechanism

The Future

The QAT Splint will be marketed as a superior and intuitive traction splint for pre-hospital treatment of mid-shaft and proximal femur fractures with competitive pricing significantly below that of other comparable traction splints on the market.

1. The Product

QAT Splint

The QAT Splint quickly and simply applies traction to a lower extremity of a patient with a mid-shaft or proximal femur fracture. Designed to address problems with other widely used traction splints, the QAT Splint possesses several advantages over other traction splints on the market. The QAT Splint offers a simple intuitive design to allow users to be proficient with it with minimal training. Due to its intuitive design, the time required to apply the QAT Splint is reduced to a minimum. A simple squeeze lever mechanism applies tension to the traction splint with no tension straps to tighten or pull. Because the component being tightened is the shaft of the splint, the QAT Splint protrudes only a small constant distance from the patient’s ankle where tension is applied. This ensures that the traction splint will not get in the way of any doors on an ambulatory vehicle. The end result is a traction device that saves time at the scene of a medical emergency without getting in the way.

|Qualitative Comparison of the QAT Splint to Other Leading Competitors |

|QAT Splint |Hare Traction Splint |Sager Traction Splint |

|Consistent minimal protrusion beyond patient’s |Large protrusion beyond patient’s foot |Minimal protrusion beyond patient’s foot |

|foot | | |

|Simple intuitive operation |Requires repeated practice to use effectively | |

|Relatively low retail price |Relatively low retail price |High retail price |

|Does not interfere with spinal immobilization |Very cumbersome when using with spinal |Does not interfere with spinal immobilization |

|devices |immobilization devices |devices |

| | | |

• Simple one-handed squeeze action to apply traction

• Minimal training required

• Simple for one person to apply

• Provides quality traction matching competitors

2. The Organization

2.1 Registered Name

Medtraction, Inc.

2.2 Commencement of Operations

Our company will commence design operations in Pittsburgh, PA through the fall 2005 semester and continue to prototyping, testing, and manufacturing through May 2006.

2.3 History

This assignment is a required course at the University of Pittsburgh, Department of Bioengineering. This endeavor grew out of an understanding that current traction splint designs have significant room for improvement. While these devices are effective at relieving patient pain from a mid-femur fracture, they are often neglected to be used because of their complicated nature to apply. As a result, our management team decided, with the help of Mark Gartner, Tom Platt, and the Center for Emergency Medicine at the University of Pittsburgh, to take on a challenge: design a traction splint that would encourage the EMS community to use them more often.

2.4 Mission Statement

Medtraction, Inc. has set out to make intuitive, safe, and effective improvements in the medical device industry, specifically to traction splints. We hope to design, test, and manufacture the next-generation traction splints to EMS providers across the country. We strive to delivery quality and effective products in a sensible time scale.

2.5 Organizational Values

• Transparency in all dealings with key stakeholders

• Commitment to customers

• Collaborative approach to new products.

2.6 Founders and Management Team

The management team consists of David Weiser, Stephen Smigel, Azita Elyaderani, and Andrew Malkiewicz. The management team is overseen by two advisors: Tom Platt and Ronald Roth, MD. Both are experienced professionals at the University of Pittsburgh Center for Emergency Medicine. Our team is energized, well educated, and highly motivated. As instructor of this course, Mark Gartner is also available to offer his expertise in the medical device industry as well as in the overall design process. The management team has:

• Actively involved and experienced advisors

• Funding and support from the University of Pittsburgh Department of Bioengineering and Center for Emergency Medicine

• Personality profiles that will result in positive group dynamics

2.7 Major Milestones Achieved to Date

• Individual and group project matrices

• Introductory design brief

• PDS

• Initial Hazard Analysis

• FMEA

• Fault-tree diagram

• EMS Student Survey on the use of traction splints

• Clinical and professional interviews on current traction splint designs

• Commitment of design team through investment from bioengineering department

2.8 Brief Resumes of the Management Team

|Andrew Malkiewicz – Design Engineer |Azita Elyaderani – Marketing and Finances |

|Andrew is a senior biomedical engineer at the University of Pittsburgh|Azita is a senior biomedical engineer at the University of Pittsburgh |

|enrolled in the biotechnology and artificial organs track. He is |enrolled in the biotechnology and artificial organs concentration |

|minoring in chemistry and is attaining a certificate in ASL studies. |track. Azita has research experience in the areas of biomechanical |

|He has completed an internship with the VA hospital on programming |properties of the Brooke’s Membrane and is now conducting artificial |

|Matlab code capable of analyzing ultrasound images at the wrist, and |liver research for Dr. Jack Patzer. |

|an industrial internship with Cook Vascular in cardiac pacemaker lead | |

|extraction. | |

|David Weiser – Market Research Ergonomics |Stephen Smigel – Manufacturing and Testing |

|David is a senior biomedical engineer at the University of Pittsburgh |Stephen is a senior biomedical engineer at the University of |

|enrolled in the bioinstrumentation and imaging track. David has |Pittsburgh enrolled in the bioinstrumentation and imaging track. |

|extensive design experience in the electronics and rapid injection | |

|molding of the Sonic Flashlight, developed by George Stetten, MD, PhD | |

|at the University of Pittsburgh. | |

|Tom Platt – Academic Advisor |Ronald N. Roth, MD – Academic Advisor |

|As the Associate Director of Education, Mr. Platt manages all of the |Dr. Roth is an associate professor of Emergency Medicine, a division |

|EMS-related education programs sponsored by the Center. Mr. Platt is |chief EMS provider, and is the Medical Director of the City of |

|an Assistant Professor in Emergency Medicine at the University of |Pittsburgh Department of Public Safety. |

|Pittsburgh, School of Health and Rehabilitation Sciences. Mr. Platt | |

|has an undergraduate degree from the University of Pittsburgh and | |

|Master’s Degree in Adult Education from Penn State University. He is | |

|currently pursing a doctoral degree from the University of Pittsburgh | |

|School of Education. | |

3. Strategic Analysis

3.1 External Environmental Analysis

3.1.1 Macro Environmental Analysis

Technological Developments

Technological developments in the industry have only produced one alternative to the Hare Traction splint that is intended for use by ambulance personnel (namely, the Sager Traction Splint). However, while the Sager Traction splint addresses many of the issues existing with the Hare Traction splint, many ambulance personnel still feel that it is difficult for one person to use efficiently at the scene of an emergency.

Hare Traction Splint

• Large and bulky design makes the Hare Traction splint difficult to use with higher priority spinal immobilization devices.

• Smaller ambulatory vehicles, such as van ambulances and helicopters, offer very little space between the foot of the stretcher and the back door. The Hare Traction splint usually sticks out too far beyond the foot of the patient to fit in that space and often cannot be used.

• More than one person is required to properly apply the Hare Traction splint.

Sager Traction Splint

• The Sager Traction Splint retails for a premium price that many ambulance companies are unwilling to pay due to the infrequency of use.

• Despite claims by the producer that the Sager Traction Splint can be applied by one person, some EMS personnel complain that it still requires more than one person to apply quickly.

3.1.2 Market Description

• In 2005, the American Ambulance Associated reported that approximately 23,575 ambulances were in service in the United States.

• Every ambulance in the United States is required to carry a traction splint on-board.

3.2 Internal Environmental Analysis

See Appendix A for Summary of Bell Mason Diagnostic. Major strengths and weaknesses that were identified appear in the SWOT analysis in Appendix C.

4. Key Strategic Issues

4.1 Sustainable Competitive Advantage

MedTraction, Inc. will “succeed” because of the following:

• Superior and competitively priced product

• Pressure from physicians to apply traction splints at the scene of an emergency

• Strong team of committed people

4.2 Basis for Growth

The basis for growing the venture is reflected in the following two strategies:

Priority 1: Continue research and development of new and innovative ways to make traction splints more user friendly.

Priority 2: Enter European market (EU)

5. Marketing Plan

5.1 Marketing Objectives

• Establish a strong presence in the US market

• Acquire FDA approval for the QAT Splint

• Acquire state approval for the use of the QAT Splint by EMS responders

• Establish significant high margin sales

5.2 Marketing Strategy

The key to the marketing strategy is to identify key training facilities and ambulance companies that will yield the greatest amount of exposure to the QAT Splint. These facilities and companies can be identified by networking with the individuals in state EMS offices and through trade shows. This marketing approach will expose a large number of individuals whom are responsible for equipment on board ambulances to our superior traction splint. Emphasis will be placed on ease of use and competitive pricing.

5.2.1 Product

MedTraction, Inc.’s QAT Splint will be positioned as a reliable, easy to use, and affordable traction splint ideal for the pre-hospital EMS environment. The QAT Splint will become the leader in traction splint designs through it’s ease of use and affordability. The competitive pricing will also enable a very large number of smaller ambulance companies and volunteer ambulance companies to upgrade from the Hare traction splint.

5.2.2 Price

The QAT Splint will be priced at approximately $200. This pricing strategy will be high enough to convince consumers that the QAT Splint is quality traction device while at the same time remaining within affordable range for ambulance companies with smaller budgets.

5.2.3 Distribution

• Product distribution will be facilitated through well known distributors that are trusted by the EMS community

• This strategy will ensure a presence in the market that increases awareness and builds demand

5.2.4 Promotion

• Seek out the decision-makers in large ambulance companies

• Direct mail corporate material to the above

• Undertake a campaign of personal selling, targeting decision-makers

• Advertise in EMS magazines, on the Internet, and on our website

• Attend exhibitions and trade-shows

• Continual PR: press write-ups; personal interviews; testimonials; product trials

6. Production Plan

The initial assembly plants for MedTraction Inc will be located at the University of Pittsburgh until outsourcing resources can be obtained.

6.1 Production Policy

• MedTraction Inc. will outsource production aspects where possible.

• Components are delivered on a "just-in-time" basis.

• Quality checks are in place throughout the assembly process.

6.2 Plant Location

• Benedum

• Swanson Center

3. Goals for Final Production

• Minimize length

• Allow for one EMS provider to apply traction

• Incorporate a more ergonomic mechanism for applying traction

• Reduce amount of time necessary to apply traction

• QAT Splint does not interfere with spinal immobilization devices

6.3.1 Minimizing Length

• By utilizing a nested tubing design and fixing the patient to the device at the ankle, the device will extend only as long as the patient’s leg in traction.

6.3.2,3 Reduction of Necessary EMT Providers

• The incorporation of a ratcheting handle that gives the user a mechanical advantage will allow traction to be applied by one provider.

6.3.4 Reduce amount of time necessary to apply traction

• Introduction of Caribiner-like clip at distal end will allow user to simply hook and lock the patient’s ankle pad to the traction splint quickly and easily. This is an advantage over current models which requires health provider to thread straps through narrow slits or through plastic clips.

6.3.5 QAT does not interfere with spinal immobilization devices

• Compact design and Ischial pad allow QAT splint to rest on horizontal surface such as a backboard or stretcher.

4. Fabrication

• Ischial pad – will be tooled at the Swanson Institute from two parts designed with Solidworks. The two components (base and shaft) will be bolted together from stock hardware and made from stock aluminum.

• Tensioning mechanism - borrowed from a Quick-Grip bar clamp

• Extention bar, prototyped via Solidworks model from aluminum stock, tooled by David Weiser

7. Organizational Plan

Organization Structure Chart

The Organizational Structure charts appearing below show how the organization's staffing needs change over the next five years.

|Year 1 |Year 5 |

|Board |Board |

|CEO |CEO |

|Design Staff 1 |Marketing Staff 2 |

|Marketing Staff 2 |Production Staff 6 |

|Production Staff 1 |Finance Staff 2 |

| |Sales Staff 2 |

Appendicies

B. Critical Risks and Problems

Development Risk – Zero

The development risk is zero because the initial funding is provided by Department of Bioengineering at University of Pittsburgh.

Marketing Risk – Moderate

This product is new to the market, so it will need substantial advertising. Also a broader market needs to be educated about the benefits of this product over leading competitors. This process will be time consuming.

Management Risk – Moderate

There is a great team in place but the team experiences are limited. Also there is a risk of communication problems among the members of the team as it is the case for many other management teams. The management problems can be eliminated by creating schedules, assigning responsibilities and having weakly project updates from the team members.

Critical Risks and Problems after Production:

Device Breaks – Low/Moderate

This can cause the device to lose traction or it can create material with sharp edges. To avoid running into this problem, the observation of medical personal and manual check of the device before use is needed.

Manufacturing – Low/Moderate

Error in manufacturing can lead to missing pieces, components that do not fit together properly, rough surfaces and incorrect labeling. These can slow done the treatment, create new health conditions, create patient discomfort. Also in case of incorrect labeling it can lead to applying improper traction. These can be avoided by doing quality control at the manufacture.

Operator Error – Low

Operator error comes from not knowing how to use the device properly. This can lead to patient discomfort by causing a reduction of circulation and farther damage to the bone. By having proper device training and effective labeling.

C. SWOT Analysis

|Strengths |Capitalize on Strengths |

| | |

|1. Quality Product |Costumer Satisfaction |

|2. Skilled and Committed team |Ability to work toward a common goal |

|3. Competitive Price |A better market for the product |

|4. Simple intuitive operation |A Strong factor in attracting costumers |

| | |

| | |

|Weaknesses |Address Weaknesses |

| | |

|Marketing the product |Run a successful and effective advertising campaign |

|Management team has not worked together for long period |Assign responsibilities and weakly meetings addressing those |

|Time limitation |responsibilities |

| |Creating a time schedule |

| | |

| | |

|Opportunities |Maximize Opportunities |

| | |

|Expanding Traction Splint market |Build consumer preference for our design |

|Multiple repeat purchases of product for other outlets operated |Sell benefit |

|by initial purchasers |Holding educational sessions at centers for emergency medicine |

|Increasing awareness of our design |Commitment to relentless innovation ensures market bench marks |

|Scope for innovation in existing market |challenged |

| | |

| | |

| | |

|Threats |Minimize Threats |

| | |

|Competitors(Sager Traction Splint) |committed to create an improved product |

|Imation Products |IP protection |

| | |

| | |

| | |

D. Action Plan

Tentative project schedule:

|October |Market and product research |

|November |Product research |

|December |Initial design |

|January |First prototype built |

|February |Preliminary testing |

| |Refined design |

|March |Final testing |

|April |Project completed |

Continued Market Analysis

• Research annual sales figures of traction splints

• Research the rate of new ambulances being put into services

• Find ergonomic data on leg length

Building First Prototype

• Reverse engineer a Quick-Grip bar clamp

• Modify Quick-Grip bar clamp to act as a spreader and accommodate connections to an ankle strap and a brace against the pelvis

Preliminary Testing

• Test initial design within design group to verify functionality as a traction splint

o Material compressive / pull testing on Instron

o Cyclic load testing

o Verify traction sustainability with spring model of human leg

o Human qualitative testing

• Paramedic student appraisal of initial design

o Application time, single EMS provider application

Refining Design

• Reengineer any design problem areas identified in preliminary testing

o Verify that problems have been corrected

Final Testing

• Perform a series of field simulations with a group of Paramedic students to verify usability

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