BAE ORTHOTICS
BAE ORTHOTICS
Erika Franzen
William Porter
Alexis Wickwire
Baby Bootie
-1-
BAE ORTHOTICS
1.0
EXECUTIVE SUMMARY
1.1
1.2
2.0
6
PRODUCT NEED ................................................................................................................................. 6
PRODUCT DESCRIPTION .................................................................................................................... 6
COMPETITIVE COMPARISON ............................................................................................................ 7
9
MARKET SEGMENTATION................................................................................................................. 9
INDUSTRY ANALYSIS ......................................................................................................................... 9
MAIN COMPETITORS......................................................................................................................... 9
STRATEGY AND IMPLEMENTATION SUMMARY
5.1
5.2
6.0
COMPANY SUMMARY ........................................................................................................................ 5
COMPANY OWNERSHIP ..................................................................................................................... 5
MARKET ANALYSIS SUMMARY
4.1
4.2
4.3
5.0
5
PRODUCTS
3.1
3.2
3.3
4.0
OBJECTIVES ....................................................................................................................................... 3
MISSION ............................................................................................................................................. 4
COMPANY SUMMARY
2.1
2.2
3.0
3
STRATEGY AND IMPLEMENTATION SUMMARY ............................................................................. 11
PHASE BREAKDOWN AND MILESTONES ........................................................................................ 11
PHASE 1 ............................................................................................................................................. 11
PHASE 2 ............................................................................................................................................. 11
PHASE 3 ............................................................................................................................................. 12
MANAGEMENT SUMMARY
6.1
6.2
6.3
11
13
MANAGEMENT SUMMARY .............................................................................................................. 13
ORGANIZATIONAL STRUCTURE ..................................................................................................... 13
MANAGEMENT TEAM ...................................................................................................................... 13
-2-
BAE ORTHOTICS
1.0 Executive Summary
The expense in receiving medical treatment for congenital talipes equinovarus (clubfoot) escalates
exponentially as the cost for the currently preferred treatment devices can range on average from $200 to
$300. Being one of the most common pediatric orthopedic conditions, clubfoot is a deformity that affects
approximately 1.2 of every 1,000 live births in the United States alone. Comprehensive treatments
typically involved surgical management of the clubfoot deformity until recent when long-term follow-up
studies revealed complications of recurrence, overcorrection stiffness, and pain. Although treatment of
patients has turned to non-surgical techniques, up to 50% of overall corrective procedures fail that
subsequently necessitate additional expensive and painful corrective therapy using aggressive methods.
Typical failure is due to poor wear of the device on the deformed foot. Moreover, non-surgical current
therapies are costly, cumbersome, and requiring of multiple devices to accommodate child growth.
Specifically, the Ponseti Method is currently the most highly recommended means of treatment of
clubfoot. This method involves gentle, manual manipulation of the child’s afflicted foot (or feet) and
application of toe-to-groin plaster casts. The casts are then changed weekly (5-6 weeks on average)
following clinical manipulation of the softened foot ligaments to gradually achieve near-normal muscle
and bone alignment; cast changes are also used to accommodate natural growth of the child. After
completing the casting procedure, the clinician prescribes a device (corrective brace) to be worn, on
average, full-time for three months and part-time for two to three years. Exclusive of the expense in
purchasing multiple braces, cost of the Ponseti Method amounts to approximately $2,000.
Furthermore, prevalence of the clubfoot deformity is 5 to 7 times greater in most third-world countries,
such as Uganda and Honduras. In Uganda alone, there are 10,000 known current cases of clubfoot.
Availability of medical personnel is severely limited in such countries and treatment costs of $2,000 are
unrealistic and economically impractical for these patients.
BAE ORTHOTICS is a medical device company that proposes to manufacture and market a novel medical
device with corrective treatment techniques for congenital talipes equinovarus. BAE ORTHOTICS’s Baby
Bootie is a patient-pending, low-cost, foot orthosis that provides corrective therapy in treating congenital
clubfoot. The unique design will allow more widespread implementation of non-invasive means of
therapy with improved clinical results at minimal cost to the patient.
1.1 Objectives
Design of the Baby Bootie incorporates features to create for a marketably competitive orthotic
device to non-surgically treat clubfoot, as well as constructing a feasibly cost effective device for
patients in underdeveloped countries. Cost of current devices can range from $200 to $300 for the
Dennis-Browne Splint and approximately $200 for The Wheaton™ Bracing System (KAFO), the
two primarily prescribed products in the United States. Both of these then require continual
replacement by larger sized product models as the child grows during natural development. A
non-complex design created by BAE ORTHOTICS with specifically chosen materials will keep
market cost to a minimum. The Baby Bootie design provides adjustability features to improve
wear by limiting undesired movement within the brace, in addition to accommodating for patient
growth. One of the largest sources of failure using current products is poor wear that affords ill-3-
BAE ORTHOTICS
positioning on the foot within the orthosis and/or allows distraction from the foot with the device.
Additionally, the design set forth by BAE ORTHOTICS provides unilateral treatment and
independent movement of each leg. This is particularly beneficial for patients with the deformity
present in only one foot rather than in both.
1.2 Mission
The goal of BAE ORTHOTICS is to manufacture and market a novel device that is cost effective and
simple to use with a unique design allowing for more widespread implementation of this means of
corrective therapy with improved clinical results on a global scale. Therefore, we endeavor to
market our device at a selling price of approximately $30.00. This retail price is exclusive of
clinical fees which may incur upon acquisition of the device for instructional use. The price
estimate amounts from material and labor costs in the United States. As with any self-sustaining
business, BAE ORTHOTICS wishes to generate return on the product, although we strive to
penetrate the market with a competitively low price.
-4-
BAE ORTHOTICS
2.0 Company Summary
2.1 Company Summary
BAE ORTHOTICS will manufacture and market a novel medical device. Current company
developmental activities consist of design, preliminary construction, market analyses, and safety
analyses.
2.2 Company Ownership
The structure of BAE ORTHOTICS consists primarily of three bioengineers:
Erika Franzen
William Porter
Alexis Wickwire
Professional and production consultation is carried out by a business professional within the
medical device industry:
Mark Gartner
Clinical consultation is handled by a senior member of the Children’s Hospital Orthopedic
Department, located in Pittsburgh, PA:
Dr. Morey Moreland
-5-
BAE ORTHOTICS
3.0 Products
BAE ORTHOTICS will produce an orthotic device in treatment of the clubfoot deformity: Baby Bootie.
3.1 Product Need
Clubfoot (congenital talipes equinovarus) is a deformity of all tissues (bone, muscle, ligaments,
nerves, and blood vessels) below the knee present at the time of birth. It is characterized by ankle
equinus, heel varus, forefoot adduction, and midfoot cavus. In short, the foot is curved and
pointed in an inward and downward direction. Without proper treatment to reduce or eliminate all
components of the deformity, the child will never achieve a functional, plantigrade, mobile,
painless foot. In severe cases, the deformity forces the child to walk on the outer side of the foot.
Other effects of this condition include less developed muscles in the calf as well as shortened and
tightened ligaments and tendons in the ankle. These compounding factors caused by the condition
restrict movement of the ankle and limit normal mobility. Untreated clubfeet result in persistent
deformity with increasing stiffness, painful ambulation, and inability to wear normal footwear.
Although many etiological theories have been proposed, none alone can fully account for the
complex deformity. There is no cure to clubfoot anticipated in the near future as a consequence of
the obscurity in its multi-factorial etiology. Moreover, the deformity is considered a familial
condition. It is reported that having one affected child increases the probability of a sibling
having clubfoot by 20 to 30%. A family history of the condition is reported in 24% of affected
children. Race also operates as a major variable. Oriental populations (0.39:1,000) are noted as
having the lowest affliction rate, while Polynesian populations (6.8:1,000) have the highest.
To date, several methods exist in treating clubfoot. The affected individual can live an unhindered
life with minimal residual effects of the deformity if treatment is successfully achieved. The
methods of corrective treatment can either be surgical or non-surgical, each with multiple
techniques in administering the treatment. Some non-surgical methods include soft-tissue
manipulation, continuous passive motion, strapping, and casting. The most highly recommended
technique is the Ponseti method, which consists of casting followed by the use of a brace to
maintain the correction while child growth and development continues. As a more aggressive
approach, surgery can also be used. Several surgical methods differ between various corrections
of soft-tissue and/or bone.
In addition to efficient medical treatment, our target customers have a two-fold need of the device:
1) minimizing cost and 2) optimizing comfort during wear/use.
3.2 Product Description
A more specific description of the Baby Bootie is as follows:
-6-
BAE ORTHOTICS
The device consists of two main units that work together to provide overall corrective treatment.
The first is the shoe-shank component—the functional brace component. Shoe-shank composition
consists primarily a medium weight leather as to not be too flimsy while allowing for a large
extent of flexibility. Leather extends from the inferior edge of the mediolateral portions of the
foot to approximately mid-calf. Semi-rigid supports that allow for limited flexibility are built into
the lateral side of the brace from the most superior region down to the region of ankle articulation
to act as struts for the brace. Another strut composed of a more rigid (less flexible) material is
included along the posterior side along the length of the leather; this provides support to maintain
shape and resist compression/collapsing. Interwoven laces across the top of the shoe allows for a
secure, yet adjustable, fit with the foot. Additionally, the shoe has an open-heel design to reduce
unnecessary pressure on the heel and Achilles tendon. The open-heel also provides a means of
visual validation of proper placement of the child’s foot in the shoe.
The second component is the sole and strapping unit. A rigid material will be formed into the sole
and ultimately attach to the inferior portion of the shoe-shank component with an adhesive.
Adjoined at specifically designated locations, two straps are reinforced to the sole and ultimately
attach at respective connectors. The connectors are adjustable plastic devices. Plastic material
composition prevents injury to the patient during wear/use while providing a secured means with
adjustability features to achieve the required positioning (approximately 70° of external rotation
and 15° of dorsiflexion). Foot positioning specific to the patient is to be determined by either the
practicing physician or physical therapist.
Construction is completed using biocompatible and minimally hazardous material in conjunction
with anthropometric dimensions of the foot and leg to achieve ultimate comfort and safety for the
child. In consideration of the child’s delicate skin, the inner side of the brace will be non-abrasive
although a sock is to be work under the brace. Furthermore, chosen materials will be able to
withstand expected forces generated with wear over long durations of time.
3.3 Competitive Comparison
After speaking with pediatric orthopedic doctors, the need for an improved device was addressed
and confirmed. An important aspect to the success in treatment of this condition is the ability to
keep the foot stabilized in the desired position during the growth of the still-developing child. Use
of the brace can last as long as four years. One primary flaw of current devices identified by
doctors is that the product designs allow children to remove the braces by slipping them off after
properly being place on their feet. One of the goals in designing the Baby Bootie includes
inhibiting removal of the device by the child, but also to increase the comfort during wear to
minimize the desire to remove it.
Cost raises another identifiable issue with devices currently on the market. Indications for a costeffective device that could be utilized in third-world countries for the correction of clubfoot are
unequivocally clear. This introduces an even bigger market that has not yet been addressed.
Success of the Baby Bootie relies on establishment of low production cost. In addition, the design
must create a degree of easy usability and function without degradation of the materials in a
variety of environmental conditions.
-7-
BAE ORTHOTICS
-8-
BAE ORTHOTICS
4.0 Market Analysis Summary
In a 2000 National Vital Statistics Report, it was reported in 49 states and the District of Columbia that of
4,031,591 reported births, 2,271 were diagnosed with having congenital clubfoot. Although this seems
like a small number, it is usually reported that approximately 1.2 in 1,000 infants are born with clubfoot,
which is a close estimate to that of the statistics from 2000. St. Louis Children’s Hospital alone reported
that it treated 120 infants in 2004. Underdeveloped countries are reported having 5 to 7 times greater
prevalence of the deformity. Although causes of the condition are not substantiated, it is know that
clubfoot is familial. Based on this data, if is apparent that the market is constant for a device such as
proposed by BAE ORTHOTICS.
4.1 Market Segmentation
Currently the market for this product is primarily domestic. A patient will need a device for
several years with treatment that can last up to four years. Despite adjustability, children with the
condition will need multiple devices to account for a range of product sizes owing to natural
growth and development. In addition, if the patient is afflicted with the condition in both feet,
he/she would need to utilize two devices simultaneously.
However, medical professionals are discovering the need for treatment of clubfoot in third-world
countries where medical treatment is not only extremely costly, but also difficult to acquire. This
market could be a huge resource for customers if an appropriate product can be developed to fit
their medical and economic needs.
4.2 Industry Analysis
Prices of current treatment devices tend not to allow accessibility of the product for many patients
in foreign countries. BAE ORTHOTICS attempts to take advantage of this tendency. There has been
recent work done by domestic and foreign medical professionals to increase this accessibility to
patients who cannot normally afford extensive medical care treatment.
As well as the cost factor, statistical data illustrates that only unilateral treatment is necessary in
approximately 50% of reported cases. Bilateral treatment devices are unnecessary in these cases.
Again, BAE ORTHOTICS intends to capitalize on this fact.
4.3 Main Competitors
Currently there exist several competitive products on the market designed to be used as a foot
orthosis for correction of clubfoot. The two primary devices that BAE ORTHOTICS will encounter
on the market are: 1) the Dennis-Browne Split and 2) The Wheaton™ Bracing System (KAFO).
-9-
BAE ORTHOTICS
One respectably prescribed orthosis is the Dennis-Browne Splint, which was developed to aid in
the treatment of clubfoot following manual manipulation and castings of the foot as described by
the Ponseti Method. The splint consists of two specialized leather shoes that are connected to one
another via a rigid (metal) bar. This bar allows the shoes to be rotated outwards and slightly bent
to place pressure on the foot in an upward direction, thus creating plantar extension of the heel.
Even if the clubfoot condition is only present in one foot (unilateral), the splint restrains both feet
to establish the position and posturing used for treatment. The Dennis-Browne Split is a
substantially expensive orthotic device.
Another commonly prescribed device is The Wheaton™ Bracing System (KAFO), developed by
Wheaton Brace, Corporated. This product is a thermoplastic brace with touch fasteners. Wear
confined to a single leg remains one of its greatest advantages. Therefore, if affliction of the
clubfoot deformity occurs in only one foot, restraining the other leg during treatment becomes
unnecessary. Two separate elements form The Wheaton™ Bracing System (KAFO): the upper
and lower components. The lower component corrects the position of the foot, whereas the upper
part maintains the knee in 90º of flexion while used in conjunction with the lower component.
Similarly to the Dennis-Brown Splint, The Wheaton™ Bracing System (KAFO) is economically
ineffective with a high retail cost.
- 10 -
BAE ORTHOTICS
5.0 Strategy and Implementation Summary
5.1 Strategy and Implementation Summary
The aim of BAE ORTHOTICS, as previously stated is to manufacture and market a foot orthosis
fabricated from a novel design as a means of treatment for the debilitating deformity commonly
known as clubfoot. The development of this device is to ultimately occur in three main phases.
Phase 1 consists of research and preliminary analyses. Stage 2 primarily focuses on the product
designed based on the information gathered during Phase 1 with considerations of the previously
established design requirements. Redesign and further development of the proposed device and
preliminary testing occur during this time. Product validation and verification, following the final
design construction, will take place during the third phase prior to marketing of the Baby Bootie.
Upon satisfying all validation and verification protocols, the novel orthotic device will be made
available on the market to patients in need.
5.2 Phase Breakdown and Milestones
Manufacturing and marketing of the Baby Bootie can be segmented into three main phase
breakdowns as follows:
Phase 1
The foremost purpose of the initial phase was to gather all necessary data and information. In
doing so, extensive research was performed to fully understand the medical condition of
interest (congenital talipes equinovarus). Largely, tasks were split by market analyses and
medical background between Alexis and Erika, respectively. An understanding of the
physiological condition, means of treatment, complications and limitations of the current
treatment methods, and related statistics were obtained. A market analysis was performed
with the collected information. From this, the need for an improved device was established
and further confirmed by BAE ORTHOTICS’s clinical consultant, Dr. M. Moreland and
similarly qualified pediatric orthopedists. Erika functions as our clinical liaison with medical
professional.
Phase 2
Product design of our novel design—the Baby Bootie—summarizes the second phase in its
development. Before formulating design concepts, preliminary risk analyses were performed.
Input from all team members were compiled in completing the analyses and estimated risks
were considered during conceptualization. Preliminary design was formulated by Alexis.
After analyzing the proposed design and receiving feedback from both consultants, Bill and
Erika completed a redesign of the orthotic device with additional input from Alexis. As with
the first proposal, each redesigned product received extensive analysis of its potential
effectiveness and safety by all team members and consultants.
In addition to
conceptualization, Bill researched and evaluated potential materials to use during construction
that satisfy our predetermined needs: bio-compatible, cost-effective, minimally hazardous,
design compatible. Upon completing the final design used for fabricating the prototype, Bill
- 11 -
BAE ORTHOTICS
made the necessary contacts and obtained materials. Bill also established product validation
and verifications protocols during this phase. As an extension to the market analyses and
understanding of current competitor products, Alexis handled the necessary business
management, including composing the business proposal for BAE ORTHOTICS.
Phase 3
Phase 3 mostly involves fabricating the proposal orthotic device. This is the current status of
the device stands. Validation and verification protocols will be implemented on the Baby
Bootie based on those previously established by Bill during Phase 2. To satisfy these
protocols, the orthotic device will be evaluated by both the clinical and professional
consultants. From this point, BAE ORTHOTICS proposes test the device to validate its function
and comfort for the child while receiving treatment.
- 12 -
BAE ORTHOTICS
6.0 Management Summary
6.1 Management Summary
The founding team members of BAE ORTHOTICS are Erika Franzen, William Porter, and Alexis
Wickwire. Each serves as an active participant with equal contributions to the overall functioning
of the company. Specific tasks are delegated as seen fit by the team as a whole based on
knowledge and experience backgrounds. The various strengths of each member will combine to
ultimately achieve our unifying goal.
There is also the essential involvement of and contributions by two consulting team members.
6.2 Organizational Structure
As previously stated, distribution of duties will be delegated on a specific task basis to the three
primary team members.
Feedback and additional assistance, if necessary, will be requested from the consultants at various
stages of the process.
6.3 Management Team
Erika Franzen
BS, Bioengineering, University of Pittsburgh
Erika began her training in bioengineering at The University of Pittsburgh and has a depth of
study in biomechanics. She has held positions in bioengineering research at two separate
facilities, gaining experience with in-depth computer usage of programming and data analysis.
The laboratories where she performed these duties were at the Human Engineering Research
Laboratories (HERL) and the Eye and Ear Institute (EEI) in Pittsburgh, Pennsylvania. Erika
has also experienced the industrial work environment of bioengineering with employment at
Respironics, Inc., also located in Pittsburgh. As part of the research team, she used
anthropometric and comparative analysis to develop a mask-sizing tool for medical respiratory
facemasks.
William (Bill) Porter
BS, Bioengineering, University of Pittsburgh
Bill received academic instruction in bioengineering from the Department of Engineering at
the University of Pittsburgh. His studies focused primarily on biomechanics. During the
- 13 -
BAE ORTHOTICS
course of his instruction, he also gained practical experience in both industrial and research
settings. Previously, he has worked at the National Institute of Occupational Safety and
Health (NIOSH) performing ergonomic evaluation of laborers in the mining industry.
Specifically, his duties included site evaluations of the occupational biomechanics of the tasks
being performed by the workers. Bill currently works as a part time engineering at the Human
Movement and Balance Laboratory (HMBL) in Pittsburgh, Pennsylvania. He assists in
utilizing robot technology for research project on human foot performance as a collaborative
study with the Musculoskeletal Research Center (MSRC).
Alexis Wickwire
BS, Bioengineering, University of Pittsburgh
Analogous to the other team members, Alexis has received her academic background in
bioengineering at the University of Pittsburgh, with in-depth instruction in biomechanics. Her
experience consists of hands-on research at the Musculoskeletal Research Center (MSRC), an
orthopedic research center. Alexis specifically worked within the shoulder laboratory.
During her time at the center, she has been lead engineer on two separate research projects.
Her current project involves extensive use of robotic technology with human cadaveric
specimens.
Presently still working at the MSRC, Alexis intends to continue her studies in bioengineering
for a master’s degree at a graduate institution, eventually leading into doctoral (Ph.D.) studies.
- 14 -