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BMEStart 2015 Application
By:
Afshin Jahromi: Bioengineering (June 2015)
Afshin Mostaghim: Bioengineering (June 2015)
Christel Italiaie: Bioengineering (June 2015)
Winson Wong: Bioengineering (June 2015)
UNIVERSITY OF CALIFORNIA

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Table of Contents
Executive Summary..............................................................................................................................2
Description of the problem to be solved .................................................................................................4
Project objective statement ..................................................................................................................4
Documentation of the final design .........................................................................................................5
Final Design Prototype..........................................................................................................................6
Final Design Functionality .....................................................................................................................7
Patent Search......................................................................................................................................8
Anticipated regulatory pathway.............................................................................................................9
Reimbursement...................................................................................................................................9
Estimated manufacturing costs............................................................................................................10
Potential market and impact ...............................................................................................................10
Works Cited ......................................................................................................................................11
Letter of Support from Faculty Advisor .................................................................................................12
Key Team Members ................................................................................... Error! Bookmark not defined.
Project Video:
https://vimeo.com/128552648

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Executive Summary
The Problem: The current surgical solution for metacarpal shaft fractures is an extremely invasive
procedure called ‘open reduction internal fixation’ or ‘ORIF’ using dynamic compression plates.
This technique requires a one to two inch incision along the fractured metacarpal bone and
devascularization of the fracture site. Orthopedic surgeons devascularize the area of fracture by
shaving bone, removing vessels, and removing any bodily materials that would prevent the
fixation of an implant onto the site of fracture. This can ultimately lead to: nonunion, infection,
painful hardware, and in certain cases compartment syndrome. (For a demonstration of this
procedure click here.)
Our solution: In collaboration with local orthopedic surgeons we have developed the Metacarpal
Nailing System, which is engineered to treat metacarpal shaft fractures by fixing a rod within the
metacarpal medullary canal. This procedure utilizes a small incision distal to the fractured
metacarpal head and implantation of a rod into the medullary canal. The procedure is minimally
invasive, load sharing, and allows the fractured hand a range of motion during the early stages of
healing. (A step-by-step surgical procedure + images can be found in the appendix - Optional 2)
Our Competition: The following orthopedic surgical device companies offer dynamic compression
plates to be used in performing an ORIF surgery: Biomet, DePuy Synthes, Orthofix, Stryker, and
Zimmer. We only consider companies offering surgical solutions. *Sales & Marketing.
Differentiation: The main differentiating factor in the Metacarpal Nailing System is its minimally
invasive characteristic. This factor demonstrates that our procedure is operated with less injury
to the body than with open surgery [4]. This minimally invasive feature allows the Metacarpal
Nailing System to completely bypass the need to devascularize the hand which results in shorter
surgery times, shorter recovery times, and gives the patient a greater range of early motion.

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Technical feasibility: We created a mock setup of the surgical procedure in order to assess the
technical feasibility of our product. Using 3D printing technology we have constructed
anatomically similar models of adult metacarpal bones. Using saws we have cut the models to
resemble comminuted fracture patterns. Our implants have been implanted into the plastic
models and provide effective fracture fixation and rotational stability. To test the feasibility of
our intramedullary rod delivery system (which will henceforth be referred to as the Guidance
Arm or GA) we have set up an apparatus using 3D printed bones and supporting rods to mimic
the anatomic composition of a human palm (4 metacarpal bones). The Guidance Arm and
intramedullary rod assembly have been successfully tested on this apparatus
Regulatory & Reimbursement: Our product will require 510K clearance for the implantable
portions of our product package - intramedullary rod (stainless steel 316), intramedullary rod
(30% filled Carbon PEEK), and Guidance Arm: interfacing tool (stainless steel 316): Case II. Three
of the four Guidance Arm parts will not come in contact with the body and will not need FDA
clearance - Guidance Arm parts 1, 2, 3: Case I. Reimbursements will be handled through
hospitals claiming insurance codes once our product has been implanted.
Sales & Marketing: In 2009 the SED database reported 257,712 metacarpal fractures in the USA.
Of those fractures [8], ⅓ required surgical treatment (not casting). This yields roughly 85,904
surgically repaired metacarpal fractures [9]. We estimate that ⅓ of the remaining 85,904 are
shaft fractures which leaves roughly 28,635 metacarpal fractures to service. We are going to
market this product to orthopedic surgeons who will ultimately decide which device to use on
their patients. The hospital pays for the use of our product. We plan to have an in-house sales
force that will deal with sales and educating surgeons on the proper use of our products. We

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plan to price the metacarpal nailing system at $700 (for stainless steel implant package) and
$750 (for CPEEK implant package) which mirrors the current compression plate pricing.
Description of the problem to be solved
Metacarpal fractures are the most common fractures in the hand with the two main causes of
trauma being falling and punching. The current procedure to fix such fractures is called an open
reduction internal fixation. First, a surgeon makes a 1-2 inch incision along the fractured bone
and devascularizes the fracture site. Second, they place a dynamic compression plate on the
dorsal face and insert the screws into the fractured metacarpal bone. Lastly, they close the
wound site using stitches. According to the surgeons we collaborated with, without vascular
support fractures take tend to require longer periods of time to heal. Devascularizing the site of
fracture results in surgeries unnecessarily requiring excessive amounts of time (We approximate
this surgery to take 75-90 minutes – Approximation based off of 17 observed metacarpal ORIF
procedures at Riverside Community Regional Medical Center by team member Christel Italiaie).
Likewise, the devascularization increases recovery times in patients and simultaneously limits
their range of motion.
Project objective statement
Our Metacarpal Nailing System will provide a minimally invasive surgical procedure for
metacarpal shaft fractures. This Metacarpal Nailing System is composed of an Intramedullary
Rod, a Guidance Arm, and supplementary tools which help guide the rod into the bone. This
procedure is vastly less invasive because it bypasses the process of devascularization through the
usage of an intramedullary rod as opposed to a dynamic compression plate. This is because
fixation of intramedullary rods utilizes minimal incision techniques that do not require the

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surgeon to have direct vision of the exposed fracture site. Thus our design is engineered to
minimize invasiveness, maximize biomechanical stability, and shorten recovery times.
Documentation of the final design
Standards used:
 ASTM F1264-03 (2012): This specification is intended to provide a characterization of the
design and mechanical function of intramedullary fixation devices [2]. We used this
testing standard as a reference for our tests. This specific specification is intended to be
used in testing of intramedullary devices for large bones (i.e. radius, femur, tibia). Our
implant does not meet the specified dimensions. Due to this we have made modifications
in the standards to test our implant. Our modifications and acquired data can be found in
the testing document. No official standard currently exists for smaller rods.
 ASME Y14.5 - 2009: The Y14.5 standard is considered to be the authoritative guideline for
design language and geometric dimensioning and tolerance - GD&T [3]. Our technical
drawings and design have been completed following this standard. This has helped
reduce guesswork throughout the manufacturing process, improve quality, lower costs,
and shorten manufacturing times [3].
Risk Analysis:
Considering that the Metacarpal Nailing System is a surgical implant we anticipate the following
standard surgical complications [5]:
 Surgical Infections
 Injury to nerves, tendons, and blood vessels.
 Blood Clots
 Fat Embolism1
 Malalignment or the inability to correctly position the broken bone fragments
 Delayed union or nonunion (when the fracture heals slower thanusual or not at all)
 Hardwareirritation(sometimes the end of the nail or screw can irritatethe overlaying muscles and
tendons.
1 bone marrow enters the blood stream and can travel to the lungs; this can also happen from the fracture itself
withoutsurgery

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Final Design Prototype
Figure 2 working prototype. Image shows a part
out of the implanting procedure using our saw
bone apparatus.
Figure 1 exploded view and bill of materials for the Metacarpal Nailing System. A full breakdown of parts
and their dimensions can be found in the appendix. **Implant design resembles [7]

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Final Design Functionality
Figure 5 comparison of load (lbs) vs. displacement
(in) between all samples tested in 3-point bending.
Blue: SST316L 4.4mm (diameter), Red: SST316L
4.0mm (diameter), Black: 30% CPEEK 4.4mm
(diameter), Gray: 30% CPEEK 4.0mm (diameter).
Data loosely compared to [7]
Figure 6 stainless steel 316L and 30% carbon
filled PEEK intramedullary rods (Images show
both 4.4mm diameter (left for both) and
4.0mm diameter implants (right for both).
Figure 4 guidance arm assembly
Figure 3 image shows a step in performing the
Metacarpal Nailing System procedure

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Patent Search
The United States Patent and Trademark Office was the main source for finding information
relating to previous patents on intramedullary rods and Guidance Arm. A specific search of
“intramedullary rod” and “metacarpal” yielded twenty nine results of which only one of them
pertained to our design. The Cooperative Patent Classification (CPC) of our product is A61B
which comprises of various surgical diagnostic and person identification device. One patent was
found by Randall J. Huebner; who founded the orthopedic implant company Acumed in 1989.
The abstract of the patent is as follows:
” A method of bone fixation. A guide device may be disposed such that a first portion of
the guide device is disposed longitudinally in a medullary canal of a bone and such that
a second portion of the guide device is disposed outside the bone and defines a
transverse path across the bone and intersecting the medullary canal. A transverse hole
may be formed in the bone along the transverse path, and a fastener may be disposed
in the transverse hole. A rod may be placed longitudinally in the medullary canal such
that a threaded portion of the rod enters an aperture of the fastener and engages the
fastener at the aperture to lock the rod to the fastener. The first portion of the guide
device may be removed from the medullary canal after the step of forming a transverse
hole and before the step of placing a rod.” [1]
The assessment of these distinctions occurs at the distal end of our mechanism in which our
device is threaded. A corresponding set-screw on the guidance arm allows the surgeon to
manually attach and detach our intramedullary rod from the Guidance Arm. Also, our Guidance
Arm only has holes that describe where the surgeon should lead his surgically drill. This is unique
to our Guidance Arm because our intramedullary rods have predetermined holes therefore the
sole purpose of the drill is to penetrate the bone rather than penetrating both bone and rod.
Also rather than removing the Guidance Arm and then placing the rod, our procedure does not
require the removal of the Guidance Arm in order to insert the rod. Because our patent search

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yielded a mere twenty nine results, and only one of those results was vaguely similar to ours, it’s
clear that our product is not obvious to a person with ordinary skill in the art.
Anticipated regulatory pathway
First, we consider the intramedullary rod implants and Guidance arm: Interfacing tool to be case
II. The reason for this is that we believe there are enough FDA cleared intramedullary rods on the
market today for us to pursue a 510 K through the use of predicate devices. For a list of
predicate devices and logic for selection see appendix (Optional 1). Second, we consider the
following parts to be case I: Guidance Arm: connector, Guidance Arm: back plate, Guidance Arm:
interfacing tool holder. The parts are considered case I because they will have no direct contact
with the human body during the procedure. Case I parts will not require FDA clearance for
commercialization.
Reimbursement
The Centers for Medicare & Medicaid Services (CMS) already has specific reimbursement codes
for intramedullary fixation, such as the current procedural terminology (CPT) code 26608 or
26727 and the relative value unit (RVU) code 11.39. These codes are for intramedullary fixation if
it is done percutaneously and if the fracture site is not opened. Based off of the description for
the CPT and RVU codes, our product, the Metacarpal Nailing System, fits in that category and
should be reimbursable by the CMS. To make certain that our product is reimbursable, we would
consult a reimbursement specialist and reach out to the CMS. Ultimately we plant to make our
product reimbursable under already established CPT and RVU codes and tailor our product and
procedure to those requirements.

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Estimated manufacturing costs
Figure7 Cost of making the Metacarpal Nailing System(low and bulk quantity prices). L.S. - Low
Quantity costs assumes (10 units) B.S - Bulkquantity prices assume (1000) units. *Pricing for
implants made using Surgical grade stainless steel 316L. ** Pricing for implants made using 30%
carbon filled PEEK. ‡These are estimated costs from local machineshops.
Potentialmarket and impact
The Halcyon Orthopedics Metacarpal Nailing System fits within the Medical and Surgical Supplies
industry. This industry is primarily dominated by the three orthopedic companies: Stryker,
Synthes, Smith and Nephew, and a host of smaller companies, similar to Halcyon Orthopedics,
that are each targeting their own unique niche. Consumers, surgeons in this context, have
requested a minimally invasive device that can aid in the process of mending a metacarpal shaft
fracture. Considering this need, Halcyon Orthopedics has developed a solution – the Metacarpal
Nailing System. With the Metacarpal Nailing System, there will no longer be a need for a large
incision along the fractured metacarpal bone or devascularization of the fracture site. Rather,
our product will require three small incisions (each no larger than 2 centimeters) that are later
stitched shut. The Metacarpal Nailing System is the best option for those looking for a minimally
Cost of Components
Part Name L.S. /unit (SSTL316L)* B.S. /unit (SSTL316L)* L.S. /unit (CPEEK)** B.S. /unit (CPEEK)**
Machining + Material Costs
Intramedullary Rods (SSTL316L) 32.47$ 22.94$ 45.46$ 27.53$
Guidance Arm: Back Plate (AL6061) 29.67$ 10.37$ 29.67$ 10.37$
Guidance Arm: Connector (AL6061) 26.80$ 10.20$ 26.80$ 10.20$
Guidance Arm: Interfacing Tool (SSTL316L) 32.47$ 22.98$ 32.47$ 22.98$
Guidance Arm: Interfacing Tool Holder (AL6061) 31.89$ 22.50$ 31.89$ 22.50$
Purchased parts Costs
3.5MX 0.6 Flat head Machine Screw (x2) 0.05$ 0.01$ 0.05$ 0.01$
3.0MX 0.5 Thumb Screw 0.35$ 0.10$ 0.35$ 0.10$
Total: 153.70$ 89.10$ 166.69$ 93.69$

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invasive solution. In the Medical and Surgical Supplies Industry we are looking towards the
orthopedic surgeons to be the ones who use our product. They will be the ones determining
whether or not the patient needs to have plating or use our rod in surgery. Even though
surgeons will be the ones recommending and using our product, it will ultimately be up to the
medical groups and the hospitals if they approve the use of our product. The hospitals will be the
consumers of our product and will be keeping a stock of them on hand according to how many
surgeries they do.
Works Cited
[1] Huebner, Randall J., Shawn W. O'Driscoll, BryonM. Morse, andSteven P. Horst. Rod-basedSystemfor
Bone Fixation. Randall J. Huebner, assignee. Patent8,206,309. 26 June2012. Print.
[2] ASTM F1264-14, StandardSpecificationandTest MethodsforIntramedullary FixationDevices, ASTM
International, WestConshohocken, PA, 2014, www.astm.org
[3] Dimensioningand Tolerancing: Engineering Drawings andRelated DocumentationPractices: An
InternationalStandard. NewYork, NY:American Society of Mechanical Engineers, 2009. Print.
[4] MayoClinic Staff. "Minimally InvasiveSurgery." - MayoClinic. MayoClinic, 16 Sept. 2014. Web. 22
May 2015
[5] "Femur ShaftFractures (Broken Thighbone)-OrthoInfo - AAOS." FemurShaft Fractures (Broken
Thighbone)-OrthoInfo - AAOS. N.p., n.d. Web. 26 May 2015.
[6] Bach, H. Gregory, Mark H. Gonzalez, andRobert F. Hall. "LockedIntramedullary Nailingof Metacarpal
Fractures Secondary toGunshotWounds." TheJournalof Hand Surgery 31.7 (2006):1083-087. Web.
[7] Gajendran, Varun K., RobertM. Szabo, George K. Myo, andShaneB. Curtiss. "Biomechanical
Comparisonof Double-RowLockingPlates VersusSingle- andDouble-RowNon-LockingPlatesin a
ComminutedMetacarpalFracture Model." The Journalof Hand Surgery 34.10 (2009):1851-858. Web.
[8] "UnitedStates CensusBureau." PopulationEstimates:Vintage2009:NationalTables. N.p., n.d. Web.
09 Mar. 2015. <http://www.census.gov/popest/data/historical/2000s/vintage_2009/index.html>.
[9] Tang, Jin B., Philip E. Blazar, Grey Giddens, DonLalonde, CarlosMartinez, and Michael Solomons.
"Overviewof Indications, Preferred MethodsandTechnical Tips for HandFractures from aroundthe
World." The Journalof HandSurgery 97thser. 40.88 (2015):88-97. Web.

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Letter of Support from Faculty Advisor