A business plan for a startup focused on developing a stem cell coating to be used on hip replacement prosthetics. We outlined the technology to be used, regulations to be followed, and financials for the early development of the company. We also detailed the necessary quality requirements for a quality product.

1. Hipsters R Us510 Sansome St. Suite 310
San Francisco, CA 94111
Phone: 415-398-4123
Email: contact@hru.com
Web: hipstersrus.com

2. Mission: Our stem cell therapies give
patients a new level of comfort,
improve outcomes, and reduce costs.
No pain, just gain.
Hipsters R Us

3. Ronita Mukherjee
CEO and President
Wendy Chen
CFO
Carlos Damas
VP, Operations
John Hyun Min
VP, R&D
Jessica Lee
Director, Global Marketing
Hipsters R Us

4. Jay Malmo
PM, Regulatory & Quality
Sagar Desai
PM, Engineering
Neelam Patel
Director, ClinicalAffairs
Mingju Cao
PM, Manufacturing
Hipsters R Us

5. Clinical Needs
Hipsters R Us
1st Surgery
After age of 60+, OA affects over
4.3 million adults and is one of the
most costliest diseases
to the US healthcare system.
2nd Surgery
After 10-12 years,
currently a 2nd
surgery is required
3rd Surgery
Sometimes even a
3rd after 5 years
depending on the
patients motility

6. Business Plan
Hipsters R Us
Ronita Mukherjee, CEO

7. Executive Summary and Goals
• Hipsters R Us is a medical device company that focuses
on intelligent artificial hip prostheses that will increase
patient comfort, longevity of the device inside the
body, and minimize the risk of complications
associated with artificial joint daily wear as well as
surgical insertion. We intend to implement the use of stem
cells as a novel biocompatible material such that it lasts
longer than 10 years, allows for bone/device hybridization
and is bio-degradable.
Goals:
-Enter the artificial hip joint market with a unique
technology that provides a novel patient benefit
- After launch, acquire a significant portion of the global
market shares within a span of 10 years
Hipsters R Us

8. Competitor Systems
• Stryker Accolade II
Hipsters R Us
PureFix HA Coating – Accolade
II features Stryker’s PureFix HA
coating applied proximally
which has more than 15 years
of clinical results in a different
stem.
Corail® Total Hip System now
has the most extensive
experience with a hydroxyapatite
(HA) coated stem.
J&J Corail® Total Hip System

9. Market Competitors
• Stryker
• Trident Acetabular Cup System
• Tritanium Primary Acetabular
Shell
Hipsters R Us
Trident Ceramic
Acetabular
Tritanium
Primary
Acetabular Shell
https://stryker.com/en-
us/products/Orthopaedics/HipReplacement/Acetabular/TritaniumAcetabularShe
ll/index.htm#

10. Market Competitors
• Depuy Synthes
• Porocoat Porous Coating
• Consensus
• CS2 Acetabular Cup System
Hipsters R Us
http://www.depuy.com/healthcare-professionals/product-details/porocoat-porous-coating
http://www.consensusortho.com/index.php/consensus-hip-systems/cs2-cup-system/

11. The Superior KGI Stem
System®
Hipsters R Us
-Advanced artificial hip prosthesis
design
-HA and mesHSC coating
-Porous surface ensures bone
stability
- Made of titanium alloy, increased
durability
- Due to stem cell differentiation,
less chance of rejection from the
body
-Cost-effective and equivalent
rehabilitation time

12. Prototype Drawings
Superior KGI Stem
Hipsters R Us
1
2
3
4

13. Hip Joint Physical Specifications
• Head Options:
Hipsters R Us
Wall thickness
at rim (mm)
Surface
roughness
(μm)
Mean deviation of roundness
(μm)
Head Cup
3.83 0.028 4.1 2.6
Profile
Length(mm)
Neck Angle Specifics
7-21 varied 132°, 127° Lateralized/or not
Coating Size
Calcium Phosphate 1 micron
Stem Cells >1 micron
HA Coating 1 micron
Femoral Head
Dimensions
Femoral Stem
Requirements
Coating
Requirements
Acetabular Cup
Requirements

14. Marketing Plan
Hipsters R Us
Jessica Lee, Director of Global Marketing

15. MARKET TREND
Hipsters R Us
• Osteoarthritis:
– leading cause of hip replacement
surgery
–Currently, 43 million patients
–67 million adults by 2030
–2/3 of patients are women
http://www.cdc.gov/arthritis/data_statistics/national_nhis.htm
There is a need for developing a
cost-effective implant technology
and improving patient outcomes
•Treatment Options:
–Pharmacological agents
–Hip replacement surgery

16. HIP IMPLANTS
Hipsters R Us
• 6% annual growth
•$8.6B by 2016
•2/3 patients over 65
•Biggest growth in age 45-54
http://www.prlog.org/10868056-globaldata-hip-and-knee-implants-market-forecast-
Global Implants Market ($m), 2009-2016
Market Share (%) by Company,
2009-2016

17. TIMLELINE TO MARKET
Hipsters R Us
~1 year 3-6 year 9-36 months1-2 year
Phase I & II
•Opportunity & Risk analysis
•Concept & Feasibility development
Phase III
•Verification & Validation phase
Phase IV
•Final Validation
Phase V
•Post-launch
assessment
We expect to reach the market in 7-11 years
★ Current position

18. LAUNCH STRATEGIES
Hipsters R Us
• Post-market surveillance from Y1
•Marketing effort from Y1
–Y1-3: Orthopedic surgeons and payors
•Fully trained sales representatives
•Emphasis on product quality, reduced
healthcare expenditure, patient benefit
–Y2-4: Direct-to-Consumer Marketing
•Target specific groups of patients, patient
families
•Employ celebrities
•End of Y4
–Possible acquisition of smaller brands
–Gain market share
–Product branding
–Expand product portfolio
1 2 3 4 5
5 year Projection post-launch
Post-market surveillance
Focus: surgeons & payors
Focus: DTC marketing
Marketing effort
Possible Acquisition

19. Hipsters R Us
Assumptions:
• FDA approval by 2021
• 10% Market share by 2026
• Revenues of ~$184,000,000
in 2021
• Device cost: $11,600
• Patients: ~15,800 in 2021
• Total surgeries in 2021:
~527,000
0
10
20
30
40
50
60
70
80
2021 2022 2023 2024 2025 2026
UnitsSold(Thousands)
Year
Units Sold per Year
0
100
200
300
400
500
600
700
800
2021 2022 2023 2024 2025 2026
TotalSurgeries(Thousands)
Year
Total Surgeries Expected by
Year
0 400 800
2021
2022
2023
2024
2025
2026
Revenues ($ Millions)
Year
Revenues by Year

20. Product Development
Hipsters R Us
Carlos Damas, VP of Operations

21. INPUT OUTPUT INPUT=OUTPU
T
DESIGN INPUT
DOCUMENT
DESIGN OUTPUT
DOCUMENT
Tightly fitting joint
system.
Acetabular Cup – 3 screws (
25-33mm(L), 3-4.5 mm (d)
Ball (28-58mm(d))
Femur component (4 4.5 mm
(d) cortex screws)
Yes DI100 DO100
Coating should
consist of materials
that will allow bone
ingrowth.
Coating by layer by layer
technique coats the
acetabular component with
hydroxyapatite
tri-calcium phosphate, (coat
depth 100nm – 1 micron),
then Mesenchymal stem
cells, which allow the
ingrowth of bone
Yes DI300 DO300
Should be comprised
of metal alloys to
increase durability in
the body
Forged Cobalt Chrome,
Cobalt Chrome, Forged
Titanium, and Cast Titanium
that increases the products
durability in the body.
Yes DI600 DO600
Hipsters R Us

22. DI 100 & DO 100
Hipsters R Us
http://mail.cmu.edu.tw/~jthsu/researches/research%20acetabular.htm
http://www.radiologyassistant.nl/en/p431c8258e7ac3/hip-arthroplasty.html

23. Product Production
Hipsters R Us
http://gardenrain.wordpress.com/2009/12/22/
hip-joint-replacement/

24. HA Coating
• Layer by Layer technique coating
• Hydroxyapatite
• Slow process, cheap.
• IR spectroscopy
• Verify the interaction
• Scanning Electron
• Measure the Depth
Hipsters R Us
http://newsoffice.mit.edu/2012/hip-
implants-nanoscale-coating-0419

25. Stem Cell Coating
• Adult Mesenchymal Stem Cells
• Cultured and coat Require a surface for adherence
• Differentiation and proliferation is halted
• Packaged protective foam
• Cells are frozen
Hipsters R Us
http://www.abdserotec.com/mesencyhmal-stem-cell-antibodies.html

26. Product Development
Receive Joint
Unit
Coat with
Hydroxyapatite
& Tri-calcium
Coat with with
Stem Cells
Freeze the
cells
Package
Hipsters R Us

27. Clinical Plan
Hipsters R Us
Neelam Patel, Director of Clinical Affairs

28. Pre-Clinical Studies
• Primary Goals
• Stem Cell: Conduct multiple tests with SC’s both in vitro and
animal to assess safety and efficacy of the specific cell line used
• Implant: Evaluate implant, HA coating, stem cell coating, finished
product for biocompatibility, short term + long term durability and
biosafety
• Tests:
• Stem Cell: Structural/Histological parameters with Cell Imaging, tox
kits for screening, MRI’s with tumor identification, biopsy
• Implant: Chemical/Material analysis of metal alloys- Cobalt,
Titanium, HA coating, polyetheline, packaging, stability, shelf life
• Subjects for in vivo: Mice for SC animal assessments,
Chimpanzees for both SC’s and Implants
Hipsters R Us

29. Pre-Clinical Trial Principles
• Outcome measurements for Stem Cells
• SC characteristics, ID, differentiation and biocompatibility
• Toxicology
• address administration, concentration (justify based on the intended
clinical use), migration, survival, engraftment, differentiation, and
proliferation
• Determine tox endpoints and NOAEL
• Tumorgenicity
• Tumor potential in immunodeficient mice to identify inappropriate cell
proliferation and differentiation
• Outcome Measurements for Implant
• biocompatibility, durability, performance, risk assessment
• Post-treatment follow up surveys and health assessments
Hipsters R Us

30. Clinical Trial Summary
Hipsters R Us
Purpose Evaluate safety of Ocean hip implant system for
treatment of end stage Osteoarthritis patients
Study Design Randomized, Single Group Assignment,
Controlled
Control group: Healthy non-diseased individuals
Primary
Outcome
Measures
Swelling of hip joint, deterioration of joint
function, skin allergic reaction
Secondary
Outcome
Measures
Quantitative changes in pain intensity, physical
function improvement, subchondral bone
edema, cartilage thickness
Number of
Patients
Feasibility Trial: 10, Pivotal Trial: 50
Half with
Inclusion
Criteria
End stage OA diagnosed by MRI
Follow up Clinical: 14 days, 2 months, 6 months, 1 year,
18 months

31. Clinical Trials: Outcomes and Assessments
Measurements of Outcomes
• Pharmacodynamics studies to understand SC effects
• SC Structural and histological assays with Imaging, microscopy,
histological
• Pharmacokinetic studies for SC behavior
• SC parameters: Proliferation, Viability, Differentiation, Migration
• Implant measure biocompatibility, degradation and performance
with parameters modeled from preclinical studies
Assessments of Data
• Clinical efficacy
• Use meaningful endpoints, identify concentrations for optimal therapeutic
effect, evaluate duration, longevity, biocompatibility, compare to placebo
• Clinical Safety
• Risk of procedure for both SC and implant, long-term follow ups, risk
analysis
Hipsters R Us

32. Regulatory Plan
Hipsters R Us
John Hyun Min, VP of R&D

33. FDA Class III device
Pre Market Approval (PMA)
• FDA has very set standards for what is to be included in
the PMA:
1) General Information – Device name, trade name, date
of recommendation.
2) Indications of use
3) Precautions – Patients on medications or complications
related to Device
4) Device Description – Materials and Sizing
5) Safety related issues – Adverse Effects on Health
6) Pre-clinical data on effectiveness - Worst Case
Scenario Testing
Hipsters R Us

34. Pre Market Approval
Hipsters R Us

35. Timeline of Approval
:FDA Clearance to Market the Device
Letter to file->Pre-market Notification [510(k)]- Investigational Device Exemption (IDE)-> Pre-market Approval (PMA)
• The Acetabular Cup can take anywhere from 5.5 years to
10 years from Concept and Design to Patient Access.
Hipsters R Us

36. Package Insert
• Device Description
• Indications
• Contraindications
• Patient Selection
Precautions
• Possible Adverse Effects
• Warnings and Precautions
• Storage and Handling
• Limited Warranty/Liability
Hipsters R Us

37. Package Insert Cont.
Hipsters R Us

38. Quality Plan
Hipsters R Us
Jay Malmo, PM of Regulatory and Quality Control

39. In-Vitro Stem Cell Engineering
Collection
Harvest
Receive
Cryogenesis
Document
Expansion
T-Flask culture
Build cell bank
Modifications
Measure
parameters
Document
Identification
Validate cell ID
and type
Quality testing
Plan multiple
lineage tests
Differentiation
Scaffold induced
with specific
components
Validate
differentiation
Quality
Biocompatibility
with in-vitro
models,
molecule ID’s
Biosafety with
microarrays
Hipsters R Us

40. Verification Tests for Design
“We have an entire [Stem Cell] industry without a single quality-
control standard,” Kevin Parker, Harvard Stem Cell Institute
• In Vitro Quality Control Tests
• Expansion: Growth/morphology/viability
• Create master and working cell bank, ensure quality of SC’s
• Assays: cell proliferation, differentiation, immune modulatory capacity, and gene and protein
marker expression
• Identity: Flow cytometry, qPCR, ELISA
• Ensure cells are correct identity, perform multi-lineage differentiation assays
• Differentiation: Osteogenic, adipogenic, chondrogenic
• Measured through cytochemistry and gene induction associated with each cell type
• Regenerative activity of SC: Biocompatability
• Antiinflammmatory compounds, paracrine factors: (PCR/ELISA)
• Ex factors: VEGF-α, IGF-1, EGF, keratinocyte growth factor, angiopoietin-1, stromal derived
factor-1, macrophage inflammatory protein-1alpha and beta and erythropoietin
• Biosafety: Copy Number Variation Assay with SNP
• compare differentiated vs. non-expanded with SNP arrays, identify genomic insertions and
deletions, identify potentially hazardous properties,, report variations per cell line. NGS can
identify markers that could serve as identity/safety QC parameters for epigenetics
Hipsters R Us

41. SC Upscale Manufacturing GMP
• Cell Manufacturing (GTP)
• Validate maximum production of MSC’s from donor, proper culture techniques and
analytical methods identifying growth, concentrate on up-scaling to commercial
• GMP-qualified serum with trays or t flasks to culture, but may be inefficient with
commercial requirements
• QC Assays and Instrumentation for Manufactured Scale SC’s
• Cell Imaging (Cellavista from Synentec): Uses high-res images can handle large-scale
• Cell status: cell number, confluence, size, morphology, fluorescence intensity, migration,
toxicology
• Phenotype analysis: Arrays, PCR, NGS
• Identify genotypic characteristics of production-level SC’s, may be mandatory for FDA in future
• General GMP guidelines
• Hygine, controlled environmental conditions, defined and controlled
manufacturing processes, clear instructions, operators trained, records made
manual or automatically from instruments, distribution and manufacturing records
of history, complaints with marketed products are examined
• Manufacturing future directions
• Explore Next-gen manufacturing with either serum-free workflow or through the
use of bioreactors rather than traditional, possibly outsource with CMO
Hipsters R Us

42. Manufacturing Facility + Validation Plan
• All production will need to take place in clean room
facility with designated wings that meet GMP/GTP
requirements
• Consideration of CMO to handle these requirements due
to high start-up costs, faculty and operating costs
• Materials for validation: Cell collection, seeding,
harvesting, manipulation, passages, filing, packaging,
transport and storage
• Tests: acceptance criteria related to starting materials,
SC design, SC manufacturing, additional coating
components
• Quality, robustness tests of materials, biocompatibility and
biohazard
Hipsters R Us

43. Manufacturing Facility Requirements
Cleanroom facility, with GMP
• Changing = Operators change
• Materials = Long-term storage at
controlled conditions
• Available supplies = readily accessible
short-term storage of materials
• Staging room = Preparation of
materials
• Process room = manufacturing location
for process, bioreactor/hood
• Manipulation area = Separated room
from the rest, allows for SC modification
to be contained
• QA/QC = verify and validate all steps,
separated but needs access to
• Engineering space = controls layout of
all supplies, materials, etc.
• Documentation = Storage of all written
SOPs and historical information
• Other support space = workspace,
security, network, storage, training
Hipsters R Us
Very expensive, up to
$500k
Doesn’t count operating
costs
Possibly explore CMO’s

44. Hip Implant Packaging- ISO 11607, ISO 2248 and ISO
831840
Stems
Shells
Hipsters R Us

45. Sterility Cycle & Storage
• the sterilization method used in the sterilization cycle is gamma radiation. Gamma rays generated by
Cobalt 60 or Caesium 137 radionuclides; or accelerated electrons from an electron generator.
• Radiation Validation:
• Dose mapping study: Dosimeters are placed in products at contract sterilizer.
• Determination of product bioburden:First, do bioburden test method validation
• Verification dose resistance experiment
• Dose is determined based on product bioburden.
• Irradiate products at "sublethal" verification dose level.
• Test the verification dosed samples for sterility.
• Before sterility test, do B-F testing to validate test method.
• Radiation sensitive colour discs applied to packaging, procedures to distinguish irradiated and non-
irradiated materials, Variation in density of packaging should be addressed during validation
• the sterility assurance level specification (SAL) or the probability of 1 in a million of a container being
contaminated (10-6) is 10^-6
• Prosthetic components are sterilized by exposure to a minimum dose of 25 kGy of gamma radiation.
• ISO 11137 standards
• Store at 4 °C within a freezer
Hipsters R Us

46. Label Inspection
 Device Description
 Indications for Use
 Contraindications
 Warnings
 Precautions
 MR Environment
 Overview of Clinical Studies
 Adverse Events
 Principal Safety and Effectiveness Table
 Patient Selection and Treatment
 Directions for Use
 Patient Materials
Hipsters R Us

47. Product Development Phases (Risk)
Hipsters R Us
Feasibility Design Pilot
Base
Business
Concept
Product Risk Management- On-going
Prelim. Risk Assessment

48. ISO 14875:
FMEA Design
Design
Step/Input
Function
Potential Failure
Mode(s)
Potential Failure
Effect(s)
of Failure
Sev
Potential Cause(s)/
Mechanism(s) of
Failure
Occ
Current
Controls
Det
RPN
Actions Recommended
Department
Responsible
NewSev
NewOcc
NewDet
NewRPN
Embryonic
Stem Cell
use
Improve
biocompatibility of
device
Tumor
development
Hospitalization,
Surgery, Cancer,
irreversibility from
treatment
8
ESC's are
pluripotent,
encouraging rapid
growth
5
Blood test, Urine
Tests, Medical
Imaging
4 160
Evaluation of ESC's vs.
Others, biocompatibility
improvement verification,
continual process
development
Design
Engineers,
Operations,
QA/QC,
8 2 4 64
Stem Cell
Culture
Improve
biocompatibility of
device
Tumor
development
Hospitalization,
Surgery, Cancer
8
Local stem cell
environment may
influence
tumorigenic
potential
4
Blood test, Urine
Tests, Medical
Imaging
4 128
Evaluation of in-vitro
culturing of SC's,
biocompatibility
improvement verification,
continual design
development
Design
Engineers,
Operations,
QA/QC,
8 2 4 64
Patient
Records
Provides
information with
cell culture
use/design
wrong cell
culture choice or
diagnosis
limited
biocompatibility,
hospitalization,
surgery
8
Limited or
misinformation,
unnecessary choice
2
SOP's for Patient
Records,
Diagnosis, Cell
Culture
Information
6 96
Evaluation of HHS/HIPPA
regulatory requirements,
ensure privacy and security
are followed
IT, Design
Engineers,
Operations,
QA/QC,
8 1 6 48
SC Selection
for coating
(allogeneic
/autologous)
Improve
biocompatibility of
device
Rejection of SC's
in user
Hospitalization,
Surgery, Cancer
4
Autoimmune
response, improper
patient
diagnosis/records,
wrong SC line used
4
Blood test, Urine
Tests, Medical
Imaging
5 80
Evaluation of allogeneic vs.
autologous SC's,
biocompatibility
improvement verification,
continual process
development
Design
Engineers,
Operations,
QA/QC,
4 2 5 40
Stem Cell
Selection
Improve
biocompatibility of
device
SC's no longer
function
limited
biocompatibility
3
Expiration of SC's,
no preservation,
SOP's not
performed
2
SOP's for Patient
Records,
Diagnosis, Cell
Culture
Information
5 30
Evaluation of SC's vs other
methods, biocompatibility
improvement verification
continual process
development
IT, Design
Engineers,
Operations,
QA/QC,
3 1 5 15
SC Selection
for coating
(diseased vs.
healthy
donor)
Improve
biocompatibility of
device
Rejection of SC's in
user, infection from
harmful donor
hospitalization,
Surgery, Cancer,
limited
biocompatibility
8
Ethical Issues,
Agent Infection,
Biocompatibility
Limited
5
SOP's for Patient
Records,
Diagnosis, Cell
Culture
Information
5 200
Evaluation of donors based
on records, biocompatibility
improvement verification,
continual process
development
IT, Design
Engineers,
Operations,
QA/QC,
8 2 5 80
Scaffold for
SC
attachment
Biodegradability
improves
biocompatibility of
AJ
Rejection of AJ
from scaffold
limited
biocompatibility,
repair, surgery,
replacement
6
Scaffold with SC's
cannot degrade
properly
3
Scaffold Testing
Records, Medical
Imaging, Bench
Testing
6 108
Evaluation of scaffolds via
bench testing,
biocompatibility
improvement verification,
continual process
development
Design
Engineers,
Operations,
QA/QC,
6 1 6 36
Hipsters R Us

49. ISO 14875:
FMEA Process
Design
Step/Input
Function
Potential Failure
Mode(s)
Potential Failure
Effect(s)
of Failure
Sev
Potential Cause(s)/
Mechanism(s) of
Failure
Occ
Current Controls
Det
RPN
Actions Recommended
Department
Responsible
NewSev
NewOcc
NewDet
Stem Cell
Culturing
To produce stem
cells for the
coating
Contamination by
agents (virus,
bacteria, fungi)
Health harm to
user,
hospitalization,
infection
9
Bad user handling,
no sterile
environment
2
Patient health
reports, process
sample
detection
methods
4 72
Ensure Patient Record
organization, Cell culture
SOP evaluation, continual
process improvement, QA/QC
ranges are acceptable,
Improve training
IT, Process
Engineers,
Operations,
QA/QC,
9 1 4
Preservation
of Stem Cells
cryopreservation
Cells lose
preservability
SC's are inefficient,
coating loses
function,
biocompatibility
decreases
2
Bad cryopreservation
protocol, process not
enforced
2
SOP's, process
flow diagrams
6 24
Cryopreservation SOP
evaluation, continual process
improvement, QA/QC ranges
are acceptable, Improve
training
Process
Engineers,
Operations,
QA/QC,
2 1 6
Storage of
production
materials
Preserve
materials, optimize
process
materials lose
functionality
Coating no longer
efficient, device
loses functionality
2
Neglect of SOP's,
facility loses storage
resources, lack of
company
enforcement
3
SOP's, process
flow diagrams
6 36
Storage SOP evaluation,
continual process
improvement, QA/QC ranges
are acceptable, Improve
training
Process
Engineers,
Operations,
QA/QC,
2 2 6
Cell Handling
Procedures
To ensure
protection of cells
from harm
foreign agent enters
cells, cells are
exposed to humans
SC's are inefficient,
coating loses
function,
biocompatibility
decreases, harm to
user
5
Neglect of SOP's,
lack of company
enforcement,
improper training
3
SOP's, process
flow diagrams
5 75
Handling SOP evaluation,
continual process
improvement, QA/QC ranges
are acceptable, Improve
training
Process
Engineers,
Operations,
QA/QC,
5 1 5
Patient
Record
Information
For individual,
improvement of
biocompatibility
for autologous SC
use
Patient receives
wrong cell line
Patient receives
wrong SC line,
biocompatibility
decrease, user
harm
8
Missing or incorrect
patient record
information
4
SOP's for Patient
Records,
Diagnosis, Cell
Culture
Information
6
192
Ensure Patient Record
organization, SOP evaluation,
continual process
improvement, QA/QC ranges
are acceptable, Improve
training
IT, Process
Engineers,
Operations,
QA/QC,
8 2 6
Harvesting
products from
plasma
To obtain stem
cells from
host/embryo
contamination or
transmission of
foreign agent,
inability to obtain
product
Health harm to
user, infection,
limited product yield
7
Limited technology
for harvest, SOP
neglect, Improper
training for staff
2
Continuous yield
measurements,
tests for agents,
acceptable CQA
ranges
5 70
SC Harvesting SOP
evaluation, continual process
improvement, QA/QC ranges
are acceptable, Improve
training
Process
Engineers,
Operations,
QA/QC,
7 1 5
Hipsters R Us

50. Biological Hazards Results of Risk Assessment According to ISO 14971
Hazard /
Source of Risk
Potential
Failure Mode
Potential Causes of
Failure
Harm for Patient,
User
When to
Occur
Sev
Occ
Det
RPN
Preventive Action
Bio-burden / bio-
contamination
Stem Cells
contaminate
other tissue
No GLP, SOP enforcement,
SC’s cause innate immune
response
Tumor, products
become unusable,
cancer
In use,
Productio
n
8 3 7 168
Evaluation of in-vitro culturing of SC's, biocompatibility
improvement verification, continual design development
Bio-incompatibility AJ Rejection
Infection, bad donor, wrong
cells, innate immune
response
Tumor, device
breakdown,
surgery, cancer
In use 8 4 5 160
Evaluation of ESC's vs. Others, biocompatibility
improvement verification, continual process
development
Incorrect output-
substance/energy
SC’s produce
tumors
SC’s not stable, regulated,
location-specific (spreads
outside cup)
Tumor, device
breakdown,
surgery, cancer
In use 8 4 6 192
Evaluation of allogeneic vs. autologous SC's,
biocompatibility improvement verification, continual
process development
Incorrect chemical
composition
Cup faulty,
Coating incorrect
GLP not enforced, improper
labeling
Incompatible, Cup
breaks down,
replacement
needed
In use,
Productio
n
5 2 2 20
Cell culture SOP evaluation, continual process
improvement, QA/QC ranges are acceptable, Improve
training
Toxicity
Toxic materials
exposure to user
No GLP, SOP enforcement,
materials not properly
stored/contained
Chemical
absorbed,
hospitalization,
tissue damage
In use,
Productio
n
4 2 5 40
Storage SOP evaluation, continual process
improvement, QA/QC ranges are acceptable, Improve
training
Allergenicity
Skin exposure to
materials
No GLP, SOP enforcement,
materials not properly
stored/contained
Rash or other skin
irritation for user
In use,
Productio
n
2 2 3 12
Handling SOP evaluation, continual process
improvement, QA/QC ranges are acceptable, Improve
training
Mutagenicity
SC’s cause
tumorigenisis
SC’s not stable, regulated,
location-specific (spreads
outside cup)
Tumor, device
breakdown,
surgery, cancer
In use 8 5 7 280
Evaluation of allogeneic vs. autologous SC's,
biocompatibility improvement verification, continual
process development
Teratogenicity
SC’s cause
tissue
malformations
SC’s not stable, regulated,
location-specific (spreads
outside cup)
Tumor, device
breakdown,
surgery, cancer
In use 8 5 7
280 Evaluation of allogeneic vs. autologous SC's,
biocompatibility improvement verification, continual
process development
Carcinogenicity
SC’s cause
uncontrollable
growth
SC’s not stable, regulated,
location-specific (spreads
outside cup)
Tumor, device
breakdown,
surgery, cancer
In use 8 5 7 280
Handling SOP evaluation, continual process
improvement, QA/QC ranges are acceptable, Improve
training
Hipsters R Us

51. Financial Plan
Hipsters R Us
Wendy Chen, CFO

52. Opportunity
& Risk
Analysis
• Business
model
• Financial
review
• Market
analysis
• Quality plan
• Manufacturin
g Plan
Concept &
Feasibility
• Early
concept
prototype
• Initial
regulatory
strategy
• Initiate QMS
• Preclinical
test
Design &
Development
• Design
verification
and validation
• FMEA
• Prototype
• Regulatory
strategy
update
• Biocompatibilit
y testing
Product
Launch
Preparation
• Branding
• Final
design/docu
mentation
• Manufacturin
g scale up
• Process
validation
• Sales
training
Product
Launch &
Assessment
• Continuous
sales effort
• Sustaining
engineering
• Quality
audits
• Process
improvement
• Market
surveillance
Gate 0
Product
Definition
Acceptance
Gate 1
Initial Design
Acceptance
Gate 2
Final Design
Acceptance
Gate 3
Product Launch
Acceptance
Development Phase and Functional Activities
$2.5 million $40 million
Hipsters R Us

53. 5 Steps in hip implant
manufacturing
Item Price
Manufacture of alloys and
raw materials
Forged Cobalt Chrome
Cast Cobalt Chrome
Forged Titanium
Cast Titanium
Polyethylene
$41/pound
$25/pound
$16/pound
$6/pound
$9/foot
Casting or forging
intermediate forms
Forged Cobalt Chrome
Cast Cobalt Chrome
Forged Titanium
Cast Titanium
$80/piece
$60/piece
$30/piece
$100/piece
Machining and finishing 20 Hours of direct labor
Coating -Hydroxyapatite
-Stem cell
$125/piece
$1830/dose
Packaging, Sterilization -ϒ radiation is used for
sterilization
-Packaging
$5/part
$20/box
Manufacturing Cost
• BOM:
$266.26/unit
• Outsourcing:
$532/unit
• Final Cost:
$2362/unit
(with stem cell)
Part Number
Part Name Price/ each
Amount
needed
Unit Cost Revision
Unit of
Measure
Procurement
Type
20-0001 Ti64 grade 5,Ti–6wt%, Al–4wt%V (10"-12") 115.94 0.01772 kg 2.9 A each OTS
20-0002 Titanium(IV) oxide (Coating) 100g 213 1 g 2.13 A each OTS
30-0001 Deionized Water-Type II -64 oz 29.99 5 oz 2.34 A each OTS
30-0002 Acetone -1 Liter 101.82 5 oz 15.06 A each OTS
30-0003 Methanol -4 Liter 98.32 5 oz 3.63 A each OTS
40-0001 99.999%Argon Gas 55 - - A each OTS
50-0001 StemPro®BM Mesenchymal Stem Cells-5 x 10^6 cells 2180 300,000 cells 109 A each CUM
50-0002 MesenCult™-SFCulture Kit-400 mL 524 100ml 131 A each OTS
60-0001 QuartzTube 0.1 1 0.1 A each OTS
60-0002 SiCSandpaper 0.1 1 0.1 A each OTS

54. Outsourcing Vendors
Hipsters R Us

55. year 1 year 2 year 3 year 4 year 5 year 6
Product revenue 0 0 0 0 0 0
Licensing revenue 100,000 200,000 300,000 400,000 500,000 700,000
Gross Margin 100,000 200,000 300,000 400,000 500,000 700,000
Total Operating Expenses 496000 506000 551000 658000 748500 998500
Net Income -396000 -306000 -251000 -258000 -248500 -298500
-500,000
-300,000
-100,000
100,000
300,000
500,000
700,000
900,000
1,100,000
Projected Income Statement (Year 1-6)
year 7 year 8
Product revenue 183,558,400 259,422,400
Licensing revenue 800,000 1,000,000
Gross Margin 146,982,112 207,598,632
Total Operating Expenses 1,179,000 1,199,500
Net Income 102,062,178 144,479,392
0
50,000,000
100,000,000
150,000,000
200,000,000
250,000,000
Projected Income Statement (Year 7-8)
Assumptions:
• Licensing Revenue
• Product Launch in year
7
• Positive income
• Capture 3% Market in
2021, 4% in 2022
• Value added pricing
strategy
• $11,600/device
Financial and Sales Projections

56. Funding Source and Fund Raising
Funding Source
Initial
Investment
• Founders, Friends, Family, and Fool
• $355k
Grants • Stem cell technology in tools and
technology category
• $500k to $1.1m
Angel
Investment
• $1-2m
Venture Capital • Multiple VC
• Funds will be released based on
milestones
Market and product requirement
Engineering prototype
Validation/Clinical Unit
Regulatory approval (transfer to production)
Commercial product
• $40m
1%
5%
2%
92%
Initial Investment Angel Investment
Government Grant Venture Capital
Exit Consideration:
1. Acquisition 2. IPO 3. Acquisition after IPO
Hipsters R Us

57. Conclusions
• Only hip implant system on the market that utilizes stem
cell coatings to help stabilize the femoral piece and the
Acetabular cup into the bone
• Antimicrobial properties limit risk of infection to patient
• Will last longer, be more durable and provide a more
comfortable wear for the patient
• With only one required surgery, it is cost effective and will
save the patient and healthcare system money
Hipsters R Us