1. Celebrating 20 years of turning client ideas into award winning products!
11/19/12 1

2. Our systems experts listen to
our clients, define an optimal
architecture, select the most
appropriate technologies and
leverage our strategic partners
to design, build and deliver
products that work
11/19/12 2

3. Who we are….
Incorporated - January 1992 * Experienced Management Team*Privately held
Technical Innovation and Product Development for
Life Science,
Medical
and High-Tech Industrial product companies
11/19/12 3

4. Engineering Talent
 34 Full-time employees at Sunrise Labs
 28 technical contributors
(9 EE, 16 SW, 1ME/EE, 2 QA)
Includes 5 Technical PM’s with System Design experience
 Experienced project management
 Average 20+ years experience
 Very low turnover, stable team
 Breadth and depth of experience to solve tough technical
problems!
11/19/12 4

5. Sales &
Distribution
Manufacturing
Sunrise Verification
and
Validation
Product
Development
Product
Design
Concept
And Usability
11/19/12 5

6. Development Services
 Complete System Design and Requirements management
 Battery and Power Architecture
 Complex Analog and Digital Design
 Embedded Systems
 Software Development; Real-time, Multi-tasking Systems
 User Interface Design and Development
 Project Management ……………….Project Rescue
 Verification and Validation
 Risk management ISO-14971
 Support for Regulatory and FDA Approvals
 Prototype Fabrication and Test
 ISO-9001 and ISO-13485 Certified
11/19/12 6

7. Development Environment
 Cooperative & Flexible Team Approach
 Comprehensive Project Control Procedures
 Project Appropriate Tools
 Project Appropriate process – Waterfall, Agile, etc.
 Process oriented, risk based development
 Client Version / Enhancement Tracking Database
 On-line collaboration tools
 Compliance with Applicable Regulations and Standards
11/19/12 7

8. Quality and Regulatory Processes
A demonstrated process driven by International Standards and Best Practices…
 Understanding and negotiating Regulatory Forces and
Quality Management Systems is vital to the success of any
life sciences project:
Quality Management System
(ISO 13485)
Risk Management Process
(ISO 14791)
Software Development Lifecycle framework
of processes, methods and activities
(IEC 62304)
SOP’s
(International Standards for
Software Development)
11/19/12 8

9. Project Management
 System design approach
 Technical design experts
 Quality designed in – not tested in
 Incorporate client’s guidelines & templates
 Collaborative design environment
 Client-focused teams
 Weekly Communications
 EINs to formally communicate project changes
 Deliver projects on-time & within budget
 Consistently exceed expectations
 Risk mitigation based planning
11/19/12 9

10. Technical Expertise
 System Architecture Design  Algorithm Development
 Medical Electronics  Embedded Software
 Instrumentation & Control  Display / LCD
 Single Board Computers  DSP
 Embedded Microprocessors  UI and GUI Development
 Modeling & Simulation  Image Processing
 Analog Signal Detection &  Electro-optical
Control  Windows® , Mac OS
 Power Electronics  RTOS
 Robotics  Linux Embedded
 CanBus, ModBus, etc.  Win CE / Net
 Ethernet  Embedded XP/Win7
 Electro-mechanical  C, C++, C#, OO, Assembly…
 Wireless Connectivity  PLD / FPGA
 SWQA, Risk Management  PCB Design
 RFID  Design for Manufacturing
 Regulatory Compliance  Mobile Development (iOS, Android)
 IEC 60601-1, IEC 62304  Serial Communications , USB, etc.
 21 CFR 11, 21 CFR 820.30
11/19/12 10

11. Enhancing Drug Delivery Through the Skin
 Re-design a low cost, disposable
transdermal drug delivery system to
have higher output, yet use small coin
cell batteries – Eliminating need for do-
over design
 Maximized battery performance using
a highly efficient boost converter and
power saving techniques -3x the
power!
 Modular approach for firmware
implementation streamlined changing
product requirements during
development.
 Complete FDA 820.30 documentation
 Successful 510k submission for new
combination product group at FDA
11/19/12 11

12. Revolutionize controlled respiratory hydration
Develop a patentable, easy to use
product
Complete product development of the
class II medical device
Invented techniques to control water
vaporization with breakthrough
technology using nested PID loops
Unique remote vapor generator and
sensor solved condensation and heat
control problems
Technical breakthroughs were
foundation of product. Patent
pending.
PARI Hydrate G.33 received FDA
clearance
11/19/12 12

13. Next-gen Class II Laser therapy device
Implemented a monitoring/control algorithm
with Modbus communication to laser head to
meet enhanced performance goals
FDA clearance
Increased market acceptance
11/19/12 13

14. Dental Laser-Wireless Foot Controller
Resolve design problems with a battery operated wireless foot
pedal used in dental applications and experiencing a high rate of
field returns
Performed design review and recommend design improvements
to improve reliability of the wireless link
Design was updated based on Sunrise review and
recommendations and met the required reliability metrics
Design incorporated a medical fiber laser and Zigbee wireless
technology
11/19/12 14

15. Faster-than-real-time simulator
for 1,100 km (700 miles) train system with a million passenger-per-day capacity
Provided 32,000 virtual processors using "only" 60
physical Power PC RISC microprocessors
Massively parallel real time computing system with
simulation accurate to +/- 2 seconds per day of actual
operation
Design and develop a programming language to allow
end-client programming of the system
System in use today to plan capacity and train schedules
on a daily basis
Simulation details coded by the customer using tools
developed and provided by Sunrise Labs' subsidiary
Flavors Technology including Flavors PIM and Paracell
programming language
Development environment designed to be simple enough
for customer to develop and maintain most of the domain
specific code
11/19/12 15

16. Unique Point of Care blood analyzer
Complex laboratory-quality assays in minutes
Met critical, fast track development schedule; 6 months
for Architecture, electronics, and software
Created flexible, modular architecture to support on-
going research and product for clinical use
Quick turn-around of high-fidelity implementations of
usability tested user interface
Instrumental in the development with Claros of effective
control and analysis algorithms with efficient
implementation
Created flexible development platform enabling future
menu expansion for a family of diagnostic products
CE Mark received in 2010. FDA clearance and CLIA
waiver pending
11/19/12 16

17. Surgical Robot:
System Architecture and Controller Design
 Establishment of Critical
Control Loop Right Hand
Controller
Right Haptics
Module Gigabit
(2 DOF) (6 DOF) Switch
 Design of Motor Controls Haptics
Processor
(16 DOF)
Kinematics
Processor
CPD
Controller
1
CPD
Controller
2
CPD
Controller
3
CPD
Controller
4
Required low Latency control
Vision

Left Hand Left Haptics
Controller Module Tower
(2 DOF) (6 DOF) CPD 1 CPD 2 CPD 3 CPD 4
and visual feedback to make
Gigabit
Switch
Surgeon
Foot Pedal Console
Foot Pedals HMI Control
& Illumination Processor Processor
(x4)
(SCP)
robot feel like extension of
Z-rail & Z-rail & Z-rail & Z-rail &
instrument instrument instrument instrument
Ambient Controller 1 Controller 2 Controller 3 Controller 4
Light
Sensor Head
Presence
Sensor
surgeons hands
Z-rail 1 Z-rail 2 Z-rail 3 Z-rail 4
Ethernet
Switch
Z-rail 1 Z-rail 2 Z-rail 3 Z-rail 4
Identifier Identifier Identifier Identifier
 Full System Review for Instrument/
Electrosurgical
Endoscope
Instrument/
Electrosurgical
Instrument/
Electrosurgical
60601-1 Compliance 3D Vision DVI “T”
3D Vision
System SDI “T”
SDI “T”
SDI “T”
SDI “T”
Splitter
Splitter
Vision Tower:
COTS
Endoscope
Controller,
Camera
Light
Electrosurgical Link2
DVI “T” Video Splitter
Splitter Electro-
System Splitter Electrosurgical Link 1
Proposed an update to the
Splitter Overlay Surgical
 Engine Controllers
Low Level Misc. 3rd
system architecture to mitigate
Digital Video Surgeon’s
Ethernet RS232 Serial Vision Tower CSC
Comms (SDI) Party Console
single-point-failure hazards,
and reduce product cost
10/29/2012 - Sunrise Confidential 17

18. Compact Multi-Channel Chart Recorder
Increased sample rate tenfold, reduced size, and power by 75%
Simultaneous generation of waveforms on paper while also scrolling
waveforms on a touch-screen display
ARM processor acts as a master controller to a slave DSP which performed
high speed data acquisition
Programmable anti-alias and signal filtering, and controlled the analog front-
end
Dual DAC PGA provides signal acquisition from microvolts to kilovolts
Channels galvanically isolated from each other and from ground
Custom internal Li-Ion battery charger
11/19/12 18

19. IR Paper Towel Dispensing System
.
 Redesign IR circuit to meet performance requirements
 Integrated electromechanical sensors and actuator
 Robust engineering assessment to ensure no ESD or other sensitivities
 Battery needed to provide one year of use
 Required cheapest possible production solution for Mass Production
 Sunrise design cut power use by orders of magnitude compared to prior
model
 Transitioned to China for high volume assembly
 Implemented with a PIC processor utilizing sleep/wake operation and
short bursts of IR to look for presence of a hand
 Hardware and software design required to operate on ultra low power
while scanning for a hand, then brief motor run of several amps to eject
paper
 The user interface consists of sensors to determine whether a hand was
near the ejector, and algorithms that account for user behavior
11/19/12 19

20. Electronic Valve Actuators
Developed an innovative push-button set-up procedure through
collaboration with the client's marketing and management team
significantly reducing the field set-up time from 60 minutes to 1 minute,
making this product the "industry gold standard“
Achieved significant cost reductions on existing products
Provides min drain on Solar/Battery Powered Devices in Arctic - for winter
over, or Desert or Jungle applications
Approx same drain in sleep as battery self discharge !!
 1 ma on 12 V 1 Ahr sealed Pb
Wake up on Command change, Modbus command
Wake up "peek” on 2 minute cycle for self check
2 isolated status contacts - Battery OK, Actuator OK
Processor sleep software
Switched power domains in hardware
11/19/12 20

21. Skin Graft Preparation Device
Harvest patient's skin for treatment of aesthetic and medical disorders
Accurate control of skin temperature and applied vacuum to generate
microblisters
Protect patient from heating elements in a slim package
Rapid development schedule; Proof of concept to prototype device in 6
months including Systems analysis, conceptual designs, proof of concept,
architecture, Electronics, Electro-mechanical, and Electro-thermal design,
implementation and verification
Controlled build of 15 units at Sunrise to support clinical studies
Clinical study units delivered to clinical sites on schedule
11/19/12 21

22. Keeping organs alive for Transplant
Design an electronic monitoring and control
system to keep an organ alive while it is
transported
Developed main processor board handling
data streams (Bluetooth, SPI, I2C) of organ
vital signs, interfacing with flow meters and
pressure sensors
Developed analog board to monitor
temperature and humidity sensors
Designed intelligent power supply with triple
redundancy, hot swap, and battery
sequencing
Clinical trials in Europe. First transplants
performed using a heart kept beating by the
system
The first revolutionary advance in organ
preservation in 25 years
11/19/12 22

23. Sunrise Labs Advantage
 Delight Your Company & Your Customers
 Leverage Sunrise Experts
 Apply a Proven and Comprehensive Development Process
 Smooth Transition from Design to Manufacturing
 Transform Your Bright Ideas into Award winning Products
11/19/12 24

24. www.sunriselabs.com
Look forward to hearing from you. Thank you!
2009-09-14
11/19/12 25