Dave Busch, Vice President Medical, OnCore Manufacturing Phil Aulson, Vice President Operations, Oraya Therapeutics, Inc.

1. Increasingly the Success of Your Medical
Device is Dependent upon the Ethos in
Which it is Birthed – We’ll Tell You Why
A Case Study of Medical Device Product Development
Phil Aulson, VP Operations at Oraya
Dave Busch, VP Medical Markets, at OnCore

2. Presentation Topics
•
•
•
•
Who is Oraya
Who Is OnCore
Medical Device Industry Challenges
Hypothesis: Silicon Valley’s Ethos is an Advantage for
Medical Device Development and Manufacturing
• Hypothesis Proof: A Case Study; Oraya IRay
• Hypothesis: Lessons Learned

3. Oraya Therapeutics
Company Profile
•
•
•
•
Newark, California
Founded in 2007
Privately held
~40 Employees
 Oraya Develops Innovative and nonInvasive Therapies for Diseases of the
Eye
 First Product: The Oraya Therapy


3
Non-Invasive Treatment for Wet AgeRelated Macular Degeneration (AMD)
Wet AMD is leading cause of
blindness
Oraya Therapeutics, Inc. Confidential – Not for Redistribution

4. ORAYA Therapy:
Non-invasive Radiotherapy
•
•
Three X-ray beams delivered sequentially converge on macula.
•
Minimal patient effective dose (equivalent to 1/10th of head CT scan).
•
Robotically controlled precision delivery system.
•
4
Radiation impacts AMD: anti-angiogenic, anti-inflammatory & anti-fibrotic.
Complex electromechanical system assembly.
Oraya Therapeutics, Inc. Confidential – Not for Redistribution

5. OnCore Helps Customers Achieve Their Business
Goals and Requirements
Printed Circuit
Assembly
HLA / System Build
Segment
Medical
PCBA – POP Process
Non-surgical body sculpting
Ophthalmological Eq.
Medication Management
Industrial
PCBA
Auto Engine
Diagnostics Eq.
Commercial EV
Charge Eq.
Gas Emission Analyzer
Defense and
Aerospace
PCBA
Network Encryption Eq.
Throw-able Robot
Fighter Fire Control
At OnCore we perform full system integration and box build for many of our
customer’s complex and high reliability products.
OnCore Manufacturing Services, LLC - Confidential
5

6. OnCore Offers Best of Both Worlds Solutions
EMS Market Space
The Small
The Large
OnCore Sweet Spot
Prototype & NPI Shops
Large Tier EMS
 Complex product experience,
Low Tier EMS
challenging supply chains and
regulated environments
ODM’s
 Global Footprint
 Tier 1 toolsets and processes
 Flat and highly responsive
organization--top to bottom
 Flexible solutions
OnCore is big enough to manage complexity and deliver a customized solution
…and small enough to care about you and your business as much as you do
OnCore Manufacturing Services, LLC - Confidential
6

7. Medical Device Industry Challenges
• Increasing solutions competition in the medical
device industry
• Increasing cost of introducing new devices
• Increasing time to launch a product due to:
• Increased regulatory requirements
• “Development complexity requirements”
How to reduce time-to-market and
development success rate?

8. The Hypothesis: The Ethos Required to Develop a
Device Requires a Plethora of Members
Members’ synergy increases with proximity and connectivity
Ideation
Widespread
Patient
Treatment
Product Realization
• Universities
and Teaching
Hospitals
• Distribution and
Channel Partners
OEM
• Investors
• SW Partners
• Technology
Partners
• Medical
Contract
Manufacturing
• Localized
supply
base
Silicon Valley provides an excellent “template” ethos

9. Hypothesis: Supporting Evidence
Silicon Valley continues to outstrip rest of
country in tech investing, and it's not even close
By Peter Delevett pdelevett@mercurynews.com
Posted: 11/15/2013 05:00:00 PM PST | Updated: a day ago
Things are picking up in venture capital, and nowhere is that more
true than in Silicon Valley.
Venture firms nationwide invested $7.8 billion in 1,005 startups in the
third quarter, according to the latest MoneyTree Report, compiled by
the National Venture Capital Association and Pricewaterhouse- Coopers
using data from Thomson Reuters.
That was a 12 percent increase in terms of dollars and a 5 percent hike
in the number of deals compared with the second quarter.
Nearly half that money went to companies in Silicon Valley,
whomping runner-up New England's 11 percent of the haul. No
other region broke double digits …….
• Fact: Silicon Valley garners
50% of all venture hightech dollars
• Question: is high-tech
leadership transferrable
to medical devices?
• We believe so!

10. Hypothesis: Proof – Case Study – Oraya IRay
Oraya’s challenge: take a new technology from prototype to volume
production in < 18 months
Proof of
Concept Built by
Oraya Engineers
Concurrent Engineering
• Develop Manufacturable Design
• Develop Supply Base
• Develop repeatable manufacturing
and test processes
• Develop documentation and process
adequate for regulatory approvals
Production
Ready Product
Built by OnCore
Oraya’s Challenge:
How to do this as a Start-up without heavy investment
in operations and supply chain that could drain needed
funds for R&D and product development ??

11. The Process
• The decision to engage a contract manufacturer
that would build Iray followed a three step
process:
1. Partner Selection Criteria
2. Concurrent Engineering
3. Production Readiness and Launch Process
The goal was proto-type to volume production in less
than 18 months

12. Partner Selection
Goal: to find a contract manufacturer
with medical manufacturing expertise
that complemented Oraya’s product
development expertise
Oraya defined what were their corecompetencies which stayed in-house
and outsourced all non-core
capabilities
OnCore’s core-competencies in
medical device box build, global
sourcing and project management
mapped to Oraya’s non-core
requirements
Oraya CM Selection
Priorities
1. Local proximity with
global solution
2. Medical device
regulatory and
standards compliance
3. Experience building
complex medical
devices
4. Highly responsive and
flexible

13. Concurrent Engineering
Extensive up-front
activities
• Prototypes builds
• Feedback into the
design
• Process
development
• Knowledge
transfer

14. Key Milestones to Achieving the
Objective
CM Partner
Selection
Process
Development
Production
Launch
• Surveys
• Audits / Visits
• Selection
• Process
documentation
• Test method
development
• Procurement of
+1500 p/n’s
• Operator
Certification
• Production cell
DEC
2011
SEP
2013
Knowledge
Transfer
Regulatory
Compliance
• Send / receive
teams
• Prototype
builds
• Collaborative
DFM
• Audits
• Process V&V
• Radiation
testing

15. Why We Were Successful
• True Partnership: “Communication, Cooperation and Collaboration,
trump lowest price”
• The Ethos: allowed us to execute rapid cycles of learning which
reduced costs and TTM – Examples:
• DFM feedback
• Process documentation
• Test method development
• Synergies: Examples include:
•
•
•
•
•
Proximity of the two teams
On-site send and receive engineering teams
Following a “Plan-Do-Check-Act” protocol
Flexible, localized supply-base
Easy transfer of inventories from Oraya to OnCore

16. Hypothesis Validated and Key Take
Aways
• Objective achieved – IRay is in production at OnCore’s
Fremont facility
• Proximity of design and engineering resources allowed for a
virtual team
• Both companies located in Silicon Valley allowed for near realtime interaction with supply-base, engineering partners,
regulatory experts and leading medical research subject
matter experts