Increasingly the success of your medical device is dependent upon the ethos in which it is birthed – we'll tell you why

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Information about Increasingly the success of your medical device is dependent upon the...
Health & Medicine

Published on February 22, 2014

Author: UBMCanon



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

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

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

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

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

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

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

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?

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

Hypothesis: Supporting Evidence Silicon Valley continues to outstrip rest of country in tech investing, and it's not even close By Peter Delevett 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!

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 ??

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

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

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

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

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

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

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