OBJECTIVE/AGENDA
• Objective:– Introduction to California MedTech– Insights into outsourced product development and manufacturing
• California MedTech– Clients– Services – Products
• ODM/CM Overview – Definitions– Other considerations
• Why California MedTech
• Profitable Every Year• Employee Owned• Founded 1998• Self-funded• No Debt
COMPANY OVERVIEW – FINANCIALS
Development Capabilities• 16 Full-Time Engineers
• Electrical Engineering• Software Development• Mechanical Design• Fluidics Engineering*
• Photonics Engineering*
• Industrial Design*
* Supplier network - contracted services
COMPANY OVERVIEW
Design Transfer Capabilities
• Manufacturing Engineering• Process Development• Verification & Validation• Compliance Testing• Regulatory Support
COMPANY OVERVIEW
COMPANY OVERVIEW
Manufacturing Capabilities:•High-Level Box Build •San Diego – Partners Tijuana & China•All locations ISO 13485 Certified
Fulfillment Services:•Finished Goods Inventory •Drop Shipment – US/OUS•Complete In-House Service Depot
TIBION BIONIC LEG
The Tibion Bionic Leg is the first wearable, battery operated, robotic rehabilitation tool to provide stroke patients with the possibility of regaining significant use of their impaired leg.
California MedTech provides:•Design Tx.•Production scale-up•Service•Order fulfillment
GENOMICS
Personal Genome Machine sequencer weighs less than 50 pounds and has a foot print that’s no bigger than a desktop printer, so it can fit in any lab.
Extracts samples from 384-well microtiter plates and places nanoliter droplets onto a SmartChip for genomics analysis.
SURGICAL
PEAK SURGICAL: A plasma-based, high-frequency tissue dissection system that provides the exacting control of a scalpel with the bleeding control of electro-surgery.
“ULTHERA RECEIVES FIRST-EVER FDA CLEARANCE TO MARKET ULTRASOUND TECHNOLOGY FOR FACIAL AESTHETIC IMPROVEMENT”
PHILIPS MEDICAL - INNERCOOL
Temperature Modulation Therapy encompasses inducing, maintaining, and reversing hypothermia, as well as maintaining normal body temperature or normothermia.
California MedTech provides:•Design & Design Tx.•Full scale production •Service•Order fulfillment
OTHER PRODUCTSDeveloped the NeuroVision® evoked-response nerve monitoring system for use with minimally-invasive spinal surgery. Manufactured three generations of the system.
Eye Scanner and Pupillometer: designed a handheld instrument to measure pupil and iris diameter under various lighting conditions, as well as curvature of the cornea. Project included PC application software for image archiving and post-processing.
DEFINITIONS
• Electronics Manufacturing Services (EMS) (ECM)– design, test, manufacture, distribute, and provide return/repair
services for electronic components and assemblies typically for OEMs. Also referred to as Electronic Contract Manufacturing (ECM).
• Original Design Manufacturer (ODM)**– a company which designs and manufactures a product which is
specified and eventually branded by another firm for sale. A primary attribute of this business model is that the ODM owns and/or designs in-house the products that are branded by the buying firm.
• Contract Manufacturer (CM)**– acts as the hiring firm's factory, producing and shipping units of the
design on behalf of the hiring firm.
** California MedTech, LLC
SELECTION CONSIDERATIONS• Experience with similar products and processes• Ownership – Development through manufacturing• Business model:
– High vs. low complexity– High vs. low volume (+1,000,000/year)
• Intellectual property ownership/restrictions• Stickiness - embedded proprietary hardware/software• Transparency• Capacity• Location• Track record• Crown jewels?
MULTI PRODUCT DEVELOPMENT
• Benefits of multiple product lines and continuous development.– Learning curve effects– Maintaining critical skills
Contract Manufacturer
- C
ost
/Tim
e -
- Cumulative volume -
Self – 1st Self – 2nd
MULTI-PRODUCT DEVELOPMENT-
% L
abo
r -
- Development Time/Phase -
• Resource management:– Motivation– Resource utilization • competing projects• Minimize tail effects
OTHER ADVANTAGES – ODM/CM
• Startup Business – long development cycles– CM reallocation of resources
• Minimize downside impact of “Forecast Error”• No delays with build out of manufacturing infrastructure
- N
um
ber
of
Un
its
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Animal
FIH
Commercial
- Time/Project Phase -
CALIFORNIA MEDTECH
• Experience – as a trusted outsourcing partner, we’ve designed and manufactured some of the most successful life science products and medical devices in the industry generating over $2 Billion in value.
• We make complicated things without making things complicated. We can build and service your product reliably and cost effectively.
• Full service product development and manufacturing partner.
• FDA registered, CA State licensed and ISO-9001/13485.
• Skills and resources to take products from concept to commercialization, and beyond.