The Alfred Mann Foundation Medical Device Incubator Robert ... · 7/23/2019 · Medical Device...
Transcript of The Alfred Mann Foundation Medical Device Incubator Robert ... · 7/23/2019 · Medical Device...
The Alfred Mann FoundationMedical Device Incubator
May 2019
Alfred Mann
Robert Greenberg MD, PhDExecutive Chairman
Founded 1985
AMF Mission
To develop and commercialize innovative solutions for significant unmet medical
conditions
September 2014
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Translational R&D Engine with Commercialization Emphasis
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Corporate Spinouts
• Multiple companies sold for > $7 billion to Medtronic, Boston Scientific, and Sonova
• 4 companies went public (NASDAQ: MNKD, MNMD, EYES, AXNX)
• Companies have revolutionized:– Insulin pumps and glucose sensors (MiniMed)– Cochlear implants (Advanced Bionics)– Spinal cord stimulators (Advanced Bionics)– Visual Prosthetics (Second Sight)– Functional Electric Stimulation (Bioness)– Sacral Nerve Stimulation (Axonics)
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CAPITAL, CAPITAL, CAPITAL
Al Mann COMPANY LIQUIDITY EVENT TRANSACTION VALUE
MiniMed
Advanced Bionics
MRG
Pacesetter Systems
Spectrolab
Heliotek
Advanced Bionics
Acquisition: 2001
Acquisition: 2004
Acquisition: 2001
Acquisition: 1994
Acquisition: 1960
Acquisition: 1960
Acquisition: 2009
$3.7 Billion
$2.7 Billion
$420 Million
$150 Million
Undisclosed
Undisclosed
$489 Million
EnerSys
Flextronics
$30 Million
Undisclosed
Acquisition: 2013
Acquisition: 2012
Alfred E. Mann Companies
Mannkind IPO: 2004 $1.5 Billion
Second Sight $250 millionIPO: 2014
Quallion
Stellar Electronics
AMF Bridges the Valley of Death
ConceiveOf
Idea
ResearchAnd
Development
Product Development
TestingClinical TrialsRegulatory Approval
Commercialization
Confidential
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AMF Lives Here
Potential Exit Anywhere Along the Continuum
Organizational Snapshot
AMF
~30 Technical
Employees
Idea to Regulatory Approval
State of the Art
Equipment
~50,000 Sq. Ft Facility
2 Clean Rooms
Numerous Labs
Projects
• 3 major development• 1 early stage or minor• 2 clinical studies
People
• Diverse• Educated: MD, PhD
and Masters
IP• ~225 US patents• ~250 foreign
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Confidential
AMF Core Competencies
AMF Competencies
ASIC Design
Packaging
Quality Systems & Regulatory
Submissions
Systems Design
Algorithms
Large to Small
Wireless Comm
Materials Composition
March, 2017
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Confidential
AMF Seasoned Professionals
AMF Team
MechanicalEngineers
Electrical Engineers
Accounting & HR
Professionals
Quality Engineers & Inspectors
Manufacturing Engineers &Technicians
Clinical & Regulatory
Professionals
Software & Systems
Engineers
March, 2017
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Confidential
IMES – Implantable Myoelectric Sensor
IMES Device 10
Confidential
IMES – Implantable Myoelectric Sensor
Confidential
Recent Spin-Out Companies
Confidential
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Axonics Highlights
Confidential
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• State of the Art System to treat overactive bladder• Raised $138M in IPO on NASDAQ – ticker AXNX• Pivotal study complete• Have applied for FDA approval – expected summer 2019
Medallion Therapeutics
March, 2017 Confidential
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• State of the art fully implantable infusion pump
• Smallest pump with numerous advanced safety features
• 75 patient clinical trial completed
Monolythix
March, 2017 Confidential
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• Proprietary polymer that enables fast, accurate and reliable DNA extraction
• Tested and optimal for next generation sequencing• Can be used for point of care diagnostics using a cell
phone as a light source – results in under an hour• Product is inexpensive to manufacture and is
optimized for use in a standard 96 well plate• Several revenue lines can be developed
Bioness
Confidential
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• Company mission to bring technological solutions to neural rehab market
• Developed “best in breed” products including exoskeletal systems and facility based systems
• Stim Router implant system approved and received broad labeling from the FDA following human clinical trial
Confidential
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AMF has an outward-facing incubator to support local early-stage medical device companies.
• Smorgasbord model:• Companies can rent office or lab space• Companies can rent time on equipment• Companies can get personnel support
• (engineering, clinical, regulatory, legal, HR, etc)
• Current status – 2 on-site and 4 virtual incubator companies
Bivacor
– Bivacor• 10 year old Artificial Heart company based in Orange County• Company has unique pump mechanism• AMF partnered on implant development and testing in preparation for First in Man
AMF Equipment
Braze Oven– Heated by electrical resistance
• Temperature uniformity ±1˚C– Maximum process temperature: 1,400˚C– Highest Power Load: 80kW– Average Process Time: 3-4 hours– Chamber Volume: 12”x12”x18”– Modes of Operation: High Vacuum Inert
Gas (such as Argon), Hydrogen– Used For:
• Joining – Brazing, Diffusion bonding and glass to metal sealing
• Heat treating – Annealing and hardening
• Bake-out
5/10/2019 Confidential
21Bldg 33Braze Oven
Vibration Testing Station– Rated output force
• Sine force 500 lbf pk• Random force 350 lbf rms• Shock force 1000 lbf pk, 50 msec pulse
– Displacement (max)• Continuous 1.0” pk-pk• Between stops 1.2” pk-pk
– Velocity (max)• 140 inches per second pk (max)
– Acceleration (max)• 100 g pk, driven• 150 g pk, resonant• 300 g pk, shock pulse
– Frequency range• DC-4.5 kHz, bare table
5/10/2019 Confidential
22Bldg 33 Vibration Testing Station
GE/Phoenix X-ray System– Industrial x-ray system with
computed tomography (CT) capability
– High resolution x-ray gun yields sub-micron image resolution
– Large flat panel solid state detector for low noise, short exposure imaging
– Automatic scanning of the images required for CT 3D volume reconstruction
– Used for product and process development, electronics inspection, and failure analysis
5/10/2019 Confidential
23X-ray GE/Phoenix X-ray System
X-ray Diffraction– A nondestructive analysis tool– Reveals the atomic structure
of the materials, and is based on the elastic scattering of X-rays
– Can determine crystallographic structure, chemical composition, and physical properties of materials and thin films
5/10/2019 Confidential
24Laser Room X-ray Diffraction
Scanning Electron Microscope (SEM)
– Uses a beam of electrons to create a high resolution large depth of field image
– Capable of about 100,000 x magnification
– Captures digital images– EDX (Energy Dispersive X-ray):
a detector system used on the SEM to determine the elemental constituents of materials (determine composition)
5/10/2019 Confidential
25Laser RoomScanning Electron Microscope (SEM)
Laser Welding– Fine temperature control– Controlled glovebox
environment (Argon / Helium)– 3-axis computer controlled
motion– Allows for very precise and
accurately controlled welding of very small components and devices
5/10/2019 Confidential
26Laser Room Laser Welding
Instron Materials Testing System
– Capable of tension, compression, flexure, fatigue, impact, torsion, and hardness testing
– Analysis software– Evaluates the mechanical
properties of materials and components
5/10/2019 Confidential
27Laser Room Instron Materials Testing System
Wire Bonder– Programmable parameters– Attach pure gold wire (.001”
diameter) between miniature electrical components
5/10/2019 Confidential
28Class 10,000 / ISO 7 CleanroomWire Bonder
Miniature Coil Winding– Uses .001” diameter magnetic
wire– Capable of accurately counting
the precise number of turns required
– Winds miniature coil
5/10/2019 Confidential
29Class 10,000 / ISO 7 Cleanroom Miniature Coil Winding
Silicone Molding– Transfer molding press used
to form parts in a mold– Can be used for implantable
biocompatible components
5/10/2019 Confidential
30Class 10,000 / ISO 7 Cleanroom Silicone Molding
Packaging– Components and/or devices
are placed inside sterilization pouches, then pouches are heat sealed
– All sealed pouches are thoroughly inspected prior to sterilization
5/10/2019 Confidential
31Class 10,000 / ISO 7 Cleanroom Packaging
Belco Tray Sealer– Programmable parameters
• Time• Temperature• Pressure
– Medical tray sealer for a variety of inner and outer trays
– Provides consistent quality seals
5/10/2019 Confidential
32Class 10,000 / ISO 7 CleanroomBelco Tray Sealer
5/10/2019 Confidential
33Prototype Machine ShopHAAS CNC Machining Center
HAAS CNC Machining Center– Completely computer
controlled 4-axis– Capable of translating 3D CAD
designs into tool cutting paths to machine exact copies
– Automated tool changing ability
HAAS CNC Lathe– Exclusively used for
fabricating round parts– Live tooling for special
machining applications– Capable of translating 3D CAD
designs into tool cutting paths to machine exact copies
5/10/2019 Confidential
34Prototype Machine Shop HAAS CNC Lathe
Vertical Mill– Manual milling machine with
x-y programmability– Digital read-out for x and y– Capable of holding tight
tolerances
5/10/2019 Confidential
35Prototype Machine Shop Vertical Mill
Toolroom Lathe– Precision lathe– Capable of holding tight
tolerances– Digital read-out for x and y– Microscope for machining
small parts
5/10/2019 Confidential
36Prototype Machine Shop Toolroom Lathe
Optical Comparator– Projects a high magnification
shadow of a part profile onto a screen allowing precision measurement
– Capable of measuring x-y– A clear pattern overlay on the
screen allows comparison with a known part profile
5/10/2019 Confidential
37Prototype Machine Shop Optical Comparator
Materials– Diversified inventory of
specialty alloy steels and plastics
– Implant grade alloys such as 316l, 304l Titanium 6-4
– Specialty plastics (polymers) such as Teflon, Pomalux®, semitron, Delrin®, etc.
5/10/2019 Confidential
38Prototype Machine Shop Materials
5/10/2019 Confidential
39Manufacturing Lab Laser Soldering
Laser Soldering– Provides precise targeting– Fine temperature control– Controlled environment
(argon)
Dicing– Diamond saw cutting of
microcircuits– Precise dimensional control– Gentle action to prevent
damage
5/10/2019 Confidential
40Manufacturing Lab Dicing
Microassembly– Requires high degree of
training and expertise– Most work performed under
a microscope• Soldering• Bonding• Component assembly
5/10/2019 Confidential
41Manufacturing Lab Microassembly
Electronic Testing– Both manual and automated
testing– Probe station testing– Dedicated test stations for
various devices– Testing performed on both
in-process and final assemblies
5/10/2019 Confidential
42Manufacturing Lab Electronic Testing
Sterilization (Autoclave)– Moist heat sterilization– Programmable time and
temperature
5/10/2019 Confidential
43Manufacturing LabSteam (Autoclave) Sterilization
Helium Leak Test – Verify hermeticity of sealed
device– Capable of detecting leakage
rates of 10-11cc/sec
5/10/2019 Confidential
44Manufacturing Lab Helium Leak Test
5/10/2019 Confidential
45Quality Control Receiving Inspection
Receiving Inspection– First Article inspections– Inspection of received materials,
Work-In-Process materials, completed assemblies, and Finished Goods
– Off the shelf and custom tooling for precision inspection
– Verify appropriate traceability documentation requirements are met
– Track equipment calibration
Precision Microscope Station– High magnification measuring– Capable of high tolerance
measurements– Captures high resolution
digital images– Network connected
5/10/2019 Confidential
46Quality Control SmartScope
High Density Storage System– Optimizes space in order to
maximize storage– Quick access– Lockable and secure– Able to easily and securely
separate groups of materials as needed
– Software based inventory control
5/10/2019 Confidential
47Stock Room High Density Storage System
Controlled Storage– Sealed Nitrogen cabinets– Maintains a dry, low-oxygen
environment for critical components
5/10/2019 Confidential
48Stock Room Controlled Storage