2. Bavaria Medizin Technologie GmbH
BMT - HQ
Bavaria Medizin Technologie, GmbH
Munich, Germany
“We are Made in Germany”
3. Bavaria Medizin Technologie GmbH
BAVARIA MEDIZIN TECHNOLOGIE
CONTRACT R&D MANUFACTURING
PRODUCT PROTOT DESI
ENG.
SERVICES
DEVELOPM YPING OEM GN
FOR
ENT LAB MFG
“We are Made in Germany”
5. Bavaria Medizin Technologie GmbH About BMT
Ø VISION – To leave a footprint in the area of innovative product
development and be regarded as a competent growth partner for our
worldwide clients.
Ø MISSION – To improve patients’ quality of life through the use of our
products.
Ø CORE VALUES:
Ø Innovative – Out-of-the-box thinking and speed in prototyping
Ø Customer Service – Relationship management through communication
Ø Quality – Deliver just the best no matter what the challenge is.
“We are Made in Germany”
6. Bavaria Medizin Technologie GmbH History
Ø 1992 – Founded R&D Group for needle injection catheter
Ø 1997 – Started OEM manufacturing and in-house balloon dev. prog.
Ø 2001 – Development of first Drug Eluting Balloons.
Ø 2004 – Business focus shifted from internal R&D to contract R&D.
Ø 2005 – Sold Drug Eluting Balloon Technology.
Ø 2007 – High volume / Low cost manufacturing facility in ROMANIA
Ø 2009 – BMT – CANADA created as the North American R&D Center
“We are Made in Germany”
8. CONTRACT R&D
Ø Product Requirement Definition*
Ø Performance benchmarking
Ø Concept and prototype development
Ø Feasibility builds
Ø Design Freeze
Ø Design Verification
Ø Design Transfer to Manufacturing
Ø Volume Ramp-up
* - Applicable to Start-up companies
“We are Made in Germany”
9. CONTRACT MANUFACTURING
Ø High and low volume manufacturing
Ø Full product traceability
Ø Cross-functional team for continuous product
improvement.
Ø JIT and Lean manufacturing
Ø Ship-to-stock program
Ø Six Sigma implementation**
** - initiative is in progress
“We are Made in Germany”
11. MEDICAL DEVICE PRODUCT DEVELOPMENT
Ø GOAL – USING BMT EXPERTISE TO REDUCE PROJECT RISK
AND TIME TO MARKET THROUGH PROOF-OF-CONCEPT (POC)
DEVICES AND FIRST GENERATION PRODUCT FOR FIRST-IN-
MAN (FIM)
Ø ADVANTAGES:
Ø Minimize Risk to the project
Ø Professional project management – PMO office
Ø Accelerate development cycle
Ø Contained development cost
Ø Regulatory Approval: CE-Mark, 510(k), PMA
Ø Biocompatibility, Sterilization validation, Animal Studies
Ø OEM manufacturing (packaging, labeling, sterilized finished goods)
“We are Made in Germany”
12. MEDICAL DEVICE PRODUCT DEVELOPMENT
l POC-to-FIM™
Ø Proof of concept through dedicated hands-on POC staff.
Ø Generate MRS and PRS
Ø Access to Key Opinion Leaders in Europe and US.
Ø Generate Commercialization and Development plans for
Fundraising.
Ø DHF organized as per FDA and ISO regulations
Ø Organize and lead animal studies.
Ø Generate first product for FIM.
“We are Made in Germany”
14. CATHETER SHAFT TECHNOLOGIES
Ø EXTRUDED TUBING
Ø Single and multi-lumen with & without loading
Ø Single and multi layers
Ø Size Range: .4mm to 10mm – ID & .5mm to 15mm - OD
Ø Tolerances: 0.01mm to 0.03mm
Ø Braided and Non-Braided
Ø “Splittable” tubing.
Ø CATHETER PROCESSING
Ø Catheter assembly
Ø Stent Crimping
Ø Bonding
Ø OTW and Rx
Ø Catheter reflow
Ø Proximal hub design and bonding
“We are Made in Germany”
15. BALLOON DEVELOPMENT PROGRAM
Ø BALLOON SIZES
Ø Coronary OD – 1.5 to 4.0mm
Ø Coronary Length – 4.0 to 40 mm
Ø Peripheral OD – 3.0 to 15 mm
Ø Peripheral Length – 15 to 220 mm
Ø BALLOON MATERIALS
Ø Grilamid, Polyurethane, PET,
Ø Vestamid, Pebax,
Ø Rilsane, Silicone
Ø BALLOON PRESSURES:
Ø Nominal Pressure: 6 & 8 atm.
Ø Average Pressure: based on design.
Ø RBP : based on design.
“We are Made in Germany”
16. CUSTOM BALLOON DEVELOPMENT
Ø BALLOON CUSTOM CHARACTERISTICS
Ø Compliance curve design
Ø Sensor integration in balloons
Ø Balloon-in-balloon design
Ø Tight tolerance for stent retention and delivery
Ø Software simulation of balloon properties**
Ø Balloon folding
Ø Non-Drug Coating on balloon outer surface
Ø Balloon bonding
“We are Made in Germany”
18. Case Study 1 – Drug Eluting Balloon
Ø Intended Use: Treatment of in-stent
restenosis.
Ø Paclitaxel coated-balloon catheters
(Paccocath®) for coronary and
peripheral applications.
Ø Designed product handling performance
and emphasized on process
development.
Ø Initiated and sponsored several clinical
studies (i.e. THUNDER, ISR I).
Ø Technology was sold in 2005 as an exit
strategy.
“We are Made in Germany”
19. Case Study 2: Long Balloons for PAD
Ø Intended Use: PTA in SFA and BTK
Ø New range of PTA:
Ø OD: 1.5 to 10 mm
Ø Lengths: 20 to 220 mm
Ø Technical challenge is to keep this long
balloons straight (e.g banana shape)
“We are Made in Germany”
20. Case Study – 3: Needle Injection Catheter – GEN II
Ø Intended Use: Local stem cell injection into the myocardial tissue.
Ø Designed a three-needle injection system.
Ø Technical challenges:
Ø Controlled protrusion of needles.
Ø Sensor to detect vessel apposition.
Ø Catheter maneuverability
“We are Made in Germany”
22. Bavaria Medizin Technologie GmbH Germany
Ø Cleanroom class 10,000
Ø Six (6) laminar flow benches
Ø Safety-work benches available
“We are Made in Germany”
23. Bavaria Medizin Technologie GmbH Canada
Ø R&D
CENTER INFRASTRUCTURE IS IN-
PROGRESS
Ø BMT-CANADA OFFICE L6-111
Ø BMT-CANADA LABORATORIES
L6-104/106
“We are Made in Germany”
24. Bavaria Medizin Technologie GmbH Romania
Ø Brand New - 600 m2 facility
Ø 175 m2 cleanroom class 10,000
“We are Made in Germany”
25. Feedback from some of North American Clients
Thomas R. Trotter, President and CEO of AngioScore, Inc.:
"We were surprised by the tremendous cooperation and attention to detail we
received from BMT. Especially when it came to special requirements which have had to
be met on short notice BMT's very quick reaction time was extremely helpful for our
fast growth in the market.”
Eric Schmid, Vice President, Engineering and Stent Development REVA Medical, Inc.:
"BMT’s expertise, adaptability and speed are matched only by their exceptional
customer service and quality. They are truly a valued development partner and ’s
success.”
Gera Strommer, former CEO of MediGuide:
"We are very pleased with the expertise, services and know how from BMT, who
helped us a lot from an early development stage up to an CE approved product.”
Ben Ewing, Project Manager – MEDRAD, Inc.:
"Despite constantly evolving project requirements and demands, BMT is
accommodating, responsive and has exceeded our expectations."
“We are Made in Germany”
