Global CapabilitiesJanuary 2017
Qure Medical Global Business
Qure Medical is owned by
Drug Research &
Drug Delivery
Fluid Management &
Catheterization
Medical & Surgical
DeviceMed Tec Bio Pharma Clean Room
Molding & Assembly
Precision Molding, Extrusion and Assembly for Medical Devices and Bio Pharma
Materials
Development
Compounding
& Mixing
Design for
Manufacturability &
Application Performance
Mold
Development
Precision
Manufacturing
Customized
Testing &
Analysis
Packaging &
Distribution
Precision
Cleanroom
Manufacturing
Cleanroom
Assembly
Quality
Automation
DevelopmentFEA ANALYSIS
Single-Source:3 Suppliers in 1!
When precision matters and you
need excellent products on time.
Blue Chip Customer Base
Key Capabilities
• Broad capabilities (HCR, LIM, extrusion, overmolding)
• Class 7&8 cleanrooms
• Internal tooling capabilities (transfer and LIM)
• Wasteless/flashless production
• Overmolding, subassembly and full assembly capabilities
• Extensive library of proprietary formulas
• Polyisoprene, organic and silicone polymers technology
• ISO 13485 certification and facilities capable of producing FDA registered products
• Vision inspection and automation
• Internal compounding
• Precision slitting for flow control
• Paralyne coatings for improved dry lubrication
Markets and SolutionsMedical Pharmaceutical
Consumer Healthcare Safety
• Firefighting
• Avionics
• Aerospace
• HazMat
• Drug delivery
• Bio-pharma assembly
• Pharma packaging
• Oral healthcare
• Women’s health
• Infant care
• Food and beverage
• Medical/Surgical
• Fluid management
• Wound care
• Enteral feeding
• Aerospace & Avionics Nose
Cups
• Baby Bottle Nipples
• Bellows
• Blood Oxygenation Bags
• Catheters
• Custom O-Rings
• Dental ID Bands
• Dental Sterilization Holders
• Diaphragms
• Duckbills
• Enteral Feeding Tubes
• Extruded Profiles
Product Development• Firefighter Mask Assemblies
• IV Components
• Medical Ports
• Nipple Shields
• PEG Tubes
• Plunger Tips
• Pulse Oximeters
• Pump Diaphragms
• Seals
• Septums
• Sleep Apnea Mask
Components
• Sleeve Stoppers
• Sterilization Mattes
• Strain Relief Products
• Surgical Bands
• Surgical Instrument
Handles
• Surgical Vacuum Ports
• Teethers
• Tubing
• Valves
• Valve Patties
• Vial Caps
• Wound Drains
• Additional custom
molded solutions by
request
1966 1994 1996 2005 2010 2011 2014 2014 2015 2016
Company Founded
EngineeringCenter Opened
Lexington Acquired
Qure Acquires Tompkins
Began Serving Medical Device
End Market
Company Begins China
Production
Q Acquires LIMTECH
3i Acquires QSR& Qure Medical & Forms Q Holding
Q HoldingAcquires Silicone
Altimex in UK
QSR - Q Seals deMexico
Established
Q Holding Company History
8
Q HoldingAcquires Degania,
Biometrix, Arthesys
2016
Silicone Tubing & Bio-Pharma
Assembly
Silicone Molding,
Extrusion, Overmolding
Business Segments
Catheter Kits
for Hospitals
Catheters for Medical
Device OEMs
Cardiovascular &
Vascular Catheters
Pharmaceutical
Packaging Products
Liquid Silicone Injection
Molding & Assemblies
Global Footprint
Saclay, France
Dongguan, China
North Canton, OH
Rock Hill, SC
Sturtevant, WI
Queretaro, Mexico
Coming Soon
Samorin, Slovakia
Degania, Israel
Nottingham, UK
Gurgaon, IndiaHatzor Haglilit, Israel
Twinsburg, OH
Headquarters
Rock Hill, South CarolinaMedical Manufacturing
North Canton, Ohio
Engineering CenterTooling & Automation
Sturtevant, Wisconsin
Medical Manufacturing
Dongguan, China
Medical Manufacturing
Total Number of
Employees: 2,188
Germany, Europe
Sales Office
Twinsburg, OhioCorporate HQ
Medical Manufacturing Nottingham, UK
Medical Manufacturing
Querétaro, MexicoComing Soon
Degania & Hazor Haglilit, Israel
Medical Manufacturing
Samorin, Slovakia
Medical Manufacturing
Saclay, France
Medical ManufacturingGurgaon,India
MedicalManufacturing
Key Capabilities
• ISO Class 7 and 8 cleanroom molding and assemblies
• LIM-Liquid Injection Molding/LSR-Liquid Silicone Rubber
• Coating application - Parylene, plasma, dip coating
• Additional capabilities:
• Implantable grade LSR
• Vision inspection
• Plastic molding
• Overmolding rubber to plastic and metal
• Full mold automation including part removal
• In-house mold design and manufacturing
• White room manufacturing
Sturtevant, Wisconsin1810 Renaissance Blvd.
Sturtevant, WI 53177
• 89,000 sq ft Facility
• ISO Class 7 and 8 cleanrooms
• ISO 13485 certified
• 55 Molding presses ranging in size from 12-200 ton
• 130 Team members
Key Capabilities
• HCR wasteless/flashless, compression, and
injection molding
• Custom material development support
• FDA drug master files
• Additional capabilities:
• Core materials: Polyisoprene, Neoprene, Butyls,
EPDMs, Silicones
• Cryogenic de-flash and chlorination
• Dedicated in-house mold maintenance
• Slitting and die cutting
• Data integration throughout plant
• Automated vision inspection
• Analytical laboratory, FTIR, UV, DSC
• ISO Class 8 cleanrooms
Rock Hill, South
Carolina663 Bryant Boulevard Rock Hill, South Carolina 29732
• 58,000 sq ft Facility
• 140+ Team members
• 58 Molding presses ranging in size from 150 to 800 ton
• 24 custom-developed automated vision inspection systems
• ISO 13485 certified
Key Capabilities
• HCR silicone extrusion
• HCR silicone molding and overmolding
• LIM-Liquid Injection Molding/LSR-Liquid Silicone
Rubber
• Additional capabilities:
• LSR overmolding (specifically onto tubing)
• Die cutting and slitting
• ASTM physical properties testing such as tensile and
tear strength
• Packaging and assemblies (FDA registered final
product pack)
• Automated vision inspection
• Pad printing
• Flow/leak testing
• ISO Class 8 cleanrooms
Twinsburg, Ohio1700 Highland Rd
Twinsburg, OH 44087
• 11,000 sq ft Facility - all Class 8 cleanroom space
• 70 Team members
• ISO 14001, ISO 13485 certified and FDA registered
• 23 Molding presses
• 3 Production extruders
Key Capabilities
• (6) Class 7 cleanrooms
• Precision extrusion and precision molding
• Bio Pharma cleanroom molding and assembly
• Additional capabilities:
• Platinum silicone extrusion cleanroom
• Cardiopulmonary tubing extrusion
• Laser controlled non-contact extrusion
• Molding presses ranging in size from MICRO to
150 ton
• Automated vision inspection system and laser
loop control
• 2 extrusion production rooms (Peroxide/Platinum)
• Braiding – pharmaceutical and medical grades
Silicone Altimex49 Pasture Road, Stapleford Nottingham, NG9 8HR UK
• 80+ Team members
• ISO 13485 & ISO 9001
• 13 extruders
• FDA registered
Key Capabilities
• HCR transfer/compression, clean room and vertical
LIM molding
• Non-organic products for medication delivery, access
devices and fluid management
• Custom material formulations
• Additional capabilities:
• Secondary operations (finishing/slitting)
• Clean room molding and assemblies in ISO Class 8
• Automated vision inspection
• Dedicated in-house mold making and automation
Dongguan, China优品(中国) Dongguan No 1 Building, E Section, Jun Da Industry Zone, Dong Keng District,Dongguan City, Guangdong, PRC
• 11,000 sq ft Class 8 cleanroom space
• ISO 13485 certified
• HCR & LSR molding presses ranging from
100 to 700 ton
• Vision inspection systems on site
• 8 team members
Key Capabilities
• Custom early stage prototyping skills
• SIGMASOFT mold flow simulation
• Mold design and flow engineering
• Additional capabilities:
• SolidWorks and AutoCad
• Ansys non-linear FEA Modeling and simulations
• CAM / CNC programming
• Power mill, part maker
• Surfcam, Gibbs cam
• Machines
• 5 axis CNC machining
• Laser marking machine
• Surface grinders
• Wasteless flashless tooling design
• Overmolding rubber to plastic and rubber to
metal mold design
Quadra Tooling & Automation
Surpassed 5K Molds Engineered and Manufactured July, 2016
3565 Highland Park Street NW
North Canton, OH 44720
• 55,000 total sq ft
• 2 R&D centers
• 28 Tool builders
• 15 Engineers
• 60 Total employees
1810 Renaissance Blvd.
Sturtevant, WI 53177
About Us
19
Proprietary & Confidential
FDA registered, ISO certified and
CE marked products
Israel (HQ), USA, France, Germany,
India, Slovakia
1700Global developer & manufacturer
of medical devices
1984
QUALITYGLOBAL PRESENCEEMPLOYEESBUSINESSESTABLISHED
Our History
20
Proprietary & Confidential
- Degania Silicone was established at Kibbutz Degania Bet, North of Israel
- First private equity investment in the company - IGI
- Commenced manufacturing in India
- Viola Private Equity acquired a controlling stake in the company
- Acquired Arthesys (France) -Cardiovascular catheters & PTCA
- Acquired Shomrat Thermoplastic Injection Molding
- Acquired Biometrix Medical (Israel) - critical care, operating room, and cardiology products
- Commenced manufacturing in Slovakia
- Change of management & reorganization plan
- Complete Post-Merger-Integration
1984 2000 2005 2010 2012 2014
- Q Holding Company, d.b.a. Qure Medical, acquires company
2016
Company Structure & Locations
21
Proprietary & Confidential
Israel Slovakia
Available on site
Headquarters
Sales & marketing
Production facility
R&D facility
France
GermanyIndia USA
Available on site
Sales & marketing
Production facility
R&D facility
Available on site
Sales & marketing
Production facility
Available on site
Production facility
Available on site
Sales & marketing
Available on site
Sales & marketing
No. of employees: 550 No. of employees: 110 No. of employees: 120
No. of employees: 1000+ No. of employees: 10 No. of employees: 5
Our Global Product Groups
22
Proprietary & Confidential
Cardiovascular& Vascular
Thoracic & General Surgery
Angioplasty catheters, stents ++
Urology Enteral Feeding
Gastric and nasogastric systems ++
Critical Care
Venous Access and monitoring devices ++
Drainage systems, custom procedure packs ++
Drainage and therapeutic catheters ++
Our Offering
A to ZComplete solution from R&D, Manufacturing Engineering, to complete (Sterile) Packaging & Private labeling with customer’s branding. Supporting our clients during the entire product lifecycle!
23
Proprietary & Confidential
Product development and design according to customer specifications
Regulatory services on behalf of the customer: FDA and CE submissions
Manufacturing and sterilization
OEM and brand labeling
Warehousing in our worldwide logistic centers -through vendor management inventory agreements
Our Competitive Advantages
24
Proprietary & Confidential
State-of-the-art technology in developing and producing medical devices
Global Manufacturing footprint including certified clean rooms
Competitive manufacturing cost
Supplier to global companies
A to Z OEM solution
FDA & CE & ISO
Ongoing innovation in product offering
Strong know-how and professional management
Close relationships with hospitals to facilitate new device ideas and feedback
Qualityyou can
TRUST
QA & RA
The Degania MedicalTM group’s Quality Assurance and Regulatory Affairs management systems, ensure that each facility meets the highest quality and regulatory level required in the medical industry.
25
Proprietary & Confidential
Certificates & Approvals
MDD93/42/EEC
510 (k)US Marketing
Clearance
Reg. Nos.8030107, 8030115,
3003646910, 3005483737
All manufacturing is
in accordance with
Product Development
26
Proprietary & Confidential
Peripheral angioplasty systems
Angiography catheters and accessories
Needle-free systems
Venous access devices
Enteral feeding systems
Products Overview – Cardiovascular
27
Cardiovascular & Vascular
Stent Delivery Systems
Angioplasty (PTCA/PTA), DEB , DES and thrombus
aspiration Catheters
Angiography and angioplasty accessories
Custom procedure trays
Products Overview – Thoracic & General Surgery
28
Wound drains and Drainage Systems
Chest Drainage Systems
ID Loops and custom made devices
General Surgery
Products Overview – Urology
29
Pigtail Drainage Catheters
Foley Catheters for wide range of applications (temperature sensing,
irrigation supra pubic etc.) Manual and Electronic Urine
Drainage Devices
Urology
Products Overview – Critical Care
30
Venous Access devices (CVC, Dialysis, PICC)
Invasive Blood Pressure Monitoring
Systems IV infusion administration
systems
Critical Care
Products Overview – Enteral Feeding
31
Gastric and naso-gastric
feeding tubes
Skin level feeding tubes Nutrition
administration Sets
EnteralFeeding/Nutrition
Thank You