global capabilities - qure medicalqure-med.com/.../3/2017/02/qure-global-capabilities... · kibbutz...

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

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCJG5oarMiMkCFQzuJgodt3YFuA&url=http://smarthealthusa.com/about-us/&psig=AFQjCNHb4oQYS5V3JoEQGVzVR5DRvbsk1Q&ust=1447339068415579

Rock Hill, South CarolinaMedical Manufacturing

North Canton, Ohio

Engineering CenterTooling & Automation

Sturtevant, Wisconsin

Medical Manufacturing

Dongguan, China


Total Number of

Employees: 2,188

Germany, Europe

Sales Office

Twinsburg, OhioCorporate HQ

Medical Manufacturing Nottingham, UK


Querétaro, MexicoComing Soon

Degania & Hazor Haglilit, Israel


Samorin, Slovakia


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


• 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


Key Capabilities

• HCR silicone extrusion

• HCR silicone molding and overmolding

• LIM-Liquid Injection Molding/LSR-Liquid Silicone

Rubber


• 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)


• 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


• 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


• Secondary operations (finishing/slitting)

• Clean room molding and assemblies in ISO Class 8


• 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


• 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


• 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


- 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


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


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


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


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


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


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

global capabilities - qure medicalqure-med.com/.../3/2017/02/qure-global-capabilities... · kibbutz...

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