Medical Products Supplies Companies

735 Pennsylvania Drive, 19341 Exton, PA
USA
Telephone +1 484 713-2100
Fax +1 484 713-2900
info.biomedical@dsm.com
http://www.dsm.com/medical

Product Categories

Product categories

01 Manufacturing of components
01.02 Plastics processing
01.02.01 Injection molding

Injection molding

01 Manufacturing of components
01.02 Plastics processing
01.02.02 Extrusion

Extrusion

01 Manufacturing of components
01.05 Surface treatment
01.05.03 Surface coating

Surface coating

02 Manufacturing of finished products
02.07 Implants (passive)

Implants (passive)

Bionate® Thermoplastic Polycarbonate-urethane (PCU)

02 Manufacturing of finished products
02.12 Dental products

Dental products

02 Manufacturing of finished products
02.17 Biomedical products

Biomedical products

03 Services
03.04 Design and development
03.04.01 product design, product development

Product design, product development

Polymer and Composite Processing

03 Services
03.04 Design and development
03.04.02 Packaging design, packaging development

Packaging design, packaging development

03 Services
03.05 Assembly

Assembly

03 Services
03.06 Contract packaging

Contract packaging

03 Services
03.07 Labeling

Labeling

03 Services
03.08 Sterilization

Sterilization

08 Raw materials, materials, adhesives
08.01 Plastics

Plastics

08 Raw materials, materials, adhesives
08.03 Ceramics

Ceramics

Bioceramics technology

08 Raw materials, materials, adhesives
08.04 Composites

Composites

08 Raw materials, materials, adhesives
08.08 Adhesives

Adhesives

08 Raw materials, materials, adhesives
08.09 Other raw materials, materials, adhesives

Other raw materials, materials, adhesives
Our products
Bioceramic medical devices

Bioceramic medical devices

Product category: Ceramics
Bioceramics technology
Medical ceramics for bone graft substitute in orthopedic, dental and sports medicine applications

DSM specializes in the design, development, commercialization…

Product category: Implants (passive)
Bionate® Thermoplastic Polycarbonate-urethane (PCU)
Bionate® PCU is well known as an industry-leading medical-grade polymer successfully used in long-term implants for many years. It has outstanding physical properties and excellent biocompatibility and biostability proven by use in a number of medical devices covering several therapeutic areas.

Bionate® II PCU is the next generation in our industry-leading family of materials with built-in surface modification technology. It offers added strength, improved oxidative stability, and enhanced processability.

These polymers feature a unique combination of toughness and biostability, making them ideal for chronically implanted devices. Extensive testing has demonstrated their outstanding mechanical properties, and Bionate® is backed by our FDA Master File with extensive biocompatibility test data.

Benefits
Bionate® PCU

Proven clinical use
Combines flexibility with strength
In vivo biostability, biocompatibility and oxidative stability
Tough, load-bearing qualities
Outstanding abrasion resistance when compared to conventional silicone elastomers
Customizable with SME® technology, utilizing surface-modifying end groups
FDA Master File

Bionate® II PCU

Wide range of potential surface characteristics using DSM’s patented Self-Assembling Monolayer End Group (SAME®) technology
Outstanding abrasion resistance
Improved oxidative stability
10% stronger than first-generation Bionate® PCU
Improved processing characteristics
FDA Master File

Product category: Product design, product development
Polymer and Composite Processing
DSM has extensive experience in the design, development, manufacture, and sterilization of medical devices made from synthetic resorbable and permanent (non-resorbable) polymers. These devices serve sports medicine, spine, trauma, craniomaxillofacial, and dental markets.

Resorbable (bioresorbable and bioasorbable) materials
Our bioresorbable materials include orthopedic screws, anchors, pins and plates, and high-strength reinforced products such as trauma repair plating systems. We also specialize in porous scaffolds made from the same resorbable materials which are cleared for use as bone void fillers and membrane barriers. Additives such as ceramics or bioactive glass can be incorporated into these devices to enhance their behavior.

Polylactides (PLA)
Polyglycolides (PGA)
Polycaprolactones (PCL)
Trimethylcarbonate (TMC)
Copolymer blends of these materials

Permanent materials
Commercial examples include orthopedic screws, anchors, pins, and interbody spine fusion devices.

Polyetheretherketone (PEEK)
Thermoplastic Polyurethanes (TPU)

Composites
Custom-blends of polymers with ceramics, fiber, fillers, or dyes to achieve unique properties including:

Enhanced strength
Better visualization
Radiopacity
Osteointegration and osteoconduction

Project and processing capabilities
We have an experienced and diversified staff of business and technical experts to be a trusted partner for our customers. Our extensive processing capabilities include:

25,000 ft² of cleanroom manufacturing space
Injection molding (vertical and horizontal)
Insert molding
Compression molding
Single and twin screw extrusion
Cleanroom machining
Laser cutting and perforation of films
Ultrasonic welding
In-house mold making

Biomedical testing services

Chemical, mechanical and analytic test capabilities
In vitro degradation and accelerated aging studies
Shelf life and packaging stability studies
Contract testing for design optimization, regulatory submissions, and lot release
Biomechanical testing

DSM is registered with the US FDA as a medical device manufacturer. Our quality management system is certified to ISO 13485 and the Exton, PA facility is UKAS accredited.

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About Us

Company details
Making the exceptional possible

DSM is the leading medical device materials development and manufacturing partner in the world. We help medical device companies develop products that address many growing trends in medicine – from treating an aging population to caring for a more active one– meeting the need for safer, less invasive procedures that are also more cost-effective.

Innovative biomedical materials and technology expertise
With more than 30 years of experience, medical device manufacturers and pharmaceutical companies have obtained the most advanced and trusted materials and technology from DSM, benefiting 10.5M+ patients annually. Our team of 400+ biomedical specialists is constantly turning ideas into innovative materials and devices of the highest quality that address the unmet healthcare needs of today and tomorrow.

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