OEM Services presentation. 1

Transcription

1 OEM Services presentation 1

2 About Simeks Introduction Established in 2010 with 42 years of experience in medical device sales and services Mission To design, develop and manufacture high quality and innovative medical devices for global market Focus Specialized in the manufacturing of excellent interventional devices for interventional cardiology and radiology 2

3 Our Main Values Quality System R&D Market Development Quality Control Customer Simeks committed quality at the highest levels. Our company meet ISO 9001 and ISO standards and European Directive for Medical Devices 93/42/CEE. All our products are CE certificated. Our R&D team includes talented engineers from different fields. They manage R&D projects and some projects are supported by science and technology agency of Turkey. The dedicated QC team operates all QC inspections from raw material income to final inspections. Visual, dimensional and microbiological inspections are performed with qualified QC stuff and validated high-tech machines. Additional to Simeks standards; customer specifies for the standards of the requested product. All specifications and QC tests can be applied according to customer demand. 3

4 Production Tubing Set Division Catheter Division Hemodialysis Bloodlines Infusion Sets Other Tubing Sets Balloon Catheters Stent Systems Specialty Catheters Other Interventional Products 4

5 Tubing Set Division 5

6 Catheter Division 6

7 Product History Semi-Compliant PTCA Balloon Catheter Drug Eluting Coronary Stent CTO Balloon Catheter Diagnostic Catheter.035ʺ OTW PTA Balloon Catheter CoCr Coronary Stent Stent Delivery System Non-Compliant Balloon Catheter.014ʺ Rx PTA Balloon Catheter CoCr Coronary Stent (New Design).018ʺ Rx PTA Balloon Catheter.018ʺ OTW PTA Balloon Catheter 7

8 Business Model Simeks Brand: Simeks has CE certificates for all Simeks branded products. These products are sold in domestic market as market leader. We also export our products to selected countries. OEM Services: We utilize our expertise and abilities to supply customized products according to client needs. 8

9 What are our OEM services? Private Label Product Simeks offers private label products to clients who want to have to enhance their brand with our support OEM & Customized Product We manufacture PTCA&PTA balloon catheters, stents and stent delivery systems in various combination according to client specifications Product Development & Prototyping Our R&D team leads projects for our client ideas or design. We can assist our client for new catheter development from idea to the product. Including prototype and serial production Technology Support Simeks offers training and process transfer services to the clients for their sub-assembly operations 9

10 Specification Options Balloon Types Semi-Compliant Non-Compliant / High Pressure Compliant CTO / Low Profile Stent Delivery Balloon Sizes Diameter from 1mm to 30mm Length from 6mm to 220mm Catheter GW Compatibility.014ʺ Rx.014ʺ OTW.018ʺ Rx.018ʺ OTW.035ʺ OTW 10

11 Product Development fast way for your balloon catheter needs Decide Balloon type GW compatibility Shaft type Identify Size matrix Customization Fine Tune Design adjustment for requirements of the application area Your Product Reach your balloon catheter need without expensive R&D costs 11

12 Development Options for your innovative product projects Balloon Shapes Other than standard balloon shape, Simeks develops specific balloons best for your applications. Elliptical, spherical or other shapes are possible. Catheter Design If your project requires different catheter design, we are here to help you. Our R&D engineers develop catheters for specific projects. Materials Innovative product needs advanced raw materials like low profile, multi-lumen tubing or reinforced tubing. Simeks has know-how on different raw materials and likes to try new ones. Features for Application Balloon catheters may look similar, however every application has its own challenges. Simeks know that by heart and design, test and validate the product in this respect. 12

13 Process Options Hydrophilic Coating Our hydrophilic coating will boost the performance of your interventional catheter. Hydrophilic coating Simeks applies is licensed from USA company. It is highly biocompatible, durable and lubricous. Sterilization Validated in-house ethylene oxide at your service for end products. 2 sterilization units and 21m 3 total capability provide flexibility for fast product dispatches. Crimping This process is made with high tech crimping machines and by skilled technicians. Our engineers develops new crimping methods for different stent types. Hub Insert Molding Simeks offers various options for catheter hub. Our customers may use our standard hub which are injected directly over hypotubes or they can have catheters with their own hub design. 13

14 Thanks for Watching 14