Leading Design and Contract Manufacturer to the Medical Technology Industry. Med-tech Pharmaceutical Diagnostics.

Transcription

1 Leading Design and Contract Manufacturer to the Medical Technology Industry Med-tech Pharmaceutical Diagnostics

2 Design & Development Synecco is a leading Design & Contract Manufacturer headquartered in Galway servicing the global Medical Technology Industry. Industrial Design Human Factors IEC ISO Standard Mechanical Design Product Development Simulation and Analysis Material Selection Process Development With manufacturing footprints in Ireland and China, Synecco s facility in Ireland extends over 66,000 sq. ft, including a Class 8 cleanroom offering similar to that of Synecco s China facility. Synecco operates to ISO 9001, ISO and FDA registration. Ireland Acquired ,000 sq. ft. Contract Class 8 Cleanroom Injection Moulding Over Moulding Blow Moulding Vertical Injection Moudling Extrusion Processes Manual Assembly Automated Assembly Post Moulding Processing Tool Design & Development China 50,000 sq. ft. Class 8 Cleanroom Injection Moulding and Extrusion Full Product Solutions Packaging and Sterilisation Gama. ETO & E-Beam Testing Validation Documentation & Traceability Tool Design & Development Injection Moulding Over Moulding 1

3 Design & Development PHASE -1 Product & Process Innovation PHASE 0 Research & Definition PHASE 1 Concept Generation PHASE 2 Product Feasibility PHASE 3 Development Engineering PHASE 4 Verification & Validation Experts in Engineering and Design, we integrate both functions to help move products quickly from concept to commercialisation, creating and manufacturing products that are durable, dependable and reliable. Innovation and strategy Strategy Alignment Product Process Innovation Research and Human Factors Ethnographic Research Usability Studies Formative & Summative Evaluations Design and Engineering Industrial Design Product Engineering Process Development Documentation ISO Certified Documentation Research and strategy Our process systematically uncovers the defendable product, manufacturing and business model breakthroughs which our customers require. This innovative approach delivers superior long-term competitive advantages to our customers. Usability Engineering At Synecco our usability engineering process is driven by the international standard IEC Utilising the standard as a guideline to our process ensures we meet full usability requirements of our customer s medical device development needs. Industrial Design The primary purpose of Industrial design is to deliver the desirability needed to drive market share growth. The look, feel, functionality and branding of objects is a key focus of our designers. Creative Engineering Experts in engineering and design, we integrate both functions to help move products from concept to commercialisation, creating and manufacturing products that are durable, dependable and reliable. 2 3

4 Ireland Synecco s manufacturing site in Ireland is a Leading Medical Technology provider for precision injection moulded components and assemblies servicing the Medtech, Pharmaceutical and Diagnostic sectors. Capabilities extend to blow-moulding, over-moulding, 2-shot and vertical moulding. PHASE 5 Contract & Supply Facility Est ,000 sq. ft. Quality ISO 9001:2015 ISO13485 Environment Capabilities Injection Moulding Class 8 Clean Room Over Moulding Blow Moulding Extrusion Processes 2-Shot Moulding Surface Printing Capabilities Quality Assurance Manual Assembly Automated Assembly Material Selection and Procurement Service 2018 New Upgrade Program; General Moulding Environment 3,000 sq. ft. ISO Class 8 Cleanroom Machines 29 Injection Moulding Machines: Size T 4 Blow Moulding Machines 1 Vertical Injection Moulder Production Capabilities Plastic Injection Moulding Two Shot Moulding Blow Moulding 4 Colour Pad Printing Value Added Assembly Support Capabilities Assembly Tooling In-House Tool Maintenance and Metrology Lab Process Development Scientific Molding 4 5

5 China Synecco s China facility extends over 50,000 sq. ft, including Class 8 cleanroom facilities. Synecco operates to ISO 9001, ISO and FDA registration. PHASE 5 Contract & Supply Material Selection and Procurement Services Clean Room Plastics Processing HDPE, MDPE, LDPE, PVC, PU, PP, PS, PC, ABS, Injection Moulding Insert and Over Moulding Blow Moulding Specialty Extrusion Post Extrusion Processes Ultrasonic Welding Silicone Spray Dispensing Metal Processing Casting Forging Machining Surface Printing Capabilities Electronics / PCB At Synecco, building quality into all our processes means that we develop and produce solutions to satisfy both customer s quality requirements as well as international regulatory standards. Through our continuous improvement approach, we are continually looking to improve our ISO13485 Medical Devices Quality Management System to meet and exceed our customer s quality expectations. All our facilities, and the facilities to which we contract manufacturing in China, are fully certified to industry standards and are U.S. FDA registered to produce products and components for the med tech sector worldwide. Critical to Synecco s offering is that we certify, approve and release all products manufactured on our behalf for our customers. Our rigorous Quality Management System ensures that we provide a consistent service that meets customers and statutory requirements. We continue to strive to improve our quality systems and processes through internal review workshops following customer audit and regulatory review findings. This process of continuous review and improvement means that we are constantly striving to perfect our quality controls to the highest standards, giving our customers total confidence in the quality of our products. 6 7

6 Case Studies Smart Colonoscopy Device The Endodex system monitors scope movement and detects if any areas of the colon have not been checked. At the heart of the system is an innovative body worn sensor which uses laser technology to detect the movement of the colonoscope shaft during a colonoscopy and transmit this via Bluetooth to a PC. This provides live feedback of colon coverage during colonoscopy procedures. Coupled with sophisticated imaging technology the Endodex device significantly improves the quality of colonoscopies. 8 Smart Controller Connected Health The design uses touch keys instead of traditional mechanical keys, it is both elegant and easy to keep clean. With a depth of just 17.5mm, these keypads are unobtrusive and easy to incorporate into any home or industrial environment including sanitising environments such as hospitals. This is an award winning security system that Synecco now manufactures for the multinational which is available in multiple territories worldwide. The move towards digital health records now allows for a more connected system where a range of stakeholders including the user themselves and clinicians, can be informed about patient compliance patterns in order to aid compliance. Synecco s customer tasked us with developing a means of adding value to their generic drug offering. At the core of the device is a film with a printed circuit that records individual blister cell breaches. The blister plugs into a smart lid which displays key data locally as well as transmitting it to a secure network. EZ-Tract This stent introducer system illustrates our integrated service offering, moving from concept generation from development and engineering through to manufacturing. The stent delivery system features a unique internal ratchet mechanism for more efficient stent delivery using the large extrinsic muscles of the forearm as opposed to smaller intrinsic muscles of the hand. Stent Introducer Mechanism Synecco was engaged in the design and development of a stent delivery system which required a high level of control and accuracy. In particular Synecco developed a ratchet mechanism to be used in a thumb-wheel hand control. This project required our creative engineering team to understand the deployment forces and design a mechanical interface to maximise usability and mechanical performance. Synecco also proposed alternate handle designs as part of this engagement and provided the capability to take the designs right through to manufacturing and supply. Balloon Tamponade System The Ebb Tamponade system is a revolutionary dual balloon catheter which replaces the traditional tamponade approach to stop post-partum bleeding. Synecco undertook a programme to research and understand the unique usability challenges that exist in this procedure and then design, develop and manufacture the optimum product solution, which has been rapidly adopted in the market and has gone on to save many lives. 9

7 Design and Development Ireland Synecco Ltd Unit 7, Racecourse Business Park, Ballybrit, Galway, Ireland H91 NP73 Ireland Scariff Road, Whitegate, Co. Clare, Ireland V94 FA03 China Synecco Ltd. B801 Rongan Plaza, No 700 South Tiantong Road, Yinzhou District, Ningbo Zhejiang, China