Advanced Manufacturing Technologies for High Impact Medical Devices

The overall idea of the project has been to develop novel and smart manufacturing technologies to enable a leap forward in cost effective production of high impact medical devices, that can help keep and increase the attractiveness of Norway as a place for medical technology manufacturing. Norway has succeeded in creating globally competitive medical device companies in well-defined niche areas, typically for complex products where development and manufacturing depends on advanced skills and competence, and therefore can demand a premium price. This project has targeted such a high impact medical device area, where market accepted medical technologies with multiple end-user benefits (patients, medical personnel, clinical labs, hospitals, research), targets unmet market needs and are safe, portable, minimally invasive and cost-saving. Sensocure, GE Vingmed Ultrasound and Medistim are medical device companies in Vestfold, Norway, that have established low/medium volume production in the high impact medical device space. The companies manufacture products covering separate areas for diagnostics and monitoring in life science, with high quality requirements for invasive and semi-invasive medical products. The main barriers are found generally in the cross-section between materials and technologies, and specifically in the intersection of bonding and sealing, microfeature moulding and automation of hitherto manual processes. The companies want to use concerted efforts in removal of the identified barriers. They want to combine existing competence with focused development of new knowledge and technology. The goal is to disruptively improve medium volume, high complexity medical technology manufacturing platforms, rather than merely enhance general manufacturing regimes. Feasibility studies have been completed for the main areas of the project: bonding and sealing, moulding and automation of production processes. Process challenges from the corporate partners have been identified and reviewed in cooperation with the R&D-partners SINTEF Manufacturing, Norner and the University of South-Eastern Norway. State-of-art methods and materials for these process challenges have been evaluated in cooperation with the R&D-partners. Based on the feasibility studies, the R&D activities are prioritized, materials and equipment have been procured and experiments have been carried out for relevant materials and methods. In the experiments, test-labs at corporate partners and R&D partners were used. In cases where tests were costly and/or advanced equipment was required, such as for welding polymers and micromolding processes, tests were carried out at external test labs. Based on the results of the experiments, prototyping and lab pilots, we have further developed product-specific technologies and material selections for polymer bonding and molding processes in order to utilize knowledge and methods in the production of existing and future medical products. Experiments have been carried out using both prototypes and lab pilots to evaluate and automate product-specific production processes, with excellent results. Technology development and development of pilots to automate production processes with high accuracy requirements have been completed in the project. External suppliers such as Robot Norway and Tronrud Engineering have been involved in technology development and the development of pilot production technology in collaboration with corporate partners and R&D partners. Video of automated production process developed in the project at GE Vingmed, have been published by Robot Norway and GE. The project has increased critical competence and knowledge within relevant production technologies, how high precision can be enabled in automation processes, dispensing methods and inspection of materials and products, as well as material properties and their ability to bond and possible surface treatment to increase bonding. Knowledge gained in the project have given the companies a solid platform to continue to develop and implement an automated, scalable and cost-effective production. Cooperation and network building in the project has been of great importance to the companies, and collaboration will continue in several of the areas we have worked on in the project. The established network of companies, R&D partners and suppliers in the project, is something the companies will benefit from in the future.

Virkninger - Resultater har gitt bedriftene en unik mulighet for å implementere nye, disruptive og mer effektive produksjonsteknologier, og dermed styrke global konkurranseevne. - Bedriftene har fått solid kunnskap som vil kunne benyttes videre i utvikling og implementering av en automatisert, skalerbar og kostnads-effektiv produksjon. - Samarbeid og nettverk har stor verdi for bedriftene i videre utvikling og implementering fremover. Effekter - Prosjektet har bidratt til utvikling av nye produksjonsteknologier, som vil kunne effektivisere og redusere kostnader for produksjon av medisinsk utstyr og bidra til at Norge er attraktivt for medisinsk teknologiproduksjon. - Kunnskap og erfaring hos FoU partnere og leverandører, vil være tilgjengelig for andre bedrifter. - Samarbeid og nettverk har styrket miljøet for medisinsk produksjonsteknologi i regionen. - Med optimaliserte produksjonsmetoder vil minimere miljøbelastningen og det totale energiforbruket.

The overall idea of the project is to develop novel and smart manufacturing technologies to enable a leap forward in cost effective production of high impact medical devices, that can help keep and increase the attractiveness of Norway as a place for medical technology manufacturing. Norway has succeeded in creating globally competitive medical device companies in well-defined niche areas, typically for complex products where development and manufacturing depends on advanced skills and competence, and therefore can demand a premium price. This proposal targets such a high impact medical device area, where market accepted medical technologies with multiple end-user benefits (patients, medical personnel, clinical labs, hospitals, research), targets unmet market needs and are safe, portable, minimally invasive and cost-saving. Sensocure, GE Vingmed Ultrasound and Medistim are medical device companies in Vestfold, Norway, that have established low/medium volume production in the high impact medical device space. The companies manufacture products covering separate areas for diagnostics and monitoring in life science, with high quality requirements for invasive and semi-invasive medical products. The main barriers are found generally in the cross-section between materials and technologies, and specifically in the intersection of bonding and sealing, microfeature moulding and automation of hitherto manual processes. The companies want to use concerted efforts in removal of the identified barriers. They want to combine existing competence with focused development of new knowledge and technology. The goal is to disruptively improve medium volume, high complexity medical technology manufacturing platforms, rather than merely enhance general manufacturing regimes.