Competences
WE DELIVER
Intelligent medtech solutions, which are based on specific customer requirements.
Future-proof solutions
Strong competences in every phase
Experienced and dedicated project managers
Solutions to create better quality of life for users/patients
We have 8 development phases in our Value Wheel. Please find detailed information about the phases below.
Use the arrows to navigate our Value Wheel. Mobile: Choose a phase from the drop down to read more about our Value Wheel.
Use the arrows to navigate our Value Wheel. Mobile: Choose a phase from the drop down to read more about our Value Wheel.
CONCEPT
During the concept phase, we develop the general idea into a new plastic element or new medical device. Working in close cooperation with the customer, we discuss wishes and challenges. We always focus on achieving a full understanding of the customer’s or end-user’s needs. Notwithstanding that our tasks are often based on complex issues, we are more than willing to explore new technologies and focus on devising a simple and reliable solution that is suitable for production. We prepare a thorough analytical report, according to which we determine the functions, user needs and storage conditions and define the target group. Our analysis results in product specifications, which form the basis for design/function models, mock-ups, prototypes and subsequent phases of product development. In the concept phase, we draw up initial documentation for the final product master file. We follow the SPT VILECON quality manual throughout the concept phase. Thanks to the many years of experience and the reliable network at our disposal, we are often already acquainted with the customer’s field, the specific organisation or even the multiple facets of and issues involved in the project in question. We are willing to help our customers draw up business plans.
We also work closely with patent agencies and help customers to apply for and register patents.
Our services include:
- Business plans
- Mock-ups (design models)
- Patents
- Product specifications
- Sketches
DESIGN AND DEVELOPMENT
At SPT VILECON, we are specialists who work in the intersection between design, development, electro mechanics and construction of medical devices on the one hand – and injection moulding on the other. As our customers are often leading international medical companies, we focus on remaining at the forefront of technology, development, risk management, regulatory conditions and documentation requirements. We design and develop plastic elements and complete medical devices, which often contain different types of micromechanics and synchronisms. We also have many years’ experience of constructing micro to medium-sized components in metal or plastic. We develop products in close cooperation with our customers, who typically take part in reviews and provide specific expertise throughout the process. We follow the SPT VILECON quality manual throughout the design and development phase, and collect relevant specifications, risk analyses, user studies, etc. for inclusion in the final product master file.
We have a wealth of experience of creating interfaces between electronic and mechanical components. To design the optimal user interface, we cooperate with industrial design experts. These companies ensure that all user-related issues are resolved in the best possible way and integrated into the final project.
Our services include:
- 3D print
- Prototypes (function models and prototypes)
- Product and device validation
- Product specifications
- Risk analysis
- Sketches and 3D/2D documentation
We follow the SPT VILECON quality manual in each of these services and collect relevant specifications, risk analyses, user studies, etc., for inclusion in the final product master file.
DFM - DESIGN FOR MANUFACTURING
In recent years, the medical and pharmaceutical markets have been subject to change and there are now great expectations with regard to growth and performance. Official requirements and regulations are becoming increasingly complex and new products are expected to reach the market faster. Time to market is decisive for success.
At SPT VILECON, we focus unswervingly on designing and developing rugged solutions, which can be produced efficiently, simply and cheaply at the right quality. DFM is one of the cornerstones in the creation of any new product. During the design and development phase, we work with provisional sketches and physical prototypes. We carry out a Moldflow to examine the design of the plastic element and check that it is optimal. The analyses cover all aspects of plastic flow rate, suction risk and injection volume options. We always carry out Moldflow analyses in cooperation with a trusted partner. This process is, of course, managed by SPT VILECON.
We design production equipment and fixtures for manufacturing purposes or for use in uniform testing of component parts and devices. We offer these services either as part of a complete project or as an isolated task. Every item of equipment is thoroughly tested to ensure optimal component quality and manufacturing conditions.
Our services include:
- Element and rig stability
- Moldflow analysis
- Optimisation with a view to streamlining manufacturing processes
- Prototype, including reviewing its suitability for manufacturing and compliance with user
- Technical assessment of rig
- Troubleshooting
DMF follows the SPT VILECON quality manual and verifies relevant specifications, risk analyses, user studies, etc. for inclusion in the final product master file.
PROTOTYPE AND TESTING
Manufacturing prototypes is an integral part of the design, product development and manufacturing processes. At SPT VILECON, prototypes and testing are important parts of the project process. During this phase, we assess technical risks, resolve product and manufacturing-related issues and monitor quality. SPT VILECON has in-house test- and production facilities at its disposal, including state-of-the-art injection moulding machinery and clean room encapsulation. Our services include commissioning and validating injection moulds, which means that we provide customers with optimal conditions for amending and rapidly optimising their solutions. We have our own basic moulds for steel inserts, which provide ideal conditions for cooling and injection moulding. We can therefore simulate full-scale production using a high-volume injection mould. Simulation is an effective and cost-efficient method, by which the customer can start the project, produce parts in final quality and use them in tests leading to official approval, and start serial production.
We source and produce injection moulds and make prototypes in close cooperation with Danish and international partners and toolmakers. We optimise at every level, including making adjustment, mould and tool production and injection moulding processes.
Our services include:
- O-series
- Adjustment, e.g. moulds
- CE labelling of production equipment
- First-out-of-tool (FOT)/Factory Acceptance Test (FAT)
- Process validation (validation of manufacturing process and equipment)
- Robotics (element release and handling)
- Systematic mould commissioning (DoE), OptiMelt, Mould-Up
- Stability assessment
We follow the SPT VILECON quality manual, including validation of the product/device for the product master file.
For details, please contact us.
We optimise at every level, including making adjustments, mould and tool production and injection moulding processes.
PILOT PRODUCTION
We are specialists in producing elements and medical devices in the pilot phase. Our team of highly proficient technicians all have many years of experience of producing prototypes, production start-ups and setting up pilot volume production. We set up pilot production and small-scale production start-ups at SPT VILECON’s testing and production facilities.
Our services include:
- Assembly processes
- Automatic and manual pilot production
- CE labelling of products and devices
- Robotics (element release and handling)
- Start-up of small-scale production
SMALL SCALE PRODUCTION
SPT VILECON has in-house test and production facilities at its disposal, including state-of-the-art injection moulding machinery. Our customers often ask SPT VILECON to run low-volume pilot production here. We can also help the customer to prepare for full-scale production. We produce escalated manufacturing volumes at SPT VILECON, on the customer’s premises or at an outsourced production facility.
SPT VILECON has a comprehensive network of very competent partners, both in Denmark and abroad.
Our services include:
- Fitting and optimising for full-scale production
- Outsourcing as an option
- Robotics (element release and handling)
- Supplier audit and monitoring
- Supplier qualification in connection with outsourcing
- Validation
Production can take place in accordance with the SPT VILECON quality manual or the customer’s quality management system.
FULL SCALE PRODUCTION
At SPT VILECON, we have a wealth of experience of successfully managing projects through the different phases of The Value Wheel – from concept through design and development to final full-scale production. By agreement with the customer, SPT VILECON can take over responsibility for specifications, tools, processes, plant installation and other tasks in connection with production start-up. We can establish start-up and full-scale production either on the customer’s or on a third party outsourcing partner’s premises.
Our services include:
- Documentation (SOP, packing instructions, etc.)
- Full implementation in the customer’s quality management system
- Outsourcing as an option • Preparation for full-scale production
- Product specifications, purchase specifications for raw materials, standard components, etc.
- Robotics (element release and handling)
- Supplier agreements
- Tools and equipment compatibility
- Validation
OUTSOURCING
A company may wish to outsource parts of its production for a variety of reasons. For example, market conditions often put pressure on prices and time to market, certain parts of manufacturing processes may require special competences or the company may lack production capacity.
SPT VILECON has a comprehensive network of very competent partners, both in Denmark and abroad. At the customer’s request, SPT VILECON can take over management of the project in the phase and guarantee full outsourcing at third-party facilities – including full implementation in the customer’s quality system.
KOMPETENCES
SPT VILECON offers strong competences and has many years’ experience of working with concepts, design, development, validation and project management in connection with plastic elements and devices for the medical industry. We already help companies of all sizes to develop, design and construct products and manage projects through every phase from concept development until production is commissioned and approved – CE labelled and FDA Medical device 510 (k) approved products. At SPT VILECON, concept development, design, validation, manufacturing and project management are essentially and specifically based on The Value Wheel.
The Value Wheel symbolises our approach to project management. Every project is steered professionally, phase by phase and 360°. We focus consistently on quality, goals, rapid implementation and on creating durable solutions. We also handle individual projects, in which we resolve tasks for our customers in individual phases of The Value Wheel. No matter whether we take on a complete project from design idea to finished product or provide isolated consultancy services, SPT VILECON delivers on its promises. Every one of SPT VILECON’s activities rests on a quality-based mindset, which is the result of several decades of experience in the medical industry. Our quality management systems meet international quality standards and are processed in the D4InfoNet quality management system.
Our project managers and their colleagues have extensive experience of working in complex project contexts. The projects we work with range in value from tens of thousands to 900 million Danish Kroner (from EUR 1,000 to 120 million). No matter the size of the project, we apply unimpeachable standards of integrity and professionalism. We act professionally and as a team. We perform all types of roles; as project manager, developer, project worker, quality manager, production technician, as well as metrological and regulatory officer.
We strive consistently to develop optimal solutions and call in the services of specialists in different professional areas, if required.
We handle all types of files for construction, development and documentation processes but work primarily in CAD programs such as SolidWorks and SolidWorks Composer.
We have built a comprehensive network of highly competent specialists within the following fields; electronics development, industrial design, user interfaces, plastic injection moulding tools, test rig installation, patent applications and a number of other specialist functions.
