We enter product development projects at any stage from idea to finished product, we design and build production and laboratory equipment and we produce in small scale in our class 8 clean room. An essential part of our services is the transfer of technology to high scale production facilities. All equipment is in house, tool shop, molding, cleanroom, test equipment, laboratory, and of course qualified employees.
At Soltech we have decades of experience in the medical device and pharmaceutical industry, we:
- Select materials
- Select production processes
- Make 3D simulations
Examples could be catheters, surgical devices and implants. We are capable of providing full documentation concerning both raw materials, production validation and CE-certification.
tWe design and construct high end production equipment to customer specifications. Most often customer specifications is the result from an intense dialogue between the customer and Soltech. Soltech e.g. deliver machines and tools for bonding and tip forming, sealing, welding and hole punching.
Our cleanroom allows us to develop and produce Products in a highly controlled environment. The standard of the cleanroom is ISO-class 8. Because of the many combined years of experience developing medical solutions, it was a logical step in the development of Soltech to build a cleanroom. It allows our clients to have demo models and prototypes,which are useable in a clinical setting. We make small scale production for in vivo testing, clinical studies or for market entry prior to the technology transfer to larger scale production.
Soltech was contacted to develop the product as well as the production method. The catheter is designed for venous drainage. Special features results in optimal flow rates independant of the blood pressure being systolic or diastolic. At the final project stages a partial technology transfer was initiated so that parts of the catheter today is produced in Soltechs clean room. The catheter itself is manufactured by the customer. The part that Soltech produces is illustrated below.
In a typical contract development process Soltech has been involved in the complete Tubingset, Heat Exchanger and Nasal Catheter from early development and to production in our ISO Class 8 clean room for clinical trial in hospitals. The product is patented and CE approved. An idea was created. This idea was to apply local cooling of the brain for stroke patients. The concept of systemic cooling is less effective and associated with side effects. A couple of problems however, showed up on the journey towards realizing the vision. First of all funding was needed, secondly they would need someone with proper know-how and the right equipment and facilities.
The Moneypeople from Moneyland agreed to finance the development of the great idea. The capability to create a product and take an active part in the product development was needed. Quickcool turned to Soltech, and all together we managed to design, produce, and validate the product. It is now in clinical Trial to prove that it really does save lives, and significantly reduces the risk of brain damage in situations like cardiac arrest, traumatic brain injury and subarachnoid hemorrhage. The product cools the brain locally so that it lasts longer with less oxygen, without the downsides of cooling down the entire body
We make custom Controller Units for individual assignments. With standard components, lots of creativity and know-how, these Controllers becomes quite clever and powefull Units. We choose in advance which "brain" would be most suitable for the assignment, to optimize the cost/benefit ratio. Most commonly, our controller Units would be used in some kind of a heat sealing, bonding, or tipforming device. It could be as simple as a Machine for sealing peel pouches. Because of the accuracy in our Controller Units, it can be set and reset for sealing different materials very easily, and still perform a fully validated sealing for e.g. a Medical Device. Data can be logged and extracted for documentation if necessary. Electric, Pneumatic, Thermostatic and Hydraulic in- and outputs are possible. Even vision control can be integrated to interact with the controller during production. This also makes a Soltech Controller capable of controlling many of our previous Machines with only few changes in the setup.