Medical Devices
MiniFAB Team has extensive Product Development experience, which required intimate knowledge and application of micro- and nano-technology, in:
- Implantable devices, including active devices
- Cochlear implants and IPGs
- Stents
- Catheters
- Endoscopic surgical implants
- Drug-device combinatory therapies
- Point-of-care diagnostic devices, particularly those utilizing electrode arrays (e.g. award winning TearLab™ for tear biomarker analysis)
- Surgical tools and instrumentation
The expertise is supported by excellent understanding of medical needs in following applications:
- Cardio-vascular
- Pain and neurological
- Orthopedic
- Gastro-intestinal and metabolic
- ENT
- Urinary
- Wound healing
Our microfabrication capabilities are described in detail in Capability section. In addition, we are very proud of our Microfluidic toolbox and MiniChemLab instrument which significantly enhance our ability to design, optimize and test microfabricated products. Internally developed Microfluidic Toolbox and MiniChemLab Instrument were originally conceived as a platform for design, optimization and testing of microfludic devices, typically diagnostic cartridges. Since, the platform capabilities have been extended to provide a useful tool in device and pharmaceutical development requiring modeling of microfluidic phenomena. For example, thrombus formation is controlled using flow control and different microstructures and monitored by optical means. Such ability to control thrombosis provide useful bench test for efficacy of anti-thrombosis drugs or input in design of implantable devices that are in contact with the blood flow. Similarly, delivery and distribution of active ingredients through microcavities may also be modeled and simulated.
Case Study
Nanofluidics Osmolarity Test Card
MiniFAB’s technical capabilities and product delivery is demonstrated in the Award winning TearLabTM Osmolarity Test Card. The TearLabTM system is a product of TearLabTM Corporation. It consists of an instrument and a disposable nanofluidic sensor the Osmolarity Test Card.
MiniFAB managed the development of the Osmolarity Test Card and delivered technical expertise in micro- and nano- fluidics and technology. From the initial concept to full manufacturing MiniFAB delivered a result in less than two years and is now the sole global manufacturer of the Osmolarity Test Card. As a start-up company, TearLabTM appreciated MiniFAB’s careful management of the deliverables, milestones and time lines while keeping within a tight budget.
The design brief was to create a cheap, disposable device capable of collecting 50nl of tear fluid, preferably without the use of active components such as pumps and valves. Internal gold electrodes were to be integrated to perform an electrical measurement on the tear sample, providing an osmolarity reading with a CV < 1.5%. Previous experiences with other vendors of microfluidic solutions had been unsuccessful, however after an initial concept was agreed, MiniFAB delivered a working proof-of-principle within 3 months.
MiniFAB formed an internal multidisciplinary team which included engineers from the client’s company. Following the successful proof-of-principle the Staged Development Plan delivered Concept Demonstrator Prototypes to evaluate the design strategy: Alpha Production units for design evaluation, a Manufacturing strategy and implementation and Beta Production units for pre-clinical trials. Today MiniFAB is the sole manufacturer of the TearLabTM Osmilarity Test Card and is now working with TearLabTM on future generations of the product. The complete development and manufacturing process was executed under MiniFAB’s ISO13485:2003 certified quality system.
For its design, TearLabTM has been awarded the prestigious Medical Design Excellence Award® 2009. We believe this is the first of many awards to come. A press release from TearLabTM can be read here:
