Cal MedTech's development team members have an average of fifteen years of experience in the industry. We only develop medical devices and laboratory instrumentation. We don’t design automotive, consumer or industrial products. Our unique focus and commitment enables us to give our clients a competitive edge by incorporating the most advanced life sciences technology into their products as quickly and affordably as possible.
San Diego Design Center
Our San Diego headquarters facility houses a complete design, development and transfer team. All development and prototyping work is conducted in private, secure laboratories. The engineering team comprises electrical, mechanical, biomedical, software, mechatronic and manufacturing engineers.
SF Bay Area Design Center
Located in Menlo Park, California, our Bay Area Design Center is staffed by some of Silicon Valley’s most talented engineers. Areas of particular expertise for this group include therapeutic medical device development, RF generator design, embedded system development, graphical user interface design and both high and low-level software development.
Intellectual Property
We keep it simple - all intellectual property developed as a direct result of services provided to our clients is the sole property of our clients.
Mechanical Engineering
Our mechanical engineering team uses the latest in computer-aided development tools, including SolidWorks, ProEngineer, AutoCAD, and others as required. These tools enable us to compress the concept development and prototyping phases into weeks or even days.
We can transform CAD models directly into physical prototypes using either in-house CNC milling or processes such as stereolithography (SLA) or fused deposition (FDM). If multiple prototypes are required and production of hard tooling is either cost-prohibitive or too slow, we can use soft-tooling techniques to generate production-appearance mechanical parts in a couple of weeks, with mechanical properties that rival those of hard-tooled parts. In special cases we will produce prototype parts made with medical-grade resins so they are suitable for use in clinical testing.
Industrial Design
We have a close affiliation with San Diego’s leading industrial design group, and together we have conceptualized scores of medical devices ranging from knee braces to IV pumps. Depending on your needs, our industrial design team can do everything from simple concept drawings to convey the design direction to more elaborate drawings and presentation-quality 3D models that can be used for focus groups and trade shows.
Electrical Engineering
Most of the products we develop require both analog and digital electronics. On the analog side, we have a lot of experience designing patient-connected circuitry, such as physiological amplifiers. We design stable circuits that thrive in the real-world environments of electrostatic discharge, electrocautery and defibrillators. On the digital side, our team uses the latest integrated development tools to give your product reliability, horsepower, and flexibility. Depending on
your requirements, we can design an embedded microsystem or build in microprocessor-like functionality without the validation challenges associated with software. For appropriate applications, we can utilize our proprietary Universal Controller Board (UCB). Our UCB allows us to get your product up and running quickly with a minimum of development time. It has a fast processor which can support Windows-level graphical user interfaces, and has lots of I/O, optical isolation, a redundant processor and hardware watchdogs -- all of which are typical requirements of life sciences instrumentation
Software Development
Our software development expertise encompasses real-time control systems, graphical user interfaces, image processing, web-based applications and database development. We develop everything from low-level embedded firmware to touchscreen-based PC application software. Languages include C, C+, C++, C#, Visual Basic, Linux, Unix, SQL, XML, OS/2, Windows 95/2000/XP, WinCE, dot Net, TCP/IP, Java and others. We also have the ability to utilize LabView software to simulate the functionality of finished products, as a way of debugging control systems and optimizing user interfaces.
Verification and Validation
As part of most development programs, we perform verification testing throughout the development process. This helps to ensure that we stay on course to a successful endpoint. We also typically orchestrate a series of validation tests after the design phase is complete, in order to flush out any shortcomings relative to the original design goals. We encourage the involvement of outside validation engineers during this process, to maximize objectivity.
Compliance Testing
We have an affiliation with two local compliance engineering firms, who can provide UL, CSA, TUV, VDE and CE testing. Because of our relationships, we can usually have a compliance engineer sit in early in the design process to ensure that no compliance issues crop up later.
Regulatory Support
For products that require FDA clearance prior to marketing, we can actively participate in the pre-clinical testing phase. For example, we can assist in providing technical information to support IDE (Investigational Device Exemption) applications, IRB (Institutional Review Board) approvals, 510(k) Pre-Market Notification submissions and PMA (Pre-Market Approval) applications. We can also write your 510(k) for you, or refer you to an associate.
Patent Assistance
We realize the importance of strong offensive and defensive intellectual property positions in order to compete effectively in today’s medical device industry. Many of the Cal MedTech team members are multiple patent-holders, and most have read and analyzed hundreds of patents. As such, we are happy to work with you and your patent counsel to perform extensive searches of prior art, to define non-infringing product opportunities, and to come up with novel, patentable product concepts. We can even author the technical portion of your patent applications, if so desired.