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 and electrocautery.

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.

 

Software Development

We develop everything from firmware for embedded processors to software for PC-based applications.  Our expertise includes real-time control systems, graphical user interfaces, image processing, web-based applications, image processing and database development.  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.  For each project, we generate the following documentation: Software Development Plan, Software Requirements Specification, Software Design Description, Software V&V Plan, Software V&V Protocol and Software V&V Report."

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.

 

Intellectual Property 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 Paragon 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.