Medical and biosciences devices hold much promise for our future, enriching lives, enhancing lifestyle, providing better wellness and promising more drug-free remedies every year. In spite of the research and growth in the industry, challenges in engineering the devices that make our lives better and longer continually rise. New products and techniques for managing health through technology might introduce new hazards. You need tools that will help you design in a way that mitigates risk to both patient and financial success of new products.

Make it Safe, Make it User-friendly

It’s a strict market for compliance. After all, a patient’s survival may be depending on the devices you design. Even presumably low-risk devices can be rendered harmful if misused, and you can’t always predict who is using your product in a stressful situation. That’s why you need tools that help you design to well-documented specifications and standards like ISO 62366. You need to be able to model the form, fit, and user interface aspects of the design up-front. You need tools that interact well with MCAD and industrial design without holding you back on requirements and ECO checklists.

Design Ergonomic, Usable Medical Devices
Meeting safe usability and product design goals does not have to be a burden anymore.

  • With Native 3D modeling, collaboration with the industrial designers and mechanical engineers is easier than ever. If a design flaw in the user interface is discovered, changes can be rapidly propagated from the MCAD model directly into the PCB design and vice-versa. 
    Learn More about ECAD/MCAD Collaboration
  • Creepage and clearance distances defined in PCB design rules can govern parts placement, and this can be pushed back to MCAD for a design compromise. 
    Learn More about Design Rules for Safety
  • With advanced version control and project management capabilities, you can work to requirements and capture every change for product certifications. 
    Learn More about Project and Change Management

Form to Fit the Body

The wearable electronics market is growing by almost 18% year-over-year and is expected to surpass US $8 Billion by 2018[ref]. Whether you’re making the latest in fitness devices, health diagnostics, or automated therapy devices, you have the unique challenge of designing the hardware to fit human body. Considering the rigidity of electronic devices and traditional PCBs, flexible circuit technology and rigid-flex become a natural choice. You need tools that will enable advanced layer stack design along with proper 3D modeling of the flexible substrate to guarantee correct form. And with more and more dense circuits having to fit snugly in and around a person, embedding components within the board can often be the only way to get your design to fit.

Flexible & Embedded in the True Sense
Our tools are the first and only tools to natively model rigid-flex PCB designs in full 3D, as well as embedded active and passive components and cavities for containing them within the rigid board substrate sections.


Barriers to FDA 510(k) Approval

The average time to approve a new medical electronic product is 145 days according to FDA published data, even though the FDA themselves have a policy of 90 days for processing applications. The FDA states this is because submittals usually have inadequate supporting data, lacking accurate device descriptions and traceable documentation[ref]. 55 additional days or more due to bad or missing compliance data can hamper what could have been the successful launch of your new product. 

Get Design Documentation Into a Complete Lifecycle-Managed Package
Using the Altium Vault (Now Altium Concord Pro) to properly manage data provides an easy-to-use framework for collecting and publishing the right data not only for manufacturing purposes but also for certifications and lifecycle approvals. 

  • Create correctly formatted, predictable, reliable data release bundles and assign unique identifiers for each revision, managing the lifecycle of the data for fabrication, assembly, and documentation outputs.
    Learn More about the Release Process
  • Use Managed Projects, Version Control, Lifecycle Management, and To-Do lists to manage and track certification-critical tasks, feeding to documentation and reports. 
    Learn More about Version Control, Lifecycle Management, ECO Reports, To-Do lists
  • Establish lifecycle-managed predefined configurations (configuration management) for generated outputs, user profiles, schematics, and PCB project templates. Each time a new product design starts, you then have a guaranteed, correct-by-configuration project and template set. 
    Learn More about Configuration Management
  • Give the right access to the right data and configurations to the correct people, so every change is approved and documentation captured. 
    Learn More about Users and Roles
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