Product Development

Your concept has legs. Let’s bring it to market.  

Moving from research and development to product development is challenging. During R&D, the architecture and system is generally built to be flexible so you can explore various solutions with the lowest overhead. You can use Arduino boards and all types of great demo kits to move quickly and refine your product definition.  The pivot to the product development phase requires a change in mindset.  

While a key tenet in research and development is flexibility, in product development, the focus is on risk management and safety. The goal of the system architecture design changes significantly and the environment transforms from a permissive, experiment-driven framework to one driven by the design control framework, where activities are planned, executed, and reviewed with rigorous documentation. 

we integrate with your team to drive a design-controlled process compliant with your market needs.

Planning, System Architecture, Design Controls

Using the tools that work best for your team, we work with you to map out your project timeline with key deliverables and milestones, from early phase through regulatory submission and clinical trial navigation. As product development progresses, effective design of the system architecture is critical for maximizing the safety of your product while simultaneously minimizing the burden in design and testing. We work with your team to create and refine these fundamental structures for an efficient, traceable, and controlled development process.

• Project, design, and V&V plans

• Multi-level requirements generation

• Risk management file

  • Preliminary Hazard Analysis

  • Risk estimation, assessment, analysis, and mitigation

  • Failure Modes and Effects Analyses (FMEAs), Fault Tree Analyses (FTA), and other supplemental tools

  • ISO 14971 compliance

• Design History File and traceability

• Integration with client-preferred toolsets and methods of management

Human Factors & Usability

Development compliant with IEC 62366 and utilizing the regulatory guidances of your target markets

At the end of the day, your product will be in the hands of a person, be it a patient, a clinician, an engineer -- or possibly, someone with no idea what that product is but simply trying to lend help to another in need.  

As consumers, we expect the products we invest in to be intuitive and easy to use, and this experience ties directly to the market success of the product itself. Medical devices should be no exception, and so we apply these same fundamental design principles throughout the development process.  

To develop a safe, effective, and market-approvable medical device, every design decision must be tied to the core user need.  

We start by truly aiming to understand the users’ core needs. (Sometimes this is different than what people think they need!) Asking the right questions and gaining the insights of the key stakeholders helps bring this process to life. Another key step in this process is understanding not only how we want users to engage with the device, but also to learn quickly how users actually engage with the device. In that way we can iteratively transform concepts into feasible, user-friendly designs that can be proven to be safe and effective products. 

We encourage and directly support a very hands-on approach, integrating key users and field experts to propel the process of generating multi-level customer and system requirements that drive downstream technical design. We aim to gather early feedback using a combination of techniques and resources to more efficiently refine the design of what will eventually become your finalized product.  

This process is supported every step of the way with key documentation that meets the industry standards and the expectations of your regulatory reviewers.

Support areas include key, IEC 62366-compliant documentation and participation in core activities of the the Usability Engineering File, including but not limited to:

• Usability planning

• Use Specification

• User workflow mapping

• Formative Test Protocols

• Summative Test Protocol

• Summary Report

Verification & Validation