Your Medical Device & Consumer Health Product Development Partner

Mechanical & Electrical Design/Engineering

Simbex approaches Mechanical and Electrical Hardware Design from a systems integration viewpoint. Our process starts by defining functional requirements and specifications of the design that take into consideration every step of the product life cycle. The outcome allows the final product to not only seamlessly integrate together to meet functional needs, but also allows the product to integrate with external systems to meet manufacturing, distribution, packaging, and maintenance needs.

• 3D Modeling and Simulation
• Injection Molding, Sheet Metal Design, Rapid Prototyping, Enclosure Design and Packaging
• Control and Automation, Data Collection, and Remote Monitoring
• Materials and Component Selection
• Ultra-Low Power Digital Circuits
• Sensor Interfaces and Signal Conditioning
• Wireless Networks and Power Supply Design
• IEC 60601-1 Compliant Medical Systems

Design & Human Factors

By incorporating user feedback throughout development, Simbex creates products that meet human needs. We begin this process by obtaining the user’s product requirements which are then verified and validated during critical times in the product development process. These services include:

• User Experience
• Design (consumer and medical)
• Product verification & validation
• Graphic design (GUI, website)

Software & Web Development

Software development continually evolves with increasing complexity and integration of new technologies to help keep pace with customer expectations.  We have a diverse group of developers to cover the needs of users from embedded firmware to cloud based solutions.  We utilize an agile approach to software development to ensure development remains on track, and customer needs and requirements are met.  Our DevOps and quality assurance processes helps ensure each project is “rightsized” with a focus on delivering the right software at the right time and with the appropriate level of verification/validation from unit testing to integrated systems testing.

• Embedded software/firmware
• Machine Learning & Artificial Intelligence
• Software Design & Architecture
• Embedded graphics and touchscreen controllers
• Desktop App
• Web/Web App/Web API
• Mobile App
• Sensor Data Acquisition, Processing, & Visualization
• Algorithm Development
• Database
• Cybersecurity & Regulatory Affairs

Transfer to Manufacturing

By focusing on Design for Manufacturability, Simbex incorporates manufacturing processes into product design from the start of the project.  New as well as established manufacturing processes are utilized to create revolutionary new products and the manufacturing processes are evaluated and documented using a robust Quality Management System.  By taking a full-systems approach every step is thought-out, reviewed, documented, and evaluated to ensure a consistent manufacturing process produces a consistent product.  Services include:

• Process Validation and Verification
• Quality System implementation
• Manufacturing system integration
• Manufacturing process development, documentation, and implementation
• Machine and fixture design
• Machine controls (software/database integration)
• Contract Manufacturer identification/selection and interface

Applied Research

Drawing from our background in academic research and data analytics, we help drive product direction and strategy that is based on sound science and actionable data.  We become experts in the field to thoroughly understand the product we’re developing and the underlying mechanisms of action, while leveraging real-world data to validate the product and its benefits. The emphasis on scientific integrity has allowed Simbex to create products of the highest quality and proven benefits.  We consider our applied research expertise a critical component of our product development partnership.  For us, applied research includes:

• Basic Research
• Wearable technology
• Translational Research
• Data Analytics
• Clinical Study Execution
• Experimental Test Design
• Algorithm Development

With significant expertise in Head Impact Biomechanics, Human Gait, Human Performance, Neuromodulation, Pressure Ulcer Prevention, Fall Prevention, Balance, and Rehabilitation.

Quality

Simbex maintains a Quality Management System which is compliant to ISO 13485 and the FDA’s Quality System Regulation 21 CFR 820 for the development of medical devices.

Our experienced engineering staff has developed products and devices for many industry leading companies and will provide a detailed Design History File, Device Master Record, and complete Risk Analysis compliant to ISO 14971 that will meet your specific regulatory requirements.