MEDICAL DEVICE DEVELOPMENT CAPABILITIES
Medical devices are subject to regulatory requirements that ensure a well-documented and reviewable design process — and ultimately, a safe product.
At Simplexity, our core design philosophy is that the best solution is the simplest one to reliably accomplish your goals. This guiding principle is particularly relevant in the medical device space, where reliability, safety, and intuitive design are of the utmost importance.
Our ISO 13485:2016 certified quality management system ensures rigorous design and development of devices that are safe for their intended use.
Common Challenges and Needs That Bring Medical Device Clients to Simplexity:
- Medical device prototype development to support clinical trials
- Product architecture expertise for new medical devices
- Technology feasibility evaluation or isolated technical hurdle resolution
- Proof-of-concept devices for technology demonstration & usability
- Comprehensive program planning, phase-gate product development process, risk assessment, development budget, product cost estimation
- Full medical device development
- New Product Introduction (NPI): build planning and coordination, contract manufacturing selection, tooling strategy, test planning, quality engineering and design for manufacturability
- Characterization tools to execute design of experiments during device development
- Developing under quality system design controls and performing design verification
- Medical products developed in compliance with IEC 60601 and IEC 62304
- Low power design – both electrical and firmware
- Miniaturization of electro-mechanical design
Simplexity Medical Device Expertise
- Medical device product architecture and development
- Pre-production builds for design verification & usability testing
- ISO 13485:2016 certification for medical product design and development
- NSF-audited certified Quality Management System
- DHF documentation
- New Product Introduction (NPI)
- Production and characterization test tools
- Design for Manufacturing (DfM) and Design for Assembly (DfA)
- Risk management
- Robotic systems
- Wireless connectivity
Supported Product Categories:
Simplexity’s large, fast-ramp team of expert product engineers and project managers have worked with medical device clients to design products and systems in the following categories:
- Medical wearables
- Patient monitoring devices
- Surgical tools
- Endoscopy and catheter-based devices
- Home health devices
- Low-power wireless devices
Product Development Competencies:
As an engineering and technology-focused design company, we have assembled the best design team in the industry around core competencies of product development and medical devices. These include:
Risk Management
- Hazard and risk analysis
- Class II documentation requirements
- Operating room environment considerations
- Fluid handling contamination concerns
- Biometric sensing
- Biocompatibility of materials
- Secure wireless data transfer
Product Design and Development
- Compact electro-mechanical design
- Printed Circuit Assembly (PCA) & flexible PCA design
- Sensors and actuators: motors, buttons, haptics, displays
- Firmware and software integration
- Communications: Ethernet, USB, Wi-Fi, BLE, NFC
- Low-power devices
- Optical and opto-mechanical systems
- ISO 13485:2016 certified quality management system
Process and Test Development
- Characterization testbeds
- Workflow analysis and automation
- Characterization DOE and test
- Design analysis
- Production process analysis
- Tolerance analysis
Why Simplexity?
Medical device leaders choose Simplexity Product Development to accelerate and de-risk their product development. Since 2005, we have been a trusted partner in product commercialization, with a depth of expertise in product architecture, mechatronics, and complete system design for cost-effective manufacturing. Simplexity engineers hold over 200 patents collectively.
Simplexity has considerable experience with and understanding of the medical device development space and the unique requirements that must be met to achieve success. We look forward to partnering with
your company’s core technology experts, working shoulder-to-shoulder to enable the rapid transformation of novel concepts into reliable, safe products.
If you are designing an innovative product and either don’t have the team you need nor the time to hire, Simplexity’s
flexible engineering services and full product development engineering team are here to help. Let our experienced
team of mechanical, electrical, firmware, software, quality, and systems engineers turn your promising prototypes
into market-ready products.
Contact us to learn more about medical device development capabilities. We look forward to partnering with your company’s core technology experts, working shoulder-to-shoulder to enable the rapid transformation of novel concepts into real, safe products.
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking