Simbex
Product development and commercialization partner for medical device and consumer health products. Offers systems engineering (mechanical, electrical, embedded firmware), algorithm and data analytics for wearable sensors, prototyping and transfer-to-manufacturing, quality and regulatory strategy and execution (ISO 13485, FDA QSR, EU MDR), and commercialization support including market assessment, reimbursement strategy, and IP/technology review.
Industries
Nr. of Employees
small (1-50)
Patents
Fall prevention training system and method using a dynamic perturbation platform
US-7980856-B2
View Details
Fall prevention training system and method using a dynamic perturbation platform
US-7980856-B2
View DetailsProducts
Instrumented perturbation treadmill for fall-prevention
Research/clinical treadmill that delivers controlled perturbations to induce slips and trips for balance training and fall-prevention research.
Wrist-worn IMU-based fall-detection wearable
Wrist-worn IMU device with onboard algorithm for automatic fall detection using accelerometer, gyroscope and barometric pressure signals with context-aware decision logic.
Helmet-integrated impact monitoring system
Helmet sensor inserts and alerting systems designed to detect and report head impacts for sideline awareness and data collection.
Objective monitoring wearable for orthotics/prosthetics
Wearable monitoring tools that provide objective functional insights for orthotic and prosthetic patients to support clinical decision-making.
Instrumented perturbation treadmill for fall-prevention
Research/clinical treadmill that delivers controlled perturbations to induce slips and trips for balance training and fall-prevention research.
Wrist-worn IMU-based fall-detection wearable
Wrist-worn IMU device with onboard algorithm for automatic fall detection using accelerometer, gyroscope and barometric pressure signals with context-aware decision logic.
Helmet-integrated impact monitoring system
Helmet sensor inserts and alerting systems designed to detect and report head impacts for sideline awareness and data collection.
Objective monitoring wearable for orthotics/prosthetics
Wearable monitoring tools that provide objective functional insights for orthotic and prosthetic patients to support clinical decision-making.
Services
Systems engineering, mechanical and electrical design, embedded firmware, software/web development, algorithm development, prototyping and transfer-to-manufacturing support for medical and consumer health products.
Regulatory pathway determination, submission preparation and review (US FDA and EU MDR), CE technical documentation review, PRRC services, and US Agent services.
Design and maintenance of QMS compliant with ISO 13485 and 21 CFR 820, including DHF/DMR generation, risk management (ISO 14971), CAPA, complaints, and internal audits.
Market assessment, business model development, reimbursement strategy and fundraising guidance to align product design with market and payer requirements.
Systems engineering, mechanical and electrical design, embedded firmware, software/web development, algorithm development, prototyping and transfer-to-manufacturing support for medical and consumer health products.
Regulatory pathway determination, submission preparation and review (US FDA and EU MDR), CE technical documentation review, PRRC services, and US Agent services.
Design and maintenance of QMS compliant with ISO 13485 and 21 CFR 820, including DHF/DMR generation, risk management (ISO 14971), CAPA, complaints, and internal audits.
Market assessment, business model development, reimbursement strategy and fundraising guidance to align product design with market and payer requirements.
Expertise Areas
- Wearable medical device development
- Embedded systems and low-power wireless design
- Algorithm development and sensor signal analytics
- Quality management and regulatory compliance (ISO 13485, FDA QSR, EU MDR)
Key Technologies
- MEMS sensors
- Inertial measurement units (IMUs)
- Accelerometers and gyroscopes
- Barometric pressure sensing
News & Updates
Guidance on technology evaluation, literature search, freedom-to-operate analysis and patenting considerations to support early-stage product assessment and commercialization.
Regulatory recap covering FDA cybersecurity premarket guidance and reimbursement process dynamics affecting MedTech commercialization.
Recognition for an impact response system product as a state-level high-tech product finalist.
Work recognized by outlets and awards including Time Magazine Best Inventions, Inc. 5000, Edison Awards and others.
Guidance on technology evaluation, literature search, freedom-to-operate analysis and patenting considerations to support early-stage product assessment and commercialization.
Regulatory recap covering FDA cybersecurity premarket guidance and reimbursement process dynamics affecting MedTech commercialization.
Recognition for an impact response system product as a state-level high-tech product finalist.
Work recognized by outlets and awards including Time Magazine Best Inventions, Inc. 5000, Edison Awards and others.