Simbex LLC

Simbex LLC is a medical device and consumer health product development firm based in Lebanon, New Hampshire. The company provides end-to-end engineering services and commercialization strategy for healthcare innovators, with particular expertise in wearable technology and biomechanics-based monitoring systems.

The company's engineering capabilities span mechanical and electrical engineering, product design and human factors, software and firmware development, algorithm development, data analytics, and transfer to manufacturing. Their commercialization services include business model development, regulatory strategy, reimbursement strategy, market assessment, competitive analysis, and patent development. The team includes professionals with backgrounds in biomedical engineering, regulatory affairs, and clinical medicine.

Simbex has worked with notable clients including Riddell for head impact detection systems, MedRhythms for mobility deficit solutions, and Silvertree for fall detection technology. The company's leadership team includes individuals with deep experience in medical device regulations, clinical practice, and technology development across healthcare sectors.

Choose Simbex when you need a partner who understands both the technical complexity of medical device development and the commercial realities of bringing health products to market. The company's model of combining engineering services with commercialization strategy helps clients avoid common pitfalls in regulatory planning, reimbursement strategy, and market positioning.

Expect a team with hands-on experience developing their own medical devices who can anticipate challenges in FDA submissions, transfer to manufacturing, and customer adoption. Their work with companies ranging from startups to established brands like Riddell demonstrates ability to scale support to different organizational needs.

Simbex operates exclusively in the healthcare sector, focusing on medical devices and consumer health products. The company's expertise centers on wearable medical technology for applications including fall detection for older adults, head impact monitoring for sports safety, mobility assessment for neurological conditions, and monitoring systems for orthotic and prosthetic patients.

Their regulatory affairs team, led by a RAC-certified director, provides FDA compliance oversight, quality assurance, and regulatory strategy development. The company also offers healthcare-specific commercialization services including reimbursement strategy and clinical validation support for decentralized trials.

Medical device innovators and digital health companies developing sensor-based monitoring systems, wearable health technology, or biomechanics applications who value a partner with integrated technical and commercial expertise. Companies seeking guidance on regulatory pathways, reimbursement strategy, and market validation alongside engineering development will benefit most from Simbex's dual capability model.