Device & Implant Innovations
Device & Implant Innovations LLC (dII), founded in September 2004, specializes in biomedical engineering consulting services focused on solving challenging product design, verification testing, and failure investigation problems in medical device development. The company aims to help clients develop, receive regulatory approval, and market medical products and therapies to improve clinical outcomes. They work with large corporations, venture capital and angel investment firms, startups, and academia to identify opportunities, assess technologies, raise funding, and conduct R&D for commercialization. They also lead failure investigations supporting product liability, malpractice, and recalls.
Industries
Nr. of Employees
small (1-50)
Device & Implant Innovations
Mason, Ohio, United States, North America
Services
Consulting across discovery, concept feasibility, design inputs/outputs, and development planning to move technologies toward commercialization.
Design and management of bench and preclinical studies for biocompatibility, host response, coagulation assays, and histopathologic evaluation to inform device design and regulatory filings.
Development of verification test plans and novel test methods that align with consensus standards to support regulatory submissions.
Root-cause investigation, event simulation, technical analysis, and expert witness testimony for device failures, recalls, and malpractice litigation.
Preparation and support for 510(k), pre-IDE/IDE, and PMA pathways including development of supporting scientific justification and documentation.
Scientific due diligence, opportunity identification in clinical environments, and early feasibility testing to inform investment or acquisition decisions.
Consulting across discovery, concept feasibility, design inputs/outputs, and development planning to move technologies toward commercialization.
Design and management of bench and preclinical studies for biocompatibility, host response, coagulation assays, and histopathologic evaluation to inform device design and regulatory filings.
Development of verification test plans and novel test methods that align with consensus standards to support regulatory submissions.
Root-cause investigation, event simulation, technical analysis, and expert witness testimony for device failures, recalls, and malpractice litigation.
Preparation and support for 510(k), pre-IDE/IDE, and PMA pathways including development of supporting scientific justification and documentation.
Scientific due diligence, opportunity identification in clinical environments, and early feasibility testing to inform investment or acquisition decisions.
Expertise Areas
- Medical device design and development
- Biomaterials development and evaluation
- Tissue-device interaction and mechanobiology
- Preclinical study design and biocompatibility testing
Key Technologies
- Biomechanical testing
- Histopathology
- Scanning electron microscopy (SEM)
- Surface modification techniques for biomaterials