Our consulting services provide more than a theoretical approach to transcatheter heart valve development. We deliver actionable, practical, and realistic strategies designed to fit our client’s needs. Our team of well-qualified PhD scientists, tissue engineers, delivery system and stent experts, and skilled technicians will make it seem like a natural extension of your own R&D department and operations staff. Our associates work with your company at different levels to identify and recommend strategies that will help in saving time, cost & bringing your product to market fast.
Our consulting expertise is built upon our in-depth knowledge of the medical device manufacturing industry in particular structural heart valves. Our expertise in devising effective valve development strategies for TAVR, TMVR or Tricuspid Pulmonic Valves using either bovine or porcine tissue makes us one of the leading consulting companies in this industry.
Our experience allows us to assist our clients in devising proactive strategies that save on cost and time.
Transcatheter heart value therapies
- New concept design evaluation & Prototyping
- Stent & delivery system
- Tissue cleaning & cross-linking
- Set up manufacturing facility for tissue fixation
- Set up chemistry lab with chemicals and equipment needed
- Guidance on large animal testing
- Transcatheter valve crisis management
Regulatory
- Regulatory submission strategy
- Develop strategy for regulatory submission – CE mark, FDA, China, Japan, Australia, and Canada.
- Prepare FDA submission documents
- Regulatory submission readiness assessments
- ISO 13485 certification
- Technical file and Design dossier review
- Product design and process change notification
Sterilization & Biocompatibility Testing
- Develop test strategy
- Coordinate and conduct testing
- Write test plans and reports
- Biological safety expert reviews
- Evaluation of chemical residuals (cleaning)
- Conduct ethylene oxide (ETO) residual testing
- Liquid Chemical Sterilization
Device R&D
- New product design and development
- Design prototyping
- Iterative build out new designs
- Verification and validation testing (V&V)
- Coordinate and conduct V&V testing
Tissue Of animal origin
- EDQM certification
- Viral Inactivation studies
- Transmissible Spongiform Encephalopathy (TSE)/Bovine Spongiform Encephalopathy (BSE) elimination studies
- Tissue risk assessment as per ISO 22442-1 & related risk mitigation and management
- Tissue supplier controls as per ISO 22442-2
- Tissue traceability SOPs and implementation
- Disease monitoring as per ISO 22442-3&Literature searches
Facility Set-up & transfers
- Facility set up – strategy and design of facility (e.g.: clean room, material flow, etc.)
- Facility transfers – develop strategy and transfer plans (e.g: adapt from old facility, invent in new facility)
- Regulatory filings & approvals
- Facility Consolidation – develop consolidation strategy
Training
- Tissue cleaning, cutting and cross linking, etc.
- Chemical lab setup and solution preparation
- Tissue sewing to stent
- Train personnel in the various skills needed to manufacture the value.
