Consulting
General Capabilities
BDC offers consulting services in product development, project planning, process development, sterilization, and packaging of biological, textile, and synthetic devices. Proven experience in:
- Vascular Implants
- Endovascular Stent Grafts
- Peripheral Stents and Stent Grafts
- Artificial Heart and LVAD Systems and Controllers
- Heart Valves
- Venous Valves
- Nitinol Devices
- Extracorporeal Filters and Oxygenators
- Medical Textiles
- Catheters and Leads
- RF Energy Systems
- Biomaterials
- Explant Analysis
- ePTFE Technology
Test System and Protocol Development
BDC can provide support in the area of protocol and test plan development in support of R&D activities and regulatory submissions. Our specialty is new and novel product design concepts where existing historical precedent does not exist. Single test to full test plan development is available depending on your needs.
Product and Process Validation Protocols
Protocols for process and product validations can be prepared by BDC to meet your internal and/or regulatory requirements. BDC can also assist your R&D team in the preparation of your ISO 10993 Biomaterials testing, animal studies, explant analyses, and sterilization validation protocols.
Product Design
BDC has extensive product design experience in the areas of disposables and implantable devices. Examples include: vascular grafts (textile, biologic, and ePTFE), stent grafts, oxygenators, blood filters, catheters, leads, heart valves, bone growth stimulators, absorbable coatings, as well as many other high technology medical devices.
Biomaterials Support
BDC can help in the selection of specific biomaterials to meet your product needs. Through BDC's extensive network, we can assist your R&D team to obtain complete biomaterials characterization as well as specialized testing which may be required for R&D, QA, manufacturing, or regulatory support purposes.
Marketing Support
BDC can prepare technical analyses of existing products and help in the definition of new product concepts and specifications. Allow us to work with your marketing department to provide technical input into your new design concept and development of new business opportunities.
Regulatory Support
BDC can provide support to your internal regulatory professionals in formulation of regulatory strategies and in the preparation of regulatory submissions. BDC Laboratories can be leveraged to fill gaps in the pre-clinical data required for submissions BDC can also provide valuable technical guidance in responding to interactions with U.S. and International regulatory agencies.
Manufacturing and Q/A Support
BDC can help speed up the resolution of production related "firefights", process development, process improvements, process validations and development of new cost effective processes.
Venture Capital Support
Prior to funding a new venture, BDC can provide consultation services in evaluating new advanced technologies and concepts. In addition, we can provide assessment of competitive products and testing of new concepts. After funding, BDC Laboratories can support the initial testing efforts while transitioning until the company has established testing capabilities.
References are available on request