Services - Viscus Biologics

D4 Design, Development, and Manufacture Services

Our rapidly expanding product portfolio can be customized to your specifications and labeling requirements. Contact us for more information.

Viscus Biologics utilizes an Original Design Manufacturing (ODM) model in combination with our core competencies in the design, development, and manufacture of natural polymer and extracellular matrix biomaterials. The D4 process can be used with an existing Viscus Biologics product platform, or a new product platform can be jointly developed. In addition, a customer’s product platform can be transferred into the appropriate design service phase.

DEFINE

The scope of the product & the plan to commercialize it

DISCOVER

The required technology & processes to bring this product to market

DEVELOP

The concept into a product that meets requirements & can be manufactured

DELIVER

A finished end product that meets all user & regulatory requirements

Define Phase

The scope of the project and the plan to commercialize the product.

Idea generation/ideation
Needs establishment for product
Technology and biomaterial assessment
Development of product concepts
Market research and end user assessment
Financial review and margin analysis

Discover Phase

The required technology and processes to bring the product to market.

Project planning and prototype generation
Tissue decellularization, lyophilization, and form factoring
Packaging design and sterilization review
Biochemical, mechanical, and preclinical testing
Advanced market research and competitive review
Regulatory and reimbursement review

Develop Phase

The concept into a product that meets requirements and can be manufactured.

Program management and marketing support
Enterprise resource planning (ERP) and supplier qualification
Biocompatibility, toxicity, viral clearance, and packaging testing
Sterilization validation and shelf-life testing
Regulatory submissions
Equipment procurement and work cell establishment

Deliver Phase

A finished end-product that meets all user and regulatory requirements.

Material resource planning (MRP) and supplier management
GMP cleanroom manufacturing at scale
Sterilization management, finished goods testing, and lot release
Product storage and logistics support
Business development, sales training, and strategic alliance assistance
Post-market clinical evaluations

We have experience with various material formats including powders, gels, foams, and sheets. Monolithic or composite structures can be developed with partners. We will deliver on your development and contract manufacturing needs!

D4 Design, Development, and Manufacture Services

Define Phase

Discover Phase

Develop Phase

Deliver Phase