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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!