Design Services

Define | Discover | Develop | Deliver

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 dynamic and versatile D4 process can be used with:

an existing Viscus Biologics product platform,
a new product platform that is jointly developed, or
a customer’s product platform that is transferred into the appropriate design service phase.

Define

The scope of the product & the plan to commercialize it

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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

The required technology & processes to bring this product to market

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

Develop

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

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

Deliver

A finished end product that meets all user & regulatory requirements

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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

Working Together

Our design services process has been well-tested and is quite straightforward. We set up an initial call where we share our capabilities and learn about your project, follow up by sending you our mutual confidentiality and master services agreements, and schedule a few meetings to gather all critical inputs. Our team then prepares a free detailed proposal for your review and feedback.

To facilitate communication and transparency, we use the Teamwork project management platform where you can check details about the project at any time.

As your product development needs evolve to pilot and commercial scale manufacturing, our contract manufacturing services ensure a smooth transition. Our facilities are specifically designed to allow for the development of manufacturing cells that cater to your product requirements.

While many projects utilize our decellularized ECM technology, several more projects involve either new technology jointly developed or the customer’s own product platform that our team helps with product development and manufacturing. We have worked with both companies and academics who want to transition their technology out of academic labs and into a well-defined and validated process that meets stringent regulatory requirements.

Contact us to schedule an initial call to assess fit and determine next steps.

Let’s Talk Design

Design & Development

Our product development team has the expertise and resources to guide you through the project and support all activities including raw material qualification, packaging, labeling, biocompatibility, usability, sterilization validation, viral clearance, product stability, and much more.

Regulatory Support

We support 510k, de novo, and PMA submissions from the initial define phase through product delivery, either by working with your regulatory team or by providing our own.

Quality

We are ISO 13485 certified and compliant with FDA 21 CFR 820 and other applicable medical device regulations using our Greenlight Guru electronic quality management system.

Supply Chain Management

We offer a vertically integrated supply chain and source medical-grade, cost-effective, quality suppliers for our raw materials.

Extracellular Matrix
Biomaterials

Medical
Applications

Design
Services

Contract
Manufacturing