Commercialization Services

Medical Device Commercialization Services

Cytophil Business Development customizes our services to meet your development and marketing needs. Services are available à la carte so we can assist you just where you need it most or a complete program.

Following is a list of available services at Cytophil.com. If you are interested in learning more about these services, or would like to have us design a custom service to meet your needs, please contact us at gjohnson@cytophil.com.

Market Needs Assessments

Identifies those who benefit from your invention. Market assessment research includes competition, unmet market need analysis and relevant trends.

Product Development

Defines and attains characteristic features via Design Control Procedures. Through scientific study, a final product will be defined to meet customer needs.

Physical/Mechanical Testing

Cytophil has lab and cleanroom space to generate product prototypes and perform evaluations.

Preclinical Studies

Is research using non-human living organisms to determine if a device, procedure, or treatment is likely to be safe and useful. Preclinical studies take place before any testing in humans is initiated.

Shelf Life Testing

Determines the length of time your product can maintain an acceptable level of quality. Cytophil can recommend and conduct shelf-life testing for your products.

Market Development

Product promotion to physicians is essential in marketing a new medical device. We communicate through various means including annual society meetings and peer reviewed publications to facilitate recognition of your product.

Quality Assurance

Is the planning and systematic process of determining if products meet their intended purposes. Quality assurance is a process-driven approach with specific steps to help define and attain design objectives.

Regulatory Approval

Approval or clearance is required before marketing a medical device. Cytophil has experience writing successful regulatory documents including 510(k)s and PMAs. We can help you select, write and submit applications for the appropriate approvals.

Preparation of Products for Clinical Trials

We can manufacture, package, release, and distribute for clinical studies through a quality system. Clinical product manufacturing takes place in an appropriate environment with the essential documentation.

Validation and Verification

Cytophil utilizes certified cleanrooms, validated manufacturing processes, qualified equipment and controlled documentation to perform process and product verifications and validations.

Pilot Production

Cytophil can conduct pilot production of your product on a limited volume basis. This often leads to a better final product, lower development and manufacturing costs, more efficient factory operations, and earlier introduction of the product.

Contract Manufacturing

Cytophil has facilities and infrastructure paired with expertise to manufacture efficiently and effectively.

Commercialization Services

Commercialization Services

Commercialization Services