Market Needs Assessments
Identifies those who benefit from your invention. Market assessment research includes competition, unmet market need analysis and relevant trends.
Our company has successfully developed, implemented, and manufactured implantable medical device products. Our expertise is the development and manufacturing of these devices.
We have extensive experience with innovation of new products and developing these products within the requirements of the Good Manufacturing Practices (GMP). Our expertise is taking a concept and making it into a marketable product to be sold.
Inventing something new is exciting yet only the first step. To move your creation from an invention to a marketable product is an intensive and complicated task. It can be difficult to undertake by yourself. You must identify what the final product will be, who will buy it, how much it will cost, where people can buy it, and how will you distribute it to customers.
Cytophil customizes the services we offer to meet your development and marketing needs. Services are available à la carte so we can assist you just where you need it most.
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.
Experience with the Following Indications:
- Orthopedic Bone Void Fillers
- Dental Bone Void Fillers
- Ear, Nose, and Throat (ENT)
- Gastroesophageal Reflex Fillers
- Stress Urinary Incontinence Fillers
- Soft Tissue Volumizing Fillers
Experiences with the Following Materials and More:
- ß-Tricalcium Phosphate (ß-TCP)
- Calcium Hydroxylapatite (CaHA)
- Sodium Carboxylmethylcellulose (NaCMC)
- Bioglass
- Biphasic
- Polyethylene Glycol (PEG)
Physical/Mechanical Testing
Cytophil has lab and cleanroom space to generate product prototypes and perform evaluations.
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.
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.
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.
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.
Product Development
Defines and attains characteristic features via Design Control Procedures. Through scientific study, a final product will be defined to meet customer needs.
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.
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.
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.
Validation and Verification
Cytophil utilizes certified cleanrooms, validated manufacturing processes, qualified equipment and controlled documentation to perform process and product verifications and validations.
Contract Manufacturing
Cytophil has facilities and infrastructure paired with expertise to manufacture efficiently and effectively.
