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)
- Polyethylene Glycol (PEG)
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.
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.
Defines and attains characteristic features via Design Control Procedures. Through scientific study, a final product will be defined to meet customer needs.
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.
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.
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.
Cytophil utilizes certified cleanrooms, validated manufacturing processes, qualified equipment and controlled documentation to perform process and product verifications and validations.
Cytophil has facilities and infrastructure paired with expertise to manufacture efficiently and effectively.