Client Profiles
DDD clients include start-ups, venture firms, and established companies and multi-national/multi-divisional Fortune 500 corporations interested in special project support.
New Companies
DDD works with inventors and new firms that require regulatory and clinical expertise but are not ready to maintain a full-time staff. Many of these firms start, and may continue, as virtual companies relying on outsourcing to DDD for some or all of their product development activities.
Overload Work/Special Expertise
A company may not have in-house expertise for developing new indications for existing products or it may not have the resources to manage the additional regulatory burden or clinical studies that are needed for FDA approval. In these circumstances, the companies call upon DDD to manage these "overload" FDA interactions, submissions and clinical studies.
Feasibility
DDD may be hired to do a feasibility study for a number of reasons. Companies may not want to commit new or additional personnel to a project until it can be determined if a project has merit (e.g.: new indication). Another circumstance might be no resident in-house regulatory or clinical expert in the project field. Another key consideration is maintaining confidentiality regarding the project within the company.
Products Experience / Clinical Experience
DDD has worked on products such as prescription and OTC pharmaceuticals, diagnostic and therapeutic medical devices, electronic devices and medical software, biotech and biochemical diagnostic kits, and biological products.