In order to demonstrate to the FDA that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device, it is imperative that you document your laboratory findings. MedtoMarket’s team assists you in preparing the documents and images necessary to complete your 510K filing with all needed consultants, researchers and lab time.
Vet your new products which are under development. Your company engineers will have the opportunity to test and experiment your prototypes in the lab with a team of end user experts. Research and development consultations can develop your products with more speed and efficiency discovering issues and enhancing the product to fit the consumer demands.
Our consultants are carefully chosen within a wide array of demographics, allowing us to provide an excellent strategic viewpoint. They understand the business of medicine and have excellent business acumen. This approach ensures our clients get the relevant feedback they expect. This unique structure offers a distinct advantage, giving your investors exactly what they need.
Voice of Customer Study
MedtoMarket’s consultants are the true “voice of the customer” businesses need. Our consultants are leaders in their fields and understand the business of medicine, while remaining active in their specialties and their communities. They use proprietary MedtoMarket techniques and templates to help guide them and keep them focused on projects on hand.
In the highly competitive medical device and pharmaceutical industries, a multi-dimensional perspective gives you a distinct advantage. Our “360 Community Study” includes physicians, nursing staff, administration, supply chain managers, and marketing experts. This diverse community of personnel helps establish a clear strategic roadmap for your initiative.
Human Factors Engineering Study
A human factors engineering project addresses and identifies the issues that your end user will face when interacting with your product. We take into account human strengths and limitations in the design of interactive systems that involve people, tools, technology, and work environments thus ensuring safety, effectiveness, performance, ease of use and user happiness.
ADVAMED APPROVED MEDICAL CONSULTING
Non-Pressured, Unbiased, and Compliant
This new model of transparency brings benefits to both sides in a time of increased government scrutiny. Our consultants are fully aware and sensitive to AdvaMed guidelines, and are able to provide feedback in a non-pressured, unbiased manner. Our industry clients are relieved of some of the new regulatory burdens, and are comfortable knowing that the relationship they have with MedtoMarket is fully transparent.
MedtoMarket’s consultants are paid by MedtoMarket for their thoughts and opinions—not pressured by outside influences and interests. They are continually educated regarding AdvaMed guidelines. This provides the necessary buffer between consultant and client to maintain compliance with these guidelines and guarantee unbiased feedback.