MedNest prepares the U.S. launch of
your sophisticated Medical Technology solutions and
IND Enabling Technologies
….and if needed, creates and operates our company in the U.S. for the first 18 to 24 months.
CLINICAL UTILITY
The relevance and usefulness of your medical solution in patient care is a pivotal concept to describe your “value proposition”. It has direct ties into the Intended Use of your Regulatory/FDA pre-marketing application as well as your reimbursement / economic model.
When aligned with curent clinical guidelines and coverage decisions, your clinical utility will gain adoption speed.
Evidence gathering plans, including clinical trials, must substantiate your clinical utility.
PRICING, PAYMENT
Understanding the Coding, Coverage and Payment options for your Medical Device, as well as the holistic Healthcare Economic benefits ( Including ICER models) of your solution are pre-requisite activities to your product design or your U.S. Market launch. MedNest will establish your Payment pathways and Pricing models and embed them in your clinical, regulatory and market access plans.
REGULATORY PATHWAYS
The pathway to approval for a medical device depends on its risk classification, and more specifically the balance between effectiveness and benefits vs risks. Because there is not much variation in the classification of devices, developers have a variety of options.
The emergence of software, mobile applications and sophisticated cloud-based algorithms creates and additional level of sophistication in medical devices.
MedNest will explore and optimize your regulatory pathways around the pivotal concept of Intended Use - tied to clinical utility and payment-, and often de-feature the technology platforms of its client to allow a multigenerational predicate-based regulatory pathway.
If needed, MedNest will coach you to prepare register your company, list your product and prepare your FDA pre-market submissions
Other regulatory requirements, such HIPAA can also be addressed.
MARKET ACCESS
With more than 5,000 hospitals of+30 different categories, a continuum of care with more than 15 different segments, +120 medical specialties, +19 categories of nurses, +1000 insurances companies and obviously 48 continental states, the U.S. is a very complex market place.
The strategic segmentation of the U.S. Market opportunity is a critical step in of a market access plan.
A focused and well funded market access plan will secure a competitive presence and/or attractive partnership proposal.
Leveraging its experience over the past 10 years, MedNest will guide you trough this process and establish your multi-generational market access plan and mid-term financial pro-forma.