Implement Best Practices
Medical device market access is dependent on valid industry information including detailed knowledge of Payers needs.
Improve Patient Outcome
We navigate you through regulatory policy and pitfalls to ensure positive outcome for the patient and your product.
Medical Devices and Services
We identify and qualify products and services in terms of regulatory status and reimbursement. We transition companies from pre-Obama care to today's value based reality. We recognize that today's approach which is based on traditional ways are no longer relevant. Our efforts focus on coordinating the various platforms necessary for applicable clinical validity, utility and economic proof sourcing. Commercialization and monetization through policy development for both CMS and Commercial payers. Beyond the 'one stop shop' approach the primary differentiator is maximizing the product and service potential via the PPACA.
We secure and embed products and services that are relevant to monetization. We insist that all parameters are followed to insure success with reimbursement, therefor we include assistance with Clinical validation and Clinical Utility.
Sui Generis Health has direct and extensive experience in addressing professional segments -- with the learned experience that, while each segment may have similarities with others, there are key hidden differences that could exhaust a budget without getting results.
We assist with obtaining life science requirements for successful clinical studies.
We achieve regulatory objectives including FDA, CMS and Commercial payers requirements. We do this in a cost effective way that will bring products to market in a satisfactory time frame. Depend on us to help you develop a fast and effective regulatory strategy.
Medical devices and technologies can help improve health care and the cost of providing that care.
We help prove that and in doing so we can inject certain products into the health care marketplace with ease. Our unique hub and spoke channel system has revolutionized the process of conceptualizing an idea and bringing that idea to market.