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Reimbursement & Admission
No healthcare provider or doctor wants to work for free
How can the products be paid by the insurance, social security or healthcare provider? Does there exist any way that hospitals and doctors get paid for conducting procedures by using the product, and how attractive is it to them? What as consequence the correct price for introducing the product in the market? No matter how innovative the pooduct is, it is essential for the commercial success of the product that the above question have an convincing answer. Our team can support your company in getting the product recommended by the specific national society or finding other ways to remove obstacles that inhibit commercialization.
i²medi has strategic alliances with the best in class local medical device registration providers. With our partners we speed up the process between 4-12 months compared to an independent approach or to other providers. The faster market access delivers positive return of investment.
Success project example
Product approval class IIb in less than 6 months in Mexico
Our local team has achieved product registration approval in hyper-velocity. More than 1000 pages of technical and clinical data have been translated and a compelling dossier has been filed rapidly to submit the complete documentation. Questions by COFEPRIS authority have been professionally managed and the product registration has been achieved within 6 months where other takes 12-24 months. Another example of i2medi´s working principles competence and persistence.
Coordinated First Latin American
Clinical Study on R.E.M.S. technology
Paradigm changing technologies require not only evidence, but NATIONAL evidence to convince the local clinicians to support the technology. The Brazilian i2medi team has recruited successfully the clinician team of the Federal University Sao Paulo to conduct a study comparing the radiation free bone densitometry with the new R.E.M.S. technology with the current X-ray based gold standard technology. Our i2medi team was actively driving the project management for the trial coordinating clinicians and the clinical department from the manufacturer in creating a powerful study design. The investigators enrolled 343 patients into the trial in only 7 months! The i2medi application specialists conducted all the measurements and supported the clinicians actively in the data collection. The study is a principal support for whole Latin American commercialization of R.E.M.S. technology and a milestone tobe accepted by medical societies for further recommendation.