Focusing on IVDs can save more lives and billions in costs
With increased focus on improving the quality, efficacy, and cost-effectiveness of lab tests, the IVD industry can drive great value for patients and the economics of the healthcare system.
Why do many IVD companies face an uphill battle with payers for reimbursement?
Despite the relative paucity of peer-reviewed studies for IVDs in general, several companies are taking steps to publish their data, which can ultimately lead to positive coverage decisions by payers
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Risk-based IVD regulations: What do they mean for the global IVD industry?
In vitro diagnostics, particularly lab-developed tests, designed for precision medicine may be among those impacted the most by risk-based frameworks, both overseas and in the U.S.
What’s the key to efficient IVD development?
A look at the advantages of different engineering models that in vitro diagnostic companies should consider adopting to improve production.
IVDs and data requirements in a value-based reimbursement landscape
Because in vitro diagnostics are so integral to patient care, particularly for oncology, developers must be aware of how quality and efficacy data pertaining to their device will be used.
Will FDA step in with lab development tests?
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Medtech to be worth $455 billion by 2018, in vitro diagnostics still predicted to be on top
According to a new EvaluateMedtech report, despite the gloomy 2013 the medtech industry has had so far, by 2018, the industry can expect to rake in $455 billion. In vitro diagnostics are forecasted to stay on top as the highest earning sector, with global sales over $58 billion, with cardiology and diagnostic imaging following closely […]