The performances of the leading medtechs in the first year of the COVID pandemic were impossible to compare and certainly unrepresentative of normal business cycles and competitive activity. Elective care was largely put on hold and emergency needs boosted exceptional demand for certain product types. More than anything else, 2020 tested management's planning skills.

Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.

The US FDA recently cleared Sight’s Olo analyzer to run complete blood counts on samples as small as two drops. The company is currently marketing Olo to hospital labs in the US but hopes to eventually earn a CLIA waiver so Olo can be marketed to smaller physician practices and pharmacies and used for other common blood-based diagnostics.

For health-care providers and medtech manufacturers alike, the decade ahead will require a coming to terms with digital technologies and integrating new methods of payment. Quality of service delivery remains the market-entry criterion, but companies will have to adapt to evolving health-care models. The stakes are high. Will manufacturers be able to capitalize on the changes in a market that is more competitive and unpredictable than ever?