While consolidation may have somewhat predictable effects in most medtech markets, this trend has a distinct impact on competitors in the outsourced devices market.
Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives.
The HIV, hepatitis B, hepatitis C, and Treponema pallidum (or syphilis) test IVD markets represent devices that apply to multiple patient groups and scenarios. As such, the size and forecast growth trends of these markets are influenced by many different factors.
Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. Recent human factors research has revealed several special considerations that, if not handled properly, can cause serious problems related to delivery of new medications.
Well-prepared manufacturers can benefit from close collaboration with the FDA during the intensive approval process, propelling their products to market in a relatively short period of time.
Despite the contentious nature of the negotiations, as well as criticism levelled at some of the new provisions, analysts appear to agree that the USMCA represents an upgrade — albeit a modest one — over NAFTA for all parties included.
Clinical research professionals often turn to healthcare professionals to critically assess the complex prioritization and planning of clinical research and to act as surrogates for the patient perspective.
Data integrity and data quality are critical success factors for artificial intelligence (AI) and machine learning (ML) solutions in life sciences. Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?
China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.
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