As medical device makers look forward to 2019, opportunities abound for growth and innovation leveraging new technologies and strategies for engaging patients, regulators, and payers. Organizations capitalizing on the 2019 medical device trends will:
- continue to explore M&A opportunities with a precision focus to value-centered integration,
- enable the use of new technology to drive external and internal improvements to business through improved capabilities and data-driven decision-making.
- leverage underutilized regulatory pathways for cutting-edge innovations,
- utilize new data sets as a result of smart medical devices to better negotiate rebates and value-based arrangements with payers, and
- actualize opportunities in artificial intelligence and machine learning to improve device development and clinical R&D.
1. De Novo Device Path to Market Growth
De novo pathways to market have been around since the end of the 1990s but use by device companies has been growing more significantly in the last 5 years. Cutting edge technologies, simplification of the application process, and increasing emphasis on patient engagement have fueled novel device creation and the use of this previously underused pathway. Properly leveraging this channel can significantly reduce the cost to market for new medical devices. Inherently, de novo classification typically carries a “high-risk” categorization so device makers must be prepared to submit a highly detailed explanation of risk to avoid that high-risk label.
2. Increasing Use of Smart Devices and Internet of Things
IOT-connected smart devices are feeding medical device makers a wide range of new data sets with potential applications across their business. Tracking performance metrics, maintenance, and compliance can provide beneﬁts for patient and manufacturer alike. With the growing awareness and role that patients are playing in their own healthcare, being able to actively provide data and information on the beneﬁts created by a device can set you apart from competitors. Beyond that, companies can use these metrics to develop new features and optimize performance based on consumer interactions recorded by the device, rather than relying on outdated collection methods such as focus groups and surveys. The proactive application and use of this data can lead to a better consumer experience in an increasingly patient-centric industry.
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Coauthor and contributions by Brandon Regnerus and Kevin Merchak