MedTech Bites July 2018 – edited by Kanmani Bala
Regulatory changes are afoot globally and in NZ – this is the first time in many decades where regulations are undergoing major review. There will be challenging times ahead for medtech companies but there are also some interesting developments ahead, which for the first time takes into account the fast-paced technology innovations in the health sector, particularly in digital health.
The NZ Government is currently working on a new regulatory framework for therapeutic products which will be aligned with international standards. This is intended to replace the Medicines Act 1981 and its Regulations. The modernised Act is shifting to a “principles-based” process based on risk mitigation and will be designed to support innovation and be adaptive to take into account technologies of the future. Check the Ministry of Health website for updates.
In one of our major markets, the US FDA continues to evolve its regulations around digital health taking into the account the fast-paced developments that occur in this area. The FDA is making good attempts to delineate between digital health tools that are to be properly regulated as devices and those that are outside this category. Examples of things that fall into the category of medical devices are software programs for processing and analysing medical images, signals from diagnostic devices, and software that predicts physiological trends to make treatment recommendations. In parallel, the FDA is developing a pre-certification pilot programme that helps fast-track digital health technologies into the market. The concept here is that if the FDA is satisfied that a software firm’s products are safe and responsible, then it will not need to regulate every product from that company.
FDA approval opens doors to markets and the number of digital health products with FDA approval continues to rise. In the 2018 April to June quarter, products from 13 more companies were authorised by the FDA including the smart inhalers from Adherium, a NZ digital therapeutics company, for over-the-counter sales.
While regulations can be testing to businesses, it can also provide market advantages. A well-defined regulatory framework not only ensures patient safety, but also supports innovation as clear guidelines reduce the risks of new developments entering the market, which in turn encourages investment and growth. Countries taking this into account will reap the benefits of new technologies.
Dr Diana Siew
CMDT Co-chair &
MedTech CoRE Associate Director
References:
1. US FDA Rolls Out Trio of Digital Health and Medical Software Guidances
2. FDA green-lights 14 digital health products, continues to evolve regulations
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