The end of the fourth quarter is a time for reflecting on the past year and looking ahead to the new year. In 2019, we have seen the various global trends in medical devices playing out within our own business. Typically, the trends of one year will blend into the new year and often beyond. In anticipation of the coming year, we isolated four med-tech trends that have had an impact on Circadiance in 2019 and will probably continue to present opportunities and challenges for 2020:
- Innovation – Circadiance is focused on our remote monitoring solutions which we expect to enhance in the coming year. We are really excited about the innovations we plan to bring to market in the coming year. Stay tuned!
- International Regulations – At the beginning of 2019, Canada enacted the MDSAP program making the Canadian market unattractive to smaller device firms. Additionally, we are in a transition from the Medical Device Directives to the Medical Device Regulations in Europe. The transition has not gone smoothly and there is now talk about a delay of the transition date to give industry members, their notified bodies and regulators more time to implement the new regulations. These regulatory changes create new barriers to international markets for small firms like ours without a clear benefit to public health.
- Tariffs – Fortunately for Circadiance, most of our supply chain is in North America. But like most manufacturers, some of the components and materials for our products are sourced in China. Tariffs have added cost to our products. We can only hope that the trade war between China and the US gets resolved expeditiously.
- Medical Device Tax – Gridlock in Washington has allowed the 2.3% medical device tax to come back onto the radar. This tax, initially implemented as part of Obamacare, has been suspended by Congress for several years. The tax is scheduled to be re-imposed on Jan 1, 2020 unless Congress can suspend (or permanently repeal) it yet again.
Our vision for 2020 is clear but, like many in our industry, much of our ability to improve care being provided at home and abroad is dependent on the direction given by governing authorities around the world. Our focus in the coming months will be on defining who we are as a company and preparing for the market trends we expect in 2020.
What trends do you anticipate for the new year?