Electronic medical devices are a big business
And they are set to get bigger. Recent estimates suggest that the global medical electronics market will reach $4.41 billion USD by 2022, achieving a compound annual growth rate (CAGR) of 5.4 per cent.
Devices which monitor various measurements and activity will likely grow at the highest rate, and these new devices are smaller, smarter, safer… and strictly regulated.
In many senses the race to reach the market with the latest innovative technology is very much on – and the traditional big players are being challenged by agile, lean start-ups. But in this sector - arguably more than in any other - the ability to deliver on time is seriously subject to delivering the product to spec.
What’s driving the growth of electronic medical devices?
A cluster of factors is causing an ideal alignment of the stars for medical device growth: these includes new technology, additive manufacture for R&D and the IoT allowing for remote control and machine learning capabilities. Factors such as these have coincided with moves in the medical sector to:
• Involve patients more actively in their own care
• Be more transparent in sharing patient data
• Move treatment from institutions to become more community or home-based
• The need to find solutions that can reduce long-term costs and administrative burden
• A greater focus on patient comfort and convenience
What’s threatening electronic medical device success?
At exactly the same time that the horizons broaden and opportunity knocks loudly on the medical electronic device sector’s door, there are a whole new range of obstacles that must be hurdled to enter the market: regulations.
Risk control has been placed squarely at the heart of a device manufacture by the European Medical Devices Regulations (MDR). This not only calls for more detailed technical documentation and auditing; it also requires stricter demands for clinical evaluation and post-market clinical follow-up, with better traceability of devices throughout the supply chain.
The updated ISO13485 similarly focuses on better risk control, better supplier management and more detailed proof of design and development. The complex rules of CE marking will also need to be followed if you are selling in Europe.
How EMS partners can help
Partnering with the right outsourced manufacturer can help OEMS in a multitude of ways.
We understand the regulations and can support you from day one with key steps such as document creation and core technologies. One requires a team that is up to speed with regulatory processes, to develop these devices most efficiently and effectively.
While time to market is critical, in the medical sector, it can be gaining approval that causes the biggest delays. We believe that, ultimately, the key to medical device quality assurance is having a correct quality plan in place and documenting everything you need. For this, you must understand what proof you need to demonstrate you have followed your quality management system activities.
Finally, it’s no longer all about electronics
As the opportunities offered by the IoT take centre stage, new skills are called for. While medical device companies understand medicine and science, they may not have the same depth of knowledge in the networking, wireless, computer, and data communication technologies that are being incorporated into leading-edge medical electronics.
The folk tale about the tortoise and hare race may seem a strange analogy to make here. But, like all cautionary tales, but it contains a grain of truth. Racing to ramp may seem like the best option in a competitive and demanding marketplace. But taking time and partnering with the best experts to ensure all processes are in place and operating smoothly is always worth the additional time and effort.
We can offer you quick, cost-effective manufacturing processes and a robust, traceable supply chain.
However, what’s equally, if not more important, is that we can combine this with design, R&D and a thorough understanding of those regulations that always seem to trip the hare up, just as it thinks it’s going to be the first to market.
For more information on what Chemigraphic has to offer, click here.