Barney Sheppard, Sales Operations Manager, Chemigraphic
Electronic medical devices are 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%.
Devices which monitor various measurements and activity will likely grow at the highest rate, including:
- Blood glucose meters
- Tomography (imaging) scanner assemblies
- Blood analysers
- Mobile monitoring devices
- And apps for fitness and health
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 a rash of agile, lean start-ups.
But in this sector – arguably more than in any other – the ability to deliver on time is seriously constrained by the necessity to deliver to spec.
Quality EMS partners are perfectly positioned to help
It looks likely that the past decade’s top earners for the EMS sector – tablets and smartphones – will lose market share to medical devices, which will be a major driver of growth.
Start-ups rely on the knowledge, design, manufacturing and understanding of the meticulous documentation required to achieve approval that EMS providers offer to get their concepts to ramp.
Meanwhile, many of the bigger players are increasingly relying on the investment in advanced technology, design for manufacture expertise and strict regulatory compliance that EMS outsourcing enables. Through this, OEMs can accelerate R&D, reduce the cost of devices and help them gain competitive advantage.
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.
- New technology
- New materials
- New battery (or alternative sources of power) capabilities
- Additive manufacture for R&D
- The ability to produce smaller and smaller devices
- The capabilities of the Internet of Things to share data and allow remote control and machine learning
And all of this has 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.
The race may be on but in very few fields are there stricter rules and regulations to pass the finish line than in the medical sector.
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, but 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 focusses 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. There are a number of hoops to jump through to obtain this, including:
- Identifying applicable directive(s) and standards and checking the essential requirements for your product
- Ascertaining if your product needs a third-party conformity assessment
- Testing the product and checking its conformity if third-party assessment is not required
- Creating and maintaining technical documentation
- Affixing the CE mark to the product according to specific rules
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. It is those who partner with a team that is fully up to speed with regulatory processes who are the ones who will be able to develop these devices most efficiently and effectively.
While time to market is critical – and our NPI experience and testing capabilities help move things along the line at a great pace – in the medical sector it can be gaining approval that causes the biggest delays. There’s no point trying to rush a product to market as fast as possible if the steps you skip, or corners you cut, mean you do not comply with all the necessary standards and regulations.
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 from the get-go exactly what proof you need to demonstrate you have followed your quality management system activities as you planned.
But we’re not just here to keep records for you!
In the past OEMs used EMS partners because their manufacturing technology and experience helped drive down costs. But, how times have changed.
Now, EMS partners can enter the process early on in order to help you optimise your product, at every stage from concept to ramp. With specialist design teams, NPI divisions, research and engineering functions, we help our customers to expedite time to market and ensure that they don’t need to implement costly changes later down the line, due to manufacturing or sourcing issues.
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.
As a quick example, here are just some of the areas we support our medical OEMs with:
- Advanced battery technology
- Connectivity and wireless technology
- Flexibility and comfort for user
- Personalised design
Tortoise and the hare
The folk tale about the tortoise and hare race may seem a strange analogy to make here. But, like all cautionary tales 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.