Choosing an electronics manufacturing services (EMS) provider is one of the first and most fundamental steps in any medical device development project. EMS services keep both the consumer and commercial medical device industries going, reporting aggregate sales of $384bn in 2020, and can range from the manufacturing of individual components to full-scale production of entire devices.
There are several things to consider when deciding on the right EMS provider for your project, but principal among them are manufacturing reliability, supply chain control and manufacturing flexibility. Many of the biggest hindrances faced by medical device companies can be addressed by selecting an EMS supplier who can deliver in these three areas.
To ensure manufacturing reliability when providing EMS services, a company needs strong processes in place and experienced personnel, as well as long-term relationships with its clients.
When seeking an EMS supplier, companies should look for reliability as a vital consideration. This is especially important for critical components where people’s health may be at risk, or where defective electronics may require expensive repair or reworking. In addition, poor quality products or late deliveries can significantly affect the customers’ final assembly lines or deliveries to the end customer, so a highly reliable supplier is essential to avoiding these issues.
The regulatory landscape for medical devices is constantly changing in line with new developments and trends in the industry. For example, the EU introduced its Medical Devices Regulation (MDR) last year and is set to bring its In-Vitro Diagnostic Devices Regulation into force in May this year after a five-year transition period. There is also the ISO 9001 standard for customer satisfaction, which measures companies’ document control procedures, as well as several regulatory standards upheld by the US Food and Drug Administration (FDA). Implementing solid quality checks on manufacturing and supplies will not only increase your likelihood of receiving regulatory approval, but safeguard against costly product recalls and counterfeiting.
“Most of the time, the system manufacturer or OEM is the one that needs to comply with all the regulations/certifications, for example, ISO 13485,” explains Adrian Garcia Munoz, business development manager at Spanish EMS company MADES. “Our processes are fully aligned with this certification. Furthermore, we can be certified if required, but most times, it is not a requirement for us as an EMS provider. Nonetheless, our expertise in different industries and senior staff help us adapt to regulatory changes maintaining the highest quality of service.”
Much of this relies on building and maintaining strong relationships with your suppliers. Establishing a robust working relationship between EMS provider and medical device company requires communication and transparency, an understanding of each other’s businesses and ensuring both parties are on the same page, among other considerations. “Trust is paramount and that is shown in every communication for the good and for the challenges we encounter,” Adrian says. “Our staff are fully committed to our clients’ success; providing areas of improvement, visibility about project performance and a detailed communication. These are the main tools to reinforce a long-term partnership.”
Supply chain control
Like many other industries around the world, the global medical device industry has been experiencing unprecedented supply chain issues in recent months. These have been caused by the ongoing Covid-19 pandemic as well as more regional factors such as Brexit, which has made it harder to approve UK-manufactured products in the EU and vice versa. Medical device companies have had to think creatively and pre-emptively in order to get around these supply chain issues.
“At the moment, the global electronics market is experiencing a chaotic situation where anticipation and foresight is essential,” Adrian says. “MADES is well experienced in working with supply agreements which allow us to anticipate most of the supply chain issues through strategic purchases. We manage the components’ obsolescence and keep our clients informed about it, as well as the potential shortage issues to come providing alternatives in advance. This allows our clients to focus on their core business, leaving co-lateral activities in secure hands and just making decisions when required.”
Adrian is clear that, as with ensuring reliable manufacturing, solid relationships between companies and their EMS suppliers are vital to avoiding or mitigating supply chain issues. “We manage these issues mainly with anticipation and communication with our clients ‒ a senior and experienced supply chain team is essential,” he says. “MADES’ strong and long-term agreements with component providers are also an added value to solve or mitigate supply chain issues.” Part of this is because medical device manufacturers do not always have the staff or resources needed to deal with supply chain issues: “When system manufacturers decide to control everything internally, they usually end up experiencing supply chain issues due to unexperienced staff for these activities or lack of resources. The impact is serious and can imply a reduction in their annual sales or committed contracts with their clients not supported.”
As mentioned above, when maintaining relationships with medical device companies, EMS suppliers must ensure that they can adapt easily to their clients’ needs and requests. This has become especially important as the industry has experienced the supply chain disruptions mentioned above. Being flexible as an EMS supplier involves developing the correct infrastructure, exercising good manufacturing practice (GMP) in the assembly of devices and printed circuit boards (PCBs), ensuring all teams and processes can work efficiently, and being experienced in reorganising production lines to meet changing demand.
In addition to the above, it is vital for both EMS suppliers and their client companies to keep communications open and clear between themselves, ensuring both sides are up-to-date on any changes to production volume or other relevant factors. “A flexible approach for both the EMS and the client is key to avoid such problems,” Adrian says. “At this point, again, communication is essential to help the client understand the benefits of it.”
For its part, MADES endeavours to plan projects thoroughly with its clients to ensure they are within both companies’ means, or that they can adapt to changing needs if this is required. “We carry out thorough pre-sales processes where we discuss with the client, analyse and evaluate the client needs/requirements and how these match MADES processes and resources,” Adrian explains. “These processes, together with flexible programme management, allow MADES to ensure that when we go ahead with a project, it has been duly analysed and all the resources are aligned to work in that direction.”
Selecting the right EMS provider for your project
All of these are key considerations when deciding who to hire for your medical device project’s electronics, to ensure the end product functions as it should and meets all regulatory requirements, keeping the customer safe and minimising supply chain disruptions. Being thorough and covering all bases when choosing an EMS provider is essential to avoid disappointment both on your end and on your clients’.
MADES has more than 30 years’ experience developing electronics systems for medical device applications, working closely with clients to ensure their needs are met. The company offers process control, highly complex parametric and functional tests, and specific environmental tests among other services.
To learn more about MADES or to get in contact, please visit the company profile linked at the top of this page.