When looking to engage with battery suppliers, there are several factors that medical device companies should consider. Although different applications will have different individual requirements, there are certain qualities that are essential for all devices.
For example, suppliers should meet the ISO 13485 certification for good process alignment and have demonstrable experience in producing ‘mission-critical’ batteries of exceptional quality. Design and manufacturing experience across a range of challenging features and performance-related topics, such as IP68, fast charging and product longevity, is also strongly recommended. In addition, the company should be verified and validated as meeting the expectations of medical businesses.
Custom battery development for medical applications
Alexander Battery Technologies designs and manufactures custom battery power solutions for a variety of medical applications. Based in County Durham, UK, the company’s products and services include Li-ion and NiMh battery packs and chargers, battery management system components, integrated power and charger solutions, and custom printed circuit board assembly (PCBA) solutions. Alexander has 40 years’ experience developing power solutions for the medical market (and other industries) across a host of applications, with some of the world’s largest medical customers within their customer base.
The process of selecting components for battery solutions largely differs from one application to the next; while some factors (such as those listed above) are non-negotiables for all devices, the main factors that must be considered often depend on the device and what it will be used for. “The component selection is determined by the customer requirement,” states Claire Brymer, finance director at Alexander. “Not every design is the same, we work closely with our customers to understand their needs and make sure the component selection meets the needs.”
Despite this, one thing that Alexander prioritises in its work is the lifespan of its battery packs. “Longevity is one of the things we look at,” Claire explains. “As the components have to go through costly and rigorous testing and can’t be changed easily, making sure you choose the correct components from the start is extremely important.”
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Addressing pain points in the battery manufacturing process
As a contract manufacturing organisation (CMO), Alexander aims to address several key customer ‘pain points’. One of these involves establishing and maintaining the status of a provider of quality, reliability and performance among its competitors on the market. Because Alexander’s customers demand optimal performance from their power solutions, the company custom-designs all its products specifically for each customer’s needs, using Tier I suppliers and carefully selecting components that can work harmoniously together.
“We take a proactive approach by using risk management tools such as design failure mode and effect analysis (DFMEA) and process failure mode effects analysis (PFMEA) to ensure the quality of the product,” states Claire. “We have a thorough process when qualifying new suppliers, ensuring that they maintain quality throughout their process. Once a supplier is qualified, we evaluate them using a technical, quality, responsiveness, delivery and cost (TQRDC) process on a quarterly basis to ensure the expected standards are not dropped.”
In addition, Claire notes that the company maintains ‘excellent’ long-term relationships with its Tier I suppliers, which are another key element of its strategy. “Tier I suppliers share the same values, processes and techniques as Alexander; we build long-term relationships with them and feel that they are an extension of how we operate,” says Brymer.
The second pain point that Alexander targets is that of time to market – developing power solutions quickly so that clients’ products can be launched on schedule, without compromising on quality or safety. “Speed to market is important to our customers, who want prototype and production products turned around quickly to ensure they remain competitive in their market,” states Ben Moody, marketing manager at Alexander. “We have developed a rapid response programme based on automotive techniques, meaning we can deliver high-quality products in weeks and months, rather than months and years.”
Alexander’s rapid response programme covers the entire production process, from concept and design to production, with average design and production times ranging from five to nine weeks depending on project complexity. The company’s design functionalities include electronics, mechanicals and enclosure supply requirements, while its development capabilities include testing, product refinement and tooling. Central to the programme are automotive techniques, which allow Alexander to ‘move through projects efficiently whilst maintaining a traceability and regulatory standards that our customers require,’ says Claire.
“We operate a managed buffer stock program and maintain priority status in the supply chain to meet flexible demand requirements and deliver on time in full to fulfil customer delivery schedules,” Claire explains. “Customers are allocated a project lead from the initial kick-off meeting and, using these techniques, we are able to deliver initial prototypes in as little as five weeks.”
Another area that Alexander aims to address in its operations is in delivering the highest possible quality for its customers so they can maintain their reputational integrity. To do this, the company aims to integrate quality into every element of its manufacturing process, from strategic direction to Lean Six Sigma training at operational level. This does, of course, look different for each stage of the development cycle, but there are certain common principles that Alexander follows to ensure quality is embedded into all points of the process.
“We use risk management techniques to mitigate the quality risk,” explains Brymer. “This is managed across cross-functional teams and all input is analysed. Then the process is broken down into small chunks where operators have electronic work instructions in front of them, highlighting critical to quality aspects of the process.”
Matching battery demand during the Covid-19 pandemic
Over the coming months, Alexander plans to invest more in its facility in Peterlee, UK, which was opened in 2019. The company saw an increase in demand for its solutions during the Covid-19 pandemic, which its Peterlee facility helped to meet.
“The new facility was designed with flexibility in mind ‒ all the manufacturing lines are capable of running any battery or charger,” Brymer says. “When we received the increased volume orders, it was easy to replicate the manufacturing lines.
“Our challenges were largely around recruiting staff and training them to maintain our high-quality standards. We were able to do this by working with a local recruitment agency and creating approximately 400 jobs ‒ every operator attends a training course, where they spend two to four weeks being trained before they go on the line.”
To learn more about Alexander Battery Technologies or get in contact, please visit the company profile linked at the top of this page.