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Patient Care

Molex Engineers Help Innovative Device Reach the Assembly Line

By: Matt Imig
Field Application Engineer

In manufacturing, “customer experience” equates to much more than the quality of a company’s products or ease of ordering. Customers look for ways to gain inspiration in how they approach their designs, and they seek confidence in their ability to effectively and efficiently produce them. They also need to stay informed of the latest technologies, practices and regulations throughout the mutually beneficial collaboration with every level of the organization, from sales to engineering and product development to manufacturing.

In fact, 84% of customers say the experience a company provides is as important as its products and services. This comes as no surprise to the sales and engineering teams at Molex, who are currently collaborating with a medical device company to help take their wireless patient monitoring device from initial prototype to the assembly line.

Customer Challenges

  • Identify a connectivity solution for an innovative wireless patient monitoring device
  • Unify a complex vendor network of electronic components, materials and manufacturing partners
  • Ensure the device is cost effective, reliable, scalable and compliant to FDA requirements

Molex Solutions

  • Molex engineering teams closely collaborated with the customer to refine the existing product design while improving reliability
  • Molex supported the full development cycle from design to prototyping and supply chain and manufacturing

Outcomes

  • Molex is poised to become the manufacturer of record for the FDA approval phase of development
  • An innovative patient monitoring device is on the doorstep of full-scale manufacturing, supported entirely by Molex

An Intriguing Engineering Challenge

The road from idea to manufacturing can be long and winding, especially in the medical device industry. That was the case for a company with an innovative idea and a promising prototype. The device in question was a low-power wireless patch, prescribed by a doctor to monitor a patient’s recovery process, and featured two printed circuit boards (PCBs) on either end. What the device lacked, though, was a highly reliable yet miniaturized connection between the two PCBs.

After engaging with several manufacturers and design teams to solve this critical component need, they turned to Molex. What they found was much more than a connector––they identified a design and manufacturing partner able to assist in addressing other design challenges as well, such as support for adherence to different skin types that may range from pediatric to geriatric.

The End-to-End Engineering Solution

The customer presented Molex engineers with their design, material stack-up and a handful of functional devices they had already built. The conversation quickly grew into a multi-disciplinary engineering discussion. After identifying the best connector for the two PCBs, engineers from Molex’s Printed Circuit Solutions team rolled up their sleeves with the customer and got to work plotting out the road ahead. Molex wanted to ensure all the miniaturized electronics inside the device could support a fully scaled and manufactured product.

As with every engineering challenge Molex faced, the project focused on quality and repeatability of manufacturing. While the initial product design made for an effective concept, it was not a cost-effective, scalable solution. By tapping into Molex’s broad product offering and decades of engineering expertise, the solutions team helped the customer realize the bigger picture with design for manufacturing (DFM) techniques and Rigid Flex solutions.

Molex’s support also extended beyond its own product portfolio. To ensure reliability at scale, Molex tapped into its extensive vendor network to source all materials for the product, such as molded foams and accelerometers. By selecting the right components and mapping out the manufacturing requirements, a new product emerged that could make it to market quickly, cost effectively and with consistently high quality.

Miniaturization Ready for Commercialization

Molex’s deep expertise in miniaturization was a significant advantage in the device, which needed to be small enough for use on pediatric patients. Incorporating all the electronics to wirelessly communicate critical patient data via Bluetooth connectivity was no small feat.

Through the production of 100 prototypes, Molex and the customer were able to analyze fail points, circuit geometry and wiring options to ensure manufacturability. The constructive back-and-forth between the Molex and customer engineering teams produced numerous design refinements, tweaks to the layout and suggestions for a more robust circuit.

Molex achieved what the customer’s previous manufacturing partners could not: the customer felt informed, inspired and confident about the future of their product.

The Road Through Compliance

As this innovative new medical device enters the marketplace, one major hurdle looms on the horizon. Before going into full production, the device must meet FDA approval. This requires medical devices to be manufactured in an ISO 13485 facility: the international standard for quality manufacturing management systems within the medical device industry.

Without a manufacturing partner certified to ISO 13485, the customer would not be able to take its product to the US, EU and many other critical markets. Molex is well positioned to be the manufacturer of record for FDA approval for the customer, manufacturing and assembling the device in its ISO 13485-certified factories.

Delivering a Better Customer Experience

Without collaboration with engineers experienced in current manufacturing techniques, great ideas can quickly reach a dead end.

That’s why Molex believes in working shoulder-to-shoulder with its customers to make the next big innovation a reality.

By actively listening and understanding customer needs, Molex sales and engineering teams work together to ensure every customer is treated individually and presented with solutions tailored to their needs. From product development to manufacturing, Molex engineers are ready to help transform the future and improve lives.

 

 

 

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