TE Connectivity IVD Solutions: "The microfluidic market calls for more secure products and more scalability"

As one of the largest CDMO providers for medical devices, TE Connectivity offers a wide range of services from medical device design and development to clinical research and production. Perhaps microfluidics is not the first thing that comes to mind, but it is no less important, especially today. Just think of point-of-care testing.

We spoke with Fran Blanco PhD-MBI, Global Head of Commercial & Strategy at TE Connectivity IVD Solutions about trends, difficulties and, of course, what COMPAMED visitors can look forward to when visiting the booth.

Mr. Blanco, what makes TE stand out?

Fran Blanco: As one of the largest contract development and manufacturing organization (CDMO) providers in the medical device space, TE is a trusted provider of medical sensors, extrusions, stems and catheters, among other products. Around five years ago, TE decided to enter the vertical microfluidic IVD business, which is not only a viable on its own, but it also provides synergy with the rest of the TE medical business. Leveraging TE’s strong supply chain has helped improve the microfluidic IVD supply chain. For example, TE has one of the largest silicon MEMS foundry networks in the world, it is now producing silicon microfluidic devices for our pharma and life science customers. These types of advancements and opportunities can only happen thanks to the incredible number of resources and experience we have available within TE.

As a supplier, producer and expert in design and development, you know the market well. Without giving too much away, what are the current issues in microfluidics when it comes to supply chains?

Blanco: Prior to March 2020, "supply chain problems" weren’t a common topic of conversation. Just-in-time inventory was the status quo and supply disruptions were rare.  Fast forward a few years and nearly every company has been affected by the perfect storm of surging demand and shortages of materials and labor. One of the issues we currently see, is that seemingly everyone knows about the supply chain constraints; but when it comes to timelines for product market launch dates, these constraints are hardly considered.

How does this impact the industry, perhaps also for the future?

Blanco: Consolidation is happening. The largest microfluidic markets, Europe and the US, are calling for more secure products and more scalability of these kind of new products. It is anticipated that other big markets like China, Korea or Japan will move forward in that direction. If your eventual goal is to obtain US FDA 510(k) clearance or CE certification to the European In Vitro Diagnostic Regulation (IVDR), you may quickly discover an increased emphasis on risk management  by regulators.

The ISO 14971 risk management standard (and the corresponding ISO TR 24971 guidance on how to implement ISO 14971) focuses mostly on product safety which includes your management of critical suppliers such as your chosen CDMO. While product safety is certainly the #1 focus, control over your supply chain should be an important part of your overall risk management plan. ISO TR 24971 points this out in section A.2.30: "Factors that should be considered include the application of new or innovative technology and changes in the scale of production. This can also involve changes in contract manufacturing, suppliers and vendors."

In addition, customers are demanding strong global supply chains to support these efforts. Because of our global footprint, industrial capabilities and resources, TE is well positioned to help develop these new supply chains.

Besides the issues, where is the trend going in microfluidics? 

Blanco: One of the trends is incorporating syndromic MDx analyzers with better clinical outputs. Thanks to our clinical research activity, we are monitoring the introduction of many clinical trials to introduce novel multiplex molecular diagnostic test, that will serve as a platform for testing respiratory diseases (COVID, Flu A and B, and other respiratory panels), STDs and other complex panels in one device. The advantages are substantial for the patient and for the healthcare systems.

In other segments like next-generation sequencing (NGS), cell analysis microfluidics is being established as the gold standard to simplify workflows and to make these new technologies accessible to the laboratories and clinics around the world. The healthcare systems are seeking faster quality responses, more clinical value, more automation and to be close to the patient. This is one of the drivers that is moving the industry and microfluidic solutions are helping many customers to improve healthcare outcomes using these innovative products.

TE is an exhibitor at COMPAMED, what new products will you have in your luggage?  

Blanco: TE is exhibiting at both COMPAMED (Hall 8a / H29) and MEDICA (Hall 3 / C40-6). We have experts available to talk about services and products we provide, such as NPD, usability, regulatory, clinical research and manufacturing. At the show we plan to highlight our capabilities in:

• Manufacturing of point of care (POC) IVD products integrating excellent reagent technologies (new blister design, lyophilization) to improve workflow automation to our customers
• Manufacturing of high-resolution microfluidic devices (with resolution of 1 micron) based on stellar microfluidic technologies specific for NGS, Single Cell Analysis and other challenging and exciting applications that demand this kind of great industrial resolution
• The launch of two new, advanced, microfluidic factories in Europe and the US that position TE as the preferred supply chain provider for customers
• New offerings in the Dx space for new product development, usability, clinical research and regulatory services in Europe to support customers in IVDR