Company insight
Support OEMs with fluid delivery products
Between soaring demand and the pressures of the pandemic, getting medical products to market quickly is more important than ever. Medical Device Developments talks to Steve Bello at Halkey-Roberts to learn how the Florida company supports OEMs – and their patients.
How important is it for OEMs to get new products to market quickly, especially in light of Covid-19? Steve Bello: Speed to market is key, whether we have a pandemic or not. From a purely business perspective, being first to market is always the goal. It allows you to capture market share quickly and drive adoption of new technology. With Covid-19, we initially saw a panic-buying spree, as healthcare systems and medical device companies were worried about a breakdown in the supply chain – which would have had devastating effects on patients. The biggest issue at this point is shipping capacity and logistics. We ship products all over the world and are seeing lead times for shipments double. This means we need to keep larger inventories of finished products – as well as raw material to better serve our global customer base. So far, we have met this challenge.
Where does Halkey-Roberts fit in here? What kinds of components do you supply, and how do you work to get them where they’re needed fast?
Halkey-Roberts supplies fluid and gas delivery products into nearly every medical device space. We supply valves that are used on balloon catheters, surgical devices and fluid delivery products of all types (including IVs) – as well as drug delivery and fluid drainage systems. All our products are designed for single-patient use, meaning they’re disposable and can perform flawlessly and efficiently. In many cases, our devices are used in life-critical applications. Our many decades of experience in supplying high volumes of valves allows us to react quickly to surges in demand. We are completely vertically integrated: we mould all of our own components in-house and employ high-speed automation to fill the needs of the market.
Halkey-Roberts supplies fluid and gas delivery products for nearly every medical device space, which are designed for single-patient use.
Halkey-Roberts prides itself on ‘mass customising’ products for customers. How unusual is this in the industry and why is it such an important pillar of your business? We compete on a global scale. We have customers across every continent and we supply many products that are commodities – so their principal value proposition is cost. Over the years, we have developed the capability to offer custom products at a low unit cost. This market is growing rapidly as our customers (large medtech OEMs) are becoming more demanding with their needs. Our ability to provide this service is a key driver to our growth. These custom products are now a large part of our revenue growth, and they allow us to add high value to our customers’ products. These products also are harder to displace by competitors – so it is a protective strategy to keep competitors from offering a lower cost replacement.
What about regulation – how does your company ensure that your products aren’t held up by the FDA? We have an advantage in that we are supplying components that do not need regulatory approval. However, our
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customers still need our support in getting FDA approval for devices containing Halkey-Roberts components. We, therefore, operate our business under the auspices of ISO 13485. All our product development through product launch is guided by this ISO standard, making it very easy to support our OEM partners when they need FDA approval for their products. In short, we operate like a medical device company – but without sending finished devices to market.
Why should a potential customer partner with Halkey-Roberts over your competition in the field? Our biggest advantage is our long-standing reputation in the industry. We have several decades of experience in supplying disposable medical products to every major medical device company in the world. Some of our relationships go back more than 50 years. We also have the financial resources and experience to react quickly to customer needs, and to produce innovative solutions for a wide variety of fluid and gas delivery applications. Our financial strength allows us to invest in the best technologies, while our decades of experience allows us to take on any challenge. ●
www.halkeyroberts.com 101
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