Summer greetings to you! I hope you’re well and enjoying some well-deserved outdoors time. In this installment of Lighthouse InSight, I’m talking about single-use medical devices and why you may want to consider this approach… and a few reasons not to.

By utilizing durable materials such as stainless steel, glass, and ceramics, medical devices have traditionally been designed and manufactured for repeated use on multiple patients. This approach has allowed for high-quality devices with top-notch performance, albeit with the added rigor of cleaning between uses. More recently, advances in materials and production methods have opened the way for competitive single-use, or disposable, medical devices to gain traction as a viable solution. Introducing single-use devices to the market does not come without serious considerations of a myriad of topics, however.

So why consider a single-use model for your medical device? The details of each device and application will be unique, but here are several top-level considerations:

Reprocessing: A reusable medical device must be properly “cleaned” after each use. Called reprocessing, this usually involves washing, disinfection and/or sterilization, inspection, and storage. This process often involves rough handling, high temperatures, and powerful chemicals that can degrade the device over time. In short, while reprocessing is necessary to reuse a device, it adds time, cost, and repair needs to the life of each device. A single-use device does not require any reprocessing.

Cross-infection: If a reusable device is not properly reprocessed using effective methods, it’s possible to transfer disease from one person to another. As devices such as endoscopes become smaller and more complicated, the methods required to ensure patient safety also become more rigorous. This can place a burden on the manufacturer to define and validate suitable methods, as well as the healthcare provider to accurately follow and inspect complicated procedures. Single-use devices not only eliminate the complication of reprocessing, but also significantly reduce patient risk and liability to the care provider.

Cost: The cost model for single-use devices can be drastically different than for reusable, and while each case will be different, there are many opportunities for both short- and long-term cost advantages. For example, a typical reusable endoscopic visualization system may cost upwards of a hundred-thousand dollars, while a disposable device may be under one-thousand dollars. Additionally, the cost of reprocessing and maintaining reusable equipment limits the cost-per-use over the lifespan of a device, creating an opportunity for a single-use device to be cost competitive per case.

Accessibility: Speaking of high initial investment, capital costs may limit an organizations ability to procure more advanced equipment with high-performance features. As the performance of single-use devices improves, this enables more wide-spread access to the latest technology.

Upgradeability: By eliminating significant investment in a particular device or technology, healthcare organizations have more latitude in adopting upgraded technology.

So, single-use devices are great, right? Not always. As the saying goes, there’s no free lunch… and here’s why:

Waste: There’s a reason why we also use the term “disposable” device. Once used, the equipment must be disposed of and, unfortunately, they don’t magically disappear. We must be considerate of the environmental impact of trashing medical equipment, particularly the plastics and batteries that enable low-costs.

Development: Medical devices are already expensive to develop and adding the challenge of keeping unit costs low requires thoughtful design, expensive tooling, and advanced manufacturing equipment. This added cost and time may be a non-starter for some devices.

Cost and Performance: While the gap is narrowing, it can be challenging to achieve both low cost and high performance in a single-use device

There’s so much to consider, what should you do? Well don’t panic. Lighthouse is here to help navigate you through this complicated set of considerations. With our experience developing and manufacturing medical devices, we work with our clients to understand their unique requirements and provide expert solutions. Maybe a single-use device is best for you needs, or maybe it should be reusable. Or perhaps a clever combination, utilizing the best elements of each in a hybrid approach is appropriate.

I’m excited to learn what new applications you can come up with! If you’re interested in learning more, I’d love to hear from you!

Lighthouse Imaging is on the forefront of the advancements in medical visualization, and we are passionate about enabling our clients to deliver world-class medical devices.  Through our turnkey solutions for medical optics and visualization, we strive to make the world a better, healthier place.  I am quite fortunate to be able to share my excitement and enthusiasm daily with the amazingly talented team here at Lighthouse Imaging; a world-leading provider of custom OEM solutions and contract manufacturing.


Be Well and Be Kind

Benjamin J. Gray
CTO – Lighthouse Imaging