Critical considerations for medical device developers
There are many factors in deciding whether to develop a reusable or single-use device for your application. In some situations, there may be an obvious choice, but most often, the decision is unclear.
This blog post is the first in a series of five exploring the considerations a medical device developer needs to evaluate when entering the world of disposable devices.
Defining Reusable and Disposable Medical Devices
Let’s start with the basics: understanding the terms.
Reusable Medical Devices
Reusable medical devices are used and reused on many different patients. Between uses, they are cleaned and sterilized, also known as reprocessing.
When a tool is costly, large in size, or easily reprocessed, the traditional approach has been to reuse the device. For example, a gastroscope is large in size, has many small components, and can be very costly. Generally, hospitals will reuse these many times, as an expensive piece of equipment cannot be economically used once and discarded. This cost amortization has been the standard practice in medicine for the last century.
Disposable Medical Devices
A disposable or single-use medical device is used once on a single patient and then discarded.
Single-use medical devices are often smaller, simpler, and lower-cost compared to reusable devices. As an example, a video laryngoscope can be manufactured as a single-use device. These scopes can include an integrated screen, are ready to use right out of the package, and are disposed of after one use. In this form, the video laryngoscope is handheld and can be deployed quickly and easily in point-of-care situations.
Reusable Devices as Capital Expenditure
Reuse of large, expensive medical devices is often necessary for reducing the cost-per-use of the equipment. This type of equipment is called capital expenditure or CapEx. It is a valuable piece of equipment that gets used repeatedly and has a long lifespan. CapEx equipment is too costly for a single-use application.
A typical example of CapEx equipment is an endoscopic tower, which can be found wherever an endoscope is used. It performs all the video processing and provides lighting, recording, and displaying capabilities. This stack of equipment can cost upwards of $100,000, which is a significant investment and must be reused to be economically viable.
New Technology
The rapid speed of modern technological advancements means more sophisticated and precise tools continue to get smaller in format. In recent years, image sensors have shrunk to sub-millimeter size, while video resolution and performance have also continued to improve. These amazing devices can be produced economically enough to justify developing them for single-use applications.
The adoption of disposable devices allows organizations to update and upgrade equipment more easily. Selecting new technology regularly over time, rather than occasionally, means the patient and end-user are benefiting from the latest medical advances at any given time.
Cleanliness
Patient safety and cleanliness are critical factors in determining the use of a reusable or single-use medical device. Cross-contamination can be deadly even when an infected device is used on one patient. Reusable devices are intended to be cleaned and sterilized, but the procedure is not always performed appropriately. If the process isn’t thorough and complete, infectious diseases can transmit from patient to patient. With this chance of infection, there are significant health liabilities considered in the decision to reuse medical devices.
The degree of infection control comes into play when determining the level of sanitization required to ensure the safety of the device and can often be quite involved. There are health liabilities and risks for patients, as well as financial considerations for medical device manufacturers, healthcare institutions, and doctors. This risk has spurred interest in disposable devices, especially with increasingly strict regulations from the FDA.
The Hybrid Solution
A hybrid solution can give you the best of both worlds – combining a CapEx reusable device with a single-use tool. Ideally, the tool that contacts the patient would be the lower-cost portion that is disposed of after each use. The non-patient contact part would consist of a more costly portion that is used repeatedly. For example, a disposable endoscopic camera can be paired with a reusable backend for video processing.
While there is a debate over whether disposable or reusable medical devices are best, a middle ground can often be found with hybrid devices. This approach balances the significant considerations of cost, cleanliness, and technology.
Stay tuned for more blog posts exploring the role of disposable devices in modern medicine!