A question must be addressed at the start of any new medical device product development process, “Will the device or a component be disposable or be durable?” With safety being of paramount importance, cost and “green” considerations also enter into the equation. This article examines both options and the considerations that must be taken into account for each.

Deciding whether a medical device should be developed as a durable or disposable product requires critical thought around total cost, safety, and user preference.

How do you decide whether to build a medical device as a disposable or durable? Disposables traditionally included supplies, such as I.V. hoses, filters, rubber gloves, drapes, gowns, needles, and syringes. Along with these items, today, clinicians are also discarding video cameras, scopes, pumps, electronic units, and even entire devices. The emergence of many of these items in the consumer world has driven their cost down, making them cheap enough to scrap. While disposables have been around since the 1960s, the real drive toward their use increased in the 1980s due to the growing H.I.V. epidemic, as more stringent requirements for cleaning medical equipment and disposing of biohazards were established.

Changing Tide?
Could the tide change again? In today’s healthcare environment, hospital executives are looking toward “green” approaches in the face of intensive cost pressures. Consider that U.S. hospitals generate more than 5.9 million tons of waste in disposable devices and supplies each year. Meanwhile, they’re facing significantly lower revenues due to decreased reimbursements. In an effort to reduce waste and cut overall spending, many hospitals are partnering with Practice Greenhealth and other environmental organizations. New trends include carefully segregating supplies to avoid unnecessary contamination, using more recyclables and durable equipment, as well as reprocessing single-use devices (SUD).

Durable vs. Disposable Quick Reference Chart

Even the government condones proper reuse of SUDs. A recent Government Accountability Office report titled, Reprocessed Single-Use Medical Devices¹, concludes that while there’s insufficient data to accurately measure the safety of reprocessed SUDs, the data that is available shows no elevated risk in properly reprocessing them according to FDA guidelines².

In addition, group purchasing organizations (GPO), like Novation, one of the largest GPOs in the nation, are also looking toward eco-friendly approaches. And of course, there is the Waste Electrical and Electronic Equipment (WEEE) Regulation to think about for devices marketed in European Union nations.

Risk Factors
On the other hand, hospitals are now being held more accountable for preventing hospital acquired infections. As part of healthcare reform, they will also soon be held accountable for preventing avoidable patient readmissions. This is all driving a heavier focus on safety and high-quality care. That brings the debate back to where it began—the strong perception that disposables reduce the risk of infection and the spread of disease. In addition, disposables can help reduce human errors with:

• More options in terms of labeling medical devices with instructions for use without concerns about labels surviving intensive cleaning, disinfection, and sterilization processes
• Syringes and other devices that come prefilled with precise measurements of surgical adhesive fluids and other bio-fluids used to support successful and more timely treatment and care
• The option of being incorporated into durable devices as components, providing more choices in making technology easier to use

For example, a first generation thermal ablation device, which treats excessive uterine bleeding in premenopausal women, was bulky and had an unintuitive design, reliability issues, and a negative perception among physicians. After an iterative design process and a series of progressively refined prototypes, the product hardware was rescaled to a smaller footprint, and a new disposable, portable cartridge component was engineered that automated connection steps and improved reliability and accuracy. With just one disposable component, the redesigned device became easier for clinicians to handle and learn to use. The revision also mitigated a number of risk factors associated with the original model.

Listening to the Market
User choice also factors in. There used to be many different ways to listen to music, until the mp3 player came out. Now, a majority of people are using only this type of device. When you put that level of consideration into a device, adoption will be higher—as long as it will provide effective and safe care at the right price point. So, whether a device is durable or disposable, what the market wants is key. No matter what it’s made from, if clinicians don’t have compelling reasons to switch to the new product being developed, they simply won’t.

So as a manufacturer, deciding whether a device will be returned to the shelf requires critical thinking early on regarding all factors that impact cost and risk, as well as what the market wants. Whether by using sophisticated software or flowcharts, device makers must weigh the many factors involved, including:

• Whether a device will be launched in America, Europe, or another nation
• The reimbursement for the procedure
• What competitors offer
• The level of human contact involved
• Materials and/or bio-fluids and their costs
• Complexity and cost to train all users, as well as to operate and maintain the device
• Whether that complexity can be simplified by including any disposable components
• The type of labeling needed and available
• Storage requirements
• Costs associated with waste
• Whether a device can be purchased repeatedly for life

Conclusion
Disposable or durable is a decision that truly warrants a total product lifecycle—not just a product—approach. While it’s impossible to say which the market will prefer, the best products result in decisions that consider all factors early on and throughout the development process.

References
¹http://www.gao.gov/new.items/d08147.pdf

²www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm

David Fink is vice president of product development at Ximedica. He has more than 30 years of successful new product development experience in the medical device industry, ranging from early phase research, strategy, and business development to product launch. Fink can be reached at 401-330-3163, x103 or dfink@ximedica.com.