If you work for a medical device company that offers surgical staplers within its portfolio, you understand that the global increase in laparoscopic surgeries is leading to a greater dependence on surgical staples. Close to $2 billion worth of surgical stapling devices were sold in the world in 2016, and revenues are expected to double by the end of 2026, according to Medical Design & Outsourcing.1
Along with the medical community’s increased reliance on advanced technology comes a greater responsibility for medical device manufacturers to exceed quality control standards—and surgical staple guns are no exception. In this blog, we’ll discuss the improper use of surgical stapler guns and why a consultative approach to custom spring manufacturing is crucial to ensuring surgical stapler safety.
Misuse of Surgical Staplers
Surgical staplers are complex devices requiring precise technique to operate. In a report recently released, evidence revealed a downside to this complexity. According to an ECRI Institute study, surgical staplers are ranked #1 in its Top Ten Health Technology Hazards for 2020 report.
Researchers identified the pitfalls of misusing surgical staplers. The consequence of a staple line failing, or staples being misapplied can be fatal. As a result, patients have experienced intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, among others.2
Complications with the use and function of surgical staplers are significant. Recent FDA analysis covered over 100,000 incident reports since 2011: 412 deaths, 11,181 serious injuries, and 98,404 malfunctions.2 Most of these reports had been previously inaccessible to the public. The experts at ECRI Institute felt the issue should receive greater attention and action towards minimizing the hazard.
You’d agree that innovative products in the medical industry require extremely high levels of quality. When dealing with the incorrect use of surgical staplers, quality control in manufacturing medical devices shouldn’t add to this problem. Doing everything you can to ensure your medical devices reach the highest bar of quality is never easy, but it’s imperative. So how can partnering with a consultative parts manufacturer help?
Benefits of a Consultative Approach
Like any complex medical device, a surgical stapler is only as good as its components. The function of surgical staplers relies on an integral piece of smart engineering: springs. Depending on the application, a flat steel spring or a custom flat spring is used. Although the surgeon may not scrutinize the flat steel spring, he surely relies on its role in a secure surgical stapler. The medical device performs better with a high grade, extremely durable flat steel spring.
The composition of the surgical stapler needs to address the challenges surgeons experience in the operating room, such as tissue thickness and movement during firing. In the product development phase, design usually takes more resources than originally planned.
You may not be able to control the timeline variability but tapping into the expertise of a reputable parts manufacturer early in the process offers several benefits.
- The engineers provide insights beyond just supplying custom flat springs that will help you conceive product improvements.
- The parts manufacturing team uses advanced tools to experiment and customize to your exact specifications.
- The capability to manufacture any batch size more efficiently results in no delays and sticker-shock of parts.
- The result is a surgical stapler that functions correctly, every time.
What will you achieve together with? A surgical stapler that provides healthcare professionals with more consistency, performance, and output in even the most demanding and busy hospitals.
How a Consultative Parts Manufacturer is Different
A consultative parts manufacturer, like us, also excels in other important ways. Most are ISO certified and provide evidence of past performance with statistical data and studies. Customer support isn’t a buzzword, but part of their lean manufacturing process. They know extreme responsiveness is your expectation, and most importantly, they understand the spring’s role in medical devices.
Because they recognize you’re relying on them to keep the project moving forward, they deliver fast and honest turnaround times. What will you achieve when you work together on developing a state-of-the-art surgical stapler? A medical device that provides healthcare professionals with more consistency, performance, and output in even the most demanding and busy hospitals.
Want to know more about how we assist medical device manufacturers like you? Check out our Design Guide or contact us. Our responsive and helpful team is standing by.
