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Does new always equal better?
“New” and “improved” have been marketing buzzwords ever since the early days of Madison Avenue. A newer version of a car or airplane or charcoal grill usually is the culmination of years of use and lessons learned from failures. It’s logical to believe that the newest version of something represents the best that technology and human ambition have to offer. But do they always mean the same thing? And how does this relate to medical devices?
The 510k process requires a predicate device
More than eight out of every 10 medical devices that made it to market in 2018 were cleared through the 510k submission process. This is also required when an existing device has significant changes or modifications to design, components, methods of manufacture, or intended uses. The route to the market for these Class II medical devices includes comparisons to a previous device. This is called a predicate. The choice of a predicate device resolves a number of complexities in the approval process. An existing device is assumed to be safe and effective and serves as physical proof that the device is appropriate for medical use. By comparing a new device to this, it creates a standard that the FDA can use to determine the efficacy of the new device.
The issue is that some predicate devices are more than 10 years old. This is an indication that the devices aren’t undergoing significant improvements.
What happens when new doesn’t equal better?
Many Class II medical devices have been recalled or taken out of the market because they were not as good as their predicates. If a device that was cleared is found to not perform as well as the predicate device, it is possible for a manufacturer to use the newer device as a predicate for another device. This would be done to avoid comparisons to an older device that performs better leading to a deterioration of the standard. When new advances in technology are compared to older technology that has successfully been used as a predicate, the new technology may be prevented from reaching the patient.
The FDA is working to streamline the process
It is comforting to think that all medical devices get better with new advancements in technology and by knowledge gained through clinical trials and actual use. The FDA regulations are there to make sure the process evaluates new devices against advances in technology. This new 510k clearance pathway will allow a medical device manufacturer to compare the performance of some new devices to FDA-identified criteria rather than measuring them against predicates. This final guidance is planned to be released by the FDA in 2019. The hope is that these guidelines will be a more logical way to validate new devices, be a quicker pathway to acceptance and use, and eventually supplant predicate device comparisons.
The medical field moves fast—and MedTech manufacturing is changing to keep up. Stay ahead by discovering the latest trends in medical manufacturing.
MedTech outsourcers are feeling an increasing amount of pressure to deliver reliable, cost-reducing solutions for their customers while still maintaining positive business outcomes. This tension means that these outsourcers must find alternative sources for the traditional products that we need. They need a way to produce equal or greater performance at lower costs. This mission is a tall order for much of the medical device manufacturing community.
What Is Cold Forming?
The cold forming process involves a technique where the application of force with a punch to a metal blank staged in a die. The force of the punch exceeds the alloy’s elastic limit which causes the plastic to flow until the metal blank assumes the shape bound by the punch and the die. One of the benefits of this process is that it does not damage the original metallurgical structure of the raw material as other methods do. In fact, the result of this process is stronger formed parts.
This is not a ground-breaking new method. It has been around for many years, but it has been overlooked for some time. Due to its low visibility in the industry, cold forming has largely been ignored by medical device companies. In this blog, we are going to discuss a handful of the reasons that MedTech outsources should start to consider cold forging as an effective alternative.
The Advantages Of Cold Forming
- Cost Savings: No matter what industry you operate in, the cost of production must be considered as the main priority. One of the most significant factors in favor of cold forming is that fact that it basically eliminates scrap or wasted materials. This forming process compresses the raw material rather than removing the excess. Getting rid of wasted materials cuts back on the costs of energy, labor, and recycling.
- Dependable Supply: Cold forming machines are able to run 24/7, and only one operator can manage multiple machines at the same time. This means that there are rarely any issues with meeting the demands of back orders or late deliveries. Your supply chain will run smoothly and be able to adapt to increased demands quickly.
- Clean Operation: Very little lubricating oil is needed in the cold forming process. This makes the machines easier to clean and upkeep less extensive. The forming process itself creates less waste than most alternatives as well. All of this also means that cold forming is a more eco-friendly process.
- Increased Durability: As we’ve explained before, the process of cold forming compresses the raw material which increases the tensile strength of the product. Many consumables in the healthcare industry require durability for their use, and this process delivers a stronger overall product.
The Other Possible Solutions
There are several possible solutions to this issue. Each one has its benefits, but in this blog, we have focused primarily on one possible solution. We still believe it is appropriate to mention some of the alternatives:
- Screw machining is a resource in the medical device industry that delivers high-quality, repeatable, and tight-tolerance products.
- Additive manufacturing like metal injection molding or 3D printing is also another possibility.
- Cold forming is an often overlooked possibility that offers several advantages and is the topic we focused on today.
The Final Verdict On Cold Forming
The motivation behind this blog is to promote all of the advantages of cold forming in the medical device industry. Our goal is to offer possible new product design alternatives to engineers in the world of outsourced manufacturing. Despite all of its benefits, cold forming has often been overlooked. This technique could be used to lower costs, reduce waste, enhance product yield, and raise quality.
To learn more about cold forming and the process behind other medical device manufacturing methods, reach out to Remington Medical today.
Oncology Supply has provided chemotherapy and supportive care products to independent oncology practices for over 35 years.
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