Remington Medical explains the FDA’s Breakthrough Devices Program and how to determine if your medical device is eligible.

Remington explains FDA best practices for medical device patient labels, why you need them, and guidelines for usage.

Remington explains medical device packaging best practices and tips for overcoming common challenges.

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.

Healthcare has always depended on technology to provide the best care to patients and AI is no exception.

Cutting-edge technology is a wealth of opportunity and nowhere is this more advantageous as healthcare. The world is going through a technological revolution and artificial intelligence is permeating all kinds of industries making processes simpler, quicker, and safer. One area where AI is being deployed is healthcare.


From initial hurdles to widespread acceptance

As the use of AI grows, it still has a long way to go to reach mainstream acceptance. Technology is intimidating, especially to people who are used to tried-and-true methods of doing things. To healthcare organizations, we are predisposed to be even more cautious as we deal with matters of life-and-death.

Artificial intelligence and machine learning are going to be game changers to the healthcare industry. Instead of a disruption, stakeholders across the entire healthcare spectrum from doctors to hospital administrators to medical researchers will use this technology in various ways to improve care and bring better patient outcomes.

Managing medical records

The ability to compile and analyze data is critical in healthcare. Data management is a common and obvious use of digital automation. This is especially relevant since medical data can exist in so many different formats. Because of this wide range of data, and the need to accurately, and quickly recall and analyze it, AI allows this process to be manageable and streamlined.

Providing better diagnoses

Diagnostic errors play a role in hospital complications and even patient deaths. The human mind, no matter how educated and experienced, will make mistakes. Artificial intelligence systems can analyze thousands of sources of data, notes, and reports from a patient’s file, external research, healthcare data, clinical knowledge, and case studies to arrive at suggested ways to treat a patient. AI may not be able to be the sole provider of a medical diagnosis, but a hybrid of human problem solving and computer interpretations will result in more precise decisions when it comes to treatments.

Health monitoring

Smartphones and wearable health trackers from companies like Fitbit, Apple, and Garmin can gather an extraordinary amount of medical and fitness data about a patient. This can be used to supply data about patient habits that will help doctors better satisfy their needs.

Drug creation

Clinical trials can take more than a decade to complete and they cost billions of dollars from start to finish. Medical researchers have a difficult task of finding effective and responsible ways of making this process faster. Artificial intelligence is a quicker way to analyze the effectiveness of a drug and measure its ability to treat or cure a condition. Making this process quicker and cheaper can bring life-saving drugs to patients faster and save countless lives.

Doing repetitive tasks

Many medical staffs get caught up in time-consuming, yet important tasks such as analyzing tests, x-rays, and CT scans that can easily be done by AI. This frees staff to concentrate more on patient outcomes rather than following long and tedious processes.

This is only the beginning

Artificial intelligence will continue to have an impact on our daily lives. Data science and medical analytics will influence AI development play a critical role in curing diseases and helping patients live longer, more fulfilling lives. As AI technology continues to grow, healthcare providers like Remington will use it to reduce costs, save time, and allow healthcare providers to provide as accurate a diagnosis as possible.

The good news is that the medical device manufacturing industry is on the rise. There is a steady and dependable demand for products across the country. The bad news is that this industry is still faced with a set of hurdles that will likely cause setbacks for those that are unprepared. It is challenging to stay informed on all of the advances and trends going on in MedTech today, but if you can stay up-to-date, you and your business will be much more prepared for the future when it comes.


MedTech Manufacturing Trends Of 2018

  • Workforce Issues: As we said before, the manufacturing industry is tracking some positive upward growth. However, this multi-billion dollar field is also seeing some workforce issues. In the past, manufacturers were looking for specialized talent that had at least three years of under their belts.

    Today, thanks to a labor shortage, manufacturers have found value in hiring entry-level workers with potential and offering the training they need to become medical device assemblers. This trend has shown that sometimes we must rethink the business model of hiring and training.
  • Competitive Wages: One of the advantages the manufacturing business has long held over other markets is their higher pay scale. The unfortunate news for the medical technology manufacturing sector is that other markets like retail and food service have started to raise their minimum wage. Prospective employees are now heading towards retail and restaurant work because they can make similar wages with a flexible work schedule. This trend is forcing manufacturers to offer more competitive wages across the board.
  • MedTech’s Unique Needs: The medical equipment industry is driven by innovation. As soon as a new product hits the market and is successful, the demand for it can skyrocket quickly. There is a built-in demand for new products and services while they are still in the manufacturing process. This has forced manufacturers to examine their supply chain and find the most efficient ways of assembling raw materials and getting their products in the hands of their customers. We must find ways to maintain quality and ramp up production.
  • The Era Of Automation: The process of manufacturing products is becoming increasingly automated in many sectors. One might think this is eliminating the need for a robust workforce, but the truth is that it is altering the type of workers that manufacturers are looking for. This digital transformation and machine learning mean that manufacturing jobs are becoming more tech skill-based. Employers are now looking for people with the ability to run, operate, and troubleshoot computer-directed machinery.
  • Challenging Regulations: There is a shifting tide of strict regulations across the globe that are affecting manufacturers here in the U.S. In previous years, manufacturers would first launch a product in European countries where the regulations were less strict. This would allow them to collect evidence to support the eventual approval by the Food and Drug Administration.

    Today, Europe is raising the standards of their regulations and putting one more hurdle in the path of manufacturers. The solution has been for manufacturers to hire auditors whose sole job is to keep up with regulatory standards and keep their programs on track.
  • Untapped Potential: The manufacturing industry is finally turning to one of their most untapped pools of talent: women. Aerotek reports that women make up about 47% of the U.S. workforce, but only 29% of the manufacturing labor force. Manufacturers are realizing that they can’t expect to find all of the talent they need in only 50% of the population. This has caused the manufacturing sector to increase their outreach to women to fill roles throughout the industry.
  • Veteran Experience: Another pool of talent that has been overlooked in the past are military veterans. Hundreds of thousands of service members are transitioning out of the service every year, and they are all looking for employment. These veterans even come with skill sets that are well-suited to the manufacturing industry. They are used to working in a team environment and have experience in service areas like logistics. Service members could be the workforce that comes to the rescue for the manufacturing industry.


To learn more about the medical device sector and what Remington Medical has to offer, contact us today.      


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.


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