Tag Archives: FDA

2017’s Medical Device Industry Review

2017 has been filled with constructive internal effort and focus at Hammill Medical. Our team interacted consistently with our customers, leading doctors and other industry experts to positively impact our external audience base at large. These continuous initiatives make our team one of the most credible resources and leaders within the medical device manufacturing field. We challenge ourselves to meet or exceed medical standards like FDA requirements for contract manufacturing of implantable medical devices and surgical instruments.  As a result, our manufacturing capabilities consistently evolve to allow us to offer some of the most complex implants on the market. Plus extending our knowledge on fitness, exercise, and other health-related factors keeps our standing top within the sector.

Because of the complex manufacturing occurring at Hammill Medical, we must maintain more stringent operating procedures than other manufacturing companies. The quality standards we uphold are designed to ensure consistent manufacturing results as well as to exceed standards designated by industry and federal regulations.  Hammill maintains accreditations for medical device companies as set forth by the U.S. Food and Drug Administration and as required by ISO 13485. Meeting the requirements of these organizations is consistent with our commitment to optimal manufacturing process performance. The basics of the regulations and standards can be found in our February 2017 post.

As a qualified resource, we’re happy to share (and urge you to spread) the best exercises you can do for your body. The big focuses here are spine and back. You might be surprised to learn that all exercises are not created equally, and some of your favorite workouts can actually be more of a risk to your back and spine. The best exercise options will promote spinal health and stability setting you up for possible injury prevention down the road. Options like Pilates, yoga, and swimming help teach your body to move and support your spine during everyday activities. We recommend extreme caution with traditional sit-ups and overhead lifts as they can put too much pressure on the neck, spine, and lower back. Should you ever seek a spinal implant, we’ve got you covered.

Our most recent spotlight is an update on the advances in medical technology, specifically the benefits of Minimally Invasive Surgery or MIS. As more procedures become less invasive, the patient outcome and recovery improve. As proven through prior surgeries, MIS means smaller incisions, reducing blood loss and trauma to the patient, smaller scars from such incisions, decrease infection rates, and shorten hospital stays. Many MIS surgeries can be performed as outpatient surgeries and/or require less than a 24-hour hospital stay. As the progression of technology within the medical industry advances, it looks like this surgery option is taking a front seat over older methods.

To stay abreast of industry updates, leading technology, and the best resource for orthopedic implants, spinal implants, surgical instruments, and other implantable medical devices for Complex Spine, Orthopedic Total Joint Replacement and Minimally Invasive Surgery applications, we invite you to follow our blog, add us on Twitter, connect with us on LinkedIn, and subscribe to our YouTube channel.

To learn more about how we can help you and your business, simply contact us today.

We’d like to take a moment to recognize and thank our audience and customer base for adding to our internal success on an annual basis. Your needs are what help us develop the prototypes and product development to advance the medical device manufacturing industry year after year.

We wish you all a very happy holiday season and a healthy and happy new year!

We look forward to connecting come 2018!

 

3D Printing and Manufacturing’s Future

Modern manufacturing started with the industrial revolution, became a powerhouse when Henry Ford instituted the assembly line, and is now facing a new innovation: additive manufacturing, also known as 3D Printing. The 3D printing process begins with a set of programmed instructions that tells the printer how to lay down material (plastic, ceramic, metal) to create a 3D object.

This new technology offers exciting opportunities for manufacturers. At this point, it doesn’t look like 3D printing will be replacing traditional factories or machinery. The process is innovative, but is not yet economically advantageous to become a full-on manufacturing operation.

3D printing still complements traditional manufacturing processes, and is extremely 3D Printer Suturing Device
advantageous. What 3D printing brings to the table is in prototype and customizable product manufacturing. The ability to design and produce one item fosters new product development and aids in manufacturing specialized parts or equipment.

This specialized part manufacturing has significant benefits to the medical industry. The ability to customize items such as hearing aids or dental implants effectively and efficiently improves patient outcomes. At the most recent MD&M and Atlantic Design & Manufacturing shows, exhibitors displayed innovative medical devices made through 3D printing. Medical device designers are finding good use for new applications involving 3D printing. Products such as suture wound closure devices, custom porous cranial implants, and spinal implants were on display.

As with all medical implants, the FDA has a say in approving the devices. There has been 3D Printer Spinal Implantsuncertainty in the regulations as the FDA solidifies its view of additive manufacturing. The FDA has already approved certain resins for facial reconstructive surgeries and has a fast-track system that allows certain facilities to use a 3D printed device when there are no other patient options. It is expected that the FDA will issue full guidance on what questions device manufacturers can expect regarding 3D printed medical devices by the end of this year.

We are in agreement with the industry, that 3D printing brings new capabilities to manufacturing and we plan on purchasing our own printer. The new printer will help us explore this new technology and allow us to learn how to incorporate it to improve our capabilities. We believe that 3D printing technology will enable us to help customers with parts for improved customizations of medical implants such as prominent acetabular cups, spinal cages, and knee components.

As the technology improves, offering more material choices and higher outputs, the possibilities seem limitless. We are looking forward to offering expanded capabilities and customer options through 3D printing.

3D Printing and the Medical Industry

The topic of 3D printing has caught the imaginations of people throughout the manufacturing industry. The possibilities that this new production method presents seem endless, but it’s not just the manufacturing industry that is going to benefit from this advent. Medical science will be making big leaps forward.  These advances will come from not only the 3D printing of medical devices, but also the printing of body parts for patients in need of transplants.

Medical devices are held to an extremely high standard by the Food and Drug Administration (FDA), but the organization is sorting out how to go about approving devices created by 3D printers. Fox News reports that the FDA is looking into some of the remarkable things done with this new method of production, from a 3D-printed tracheal splint used to save a newborn’s life to an implant which replaced 75 percent of a man’s skull.

This new development has changed the way implants and devices are created, but the real impact 3D printing could have on the industry is with printed body parts, called bioprinters. “If you have a compass and a straight edge, everything you draw is a box or a circle,” said DEKA Research & Development founder Dean Kamen according to Popsci. “When you get better tools, you start thinking in different ways. We now have the ability to play at a level we couldn’t play at before.”

What can be done with 3D printing in medical science seems limitless. Popsci even goes as far as to note the possibility that bioprinters could extend the capabilities of the human body. Whether 3D printing is reimagining the way people think of the human condition, or making it easier for patients to gain access to devices they need to lead healthy lives, this technology is having an amazing effect on the medical industry.

Keep Medical Devices Safe From Cyber Threats

Medical devices are often crucial to the well being of patients and maintaining a high level of security in these machines is of the utmost importance. This made the news of medical devices’ susceptibility to cyber threats all the more alarming. The Food and Drug Administration (FDA) made its concerns over cyber threats affecting medical devices known in a statement. “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” the FDA alleged, according to Reuters.

University of Michigan professor Kevin Fu has asserted that there haven’t been any documented cyber attacks on medical devices, reports CTV News. Even though the computer science professor, specializing in health security, alleges that there is no record of any attacks occurring, medical device manufacturers and users are concerned over how safe things like pacemakers and insulin pumps are for users. If these devices were hacked, the results could be fatal.

The risk of cyber attacks increases in devices that are more connected to networks than others. The FDA is warning that machinery that works with the internet or even hospital networks, other medical devices and smartphones will be more vulnerable. The agency has made several suggestions for manufacturers to consider in their measures to prevent medical device hacking. Devices that are “life-sustaining” should have limited access ability, all devices should have increased security controls like user IDs and passwords, and in the off chance a device is attacked, there should be a failsafe to recover it before the user is affected..

Maintaining the safety of patients is a top priority to any hospital or medical device manufacturer; the potential for cyber threats is very serious to members of these industries. With the FDA’s recent announcement, the proper steps can be made to insure that medical device hacking is prevented.

Hammill Medical: The Story Continues

We’ve joined the digital revolution and with this post have launched our monthly blog posts that we hope will help to facilitate a digital dialogue with our customers, suppliers, and industry compatriots.  In the months ahead, we will be posting blog articles about industry news of interest, information about manufacturing in the U.S. and also updates about our company and products.  We look forward to you being part of this conversation and hope you will feel free to comment and let us know your thoughts.

Before we begin, we thought we’d give you an overview of who we are, where we came from and where we hope to go.

The Hammill story began in 1955 when it was founded by Ed Hammill.  Ever since Ed founded the company it has remained family owned and operated, something each generation has taken pride in and worked to continually improve on our products and services.  Since the 1970’s Hammill Medical has been fabricating orthopedic implants, spinal implants, surgical instruments, and implantable medical devices. In fact, we recently celebrated the manufacturing of our 500,000th orthopedic knee implant.

We are very meticulous about quality processes to ensure that the customer receives a part that’s manufactured to their requirements and specifications and that it adheres to all the FDA requirements and follows the ISO 13485 guidelines.

We are committed to employee education and encouraging young people to learn about our manufacturing processes through our apprentice program.  Together with the state of Ohio and Owens Community College we typically have between 35 and 40 students who are going through the apprentice program.  These students come away from the program with the equivalent to a 2-year college degree and a journeyman’s card which establishes high-level skills as a machinist.

Hammill Medical is able to bring new products to market quickly and on budget with the help of our in-house tooling and gage design and manufacturing.

So, this is how we got our start and where we are currently.  We look forward to telling you about where we are going in future blogs and sharing stories about manufacturing innovations, ideas, and current practices that we think will be of interest to you.  As well, be sure to check in with us on LinkedIn, Twitter, Facebook, and Google+.  Stop by next month for our next post.