Category Archives: FDA

Moving Towards a Painless Back: Motion Preservation is Possible with Total Disc Replacement

Doctors and experts lay great stress on the disclaimer: There isn’t a single class or type of spinal treatment that can be considered the best for a patient.

The causes of back pain must be isolated and then treated case by case for a hyper-specialized solution.

But over the past decade or so the most frequently recommended course of action has been resorting to spinal fusion.

Spinal Fusion & Loss of Motion:

The premise of spinal fusion surgery is to eliminate contact and friction. The vertebrae of the spinal cord often rub against each other and surrounding soft tissues resulting in discomfort.

Through a spinal fusion surgery, screws, rods and even pieces of bone, or bone grafts, are used to turn two separate vertebrae into one functional, supported unit.

The upside of the procedure is the reduction of pain by eliminating disc friction.

The flip side of spinal fusion surgery is the loss of motion that results from fusing the discs.

Medical breakthroughs and alternatives have thus focused on the goal of motion preservation.

Research supports that one of the best ways to permit spinal flexibility, post procedure, is to completely replace the discs that are at the root of the problem. FDA approved, artificial discs allow that process to take place.

Hammill Medical is Proud to Manufacture PRODISC C/L:

PRODISC leaves room for hope, offering pain mitigation without stiffness and motion restrictions.

It is one of the only artificial disc variants in the US market.

Hammill Medical will be using our state-of-the-art manufacturing facility and abilities to prototype and produce the next generation of orthopedic devices to ship PRODISC units of unparalleled quality.

This engagement will aim to make motion preservation a more common option for those with disc degeneration and other chronic and acute spinal conditions.

To stay updated on how we bring PRODISC to the market, please follow us on Twitter and LinkedIn.

You can also contact us here.

Keeping Up with the Fast-Paced Medical Devices Industry

Manufacturing & Medical Breakthroughs

Knowledge and skills are like radioactive atoms. They decay with time. This is particularly true in the medical field as breakthroughs happen almost every day. The voracious appetite of human beings where eradication of diseases and difficulties is concerned has not and will not wane in the near future. The only course of action open to manufacturers keen on supporting this field is constant education. And that’s what Hammill Medical is all about.

A Legacy of Knowledge & Practical Information:

Knowledge isn’t limited to books. Often the best skill upgrades happen at summits, expositions and boot camps. To this effect Hammill, is all set to be a presence at some of the most prestigious medical device and orthopedic events of 2018. Commitment to quality and thought leadership isn’t easy. With that said, our team is ready to keep up with the fast-paced medical sector.

NASS Meeting 2018:

The spine implants market is rapidly growing. And is a very viable segment for us.

The North American Spine Society (NASS) provides enduring material in the form of spirited discussions and presentations which distill the latest in spine surgery, rehabilitation and support devices for quick consumption.

This year’s winter events will highlight both surgical and medical perspectives on spine care.

These events will allow us to learn about the latest technologies and capabilities for new and upcoming customer projects in the medical device industry

The American Academy of Orthopaedic Surgeons (AAOS) Meeting 2018:

March 6th to March 10th 2018 New Orleans, Louisiana is home to a prestigious congregation of doctors, physicians, special practitioners, medical service providers and international vendors.

The reason? Up to date, accurate medical information and programs that enlighten registrants about all aspects of medicine and medical support.

We will use this opportunity to expand our circle and also stay abreast of what’s new in the industry.

More About Hammill Medical:

Hammill Medical has a 90,000 square feet state-of-the-art manufacturing facility in Toledo Ohio. We operate within manufacturing guidelines mandated by the FDA. We are ISO 13485 accredited. And most importantly, we have experience bringing new products to our buyers – on time and in budget.

We sincerely believe what we absorb at these educational events sharpens our existing abilities and equips us to embrace new capabilities.

Make sure to follow us on Twitter & LinkedIn for the latest industry updates or you can contact us here today.

2018 Predicted to Bring a Multitude of Success for the Medical Device & Implant Industries

Science has given mankind many miracles. But the most enduring and impactful of these has been the introduction and commercialization of modern medicine. It has single-handedly ended the reign of dreaded diseases, improved longevity and provided succour to those who are afflicted.

With that in mind, it comes as no surprise that the medicines, medical devices and implants industries are poised to witness consistent growth not only in 2018 but over the next 10 years.

United States is a Thriving Devices and Implants Market:

The combined value of the various players in the medical devices sector is a staggering 155 billion USD.

Implants alone account for more than 70 billion USD.

There are a few reasons why the projected expansion of this space is extremely optimistic.

–       The population in the US is aging fast. Some of the Baby Boomers – the largest segment of the American population before the Millennials arrived on the scene have already touched the 70 years mark. It is estimated that more than 24% of US citizens will be 65 or older soon. The common maladies of age and bone degradation turn the elderly into busy consumers of medical services, devices, and therapy.

–       The increasingly sedentary lifestyle of generation Y is preparing the stage for spine issues and organ degeneration in the relatively young workforce as well. Both are managed through surgical interventions and the introduction of implantable support systems.

–       Insurance availability has peaked in the past few years. Even if the freedom to visit the doctor is curtailed because of reforms presented by the administration, there will still be people who can now afford medical devices and assistance, and they will opt for them to improve their lives further fuelling growth.

Hammill Medical is Ready to Play its Part

Market research puts orthopedic implants as a leader in the medical devices category. Hammill Medical is an ISO 13485 accredited and FDA registered manufacturer of medical devices specializing in orthopedic and spinal implants.

With the ability to see production through from original concept to high-quality finished item at our 90,000-sq. ft. state of the art facility, our name has inspired trust and embodied innovation for well over half a century.

We are the perfect partner for businesses looking to capitalize on the trend of implantable medical devices. For more information contact us today.

You can also follow us on Twitter and LinkedIn.

 

Succeed with Us as Your Contract Manufacturer

Why Use Hammill as Your Contract Manufacturer?

There are several benefits in utilizing Hammill as a Contract Manufacturer including our state-of-the art manufacturing capability, remarkable flexibility, utmost attention to detail and our ISO and FDA compliant Quality System. We are committed to working with our customers from initial concept, through the design and manufacturing process. All of which serve to meet our valued customers’ needs and expectations of high-quality products at an affordable cost. We strive to ensure our manufacturing operation is supported, not just by a team of talented professionals but also by the latest in cutting-edge technology.

Additionally, we enjoy unmatched access to multiple markets spanning the globe and a fantastic scalability in serving partners from smaller start-ups all the way up to multinational corporations. The Hammill team has comprehensive knowledge and experience in working with the latest manufacturing technologies. We also ensure there are contingency plans in place to allow for uninterrupted delivery of promised product flow.

Specializing as a Contract Manufacturer

At Hammill, we are leaders in the manufacturing of orthopedic and spinal implants, surgical instruments, and implantable medical devices. We work from concept to finished product, offering our services at prices that might surprise you. As a contract manufacturer, our specialty is working closely with our partner firms to develop validated manufacturing solutions that consistently deliver a myriad of quality medical product and services on time and on budget. In addition to CNC machining and Swiss Turning, we also offer Finished Device Assembly, Laser Welding, Color Anodizing, Media Blasting, as well as Laser Marking and Validated Cleaning & Passivation – all in-house and fully validated.

A Family Owned and Operated Firm

Established back in 1955, Hammill Medical is proudly a family owned and operated firm. With over 175 employees and a location that features a 90,000-sq. ft. state-of-the-art manufacturing facility. You can find our company located in Maumee, Ohio, just outside of Toledo.  Fully registered with the FDA (#1530390) as a manufacturer of medical devices, we meet and exceed the good manufacturing practices guidelines it mandates.  We are ISO 13485 accredited as well. We are also proud to offer a 4-year formal apprenticeship program, with both state and national accreditation, helping to introduce new talent into America’s manufacturing ranks.

Bringing New Products to Market

We at Hammill are dedicated to bringing new products to market on time and on budget with our specialized in-house tooling, gage design, team manufacturing methodology and focus on quality control. Discover more about Hammill Medical by calling (419) 476-0789 or emailing us at info@hammillmedical.com. Be sure to keep up with our latest news by reading our blog, following us on Twitter, and connecting on LinkedIn.

We look forward to working with you on your next project.

Sterilization in the Medical Industry

As an industry-leading, family-owned and operated manufacturer of orthopedic and spinal implants, surgical instruments, and implantable medical devices, Hammill Medical is deeply committed to our customers; part of this commitment is the promise to keep all clients and end users safe.

At Hammill, we understand the importance of sterilization for optimal safety in the medical field — especially in surgical instruments and implantable devices that have direct contact with the human body. But within the medical community and many others, there’s no clear-cut answer regarding which sterilization method is best; this will depend on your specific product and packaging materials.

Ethylene oxide gas and gamma sterilization are the two most common forms of sterilization. A rigorous chemical method, ethylene oxide gas treatment penetrates all porous materials and kills every known microorganism. Gamma radiation, meanwhile, makes use of a highly penetrative radioisotope emission and is often used to sterilize the surfaces of disposable medical equipment.

Once the product itself is sterilized, it’s important to make sure the packaging will preserve that sterility by protecting against damage, contamination, moisture, toxins, and the growth of microorganisms. Two of the most common packages for medical devices are pouches and trays, the latter of which have a longer lead-time due to the custom equipment required to make them.

Sealed packages must undergo packaging validation and sterilization validation to increase the shelf life of the product. Though this can be time-consuming, proper medical package design is critical, as it ensures safe and proper functionality for the customer.

While many companies use a two-part process to complete manufacturing and packaging, Hammill is proud to be a one-stop shop, supplying both sterile instruments and the sterile packaging needed for shipping. From beginning concept through manufacturing and final delivery, we ensure our customers receive high-quality products quickly and efficiently — at an affordable price.

If you’d like to learn more about the sterilization processes we use here at Hammill or are interested in discussing a future project, contact us today and one of our staff members will be in touch. And, as always, don’t forget to connect with us by following our blog, Twitter, and LinkedIn, where we’ll help you stay up to date with the latest news in this ever-changing industry.

The Best Fitness Exercises for Your Back & Spine

The drive for fitness seems stronger today than ever before. Maybe it has something to do with the new world we live in – with so many jobs becoming increasingly sedentary; we need to get our movement in through other avenues. Some of it most certainly comes from the fact that now more than ever we are cognizant of what low rates of activity and lack of movement can lead to down the line, with rates of heart disease and diabetes being worse than ever before.

Not all exercises are created equal though, and some of the more popular ones may actually be more risky for your back and spine than you may realize. The good news is that there are plenty of exercises that promotes flexibility and stability of your spine. Like an old western, there’s good, there’s bad, and there’s ugly:

  • The Good: These exercises strengthen and promote spinal health and stability, and also can help prevent later injury. Pilates training helps to teach your body how to move and support your spine, not just during training, but during everyday activity. Your body learns to support the loads caused by movement and can reduce lower back pain.
  • Yoga can help to provide core strength and flexibility in your trunk, while balance exercises strengthen body awareness, reducing risk of falls that could lead to back injury. And while you may be tired of hearing about them, planks are popular for a reason – by engaging and strengthening your core and abs, your back will have the support it needs.
  • The Bad: Old-school sit-up have fallen out of favor, while they can strengthen the core, the form can put too much pressure on the neck and upper spine. Done properly, using only your abs and core, they can still be effective. Squats, while great for your legs and lower body, are dangerous if you try to squat too much weight. With perfect form, they are great exercises, so start out light and get your technique right.
  • The Ugly: Unless you have perfect technique every time, heavy overhead lifts are incredibly risky. The moment you arch your lower back, there is heavy compression being placed on the vertebrae, risking vertebrae fractures. One of the most-used machines in the gym may also be one of the worst for your back – according to Dr. Mary Ann Wilmarth, the posture used in the incline leg press puts your back in an awkward, flexed position, and of all the leg machines, it has the highest risk for a tear or long-term back injury.

If you choose some of the exercises that may cause damage to your spine and back, it could lead to the need for surgery, which is where we here at Hammill Medical come in. At Hammill, we are a family owned and operated company that specializes in orthopedic implants, spinal implants, and surgical instruments. We don’t just create stock products either – with dedicated prototype manufacturing, in-house design and engineering, and the ability to develop complex, multi-component instruments, we can be the answer for all spinal and orthopedic repair needs.

Contact us today for a quote or more information on our capabilities. If you are interested in keeping up with what we do, and the latest developments at Hammill, follow us on Twitter or LinkedIn, and make sure to visit our blog often.

Hammill Medical Meets FDA Registered Requirements

Because we manufacture medical devices and surgical instruments, Hammill works under more stringent rules than other types of manufacturing operations. The quality standards we uphold are designed to ensure proper manufacturing as well as to meet standards designated by industry and federal regulations. The main accreditations for medical device companies are set by the U.S. Food and Drug Administration and the ISO. Meeting the requirements set forth by these organizations shows the company’s commitment to optimal manufacturing processes. The basics of the regulations and standards are as follows:

  • The FDA requires all businesses that produce or distribute medical devices in the U.S. to be registered. This establishment registration is designed to get safe and effective medical devices to market quickly as well as ensuring that current devices remain safe and effective. Devices are subject to such areas as premarket notification and approval, medical device labeling, quality system regulation, and post-market studies and tracking.
  • The leading standards organization ISO develops global guidelines for manufacturers to follow to ensure that quality standards are being met. For medical device manufacturers, ISO 13485 is the highest quality management system standard. Once certified by a third party, a medical device company is proven to consistently meet the requirements for regulatory purposes.

How does Hammill Medical ensure safety within our organization and products?  With safety training, good manufacturing practices, and following the mandates set forth by these organizations! We are registered with the FDA as a contract manufacturer of medical devices and have recently received our recertification registration for ISO 13485 accreditation. These requirements are in place to keep businesses adhering to best practices. Being aware of regulations—and abiding by them—keeps our products, and those using them, safe year round.

For more information on our medical device manufacturing and industry updates follow our accounts on our monthly blog, Twitter and LinkedIn!

Hammill Medical Looks Forward to 2017

Here at Hammill Medical we are anticipating a very busy and exciting 2017. As experts in orthopedic and spinal implants, surgical instruments, and prototype manufacturing and product development, we understand the growing need for medical equipment across the U.S. and worldwide. With the turn of the new year, there is news that the Food and Drug Administration (FDA), will lessen its extreme grip, making it manageable for industry leaders to get approval. This will enable companies to become more innovative in the field.

As technology advances, so do the many components that make up products such as trauma hip systems, surgical instruments, spinal plates, and much more. We understand the growing need for components that work and how these pieces can help to build the perfect solution for many patients. Whether a professional baseball player is looking to get back into the game after an injury or a retired person is looking for a better quality of life, we offer products that truly impact lives. At Hammill Medical, we understand the many facets of these products and how they can be designed for maximum functionality. We offer design technology from customer concept to in-house design and manufacturing engineering.

Our 90,000 sq. ft. facility offers state of the art manufacturing here in the U.S. We are proud to be ISO 13485 certified and are registered with the FDA. With over 100 employees, we are able to bring your new products to market efficiently, all while staying within budget. Our quality control resources mean customers get a quality product each and every time.

All of us at Hammill Medical are looking forward to the new designing and manufacturing advancements in the new year. We are also committed to ensuring the highest level of customer service for all our customers, new and old alike. We are following all the latest trends and advancement and would love to share that information with our customers. To find out more, follow us on our blog, on Twitter, and on LinkedIn. From all of us here at Hammill Medical, we wish you a Happy New Year!

Our End-of-Year Recap: Looking Back on 2016

We can hardly believe it, but it’s almost time to say goodbye to 2016. Throughout the past year, we’ve had the chance to explore rapidly evolving additive manufacturing technology and relay exciting medical industry news in our blog. Before heading home for the holidays, we wanted to take a look back at a few of the year’s biggest accomplishments.

In 2016, our team explored two kinds of implantable technologies: high-tech welding and orthopedic PEEK implants. High-tech welding — a complex structural laser process — is an all-encompassing technology that takes implantable components from assembly to function verification and finally through cleaning and passivation before shipment. By using high-tech welding to melt components into tighter joints, we’ve been able to create safer spinal implants for patients.

PEEK implants are comprised of the organic polymer thermoplastic, polyether ether ketone — a material with mechanical properties similar to human bones. Featuring tiny pits on the surface, these flexible implants improve biocompatibility and encourage new bone cell growth in orthopedic and spinal patients. By incorporating these state-of-the-art technologies into our manufacturing processes, the Hammill team continues to work toward our ultimate goal of restoring patients’ quality of life.

This past year, we also studied how professional sports can affect athletes’ health over time. We analyzed MLB pitchers and catchers frequent elbow and shoulder injuries, specific warm-up routines to reduce injuries in youth FIFA programs, and new NFL helmet rules to minimize head, neck, and spinal injuries. Our team has worked closely with doctors and researchers to study these issues and design customized solutions for professional athletes and everyday patients alike.

Finally, in a push to give back to the industry we love, we proudly celebrated this year’s National Manufacturing Day (MFG Day). On this day — and other every day — we aim to revitalize the industry’s outdated reputation by educating the public on cutting-edge technology and exciting career opportunities. The sophisticated medical device laboratory here at Hammill is a perfect example of just how far modern-day manufacturing has come from the dirty shop floors of the past.

We would like to thank all of our customers for helping to make 2016 such an exciting, productive year, and we look forward to kicking off a successful 2017 together. From all of us at Hammill, happy holidays, and have a safe and healthy new year!

The medical world never sleeps! Continue to follow us on Twitter and LinkedIn for the latest updates in the company and within our industry!

Annual Checkup on the Medical Device Industry

The technologies making up the medical device industry are March 2016 Blog Imageevolving rapidly. The Senate just passed a group of bills in an effort to speed up medical device approvals by the FDA. With the suspension of the medical device tax, the industry is set for immediate expansion and growth in developing new devices, processes, and tools.

Opening up legislation to improve development and deployment of innovative ideas can lead to better healthcare and well-being. Futurist and innovator Ray Kurzweil recently presented a talk on the future of healthcare at MD&W West in Anaheim, CA. He is the inventor of many advances such as optical character recognition and text-to-speech synthesis that enables a computer to read a book aloud, alongside the first charge-coupled device flatbed scanner. At age 14 he wrote a paper about his theory of the neocortex, a part of the brain that is involved in higher functions. His correspondence with MIT professor Marvin Minsky led to a mentorship and the study of computer science.

Kurzweil continues to write about technology and its impact on our future. He believes that the sequencing of the human genome has transitioned the practice of medicine into an information technology and it will follow a growth curve that is similar to other technology sectors. Genome information is leading to research into gene manipulation, turning them on and off, to influence biology and change how the body works.

Combining DNA and nanobots are the latest in cutting-edge mechanisms for curing diseases. Reminding us a little of sci-fi classic Fantastic Voyage, nanobots are undergoing human tests to see if they can target cancer cells to deliver drugs directly. If this advancement is successful nanobots may be able to cure disease and keep the body in proper balance, reversing aging and give us longer lives.

Curing disease is the basis of all medicine and new efforts are being developed each day. The scientists, researchers, and futurists, like Kurzweil, will be bringing us original ideas and resolutions beyond anything we currently know or have in the field. Continue to follow our blog for recent developments in medical manufacturing. We will keep you up to date on the latest innovations and solutions impacting the industry today.