Tag Archives: medical device manufacturing

The Value of Medical Manufacturing Apprenticeship Programs

As technology evolves, operator skill sets must evolve and adapt to industry changes. Often times, staying on top of the curve can be difficult.

With a rapidly changing industry, it becomes increasingly dynamic to grow and maintain a qualified workforce that succeeds in the market. In 2016, nearly half (40%) of 42,000 global employers surveyed reported talent shortages also known industry-wide as a skills gap.

Employee training apprentice

Mentoring a Manufacturing Apprentice

As a result, manufacturers are crafting in-house apprenticeship programs to help bridge the skills gap and STEM education. Between 2013 and 2017, there was a 42% growth in apprenticeships across the nation, as per the United States Department of Labor. In the 2017 fiscal year alone, over 190,000 Americans entered into apprenticeship programs.

For employers, in-house apprenticeships can create a pipeline of workers with the necessary skillsets. Each manufacturer can target the specific skills needed for their positions in the apprenticeship program and workers have time to comprehend them over the course of the program.

At the apprenticeship program’s end, a credential is given to the worker to certify their occupational ability. By this point the apprentice knows the latest tools, technologies, and analytics from a firsthand source.

Manufacturing apprenticeships provide a long-term solution to talent issues. At Hammill Medical, we have a 4-year apprenticeship program established in 1955. The apprenticeship provides a valuable opportunity to learn a trade. Our program, in affiliation with the National Tooling and Machining Association, gives participants needed work experience and simultaneously covers class credits.

We evaluate participants every 90 days. You need 5,000 hours of experience to complete the program and apply course credit. The apprenticeship is company sponsored and can get participants a two year associate’s degree, or students can opt to continue on for a four year college degree.

The Hammill Medical apprenticeship program has 25-30 people enrolled in it at any one time. As we pay for the student investment, participants join our workforce upon program completion. Today, we currently have about 200 employed.

Teaching necessary skills through our in-house apprenticeship program provide great opportunities to those looking to enter a rewarding manufacturing career. It also advances our workforce so that we can continue to manufacture top-quality orthopedic and spinal implants, implantable medical units, and surgical tools.

Contact us today to learn more. Also, keep abreast of the latest industry news by following our blog, Twitter, and LinkedIn.

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.

 

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!

 

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!

The Future Challenges and Opportunities for the Medical Device Industry

One of the biggest questions facing the medical device industry, and the country’s medical device manufacturers, is “what will the future hold?”

Indeed, most of these manufacturers realize there are current and future challenges to be aware of; they also recognize that understanding these challenges will help them navigate the changing landscape and adapt accordingly. Those outside of the industry are also curious as to the coming changes and challenges—they want to know what to expect.

This article on medical device trends points out that while regulatory changes are a large part of today’s business climate—and certainly a major factor for most medical device manufacturers—they are only part of the challenge. It’s important to know what trends are taking place, in order to respond.

The article suggests that four major trends to look out for are:

  • Increased regulation
  • Healthcare provider consolidation
  • An aging population
  • Emerging markets

So what can we expect due to these trends? One thing that many people believe will happen is a changing business model, one that focuses more and more on cost control of components. While historically, the industry has been about innovation, the focus could move more toward cost control, in many ways emulating the evolution of the auto industry. This isn’t to say that innovation won’t be at the forefront, but cost control could be as equally important.

As the device tax has more time to show its effects, and the changing insurance landscape evolves, we may see more of an emphasis on lowering medical manufacturing costs.

Another trend many expect is the move toward all-electronic medical records. It’s already happening—Apple is currently in talks with various healthcare providers to officially roll out their HealthKit service, with the goal of making “healthcare data available for both consumers and healthcare providers to view in one place.”[1] This could present new, unique challenges for providers and device manufacturers, and new opportunities as well.

One thing is certain—the landscape is indeed changing. How we meet the needs and challenges will be interesting to see.

[1] http://www.zdnet.com/apple-in-talks-with-healthcare-professionals-over-healthkit-rollout-7000032537/

Growth in Manufacturing Jobs Continues to Rise Throughout Ohio

Manufacturing in Ohio has seen massive growth and will continue to strengthen in the upcoming years. According to The Columbus Dispatch, 54,000 manufacturing jobs have been added in the state of Ohio in the past four years. This figure signals a sense of confidence in manufacturing and will positively impact the state’s economy. The U.S. Bank’s Regional Investment Director Jim Russell states that 17 percent of Ohio’s economy is powered by manufacturing, while the U.S. represents only 12.5 percent of manufacturing.

Due to the increasing confidence and interest in manufacturing from workers and hiring managers, there are various government initiatives to promote employment in the manufacturing field. The Ohio Tax Credit Authority recently approved a number of projects based on tax credits to create thousands of manufacturing jobs in the state of Ohio. According to the Dayton Business Journal, a new auto glass factory is set to open in Ohio that will create approximately 800 new jobs, making up for some lost jobs in the auto industry.

The Cleveland Clinic is also aiding the future of technological employment. According to Qmed, the Cleveland Clinic is responsible for many projects that better the lives of their patients through biomedical engineering, cancer biology, the neurosciences, and other specific areas. The clinic also offers continuing education courses to encourage further development and advancement so that students can learn the proper skills needed for their specific technological field.

Various government initiatives are ongoing nationwide to promote education in science, technology, engineering, and mathematics, or STEM. This education policy is at the forefront when preparing students with the proper skills for a successful career in a manufacturing field. Ohio has their own initiative called Ohio Stem Learning Network that assists in starting up STEM focused schools and programs.

To encourage and promote education and proper skills in manufacturing, Hammill Medical offers a competitive apprenticeship program that has been in place since 1955. The 6,000 hour program is an excellent opportunity for talented individuals to learn in the classroom and on the shop floor. At the end of the program, students will have a thorough education in CNC machining and come away with a journeyman’s card. We will continue to do our part in educating students and promoting manufacturing jobs throughout Ohio.

 

 

A Look At The FDA’S Design Control Regulations

Since the Safe Medical Devices Act of 1990, the Food and Drug Administration (FDA) has had strict regulations for the design of Quality Management System (QMS). Design Control refers to the design of devices, along with processes and changes to existing designs and processes.

The design control requirements of the FDA’s regulations are enforced upon the design of Class II and III medical devices, along with some Class I devices, according to BoneZonePub. As the publication notes, this design control regulation “gives manufacturers just enough rope to hang themselves.” Given the different risks and complexities that come with various medical devices, companies are given the responsibility of deciding the type of design control system and the detailed implementation instructions used for their devices.

BoneZonePub claims that the following get a great deal of attention during inspection:

  • “Design and development planning versus what information ends up in the design history file
  • Identifying design inputs and then the essential outputs
  • Verification work that could eventually end up in the design history file as a formal acceptance activity
  • Validating the design from a standpoint of the intended use and user needs
  • Controlling design changes before and after commercialization
  • Reviewing design results versus the original design plan
  • Transferring the design to production while realizing the value of concurrent engineering
  • Compiling a Design History File as a basis for the Device Master Record”

Medical manufacturers take on tremendous responsibility in creating medical devices. The FDA’s Design Control regulations are one of the efforts made to ensure that medical products are of the best quality.