by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Competitive Edge for Start Up and Small MedDevices

Genesis Plastics Welding Medical Manufacturing

 

Did you know that there are an estimated 6,500 medical device companies in the United States? However, 80% percent of those companies consist of fewer than 50 employees. The large OEMs make up the bulk of the 2 million MedDevice manufacturing jobs nationally. Did you ever wonder how start-ups and small MedDevice companies can remain competitive? They depend highly on collaborative partners to help them innovate and get their products from R&D to market.

Innovation Fuels Medical Device Manufacturing

We know that innovation fuels MedDevice, and a skilled collaborative partner can mean everything in getting products to market quickly and efficiently. Genesis Plastics Welding is proud to support numerous U.S. medical device OEMs, from start-up to large enterprises, with the contract manufacturing of specialty thermoplastic devices that depend on radio frequency welding for durable and leak-proof seams. We value all our clients, but we know for start-ups and small OEMs, we’re indispensable.

Comprehensive Solutions for MedDevice Manufacturing

Genesis Plastics Welding provides comprehensive solutions for medical device manufacturing, from start-ups to large OEMs. As a leading innovator in the plastics welding industry, our team is led by experienced manufacturing professionals that are dedicated to providing the best quality product and the highest level of service.

Why Genesis Plastics Welding R&D Services:

  • Strong project management services
  • Individualized attention
  • Guidance for design for manufacturability
  • A strong quality management system
  • Material selection guidance
  • Solutions for your pain points
  • Supplier collaboration
  • Rapid prototyping

Why Genesis Plastics Welding Contract Manufacturing:

  • Diverse heat sealing capabilities for flexible thin plastics
  • Highly responsive custom service
  • Commitment to quality
  • FDA registered and ISO 13485 certified
  • Supply chain management
  • Meets government contract standards
  • Dedicated to on-time delivery
  • Cleanroom manufacturing capabilities
  • Kitting, assembly, and packaging capabilities

Whether utilizing our R&D or contract manufacturing services, the relationship with our clients is the focal point for our entire team. Our collaborative approach begins with understanding your business needs. From there, it’s all about bringing your innovative ideas to market with an eye on quality, profitability, and sustainability.

Explore Radio Frequency Welded Products Manufactured at Genesis Plastics Welding

Testimonials

We’re always interested in new projects, big or small. Get in touch and let’s chat about your project.

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Medical device industry anticipates growth, workforce challenges ahead

Recently the Indiana Medical Device Manufacturers Council’s Executive Director Kathy Heuer sat down with the Greater Fort Wayne Business Weekly to discuss Indiana’s $10 billion medical device industry, including growth, innovation and the workforce challenges ahead. Currently, Indiana is the fourth largest manufacturer of medical devices in the United States, with the average medical device worker bringing home $69,000 in wages.

Northeast Indiana’s medical device industry followed the global industry on an ongoing trajectory of growth in 2016

As the year winds to an end, the industry is hopeful that favorable legislation will pass under a new presidential administration, opening the door for a renewed focus on innovation and growth. Renewed focus on innovation This year was one for renewed focus on innovation in the medical device industry, according to Kathy Heuer, executive director of the Indiana Medical Device Manufacturers Council. A two-year suspension of the 2.3 percent medical device tax went into effect this year. The tax was crippling to some of the region’s smaller and mid-sized businesses, Heuer said.

“Once the suspension went into place, businesses were able to focus on renewed research and development, were able to take a new look at projects that had been shelved for two years due to the uncertainty of the tax, and saw a resurgence in new business, resulting in expanded employment,” she said.

Heuer said the industry is hopeful that it will see a full repeal of the tax with the new Congress. Full repeal would remove uncertainty and create an environment that is conducive to innovation and growth, she said.

At Zimmer Biomet in Warsaw, the savings from the tax suspension is allowing the company to reinvigorate new and existing research and development projects that will improve musculoskeletal healthcare, Monica Kendrick, a Zimmer Biomet spokeswoman, said in an emailed statement to Greater Fort Wayne Business Weekly.

“Permanent repeal of the tax would allow our company to move forward confidently with longer-term reinvestments, much of which would be focused on R&D projects within Indiana,” according to the statement. “Unless it is permanently repealed, the medical device excise tax threatens to slow the pace of U.S. medical innovation and undermine the global competitiveness of the medical device industry, including Indiana’s medical device companies.”

3-D solutions

Part of the renewed focus on innovation are advancements in 3-D printing and imaging, allowing more efficient, cost-effective and catered joint replacement and repair solutions.

Using only a patient’s X-rays, CT scans or MRIs, medical device companies can plan out what surgical tools are needed and better assist the surgeon in choosing what implant is best for that particular patient’s surgery. In many cases, the images allow the surgeon and orthopedic companies to work together to create personalized guides for that specific surgeon and patient. This cuts down on procedure times and the amount of tools a surgeon needs in the operating room.

Zimmer Biomet’s Efficient Care program uses the majority of its 3-D printing of surgical guides for knee, hip and dental procedures. Once a surgeon decides to use Efficient Care, Zimmer Biomet connects with the radiology centers the surgeon is using for that specific patient’s case to gain access to the patient’s images. These images are then used to provide accurate measurements so the surgeon can choose the implants and instruments that will best fit the patient. It is at this point that the Efficient Care team, if applicable, will 3-D print surgical guides that are personalized for the surgeon and the patient.

DePuy Synthes’ TruMatch is a similar program that, along with knee and hip surgeries, is used for procedures on the neck, face and skull. TruMatch uses CT scans to create a 3-D image of what will become the patient’s operation site, and then uses the surgeon’s surgical preferences and the patient’s individual needs to create the necessary tools for the surgery. This technology also allows the surgeon to choose the proper implant for that specific patient. All of this happens within three to four weeks.

“It’s a win for the surgeon because instead of making decisions in the operating theater, they can make decisions before the surgery,” said Scott Zellner, senior director of U.S. joint reconstruction marketing for DePuy Synthes, which is based in Warsaw. “We can bring in one to two instruments rather than seven.”

Beyond human care

The medical device industry is also making strides in veterinary orthopedic solutions to meet an increased demand for veterinary services.

This year, Warsaw welcomed Owl Manor Medical LLC to its medical device cluster. The company is developing and globally commercializing products that support both animal and human health interests. Its animal health division, Owl Manor Veterinary, is currently focused on point-of-care regenerative medicine technologies, which are targeted toward the canine and equine markets for the treatment of joint, soft tissue and wound related conditions.

After seeing the success of different platelet concentrations and bone marrow solutions for joint and soft tissue in humans over the course of 15 years, the founders of Owl Manor saw the potential for similar products in the animal world.

CEO Mark Schindel and Owl Manor COO Mike Leach spent time in the orthopedic world of humans at Biomet and Zimmer and have since transferred their skills to animal orthopedic solutions.

The company’s products use an animal’s blood and cells to create solutions. For example, one joint medicine uses the animal’s own white blood cells and reprograms them to act as anti-inflammatory proteins, called interleukin 1 receptor antagonist proteins. Afterwards, the blood is reinjected and keeps the animal’s joints uninflamed and regenerates cartilage for up to a year.

Value-based healthcare

Over the past year, the federal government launched two major value-based healthcare mandates that base reimbursement more on patient outcomes from procedures rather than the number of procedures and treatments performed.

“For the medical industry, this shift meant that we had to go beyond demonstrating the effectiveness and benefit of our products, and showcase how we helped increase value and care efficiency,” Kendrick said.

The federal initiatives led the company to developing Zimmer Biomet Signature Solutions, a package of clinical services and technologies intended to help hospitals and physician practices conform to value based healthcare models that focus on quality outcomes for patients.

“This offering represents the new face of innovation for the medical device industry, which has traditionally focused on product innovation and implementation,” she said. “However, with the changing healthcare landscape placing new challenges and demands on our customers, we saw an opportunity to take a broader view and create value-driving technologies and services to support the emerging needs of healthcare providers.”

Workforce development

As baby-boomer workers retire, the medical device industry faces a challenge in workforce development.

In Indiana, the industry is focused on developing highly skilled workers ready to fill the jobs that will become available.

“As our med-tech industry features one of the highest wage earning sectors in all manufacturing, paying over 50 percent higher wages than other manufacturing positions in the state, we need to make sure our schools, both secondary and post-secondary, are offering their students the opportunity to qualify for these skilled positions,” Heuer said. “Those challenges are both regional and statewide in their nature, and we have various groups working with our schools to ensure this happens.”

Several medical device manufacturers from northeast Indiana participated in the 2016 Indiana Manufacturing Survey: Roadblocks to Prosperity. The consensus among them was their production employees needed at least a two-year technical degree, as well as some time in advanced manufacturing apprenticeship.

Respondents to the survey considered the state’s labor shortage by far the greatest constraint to growth. Many medical device manufacturers, for example, must continually hire new workers to keep pace with growing global demand for the kind of products they make, and many of them believe they could capture a greater share of their markets more quickly if they were able to accelerate their workforce expansion.

Looking forward

The global orthopedic device market is anticipated to reach $43.1 billion by 2024, according to a report by Grand View Research, a business management consultant. Driving market growth are the increasing adoption of advanced technologies and materials as well as the rising geriatric population.

In 2015, North America captured the largest market share, with 51.4 percent, and is expected to maintain its dominance through 2024, according to the report.

With the passage of the 21st Century Cures Act, Heuer is hopeful that the new year will bring policies that streamline and update regulatory processes so that patients can get more and faster access to new innovations.

“Fortunately, there are those in Congress who recognize that the agencies that regulate our industry have been underfunded and under stimulated to help patients by streamlining their processes to help give patients more and faster access to new life-changing, and sometimes life-saving innovations,” she said.

It can currently take years to get new products to market, Heuer said.

“FDA is already leading the charge in setting up policies to streamline and update their regulatory processes, and the results from passing the 21st Century Cures Act will allow more patients better access to these innovations, so we hope to see more people leading fuller and longer lives,” she said.

Full article originally appeared here: http://www.fwbusiness.com/business/latest/businessweekly/article_57f03c49-1005-5a50-ad9f-fca6cf8ae0ea.html

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2017 Contract Manufacturing Outlook

Tom Ryder, Genesis Plastics WeldingLike I’ve said in previous years, there is just something about the start of a new year – a fresh beginning, renewed enthusiasm and a dose of optimism in the air. Okay maybe in Indiana, that’s a subzero winter chill in the air, but it’s still one of my favorite times, and the 2017 contract manufacturing outlook is looking fantastic.
After the 2016 we’ve all endured – tumultuous at times and way too much political speak – we could use a dose of optimism and the promise of new possibilities.
I may be crystal ball gazing, but as I think about the next twelve months, I’m filled with anticipation at what the year will bring for the industries Genesis Plastics Welding serves – medical, military, agriculture and others. I think many are ripe for growth, notably the medical device industry. As the world continues to evolve and advance technologies, there will be even more opportunities for our team to bridge the manufacturing gap, provide solutions and bring value to the table for global clients. It’s a thrilling time, and we are proud to be primed to meet the demand for contract manufacturing expertise.

2017 Medical Contract Manufacturing

Let’s talk medical device manufacturing in 2017. New medical device product development is exploding. Many will be able to continue to innovative and thrive, but will need partners with manufacturing expertise to help them take concepts to market. With the medical device tax postponed and potentially repealed, companies large and small, will continue to race to take advantage and be the first to market with their concepts. However, due to downsized research and development departments from previous budget cuts, collaborative manufacturing partnerships will be key.
Additionally, the entire manufacturing community will keep a watchful eye on how our incoming President continues works to cultivate better opportunities for domestic manufacturing.

There has been much talk about what makes our nation great. In this manufacturer’s humble opinion, we’ve always been great, and we’ll continue to be for years to come, but at our core, it is our ability to innovate, to challenge ourselves and to continually evolve that fuels our nation’s intensity. From breakthrough pharmaceuticals to Internet of Things (smart devices) based technologies interwoven into all facets of our daily life, innovation is all around us. It’s exhilarating. An area of innovation that most excites me, in regards to our bright future, is the film industry. Numerous cutting edge thermoplastic materials are on the cusp of being released, and will allow OEMS worldwide even more options for product development, improvement and enhancement.
The Genesis team stands ready to leverage our three decades of RF welding and manufacturing expertise and be the collaborative partner that is essential for our global clients’ success in today’s market. We’re confident that 2017 is going to be amazing, not only for our team, but for our prospects, clients and industry partners as well.
Hello, 2017, let’s do this!

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team No Comments

Three Undeniable Reasons Why Genesis Plastics Welding

There is no doubt that multiple avenues exist for the contract manufacture of medical devices and radio frequency welded components. After all, competition is an important aspect of the quoting process for sourcing and procurement teams. It is key in pinpointing a single or dual source at the best price and quality, that also meets all outlined product specifications.

However, did you know competition also drives innovation and motivates organizations just like Genesis Plastics Welding to be leaders within their industries? It is a driving force that inspires us to think innovatively, focus on quality and customer satisfaction, know our customers better than anyone else and continuously seek improvement.

Here are three undeniable reasons why Genesis Plastics Welding should be your medical device contract manufacturer of choice:

  1. Nearly three decades of radio frequency welding (rf welding) expertise along with comprehensive medical device outsourcing solutions from initial concept to low or high volume production.
  2. Unmatched technical expertise in the art and science of thermoplastics heat sealing of polar and non-polar plastics, including specialty materials.
  3. As a true collaborative partner, we pride ourselves on assisting medical device manufacturing clients in the nurture of innovation with an eye on overall business goals, even if that means helping shift production outside our Indiana facility as volumes climb.
Genesis Plastics Welding: Your Medical Device Manufacturer of Choice

We understand that as a sourcing team you need to explore all avenues, but we remain confident that if you are in search of the authority on radio frequency welding and an industry leader in the manufacture of heat sealed medical devices all paths will lead to Genesis Plastics Welding.

Check out those three undeniable reasons one more time, and let’s get started. Send us your request for a quote. Schedule a visit and see us in action. Either way, simply put, Genesis Plastics Welding is your medical device contract manufacturing answer.

 

Blog Author: Jason Spoolstra, Sales Engineer