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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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[In the News] Growth Within Radial Compression Devices Market

The use of radial compression devices within the healthcare setting is rapidly rising in the United States and the United Kingdom. In North America traditional femoral artery access is still the used more often, but due to lower bleeding and lower site complications, radial access is growing considerably.

In the UK, more than 75% of percutaneous coronary intervention (PCI, formerly known as angioplasty with stent) are administered through radial access. The paralleled rise in the occurrence of radial artery occlusion may be playing a factor in the increased demand for radial compression. Experts also note a desire to adopt procedures and proven innovative devices that help bring about positive patient experiences, medical savings, and shorter hospital stays.

To read more about how radial compression devices are gaining traction and will grow to a $330 million market in the U.S. by the end of 2026, click here.

Working on developing an innovative radial compression device? Genesis Plastics Welding is a proven outsourced manufacturing partner who can help you navigate the essentials of development and production of compression devices.

radial compression devices button

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[In the News] Biobag Acts as an Artificial ‘Plastic Bag’ Womb

Biobag acts as a womb to support development of a premature lamb.

There are many new awe-inspiring medical device products currently in research and development across the global. One that has us saying “Wow” and taking note is an impressive “biobag” that acts as an artificial womb. Scientists have been able to keep premature lambs alive for weeks using this specialized RF welded medical device plastic bag womb.

Once proven through clinical trials, this device has the potential to help support premature infants and increase their chance of survival. It’s truly a groundbreaking new device, as well as, a mission-critical device that greatly benefits from RF welding for high integrity durable seams.

To read more on this cutting-edge medical device fluid bag and to see it in action, click here .

Developing a fluid bag? Be sure to download our free Fluid Bags Validation Checklist and leverage the knowledge and experience of an outsourced manufacturing partner who can help you navigate the essential elements related to successful product design, production, and quality.

 

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Being a Voice for Indiana MedDevice

Did you know the United States accounts for 40 percent of the global Medtech market and has a positive medical device trade balance of $5.48 billion more in exports than imports? Moreover, we’re a world leader in the development of advanced medical technology innovation that is driving economic opportunity and job creation. Indiana MedDevice is a big part of that growth.

The Hoosier state accounts for 54,800 Medtech jobs, with average wages starting at $58,000. Not too shabby.

AdvaMed Fly In

Earlier this month, I was honored to participate alongside IMDMC, Medtronic, Zimmer Biomet, Cook Medical, Johnson & Johnson, Boston Scientific and Roche in AdvaMed’s Fly In, which included informative legislative briefings and several congressional visits.

As my first true adventure on Capitol Hill, it was a whirlwind! It happened to be one of the most active weeks in D.C. A bit like drinking out of a firehose, but I’m glad I was able to participate and be a voice for Indiana MedDevice and the Indiana Medical Device Manufacturers Council (IMDMC). We chatted MedTech jobs, fair trade, regulatory, compliance, innovation and tax reform. Yes, the 2.3% Medical Device Tax was discussed frequently, as was the Medical Device User Fee Agreement (MDUFA), which is a bit of a mouthful of an acronym to get out, and yes I butchered it a few times.

For those unfamiliar with MDUFA, it allows the FDA the authority to collect user fees from the medical device industry to support review activities. Under the recent MDUFA reauthorization agreement, the industry will invest additional resources and the FDA will return for meaningful performance goals to improve the efficiency, predictability and transparency of the agency’s review process. These process improvements translate into more timely patient access to life-changing medical technologies.

Bringing Awareness to Indiana MedDevice and Medtech Issues

I enjoyed being able to listen, learn and advocate for Indiana MedDevice. Additionally, I gained a true appreciation for our legislators and their staff. They have tremendously busy schedules and work long hours. They’re constantly pulled in multiple directions, all while trying to go about the work of the government and accomplish objectives for their constituents. I’m extremely grateful for the time each took to sit and discuss important Medtech and MedDevice issues with us.

My additional takeaways from my Capitol Hill adventure include:

  • A great appreciation for the IMDMC’s Executive Director Kathy Heuer.
  • An awareness of exactly how much our government affairs partners, companies and agencies do
    to bring to light issues while not stepping on toes. It’s a talent indeed.
  • We’re not alone. So many organizations are walking side by side with us – AdvaMed, Biocom,
    AZBio, BioOhio, Colorado BioScience Association, Georgia Bio, Healthcare Institute of New
    Jersey, iBio, Kentucky Life Sciences Council, Life Sciences Pennsylvania, Medical Alley
    Association, MedTech, MichBio and many more.
  • Our legislators, across both sides of the aisle, enjoy a good discussion.
  • The need for tax reform and regulatory efficiencies is great.


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Innovating Sustainably in MedDevice

The healthcare industry continues to change in dramatic ways. From cutting-edge diagnostic devices to cost-effective disposable home care device solutions, medical device innovation continues to move fast. Today’s manufacturers have much to consider in regards innovative development and remaining competitive within their market. Not only must manufacturers tackle innovating sustainably, they also must be mindful of the movement towards outcome-based patient care.

Genesis Plastics Welding is a proud collaborative outsourcing partner for medical device manufacturers. With solutions from the development phase all the way to mass production, Genesis is helping global OEMs remain profitable and grow their market share one innovative MedDevice product at a time.

Innovative TPU RF Heat Sealed Pressure Sensor Membrane

One such innovative MedDevice product is thermoplastic RF heat sealed pressure sensor membrane that functions within a medical device for smart drainage in traumatic brain injuries and intracranial tumors and infections. A small portion of the overall device, but an integral part allowing for the elimination of constant manual measurements, adjustments, and interventions from the medical staff. The device enhances the patient experience, safety and has the ability to create more positive treatment outcomes.

By partnering with Genesis, the medical device OEM was able to quickly go from an innovative medical device start-up in late 2013 to a growing medical device company achieving milestones with functional prototypes and an eye on commercialization in the coming months.