by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

[In the News] IMDMC Elects Officers

The Indiana Medical Device Manufacturers Council (IMDMC) has elected four to serve as officers on the Executive Board.

Tom Barnett, Director of Government Affairs for Roche Diagnostics, will serve as Board President. Barnett joined Roche Diagnostics in 2000. Previously he had held various roles in marketing and governmental affairs, including leadership positions at Bristol-Myers Squibb.  

“The medical devices sector is one of Indiana’s largest and most valuable economic assets representing more than 150 companies and employing more than 20,000 people. I look forward to leading IMDMC as we continue to do good work serving as an advocate, connector, and resource for Indiana’s medical device companies,” said Barnett. 

Other officers elected are as follows: Tom Ryder, President and CEO for Genesis Plastics Welding, will serve as Vice President; Troy Linder, Chief Financial Officer for Fort Wayne Metals, will serve as Treasurer; and Anne Hathaway, Executive Director for IMDMC, will serve as Secretary. 

The organization works to promote, educate, and advocate for Indiana’s medical device industry to advance the performance of our member firms and to cultivate a business environment in which member companies can flourish. IMDMC member companies produce the medical devices, diagnostic products and health information systems that are transforming patient care and patient safety. IMDMC members range from the largest to the smallest medical device innovators and companies. For more information, visit

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

In This Together | A Note from CEO Tom Ryder

We’re all in this together, and we will continue to fight the good fight here at Genesis Plastics Welding.

During these uncertain times, things can feel topsy-turvy all around us, but everyone has a part of play, preparations are constant and multi-layered; everywhere. We all must do what we can to anticipate and meet the accelerating and dire needs coming down the road.

Essential supplies are still (and will be for a long time) in great need for our hospitals.

As part of America’s critical medical device manufacturing infrastructure, as a medical device contract manufacturer, our country needs the products we produce.

I want you to know that not only are we continuing to produce essential medical device products for current customers, Genesis Plastics Welding also is actively working with Federal and Local Government to see how we can help additionally during this pandemic. Read more

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

2017 IMDMC Annual Conference Takeaways

On November 1, 2017, the Indiana Medical Device Manufacturers Council (IMDMC) held its annual conference. Speakers included Dr. Suzanne Schwartz with the FDA, Rob Lyles, President Cook Regentec and Dr. Ralph Hall from the University of Minnesota. As IMDMC Vice President and Business Development Committee Chair, Genesis Plastics Welding President and CEO, Tom Ryder is proud to be a part of a valuable Indiana organization that is actively providing aid to members through collaboration, education, and advocacy.

The 2017 IMDMC Annual Conference was filled with industry insights and food for thought as the medical device industry continues to grow and innovate. Three main shares from the conference stood out for our Genesis Plastics Welding team.

Read more

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

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.

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

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. Dental Implants in Denver and other locations often make use of this technology, as an example. 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.

For businesses to be able to capture more of their market share, hiring new employees could be vital to their success. By having access to an effective scheduling software, you will be able to create and publish schedules online so that your new employees will be able to see when they are scheduled to work and when they should take their breaks. This should take the pressure off having to think about the hard work that it will entail in growing and developing your workforce.

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: