Genesis Plastics Welding (Fortville, IN) has a proud legacy collaborating with medical device manufacturers to advance innovation. “We have been working with medtech OEMs for more than 20 years,” Genesis President and CEO Tom Ryder told PlasticsToday. “In 2006, roughly 40% of our business resided within the medtech space. Today, we are approximately 85% medtech.” To respond to surging global demand for outsourced design engineering expertise, which it is uniquely positioned to provide, Genesis has introduced MedTech Launch, a division that is “strategically aligned to assist medical device clients in navigating the product launch process, from initial concept to commercialization,” said the company. Design, prototyping, quality management, risk management, regulatory support and overall manufacturability are key elements of the new program, which is led by Nathan Glass, Vice President of Product Development.
Although medical device OEMs of all stripes stand to benefit from the portfolio of services provided by MedTech Launch, startups, which often struggle to source appropriate expertise, may find it to be a particularly valuable resource. "Start-up teams and inventors often come to us with ideas that they are passionate about bringing to market,” notes Glass. “Our services work best when they have a good grasp on the patient or user need and market opportunity exists. Additionally, we help define the cost side of the go-to-market equation, which informs their investors and enables them to make sound business decisions to move the project forward."
Genesis Plastics Welding is exhibiting in booth 763 at the co-located PLASTEC East and Medical Design & Manufacturing (MD&M) East, part of the largest advanced design and manufacturing trade show and conference on the East Coast. The event comes to New York from June 12 to 14, 2018. Register now!
Glass is well qualified to assist in those endeavors. A graduate of Indiana University-Purdue University Indianapolis, Glass has nearly 10 years of project management and engineering experience under his belt. His areas of expertise include design definition, material selection, technical documentation, proof of concept, quality management, validation, design for manufacturability and project management, according to Genesis Plastics Welding.
As the head of the MedTech Launch division, Glass looks forward to “connecting the dots” for medical device OEMs. “Often, a clinician will have clinical requirements, but translating them into engineering requirements and evaluating them against recognized standards is a challenge,” explains Glass. “Similarly a device inventor may have evaluated a prototype against a standard, but making that device manufacturable can be a challenge. We can connect the clinical, regulatory, engineering and manufacturing requirements.”
|Nathan Glass, Vice President of Product Development, MedTech Launch.|
MedTech Launch can also help define cost and market placement factors, which can be a significant stumbling block for startup medtech companies, adds Glass. “Start-up teams often face the catch-22 of investment and cost. It’s challenging to determine the return on investment if you don’t know how much your product will cost,” Glass told PlasticsToday. "Cost is a factor in price, which is a factor in market placement. It can be very challenging for a team to fully commit to a project when there are many unknowns. Product investment and unit costs are big ones, and a value MedTech Launch brings is helping to define those factors."
The introduction of MedTech Launch all boils down to nurturing innovation and bringing its benefits to the marketplace, adds Ryder. “With our longevity as a leading medical device contract manufacturer bridging the innovation gap for OEMs, we’re thrilled to take this next step and support our clients through all phases of the design and development process.”
Genesis Plastics Welding is certified to ISO 13485, the international quality systems standard for medical device manufacturing. The company specializes in radio frequency (RF) welding and heat sealing applications of plastic products. Its proprietary heat sealing technology, ecoGenesis, allows RF plastics welding of very thin gauge—down to 0.001 inches—polyethylene, polypropylene and low-loss polymers and can facilitate PVC and polyurethane replacement with phthalate-free plastics.