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January Special Edition 2022

Gilero – A One-Stop Shop for the Design, Development, and Contract Manufacturing of Drug Delivery Systems

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In the past decade, the relationships between medical device original equipment manufacturers (OEMs) and contract development and manufacturing organizations (CDMOs) have undergone remarkable changes. Continuous pursuit of cost savings and operational efficiencies by medtech-branded manufacturers has increased demand for third-party services. As demand for outsourced development and manufacturing services has extended to high value-add segments of the medical device supply chain; OEMs’ vendor selection criteria have become more stringent. In response to the greater standards of quality, price competitiveness, scalability, and technological competencies demanded by customers, contract manufacturers have become larger, more technically advanced, and more vertically integrated.

Gilero is one such firm that offers contract design, development and manufacturing services for electromechanical medical devices, consumable medical devices, drug delivery systems and combination products. Skilled engineering teams, including dedicated mechanical and electrical engineers focused on design, product development, quality, and manufacturing, allow them to service medtech customers around the world. Specializing in the areas of consumable and reusable medical devices, drug delivery, combination products and complex electromechanical systems, Gilero offers a wide range of services to meet your medical or drug delivery device needs.

Designing and Developing State-of-the-Art Drug Delivery Solutions

Medical Device Testing: Gilero provides a wide range of testing services for medical and drug delivery devices, from early proof of concept testing all the way through final design verification & validation. Its testing services include test method development and validation along with test protocol development, execution and reporting. Gilero can execute most types of medical device testing in its onsite test labs, including physical, biological, electrical, and software testing. Building upon early design concepts and engineering evaluations, Gilero can identify and execute the necessary early-stage testing of a medical device concept to prove feasibility.

Quality & Regulatory Consulting: Understanding the regulatory pathway for a new medical or drug delivery device can be confusing. Gilero’s in-house experts can provide guidance and recommendations for classifying your product, while considering the intended use, technology, regulatory landscape and commercialization strategy. With this assessment in hand, the output of the design and development process provides a complete package for regulatory submissions and transfer into commercial production.

Plastic Injection Molding: Plastic injection molding is a critical piece of the manufacturing process for many medical devices. Gilero provides a range of manufacturing services, including plastic injection molding and injection mold tool building.  They focus solely on the medical device and drug delivery markets and have a deep understanding of the injection molding processes needed to get these devices to market. Its plastic injection molding services include molding, tooling, assembly, and quality management. Strict design protocols and process controls are followed to ensure all products meet the required specifications. Depending on client needs and product requirements, they can offer manual or fully automated production lines for molding and assembly. Gilero is ISO 13485 certified and follows Current Good Manufacturing Practices (cGMP).

Gilero Ventures: Gilero Ventures allows us to partner with customers whose values and vision align with theirs. The company partners with startups, doctors, inventors, universities and hospitals to design and develop their medical device projects, and help bring products to market that may not have had the funding or capabilities to get there otherwise. These partnerships bring additional value to all of their customers, both large and small, by putting more medical device and drug delivery/combination products in the position to be brought to market and/or acquired by larger companies.

The Valiant Leader Upfront

Ted Mosler is the founder and Chief Executive Officer of Gilero. He is also a founder and board member of medical device company Yukon Medical, and a founder and principal at Infield Medical, a medical device accelerator. An inventor of over 75 issued US patents; Ted has led the successful design and commercialization of multiple products on the market today. These include devices used in drug access and delivery, blood collection, needle safety, minimally invasive surgery, urology and ophthalmology, among others. Ted has been recognized by his peers for his contributions to design, entrepreneurship, and leadership as the recipient of several awards, including: Medical Design Excellence Awards in 2003 and 2014, Medical Device & Diagnostic Industry’s 100 Notable in 2004, Business Leader Media’s Top 50 Catalyst Entrepreneur in 2011, and Business Journal’s 40 Under 40 Leadership Award in 2014. Previous employers include Alaris Medical Systems (now Becton Dickinson) and Bionix where Ted held senior roles in design and product development engineering.

Ted holds a BS in Mechanical Engineering from the University of Toledo and an MBA with a concentration in Technology Commercialization from North Carolina State University. Married, and the father of four children, Ted enjoys spending free time with his family, listening to music, and taking on the occasional home construction project.

“Gilero takes a holistic approach to the design and development of complex medical and drug delivery devices. Technical, usability, regulatory, and business requirements are considered from day one in our process.”