Business Fortune
Crafting a medical device that meets regulatory standards and fulfills market demands is paramount for its success. A well-defined and meticulously designed product not only ensures compliance with regulatory requirements but also delivers the intended functionality and benefits as per market needs. In contrast, inadequately designed devices may struggle to gain market acceptance and fail to meet user expectations.
To thrive in the competitive medical device industry, a comprehensive approach to design is essential. From conceptualization to compliance, every stage of the design process demands precision and attention to detail. By integrating regulatory prerequisites into the design process, companies can enhance the value proposition for end-users and secure a competitive edge in the market.
Gilero is one such pioneering company specializing in end-to-end device design, development, and contract manufacturing for the medical and pharmaceutical sectors. With expertise in consumable and reusable medical devices, drug delivery systems, combination products, and complex electromechanical systems, Gilero offers a diverse range of services tailored to meet the unique needs of medical and drug delivery device manufacturers.
Driven by a commitment to innovation and excellence, Gilero continues to expand its manufacturing capabilities and global footprint. Recent growth initiatives include the establishment of a state-of-the-art manufacturing assembly facility in Pittsboro, NC, and the inauguration of design centers in Southern California and Chicago. Additionally, Gilero's strategic expansion efforts extend to international markets, with the opening of a manufacturing facility in Tijuana, Mexico, and the expansion of Medacys – Gilero's joint venture tool-making and medical injection molder in Shenzhen, China.
Medical Device Design and Engineering Made Simple with Robust Strategies
Strategy & Innovation: The design process for any medical device, drug delivery system, or combination product is complex, posing unique challenges and requirements specific to each device. Gilero routinely works with both startups and established companies to identify the best approach for developing and commercializing a new device. As part of this initial strategy, their engineers will work with you to understand requirements, research existing technologies, understand the patent landscape, and look for similar devices on the market. This stage of the process will not include any brainstorming or design, but will provide an opportunity to understand feasibility of the idea and determine a path forward. The company accelerates medtech innovation by helping the medical and pharmaceutical clients get their devices to market. If you have an idea for a medical or drug delivery device, but are unsure of where to begin, let the experts at Gilero help you get started.
Concept Development: With a proven track record of success in product development, Gilero prides its ability to develop an entire medical device from nothing more than a problem statement or napkin sketch. This starts in the concept development phase, where initial ideas are developed into viable concepts. Concept development begins by conducting a number of brainstorming sessions with their cross-functional engineering teams. Rapid iteration of concepts will happen through a series of brainstorming sessions, concept sketches, early CAD, and technical reviews. Each iteration will further refine the concept(s).
Prototyping: The ability to fabricate rapid prototypes in-house helps advance device design and streamline the development process. Gilero facilities have the equipment and capabilities necessary to build prototypes for medical and drug delivery device components. The company can create prototypes that look like and feel like finished products to help shorten the lead time for design iteration while evaluating the form, fit and function of the device. In-house prototyping also provides insight into manufacturing methods and costs, potentially leading to lower production costs and a smoother transition into finished device manufacturing.
Device Design & Engineering: Medical device design and engineering is Gilero's specialty. They employ a team of experts skilled in design engineering and product development that integrate with other disciplines across the company, such as human factors, quality, and manufacturing. The company focuses solely on the medical device and drug delivery markets, allowing them to provide best-in-class design and development services for medical devices, combination products, and electromechanical medical systems.
Testing: Gilero offers a range of testing services for medical devices and drug delivery systems, from early proof of concept through final verification & validation. Their medical device testing services include test method development and validation along with test protocol development, execution and reporting. Gilero can complete most types of testing in their onsite test labs. Their engineers routinely manage physical, biological, electrical, and software testing.
Plastic Injection Molding: 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. Their medical injection molding facilities follow strict design protocols and process controls to ensure that 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.
About | Ted Mosler
Ted Mosler is the Founder and Chief Executive Officer of Gilero. 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.
Mr. Mosler 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.
