Human-centered design is core to our process. Gilero conducts market evaluations and user research with target users, which may include focus groups, interviews, observations, contextual inquiry, surveys or participatory design sessions. Formative and summative studies can be performed on-site. By bringing patient and user needs into focus early within the design & development process, we deliver devices that users readily embrace and can be operated safely in real-world conditions.
With a proven track record of product development, we pride ourselves on our ability to develop an entire medical device from nothing more than a problem statement or napkin sketch. Specializing in the areas of drug delivery, minimally invasive surgical tools and electromechanical systems, we can provide a full design package or focus on developing just one component of a medical device or drug delivery product. Our cross-functional teams work together to brainstorm solutions, taking advantage of Gilero’s diverse in-house engineering talent. Most importantly, our clients retain the rights to any novel intellectual property generated through this process.
Our design team provides innovative medical device and packaging design services. Early concepts are translated into engineering design specifications under our Design Control procedures. This stage includes complete Design Controls, including design history files, detailed engineering drawings, component specifications, software & hardware specs, PCBA development, detailed requirements documentation, BOMs, assembly drawings and materials selection. We routinely handle packaging development in parallel to device development, making packaging a standard component of our process.
Gilero has in-house equipment and capabilities to fabricate rapid prototypes, including stereolithography, CNC, FDM, film forming, silicone and injection mold tooling. We can create prototypes that look like and feel like finished products to help advance design while evaluating the form, fit and function of the device. Having the ability to build prototypes and make design iterations in-house helps to streamline and expedite the development process while minimizing risk.
Our team builds upon early prototype iterations and engineering evaluations to create formal test methods and protocols specific to each device. We offer a wide range of testing options in-house. These testing types fall into three main categories: physical & biological (performance, force, flow rate, package integrity, environmental conditioning, biocompatibility, pressure decay, simulated use, etc.), electrical (power, voltage, resistance, current, etc.) and software (integration, regression, performance, etc.). We can also execute standard testing on demand and are always open to developing custom test methods. Ultimately, we will develop a DV&V plan, conduct process validation testing and deliver completed reports for regulatory submissions as part of our testing services.
Our team works to achieve regulatory compliance throughout the design and development process. We offer early regulatory planning consultations to define a clear pathway to regulatory approval. Our team is well-versed in preparing and maintaining DHFs, Design & Process FMEAs, 510(k) submissions, CE technical files and documentation to support NDAs. We identify applicable regulatory requirements, guidance documents and recognized consensus standards to be fulfilled.