Navigating your journey from front-end innovation to regulatory approval
With locations in the United States and Europe, Insight by Nemera is our independent provider of innovative contract design, development, and consulting solutions for drug delivery devices and combination products. We are a world leader in partnering with pharmaceutical companies to deliver innovative and reliable device solutions throughout the development journey. As a dedicated team of over 200 innovation and device development consultants, we possess the critical capabilities and experience necessary to accelerate your combination product’s entry to the market.
At Insight, our purpose is rooted in a passion for improving lives, a collaborative and agile approach, and scientific partnerships that drive innovation. Together, we are shaping the future of healthcare, one breakthrough device and combination product solution at a time.
Passion for Improving Lives
Improving the lives of the patients we serve is at the heart of everything we do. We thrive on solving complex challenges that advance standards of care and well-being. From innovation planning to full development of groundbreaking device solutions, we are dedicated to delivering impactful results that truly make a difference.
Collaborative and Agile Approach
Collaboration and agility are the cornerstones of our development philosophy. We understand that every customer is unique, with specific needs and goals, so we tailor our development approaches accordingly to be standalone or fully integrated. With a singular focus on healthcare, we leverage our unparalleled expertise in drug delivery, diagnostics, and medical devices. Our team is equipped with deep insights from patients, the healthcare landscape, and technology innovation, enabling us to stay ahead of the market and drive better healthcare outcomes.
Scientific Partnerships to Drive Innovation
We firmly believe innovation truly thrives when industry and academic experts come together and leverage each other’s knowledge to advance science. With this in mind, we have built and nurtured relationships with academic organizations, leading universities, scientific bodies as well as key opinion leaders. By forging these partnerships, we gain access to cutting-edge research, novel insights, and emerging technologies that inspire innovation. This ensures we stay at the forefront of advancements in healthcare.
We offer an extensive range of capabilities essential for delivering exceptional outcomes in your program, including:
- Design Research
- Human Factors
- User Experience Design
- Engineering and Prototyping
- Lab and Verification
- Regulatory and Compliance
Below, you’ll find a comprehensive overview of our expertise.
Design Research: Utilizing applied ethnography and concept testing to identify and define opportunities for innovation
Through in-context observation and interviews we gain deep insights into the complex relationships between patients, clinical stakeholders, workflows, and environments. By understanding these dynamics, we translate research learnings into actionable innovation opportunities, user needs, and design requirements. Additionally, we conduct early user-based evaluations to inform concept/ device selection, refinement, and optimization. Our expertise in healthcare enables us to effectively navigate clinical ecosystems, understand the patient experience, identify adoption barriers and drivers, while considering the role of reimbursement.
Human factors: Optimizing usability, meeting regulatory requirements, and reducing risk
Our team follows the most current FDA and ISO usability standards, providing comprehensive support throughout the development process. We establish a solid human factors planning foundation aligned with your regulatory strategy, including expert reviews, use-related analyses, and the characterization and definition of user groups. We also actively support soliciting feedback from the FDA and other regulatory bodies to ensure compliance. By integrating our human factors efforts with design and development activities, we ensure that human factors are appropriately considered at every stage for devices and associated assets such as instructions for use, training programs, and secondary packaging. Our expertise in healthcare extends beyond human factors engineering to encompass a detailed knowledge of the regulatory framework that it operates within which drives our iterative approach to formative usability evaluations to ensure that potential sources of use error are mitigated as early as possible in the design process. We deliver robust output that informs design refinements based on how users might be expected to operate the devices developed for them. We also manage the process of designing and implementing summative usability studies and human factors engineering documentation for use in FDA submissions and regulatory filings.
User Experience Design: Creating optimal user driven product and digital experiences
We believe great design simplifies a complex world. Our team uses unmet needs and new opportunities to drive idea generation for new offerings across the entire patient journey. We utilize iterative and agile design processes to develop physical and digital products that address all aspects of user experience including devices, digital experiences, instructional materials, and packaging. We employ a variety of prototyping tools and techniques to bring new offerings to life in close collaboration with our customers. By incorporating the physical, cognitive, and emotional needs and desires of patients and other stakeholders, we ensure seamless experiences across the treatment administration and longitudinal patient journey. To reduce risk and speed timelines we incorporate core design for manufacturing principles early in the process leveraging our broader expertise at Nemera. The result of this process is innovative, safe, effective, and differentiated products.
Engineering and prototyping: Designing and optimizing systems to meet user and performance requirements
Our team of mechanical, software, and electronics engineers creates, leverages, and adapts technologies that enable exceptional user experiences. This includes technology accelerators based on our extensive experience developing Nemera IP. Early in the development process, we mitigate risk by developing, prototyping, and evaluating core functional engineering within critical subsystems. System solutions are developed under rigorous design controls, with each step driven by well-defined design inputs and specifications. Additionally, we offer agile pre-clinical supply capabilities through our mold-making expertise, enabling us to accelerate our customers’ timelines. Throughout the development journey, we collaborate closely with our manufacturing experts to ensure a seamless transition into industrialization, leveraging our commercial manufacturing expertise.
Lab and Verification: Extensive laboratory and analytical services
We offer comprehensive lab and verification services to support your device development initiatives. Our global lab capabilities can be seamlessly integrated into your program, providing on-demand testing solutions. This includes metrology, material sciences, testing with active ingredients and CT scanning capabilities. From developing fit-for-purpose testing plans and specialized fixtures to conducting method validation and delivering formatted testing results, our experienced team ensures accuracy and efficiency. With our device verification testing reports and in-vitro bioequivalence expertise, we help you meet regulatory requirements for product registration. With cGMP compliant laboratories we can serve as your single partner for testing services across all routes of administration. This will accelerate your device development journey with reliable and precise lab and verification solutions.
Regulatory and Compliance: Navigating your pathway to approval
Our experienced team specializes in strategy, planning, classification, regulations, standards, risk management, and clinical evaluation. With extensive experience in successfully navigating submission procedures across over 54 countries, we cover various drug delivery systems, routes of administration, and state-of-the-art requirements. From regulatory strategy development to preparing submissions, curating regulations, providing regulatory intelligence, and ensuring the reliability and safety of your product through robust risk management and research, our team delivers positive outcomes. With a global reach, we guide you through regulatory registrations, CE marking, and interactions with notified bodies, ensuring compliance with international standards. This expertise allows us to partner with you to unlock regulatory success and bring your combination product to market efficiently.
Mold making and assembly: Accelerating your initial supply requirements
To support device development and pre-clinical, as well as fit-for-purpose clinical supply, we offer comprehensive mold making and assembly services. With in-house tool making capabilities and global asset management, we ensure high-quality standards are met. Our expertise extends to small series cGMP clinical device supply and dedicated tool maintenance facilities. Count on us for streamlined solutions that support your early-stage device requirements and drive development success.
Nemera Innovation labs
With a deep understanding of what it takes to translate technology into commercial success, we partner with top healthcare entrepreneurs and leading university technology programs to help drive innovation and business growth, fuel the momentum of Chicago’s health tech startup ecosystem, and improve people’s lives. From early IP and product concept to the technology scaling and manufacturing phase – we help our member companies close the gap between core technologies and commercializable solutions by leveraging more than 20 years of experience in medical device technology innovation and bringing one of the most experienced development teams in the world to support on each project.