ISO 13485 | AS9100
DUAL-CERTIFIED QUALITY SYSTEM
DUAL-CERTIFIED QUALITY SYSTEM
Our dedicated industrial design team brings creativity and expertise to the forefront, transforming concepts into visually striking and functional designs. We emphasize prototyping to bring ideas to life in tangible forms, enabling us to refine and perfect the design before production. Additionally, our human factors evaluations ensure that the final product offers an exceptional user experience that aligns with ergonomic and usability standards.
Explore our other User-Centered Design services
We are driven by creating quality devices that people love
At Nectar, we are a creative group of people who want to design products FOR people. As big believers in sustainability and ethics, our passion for bettering the world drives us. We will work with you to help create the perfect medical device that is safe, will stand out against competitors, flourish in the market, and most importantly – improve people’s lives. Because when clients are happy, we are happy.
See your product come alive with our comprehensive Prototyping process
Within the medical device design process, prototyping is an important step. It produces tangible, functional samples and material specifications that can be used in product testing. This will inform risk analysis and enable critical design changes before commencement of large-scale production distribution.
We have the facilities to aid the prototype production process. We’ve been designing, testing, and commercializing innovative medical devices for over 30 years.
We are leaders in Human Factors Design
Our user centered design process helps keep the focus on all possible end users. Human factors is critical to designing for real people. This involves applying our knowledge about human behavior, abilities, limitations, and characteristics of the end users to the design of the device. This can include physical and digital interactions with a product. Human factors research and testing is a key component to Nectar’s proven design strategy and expertise.
Softgood design is a critical part of product development in the medical industry. Wearable devices are becoming increasingly more commonplace in hospitals and clinical settings. We have the capabilities in-house to create prototypes from a wide variety of materials. We also maintains relationships with top notch material suppliers to ensure that we’re staying up to date with the latest trends and technologies.
Some medical devices may come into contact with skin. In the interest of patient safety, these products must be certified as biocompatibile, which ensures clients will not encounter any harm when they use these products. Nectar assess the biocompatibility of different materials by conducting in-depth testing, identifying any potential adverse reactions resulting from contact of the medical device with the body and whether these associated risks are acceptable. We place the end-users at the forefront of this process, creating safe devices that they love and trust in.
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Darren is an accomplished, dynamic leader who founded Nectar, X-Naut, and BreathDirect. He is committed to improving the world through the synthesis of technology, science, and art. Under Darren’s leadership, Nectar is leveraging the latest advances in cutting-edge technology to transform medical device development and design. As part of his
Stefanie brings over 10 years of experience in regulatory affairs and quality assurance, guiding a wide range of medical devices and pharmaceutical products through complex global requirements. She has successfully managed FDA 483 responses, 510(k) submissions, and audits across U.S., EU, APAC, and LATAM markets. Known for her collaborative and solutions-driven approach, Stefanie helps both startups and established companies navigate evolving regulatory landscapes with creative, compliant strategies.
Bryan Chan is a Senior AI and Software Architect with extensive experience in developing AI-driven medical technologies that are both innovative and compliant with industry standards (ISO 62304). His accomplishments include leading the development of: an AI-powered, contactless remote patient monitoring device with LLM-based voice engagement, a closed-loop insulin pump for Type 2 diabetes using on-body sensors, a motorized smart walker with real-time gait analysis, and an FDA-compliant AI SaMD platform for gastrointestinal disease detection. Bryan excels at defining technical vision, building high-performance teams, and navigating complex regulatory pathways to deliver scalable, market-ready MedTech solutions.
Adam Marten has worked in the aerospace and consumer products industries since 2006 with lead engineering experience in conceptual design, product development, analysis and performance qualification testing. Adam has experience leading a range of technical projects, including multiple structural analyses for military and aerospace applications. He has also worked directly with engineering teams to develop medical devices and laboratory instrumentation.
James is a seasoned professional with over seven years of experience at Nectar, where he brings his expertise in industrial design, user interface, and user experience to the table. With a background in the highly competitive automotive industry, working for heavyweights like Daimler and Tesla, James is a true asset to the Nectar team. He is responsible for ensuring that the company adheres to user-centered design best practices, and he works closely with clients and partners on crucial human factors strategies for FDA submissions and the overall usability engineering process. James’ achievements in this field speak to his exceptional skills and dedication to the work he does.
With over two decades of experience in healthcare innovation, Kerry has been instrumental in transforming patient care and improving patient outcomes across the globe. Her extensive knowledge and expertise in the cardiovascular and cardiothoracic operating room, as well as her experience in emergency medicine, geriatrics, pediatric psychiatry, and main OR, make her a versatile and valuable member of the team. From small hospitals to large teaching institutions, Kerry’s 20 years of experience with patient documentation, including the use of EPIC, Cerner, and Meditech electronic charting systems, have positioned her as a leader in her field. Her recent involvement in helping transition the Providence St. Vincent Medical Center’s Cardiac Surgery program from paper charting to electronic documentation further underscores her commitment to advancing the healthcare industry.
Jonathan is a Human Factors Engineer with a background in psychology and sociology, bringing a unique perspective that bridges human behavior, usability, and inclusive design. Grounded in universal design principles, his work focuses on creating safe, accessible, and intuitive user experiences informed by both qualitative and quantitative research. At Nectar, Jonathan leads the Human Factors team, guiding research and risk management efforts through user testing, field studies, and evidence-based evaluations to ensure that every product decision reflects the real needs of its users.
Jenny is a Human Factors Engineer with a strong foundation in psychology, bringing a research-driven approach to usability, workflow analysis, and user-centered design. She has worked across clinical, consumer, and emerging technology spaces, leading studies that examine cognitive workload, fatigue, task performance, and product interaction to optimize safety and usability. At Nectar, Jenny collaborates with cross-functional teams to translate user needs into actionable design recommendations, supporting risk management, formative evaluations, and usability strategies for regulatory submissions.