ISO 13485:2016
DEVICE DEVELOPMENT

BDR-19™ Critical-Care Ventilator

The BDR-19™ Critical-Care Ventilator is an easy to use, mass produced, full featured critical care ventilator that was created as a response to the global Covid-19 pandemic. It required the Nectar team to dive into an unforeseen remote work environment while navigating tight timelines and extreme supply chain challenges.

The unmet need that hospitals around the country were facing called for ventilators that are both easy to train on and mass producible with easily sourced components, something that would typically take years to develop. Nectar rose to the challenge, delivering an FDA approved ventilator created with locally sourced components within 10 months of the project start date.

BDR-19™ Critical-Care Ventilator

Leveraging Our Resources to Help Patients Breathe Easier

While continuing to develop other projects on schedule, Nectar’s team recognized that lives were being lost as a result of ventilator shortages. With daily interdisciplinary meetings, agile methodology, and a commitment to our company values, we worked with engineers, designers, and clinicians to ensure that these ventilators would be available to save lives as soon as possible.

We leveraged our team’s experience with medical and critical care devices, our existing presence within the supply chain, and our ISO 13485:2016 QMS Certification to take the BDR-19™ Critical-Care Ventilator to hospitals around the world.

 

BDR-19™ Critical-Care Ventilator in desk

Overcoming Unique Production Challenges with Local Resources

Based on challenges many medical device producers were facing, Nectar evaluated the supply chain early in the process; we could see that the pandemic was preventing other ventilator companies from increasing production because they couldn’t get their components through the supply chain.

As a result, our early stage design was based on readily and locally sourced components that we knew we could use for mass production, regardless of border’s closing or international shortages. During a tough economic time, our device has not only saved lives, it’s also been a part of creating California jobs due to our emphasis on local sourcing and production.

Ventilator- medical device formative studies

Undertaking a usability assessment at to guarantee the utmost level of safety.

Prior to launching a medical product into the market, it is crucial to ensure the device is both safe and user-friendly, as inadequate usability can potentially result in loss of life. To collect feedback on the design and validate its ease of use, we conducted a usability study with nurses and respiratory therapists at a partner hospital

The participants in this study were given a short video tutorial on how to operate the device before being given a variety of tasks to complete by the facilitator. This enabled Nectar to test the critical tasks associated with the use of the device and ensure the device was safe and easy to operate without mistakes. After synthesizing the results of the study it was determined that the BDR-19 was safe and easy to use.

using-BDR-19™ Critical-Care Ventilator

The BDR-19™ Critical-Care Ventilator is affordable, mass producible, and simple for clinicians to use.

It’s been designed to offer:

  • Full spectrum ventilatory support for recovering patients and those in the ICU
  • Durable battery life and enhanced portability
  • An easy-to-learn user interface, with all-controls-always-visible (ACAV™) technology
  • Simplified sourcing and affordable pricing, with no proprietary vent circuits necessary

Nectar’s CEO, Darren Saravis, is extremely proud of the Nectar team for pulling together such an efficient, life-saving product at an unheard of pace. As he shared afterwards:

“It’s truly amazing to see what people are capable of when they really need to pull together and make something happen.”

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Darren Saravis

CEO

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

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John Duval

Principal Engineer

John is a true asset to Nectar, having been a founding member and instrumental in shaping the company’s portfolio and establishing its reputation for engineering excellence. With over 30 patents and numerous design awards to his name, John is a master of product architecture and subsystem integration, as well as design for manufacture, mechanisms, and root cause analysis. His passion for creating simple and holistic solutions that take into account a wide range of variables is evident in his work and has made him a valuable member of the Nectar team.

Stefanie Ng

Regulatory & Quality Expert

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

Senior AI and Software Architect

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.

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Adam Marten

Senior Mechanical Engineer

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.

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James Wilkin

Design & Usability Manager

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.

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Belen Quintero

Associate Project Manager

Belen is a project manager at Nectar who brings a wealth of experience and expertise to her role. With a strong background in Mathematics and Philosophy from the University of California, Riverside, she has honed her skills in a variety of industries including healthcare ,education, food manufacturing, and engineering. Belen’ success as a project manager is due in large part to her ability to align projects with business goals, clearly define project needs, lead cross-functional teams, and effectively communicate results to stakeholders. With her proven track record of success, Belen is a valuable asset to the Nectar team and a key player in driving the company’s projects forward.
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Erjon Ameti

Mechatronics Engineer

Erjon Ameti is a highly knowledgeable Mechatronics Engineer with a wealth of experience in both academic settings and startup environments. With a strong background in electronics, robotics, and 3D modeling, he possesses a unique combination of skills that allow him to excel in the fields of automation systems and mechatronics. Over the past five years, Erjon has honed his expertise in product development and industrial automation, emerging as a leading authority in his field. Currently, Erjon works at Nectar as a hardware engineer, where he is responsible for documentation, CAD design, and electronics in general. He has been involved in the entire process of Nectar engineering, bringing his expertise and experience to the forefront of the company’s success.
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Redon Berisha

Electronics Engineer

Redon is a highly skilled engineer with a passion for technology and innovation. He has a background in mechatronics, which has given him a strong foundation in electronics, including electronic design, PCB design, and cable design. Redon excels in the critical components of the design process, including documentation for assemblies, testing, debugging, and ensuring each project is completed to the highest standard. At Nectar, he plays a crucial role in the creation of cutting-edge technology, bringing his unique vision to life and making him a valuable member of the team. With his technical expertise and creative vision, Redon is a leader in the field of electronic design.
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Kerry Eiss

Clinical Expert - RN, BSN, CLNC

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.

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Flaka Brahimi

Marketing Manager

Flaka, a highly skilled professional with a background in Architecture and Spatial Planning from the University of Business and Technology in Pristina, holds a dual role at Nectar as both the Marketing Project Manager and a valuable member of the Business Development team. In her role as Marketing Project Manager, she is responsible for overseeing the development and execution of marketing strategies and as a member of the Business Development team, she actively contributes to the growth of the company by assisting in the creation of impactful marketing tactics. With her diverse background and expertise, Flaka plays a crucial role in ensuring the success of Nectar’s projects.
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Brayton Hammerli

User Experience Designer

Brayton is a multi-disciplinary designer with a A.A in Studio Arts and a B.S in Industrial Design from California State University Long Beach. As a user experience designer, Brayton specializes in usability evaluations, user research, feedback studies, GUI design, mobile app design, human factors evaluations, and formative studies. In his free time, Brayton enjoys outdoor activities such as hiking, mountain biking as well as other creative pursuits. He approaches problems with a solution-focused mindset and enjoys exploring ideas. 
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Toska Ukaj

Scientific Content Writer

Toska Ukaj is a gifted writer who brings a wealth of expertise and passion to Nectar. With a background in medical science and years of experience producing high-quality scientific and medical publications, Toska’s writing skills are unparalleled. She boasts an excellent educational record, advanced interpersonal skills, and a deep passion for healthcare. As Nectar’s writer, Toska consistently produces clear, concise pieces that can be easily understood by the public and truly captures the essence of Nectar’s mission. With her exceptional writing abilities and commitment to healthcare, Toska is an invaluable asset to the Nectar team.
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Jonathan Cantera

Human Factors Engineer

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.

Vesa Hyseni

Purchasing Manager

Vesa is a skilled Purchasing Manager with a strong focus on procurement strategies and vendor management. With a track record of successfully leading procurement teams, Vesa excels in optimizing procurement processes, consistently striking a balance between quality assurance and cost-effectiveness. Her ability to identify cost-saving opportunities and manage supplier relationships effectively makes her an indispensable asset to Nectar.

Uran Çabra

Software Engineer

Uran Çabra, with a background in Mechatronic Systems Engineering, has been working on Embedded Systems, specifically on IoT product development. His responsibilities include firmware development and electronics design and testing. He holds a master’s degree in Electrical Engineering with a focus on Autonomous Mobile Robotics.

Sarah Clark

Industrial Designer

Sarah has a background in fine art & graphic design with a B.S in Industrial Design from California State University Long Beach. As a user experience designer her specialties include: keen aesthetics, creative problem solving, a detail oriented approach to research, and improving user journeys within complex experiences.

Jenny Tran

Human Factors Engineer

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.