ISO 13485:2016
DEVICE DEVELOPMENT

Revolutionizing Medicine with Combination Drug Delivery Devices

Revolutionizing Medicine with Combination Drug Delivery Devices

Revolutionizing Medicine: Combination Drug Delivery Devices and Compliance with ISO 13485, and Design Control Guidelines, with a Focus on Wearable Innovations

Emerging Trends in Medical Device Development

The medical device development industry has recently seen a surge in interest towards drug delivery combination devices. These innovative technologies, often designed in compliance with ISO 13485 standards for medical devices, represent a groundbreaking approach to medical treatments, extending far beyond traditional drug delivery methods. This surge is fueled by the growing recognition of the benefits these technologies bring in improving patient outcomes and treatment efficiencies. For more details on our development standards, explore our medical product development approach.

Enhancing Drug Delivery Precision and Effectiveness

One of the primary goals of these devices, developed in accordance with ISO 14971 risk management guidelines, is to enhance the precision and effectiveness of drug administration. This precision is especially beneficial for managing chronic conditions and complex diseases, where precision in drug delivery can significantly improve the quality of life for patients. The application of these devices spans a wide range of therapeutic areas, from diabetes management to cancer treatment, each requiring its unique approach and consideration.

Diverse Technologies in Drug Delivery Devices

The spectrum of drug delivery combination devices is broad, encompassing technologies from wearable devices for continuous monitoring to implantable devices for controlled medication release. These versatile solutions cater to a wide range of medical needs, each designed to address specific health challenges effectively. The integration of advanced materials and electronic components in these devices has opened up new possibilities in drug delivery, making treatments more efficient and less invasive.

Innovative Solutions in Inhalation Medication: KOS Pharmaceuticals and Nectar

KOS Pharmaceuticals, now part of Abbott Labs, has emerged as a leader in this field. Their collaboration with Nectar Product Development led to the creation of a breath-coordinated inhaler, an advancement in inhalation medication delivery, developed in line with Design Control Guidelines to ensure effectiveness and safety. This device exemplifies how innovative design can lead to more effective treatment outcomes for respiratory conditions. Discover our award-winning products that showcase our commitment to innovation and quality.

Ensuring Efficacy and Safety: The Role of Testing

The development of sophisticated drug delivery combination devices necessitates a comprehensive testing process that prioritizes both efficacy and safety. At Nectar, our unyielding dedication to excellence in formative and summative testing has been instrumental in not only meeting the rigorous FDA regulations but also establishing elevated standards in the realm of medical product development.

Our commitment to testing goes beyond mere compliance with regulatory requirements; it is rooted in our aspiration to surpass the expectations of both patients and practitioners. Through meticulous testing, we ensure that every device we design and develop is not only in accordance with the necessary regulations but also excels in terms of usability and performance. This unwavering commitment to quality testing serves as a testament to our pursuit of delivering devices that elevate the standards of patient care and treatment outcomes.

Emphasizing Good Manufacturing Practices (GMP) in Device Manufacturing

In manufacturing these innovative devices, strict adherence to Good Manufacturing Practices (GMP) is crucial. GMP is not just about meeting regulatory requirements; it’s about ensuring each device’s highest quality and safety for patient use. Our manufacturing processes are meticulously designed to uphold these standards. This commitment involves thorough quality control checks at every stage, from sourcing raw materials to the final assembly, ensuring every product is made with the utmost care. By adhering to the best practices in the industry, we maintain the integrity and reliability of our medical devices, contributing to the overarching goal of enhancing patient care and treatment outcomes.

Advancements in Wearable Drug Delivery Devices

Wearable drug delivery devices are at the forefront of revolutionizing patient care by offering continuous monitoring and real-time data. These devices, meticulously designed to be compliant with ISO 10993 standards for biocompatibility, are showing immense promise in the management of chronic conditions. They mark a significant advancement in patient-centric care, enabling real-time adjustments in treatment regimens. This not only ensures a more personalized healthcare experience but also empowers patients with greater control and understanding of their health management. By seamlessly integrating into daily life, these wearable devices are transforming the approach to chronic disease management, making it more responsive, effective, and tailored to individual patient needs.

The Role of Data-Driven Insights in Enhancing Device Development

Leveraging data-driven insights, including comprehensive analysis from sources like PDA Technical Reports, plays a pivotal role in the development of drug delivery combination devices. By meticulously analyzing patient data and integrating findings from current industry research, developers are equipped to fine-tune these devices to align precisely with specific patient needs. This approach significantly enhances the overall effectiveness of treatments. Our dedicated team is committed to staying at the forefront of industry advancements, ensuring that our products are not only innovative but also grounded in solid scientific research and evidence. This commitment to research and data analysis allows us to continually refine our products, ensuring they offer the most advanced and effective solutions for patient care.

The Crucial Role of Education in Device Adoption

Education plays a vital and transformative role in facilitating the adoption of these groundbreaking drug delivery combination devices. It involves a two-fold approach: training healthcare professionals and educating patients about the manifold benefits and proper usage of these devices, all developed in strict accordance with regulatory guidelines.

Ensuring the successful implementation of these devices hinges on comprehensive education. Healthcare professionals must be well-versed in device operation, maintenance, and integration into patient care protocols. Equally important is patient education, empowering them with the knowledge they need to effectively use and benefit from these devices as part of their treatment regimen.

At Nectar, our commitment to education and training is unwavering. We understand that well-informed practitioners and patients are the linchpin of successful device adoption. This dedication ensures that both practitioners and patients are thoroughly educated about our products, resulting in enhanced treatment outcomes, increased patient satisfaction, and ultimately, a higher quality of healthcare delivery.

Sustainability in Healthcare Through Innovative Devices

Another critical and noteworthy aspect of these innovative devices lies in their significant contribution to sustainability in the healthcare industry. These devices are engineered to optimize drug delivery, minimizing waste and maximizing the efficiency of treatment. This dual benefit not only enhances patient care but also aligns with the growing emphasis on environmentally friendly healthcare practices.

At Nectar, our commitment to sustainability is ingrained in every facet of our product development cycle. From the initial design phase to the meticulous manufacturing processes and eventual disposal considerations, sustainability is a guiding principle. We recognize that sustainable healthcare not only benefits patients but also reduces the environmental footprint of medical practices. By prioritizing sustainability, we contribute to a greener and more responsible approach to healthcare delivery.

Collaborations Between Pharmaceutical and Medical Device Industries

The future of drug delivery combination devices lies in the collaboration between pharmaceutical and medical device industries. By working together, these sectors can create devices that are both medically effective and technologically advanced, adhering to regulatory standards like ISO 14971 and ISO 13485. These collaborations are essential in pushing the boundaries of what’s possible in medical technology and bringing innovative solutions to market.

Investing in Research and Development

Investment in research and development is the key to unlocking the full potential of drug delivery combination devices. Continuous innovation and exploration of new technologies, guided by PDA Technical Reports and Design Control Guidelines, will pave the way for more advanced and effective treatment methods. Our dedication to R&D is unwavering, as we continuously seek to improve and innovate in every project we undertake.

Staying Ahead with Nectar Product Development

For the latest in innovation and to be a part of this exciting journey, engage with Nectar Product Development. Our commitment to excellence and innovation in medical product development is unwavering, and we invite you to join us in shaping the future of healthcare. Our multidisciplinary team of experts is always ready to tackle new challenges and push the envelope in medical technology.

Connect with Nectar for Future Collaborations

To stay at the forefront of these developments and explore collaboration opportunities, Contact Us at Nectar Product Development. Together, we can continue to drive innovation and improve patient lives. We are always looking for new partnerships and collaborations that can help us bring the next generation of medical devices to life.

Continued Learning and Engagement

Delve deeper into the nuances of product development and stay informed by listening to Nectar’s Podcast “The Product Development Book”, offering insights into the challenges and successes in the medical device industry. Our podcast is a great resource for anyone interested in the latest trends and developments in medical technology.

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Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
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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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Steven Wells Ph.D.

Director of Operations

Dr. Steve Wells holds a critical role in steering Nectar’s operations and defining its strategic direction. His impactful leadership has established a clear course for the company’s success. He has revitalized the company with a passion for maximizing impact through expert resource utilization since taking the helm in 2020. Steve has boosted Nectar’s portfolio, streamlined processes, and reinvigorated its innovation agenda, all with the goal of developing life-saving and impactful products. His background in senior leadership roles at Georg Fischer and his people-focused, results-driven leadership style make him an invaluable asset to our team. Steve’s extensive knowledge in chemistry, biocompatibility, and biology only adds to his value as a team member.

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Nellie Roque

Director of Finance and Accounting

Nellie Roque is a seasoned professional with over 17 years of experience in the fields of accounting, human resources, and payroll. She has a wide range of experience, having worked in industries such as manufacturing, software, and non-profit organizations. Nellie holds a Bachelor’s degree in Business Administration and Accounting, demonstrating her strong foundation in financial management and human resource practices. Throughout her career, Nellie has gained extensive knowledge and expertise in these areas, making her a valuable asset to any organization.
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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.
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Aaron Gifford

Principal Engineer

With a wealth of experience as a medical device developer, Aaron is a valuable addition to the Nectar team. His expertise in transferring medical devices and IVD instruments to production is unmatched, and his 25 years of professional engineering experience speaks to his expertise. At Nectar, Aaron plays a crucial role in ensuring regulatory compliance throughout product development and manages projects with skill and precision. His recent leadership in the development of the critical care Covid EUA BDR-19™ ventilator is a testament to his abilities, and his 13 patents in the medical device space further highlight his contributions to the field.
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Larry Larson

Director of Hardware and Firmware Engineering 

Larry Larson is a highly experienced engineering professional who has served as Nectar’s Director of Engineering for several years. He has extensive experience in leading, overseeing, and managing the design and development of innovative products, and has been involved in 70 unique product design cycles to date. With a deep understanding of highly regulated industries such as medical and aerospace devices, Larry has been instrumental in bringing cutting-edge technologies to market and delivering solutions that meet the needs of his clients. He has a passion for engineering and is dedicated to advancing the field by delivering products that are safe, effective, and of the highest quality.
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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

Industrial Design 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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Rejsa Kuci

Business Development Coordinator

Rejsa is a dynamic force in driving sales and acquiring new projects at Nectar, where she excels in seamlessly aligning the Sales and Operations teams. Holding a prestigious double degree from the Rochester Institute of Technology in Management and Multimedia, Rejsa brings a wealth of experience to her role as a Project Manager, Digital Marketing Strategist, and Creative Lead. With over four years of expertise in the digital world, Rejsa is not only highly skilled but also enthusiastic about following the ISO 13485 path to ensure successful project completion. Her ability to effectively bridge the gap between Sales and Operations, combined with her passion for driving projects forward, makes her an invaluable asset to the Nectar team.
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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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Stephanie Rodriguez

Accounting Coordinator

Stephanie Rodriguez is a highly experienced administrative professional with over 10 years of expertise across a diverse range of industries, including contract manufacturing, financial and wealth management, and the medical field. She holds a Bachelor’s degree in Humanities from Northern Arizona University. As a valued member of the Nectar team, Stephanie plays an integral role in supporting the engineering teams by acquiring materials and parts for the prototype phase of our clients’ projects. She also assists the Director of Accounting by issuing purchase orders and provides project managers with accurate data to effectively manage and track budgets for each stage of the statement of work. Stephanie’s knowledge and skills, combined with her dedication and drive, make her an asset to Nectar and a key player in ensuring the successful completion of our projects.
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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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Sean Wells

Mechanical R&D Technician

Sean plays a critical role at Nectar. He has a wide range of skills that help keep the company and equipment running. His background in machine and building maintenance means he has skilled hands ready for anything. Sean runs our lab equipment including 3D printers and a laser cutter. He also helps with complex project builds, assemblies, and testing.
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Jonathan Cantera

Quality Manager

Jonathan at his core is a Human Factors Engineer with his M.S. in Human Factors and Minor in Sociology from California State University of Long Beach. At Nectar, Jonathan is responsible for managing and maintaining the company’s ISO 13485 Quality Management System keeping in compliance with US and international regulations for product development. Jonathan’s role ensures each department is in compliance every step of the design process, making him a critical Nectar team member. Jonathan’s Human Factors background also allows him to aid in user research, feedback sessions, usability evaluations, and formative studies such as risks assessments. When he’s not in the office, Jonathan enjoys film photography, and reading.
Vessa Hyseni Purchasing Manager

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.
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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 UX UI Designer

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.