ISO 13485:2016
DEVICE DEVELOPMENT

Human Factors in Product Design

Human Factors in Product Design

Enhancing Medical Product Safety through Human Factors Engineering

The evolution of product design, particularly in the medical field, has been significantly influenced by an understanding of human factors engineering (HFE). Since the pivotal FDA study in 1989, which revealed that 45 to 50 percent of device recalls were due to poor product design, there has been a concerted effort to integrate HFE into the product development process. This shift is evident in the stringent adherence to FDA Regulations, the application of OSHA Standards, and a commitment to GMP Compliance.

ISO 13485:2016 – Setting New Benchmarks in Product Design

In response to these challenges, the medical device industry has embraced the ISO 13485:2016 standard. This international standard outlines specific requirements for a quality management system, emphasizing the role of effective product design in ensuring user safety and product efficacy. By conforming to these standards, companies like Nectar Product Development ensure that every aspect of medical product development is held to the highest safety and quality benchmarks.

The Crucial Role of HFE in Medical Device Development

At the core of this quality-centric approach is Human Factors Engineering. HFE isn’t just about compliance; it’s about understanding the intricate relationship between humans and the products they use. This understanding is crucial, especially in medical product development, where products are often used in high-stakes, safety-critical environments.

Safety-Critical Design: Prioritizing User Safety

Safety is paramount in medical device design. The principles of HFE help ensure that products not only fulfill their intended purpose but do so in a way that guarantees user safety. This aspect of design is particularly significant in the context of healthcare device safety, where the margin for error is minimal.

The Impact of Human-Centered Design on User Experience

The concept of human-centered design goes beyond mere functionality. It’s about creating products that are intuitive and comfortable to use. Nectar Product Development, for instance, focuses on this aspect, ensuring that their award-winning products are not only effective but also user-friendly.

Formative and Summative Testing – Ensuring Product Efficacy

Testing is a critical phase in product development. Through formative and summative testing, products are rigorously evaluated to ensure they meet the required standards. These tests are integral to understanding how products will perform in real-world scenarios, forming a crucial part of the FDA Compliance Guidelines.

Addressing Bias in Human Factors Testing

Bias in product testing can significantly impact the outcome. An experienced UX team can navigate these challenges, balancing feedback and using it constructively. This balance is vital in maintaining objectivity and ensuring that the product truly meets the needs of its intended users.

Effective Design: The Intersection of Innovation and Usability

Innovative design must also be practical. The effectiveness of a design is often realized when it is in the hands of the user. This practical approach to design is embodied in the concept of a User-Centric Design Approach, where user interaction is central to the design process.

Product Assessment and Evolution: A Continuous Journey

Product design is not a one-time event but a continuous process of improvement. This is especially true in the realm of scientific software and instrument development, where evolving technology and user needs dictate the pace of innovation.

Risk Assessment in Design: Mitigating Potential Hazards

Risk assessment is a critical component of product design, particularly in the medical field. By proactively identifying and addressing potential risks, designers can ensure that the products they create are not only effective but also safe for end-users.

Product Testing Protocols and Usability Analysis

Product testing protocols are essential for evaluating a product’s performance and safety. Product usability analysis plays a significant role in this process, providing insights into how a product will be used and the potential challenges users may face.

The Multidisciplinary Approach to Product Design

In the complex and ever-evolving world of product design, particularly in the realm of medical and healthcare devices, a multidisciplinary approach is not just beneficial—it’s essential. This approach involves the integration of diverse fields of expertise, each contributing its unique perspective and skill set to create products that are not only innovative but also safe, reliable, and user-friendly. Our multidisciplinary team of experts at Nectar Product Development brings together diverse skills and perspectives, ensuring that every aspect of the design process is thoroughly considered.

Harnessing Collective Expertise for Holistic Solutions

At Nectar Product Development, the multidisciplinary approach brings together experts from various disciplines such as engineering, human factors, UX/UI design, risk assessment, compliance, and project management. This collective expertise ensures that each aspect of product development, from initial concept to final production, is handled with the utmost precision and care.

Engineering and Design Synergy

The synergy between engineers and designers is a critical aspect of this approach. Engineers bring technical know-how, focusing on the feasibility, functionality, and safety of the product. Designers, on the other hand, contribute a deep understanding of user experience, ergonomics, and aesthetics. This combination ensures that products are not only effective and compliant with Safety Engineering Standards and FDA Compliance Guidelines, but also appealing and easy to use.

Nectar’s Commitment to Excellence in Product Development

At Nectar Product Development, the focus is always on creating products that are not only innovative but also safe and reliable. This commitment is evident in their approach to product development, where safety engineering standards and quality management systems are integral parts of the process.

The Future of Product Design: Embracing Change and Innovation

The Future of Product Design: Embracing Change and Innovation

The future of product design is a fascinating intersection of technology, human needs, and innovative thinking. As we move forward, several key trends are set to shape this landscape, profoundly impacting how products are designed, developed, and used.

Technological Advancements Driving Innovation

Technological advancements are at the forefront of driving change in product design. The integration of artificial intelligence (AI), machine learning, and advanced data analytics is enabling designers to create more personalized, intuitive, and efficient products. For instance, AI can predict user preferences and behaviors, leading to designs that are more user-centric and tailored to individual needs. Additionally, advancements in materials science are allowing for the creation of more durable, sustainable, and adaptable products.

Emphasis on Sustainability and Ethical Design

Sustainability is becoming a central focus in product design. As environmental concerns continue to grow, designers are increasingly tasked with creating products that are eco-friendly and ethically sourced. This shift is not only about using sustainable materials but also about designing products that have a longer lifespan and are easily recyclable at the end of their life cycle. Ethical design also encompasses a broader responsibility towards societal impacts, pushing designers to consider the wider implications of their creations.

The Rise of Human-Centered Design

Human-centered design is gaining prominence, placing greater emphasis on creating products that enhance human capabilities and experiences. This approach involves a deep understanding of human behaviors, needs, and ergonomics. As part of this trend, there is a growing importance placed on inclusive design – creating products that are accessible and usable by people with a wide range of abilities and disabilities.

Integration of Virtual and Augmented Reality

Virtual (VR) and Augmented Reality (AR) are redefining the realms of product design and testing. These technologies allow designers to create and test products in virtual environments, significantly speeding up the development process and reducing costs. VR and AR also offer new ways for users to interact with products, opening up possibilities for more immersive and engaging experiences.

The Role of Big Data and Predictive Analysis

Big data and predictive analytics are becoming crucial tools in understanding user behavior and market trends. By analyzing large datasets, designers can gain insights into user preferences and predict future trends, leading to more informed and strategic design decisions. This data-driven approach helps in creating products that are not only innovative but also align with market needs and consumer expectations.

Nectar’s Educational Initiatives: Spreading Knowledge through Podcasts

Education is key to innovation. To this end, Nectar hosts Nectar’s Podcast The Product Development Book, an informative platform where topics ranging from HFE to product testing protocols are discussed, spreading valuable knowledge in the field of product development.

Engaging with Nectar for Innovative Product Solutions

For those interested in learning more about how Nectar approaches product design, or to engage with the team on a project, the Contact Us page offers an easy way to get in touch.

In conclusion, the future of product design is an exciting blend of technology, sustainability, and human-centric approaches. By embracing these changes and innovations, designers and companies can create products that are not only cutting-edge and relevant but also responsible and meaningful in today’s rapidly evolving world. As we look forward, it’s clear that the field of product design will continue to be a dynamic and transformative force in shaping our experiences and interactions with the products we use daily.

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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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FAQs

What is Human Factors Engineering (HFE) in the context of medical product development?

Human Factors Engineering (HFE) is an approach focused on understanding the relationship between humans and the products they use, particularly in high-stakes environments like medical product development. It goes beyond compliance, emphasizing the design’s usability, safety, and its alignment with user needs to ensure effective and safe product usage.

How does Nectar Product Development ensure safety and quality in medical product design?

Nectar Product Development adheres to stringent standards such as ISO 13485:2016, integrating diverse expertise from fields like engineering, human factors, UX/UI design, risk assessment, and compliance. By employing a multidisciplinary approach, they ensure every aspect of the design process aligns with safety engineering standards and FDA compliance guidelines.

What key trends are shaping the future of product design, especially in the medical field?

The future of product design in the medical sector is being shaped by technological advancements like AI, emphasis on sustainability, human-centered design principles, integration of VR/AR, and leveraging big data for predictive analysis. These trends focus on creating more personalized, sustainable, inclusive, and technologically advanced medical products that meet evolving user needs and market demands.

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We are an ISO 13485-certified design and engineering firm based in Southern California, specializing in the development of cutting-edge medical devices.

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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

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Belen Quintero

Associate Project Manager

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Erjon Ameti

Mechatronics Engineer

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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

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Stephanie Rodriguez

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Toska Ukaj

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Sean Wells

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Jonathan Cantera

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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

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Uran Cabra Engineer

Uran Çabra

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Sarah Clark

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