ISO 13485:2016
DEVICE DEVELOPMENT

Medical Device Development Challenges: FDA, Regulations, ISO

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval Medical Device Regulations for Innovation and Patient Safety

FDA Approval: Medical Device Regulations for Innovation and Patient Safety

Navigating the extensive terrain of medical device regulations is paramount for developers aiming to bring innovative healthcare solutions to market. At the heart of this intricate regulatory maze is the United States Food and Drug Administration (FDA), whose role is critical in maintaining the integrity of the medical industry. The FDA’s comprehensive guidelines and rigorous review processes are designed to rigorously assess and validate the safety and performance of medical devices. This ensures that only devices meeting the highest standards reach the healthcare community and, ultimately, patients. Understanding and adhering to these regulations are not just about achieving compliance; it’s about contributing to the advancement of healthcare technologies and patient care standards. In this dynamic regulatory landscape, manufacturers must stay abreast of the latest updates, leverage guidance documents, and often seek expert consultation to successfully navigate the FDA approval pathway.

The FDA’s Role in Medical Device Approval

The FDA’s approval process stands as a guardian of public health, with its stringent oversight ensuring that medical devices brought to the marketplace are not just innovative but also secure and reliable for patient use. The journey to FDA approval is rigorous and multifaceted, encompassing an array of premarket submissions, exhaustive clinical trials to demonstrate safety and efficacy, and strict adherence to established quality system regulations. Achieving this benchmark of FDA approval signifies a medical device developer’s dedication to excellence and patient safety. It’s a testament to the device’s quality and the manufacturer’s commitment to meticulous development practices and robust quality management. This milestone is crucial, as it not only underscores the trustworthiness of the device but also enhances its credibility among healthcare providers and patients alike, facilitating a smoother transition into the competitive medical market.

Understanding FDA Regulatory Pathways

Medical device developers must navigate through various FDA regulatory pathways. These include 510(k) clearance, which is required for devices that are substantially equivalent to existing approved devices; premarket approval (PMA), which is for new or high-risk devices; and the De Novo pathway, for low-to-moderate-risk devices that do not have a clear precedent.

The Criticality of ISO Certification in Medical Device Manufacturing

In addition to FDA regulations, developers must also consider international standards, such as those from the International Organization for Standardization (ISO). ISO 13485 certification is particularly relevant, as it specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Incorporating ISO 14971 for Risk Management

ISO 14971 is more than just a standard; it’s an integral part of a proactive risk management strategy that’s deeply embedded in the medical device development lifecycle. This critical component is indispensable for manufacturers aiming to navigate the complex landscape of medical device safety. By adhering to ISO 14971, manufacturers are equipped with a systematic approach to risk management, beginning with the identification of potential hazards associated with their devices.

Risk analysis under ISO 14971 goes beyond simple identification; it requires manufacturers to estimate and evaluate the associated risks in context, considering both the probability of occurrence and the potential severity of harm. This evaluation becomes the foundation for implementing risk control measures. The controls could range from design changes to enhance safety to incorporating alarm systems that alert users of potential issues.

However, risk management doesn’t stop at implementing controls; it’s a cyclical process that requires ongoing monitoring and review. Manufacturers must consistently assess the effectiveness of their controls, ensuring that risks are mitigated to the lowest possible level. Furthermore, the standard mandates post-market surveillance, a critical step where manufacturers monitor the performance of their medical devices once they are in the hands of users. This feedback loop allows manufacturers to continually improve safety and effectiveness, making risk management a dynamic and evolving process.

The application of ISO 14971 extends to all stages of a medical device’s lifecycle. From conception through design, development, production, and post-market activities, each phase benefits from the structured approach to identifying and managing risks. This comprehensive view ensures that risk management is not an afterthought but a core aspect of quality and safety in medical device production.

pFMEA Risk Assessment Medical Device

Leveraging pFMEA for Proactive Risk Assessment

Process Failure Mode and Effects Analysis (pFMEA) takes risk management to the operational level, offering a meticulous method for scrutinizing every step in the medical device manufacturing process. It empowers developers and manufacturers to preemptively identify where and how a process might fail, which is paramount in ensuring the reliability of medical devices.

Employing pFMEA involves assembling a cross-functional team that brings a variety of perspectives and expertise. This team methodically breaks down processes to their most granular levels, scrutinizing each step for potential failure modes. For each failure mode identified, the team assesses the effects and causes, leading to a risk priority number (RPN) that quantifies the risk associated with each potential failure.

But pFMEA is not just about assigning numbers to potential problems; it’s about taking action. The process prompts the team to devise strategies to reduce or eliminate risks, prioritizing actions based on the severity, occurrence, and detectability of each failure mode. This preemptive action is critical in the medical device industry, where the cost of failure can be immeasurably high—not just in financial terms but more importantly, in terms of patient safety.

Moreover, pFMEA is a living document that evolves with the device’s lifecycle. As processes change or new information comes to light, the pFMEA must be updated to reflect the current state of the process. This continuous improvement loop ensures that risk assessment is always current and relevant, contributing to the overall robustness of the medical device.

By leveraging the thoroughness of pFMEA, medical device developers can anticipate potential issues and engineer resilience into their devices. This proactive approach to risk assessment aligns with the principles of ISO 14971 and underscores a commitment to excellence in device safety and quality.

Incorporating ISO 14971 and pFMEA into the medical device development process represents a dual commitment to safety and quality. It demonstrates to regulators, partners, and end-users that a manufacturer prioritizes risk management not just for compliance, but as a fundamental corporate ethos. In an industry where the end product affects human lives, this commitment is the cornerstone of trust and reliability in medical technology.

MDSAP: Streamlining International Regulatory Approval

The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. MDSAP is especially beneficial for companies looking to market their devices globally, as it streamlines the auditing process across different countries.

Conclusion: Excelling in Medical Device Development

The journey of bringing a new medical device to market is fraught with challenges, but with the right knowledge and resources, developers can navigate this path successfully. Companies like Nectar play a pivotal role in this process, offering expertise and support in managing the intricacies of FDA regulations, ISO certification, and overall development strategy.

Contact Nectar for Expert Guidance in Medical Device Development

Are you embarking on a medical device development project and need expert guidance? Contact Nectar today for assistance. Our seasoned team is equipped to help you navigate the regulatory landscape and bring your innovative medical devices to market with confidence.

By integrating the essential considerations of FDA regulations, ISO standards, and a strong focus on risk management, medical device developers can ensure their products meet the highest standards of safety and efficacy. This comprehensive approach is not just about achieving regulatory compliance; it’s about committing to the highest quality in healthcare innovation.

Post New Nectar logo building
LEARN MORE ABOUT US
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.
Nectar logo color
SIGN UP FOR THE NEWSLETTER

The news you need to stay on top of cutting edge medical product development.

By subscribing, you acknowledge and agree to Nectar’s Terms of Use and Privacy Policy.

Nectar logo color

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

Our Services
Mechanical engineering, Industrial Design, Software
Firmware, Usability, User interface design, Regulatory

Acumen IQ device in use

Related Blogs

The Challenges of Medical Device Development: FDA, Regulations, and ISO Certification

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device...

Read Now

The Challenges of Medical Device Development: FDA, Regulations, and ISO Certification

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device...

Read Now

The Challenges of Medical Device Development: FDA, Regulations, and ISO Certification

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device...

Read Now

The Challenges of Medical Device Development: FDA, Regulations, and ISO Certification

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device...

Read Now
image 65

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

image 65 (1)

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.

image 65 (2)

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.
image 65 (3)

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.
image 65 (4)

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.
image 65 (5)

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.
image 65 (6)

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.

image 65 (7)

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.
image 65 (8)

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.
image 65 (9)

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.
image 65 (10)

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.
image 65 (11)

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.
image 65 (12)

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.

image 65 (13)

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.
image 65 (14)

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. 
image 65 (15)

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.
image 65 (16)

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.
image 66

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.
image 65 (18)

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.
Uran Cabra Engineer

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.