MedTech Innovation 360

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Nectar

8 episodes

2 months ago

In this episode of the MedTech Innovation 360, we delve into risk assessment and management within medical device development. Exploring the definitions of risk, we differentiate between risk assessment and risk management, stressing the importance of early identification and mitigation. Key points include the relationship between risk and hazards, the role of Failure Modes Effects Analysis (FMEA) in identifying potential failures, the significance of ISO 14971 as a guiding standard, and the ...

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Episodes (8/8)

MedTech Innovation 360

#8 Strategic Risk Management in MedTech Innovation

1 year ago

44 minutes

MedTech Innovation 360

#7 FDA Regulations Guide for Medical Device Developers

In this episode, "FDA Regulations Guide for Medical Device Developers," listeners are taken on a comprehensive journey into the intricate world of FDA regulations governing medical device development. Through insightful discussions with industry experts, including Elaine Duncan from Paladin Medical, the podcast explores key concepts such as defining medical devices, understanding indications for use, and classifying devices according to FDA guidelines. The episode delves into the importance o...

1 year ago

41 minutes

MedTech Innovation 360

#6 The Power of Marketing in the Medical Device Industry

Join host Sarah Clark and a panel of experts in this episode as they uncover the vital steps in medical device product development. With guest Mike Sleva, a seasoned professional in medical device marketing, you'll explore essential aspects of commercialization, the significance of branding, positioning, and the power of thorough market research. Whether you're a startup or a seasoned player, gain insights to stay competitive in this ever-evolving industry. Tune in for actionable strategies a...

2 years ago

45 minutes

MedTech Innovation 360

#5 Compliance Matters: Navigating FDA Clearance and ISO Certification for Medical Devices

In the fast-evolving landscape of medical device development, ensuring safety, efficacy, and regulatory compliance is paramount. Join us in this episode as we dive into the intricate world of FDA clearance and ISO certification in the realm of medical devices. From understanding the rigorous regulatory processes to highlighting the importance of meeting these standards, we explore the challenges, benefits, and implications for both manufacturers and end-users. Learn how navigating through the...

2 years ago

50 minutes

MedTech Innovation 360

#4 The Art of Innovation: How Industrial Design Shapes Medical Devices

In this episode, we explore the often overlooked role of industrial design in shaping medical devices. Medical devices are vital in healthcare, saving lives and enhancing patient care, yet industrial design's significance is often underestimated. We delve into the crucial role of industrial design, examining the unique challenges and opportunities it presents in medical device design. From cleanability and material properties to security, usability, risk mitigation, and human factors, we unco...

2 years ago

48 minutes

MedTech Innovation 360

#3 Unleashing the Power of Industrial Design

In this episode, we will be discussing the essence of industrial design and its role in shaping the world around us. From the initial spark of inspiration to the final product launch, we explore the multifaceted world of industrial design, showcasing how designers transform ideas into tangible objects that enrich our lives. We uncover the meticulous techniques and methodologies employed to strike the delicate balance between aesthetics and usability, leaving no stone unturned in the pursuit o...

2 years ago

46 minutes

MedTech Innovation 360

#2 Best Practices for Conducting User Research in Medical Device Development

In this episode, we will be discussing the best practices for conducting user research in medical device development. User research is an imperative step in the product development process, and it helps to ensure that medical devices are safe, effective, and meet the needs of the people who use them. Our speakers will discuss various aspects of user research, including how to recruit and screen participants, how to conduct interviews or surveys, and how to use different research method...

2 years ago

45 minutes

MedTech Innovation 360

#1 Designing for Patients: The Power of User-Centered Medical Device Development

Join Nectar's CEO, Darren Saravis, and Industrial Design Manager, James Wilkin, as they delve into the world of User Centered Design. In this episode, Darren and James will discuss what User Centered Design is and how it's used within medical device development. They'll explain how Nectar integrates this approach into their process and the benefits that it brings to their clients. Whether you're a seasoned medical device developer or simply curious about the subject, this episode is a must-li...

2 years ago

31 minutes