In the first episode of the newest series from the DeviceTalks Podcast Network, our guest Kirsten Carroll, CEO of Kandu Health shares her insights on the medical device product development cycle from the perspective of "The Product Director."

With more than a decade and a half in product management for Boston Scientific and Stryker Neurovascular, Kirsten discusses the roles of product management, design verification, and design validation in ensuring a successful product launch. She also highlights the significance of generating clinical evidence and tailoring it to different stakeholders. Kirsten's key message is the value of effective communication and collaboration in developing and launching medical devices.

TL;DR Key take-aways:

1. Collaboration between different teams is crucial in the medical device product development cycle.
2. User needs should be clearly defined and translated into specifications for design verification.
3. Design validation involves testing the product with the intended users to ensure it meets their expectations.
4. Clinical evidence generation should align with the specific needs of different stakeholders.
5. Effective communication and collaboration are essential for successful product development and launch.

Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent, and Cretex Medical for providing vital support.

aptyx.com
catalyzehealthcare.com
confluentmedical.com
cretex.com

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

Thank you for supporting MedtechWOMEN Talks.

How do I Drive Medtech Product Development? With Kirsten Carroll, Kandu Health

In the second episode of MedtechWOMEN Talks, our guest Kathryn Rieger, PhD, Sr. Director, Human Factors & User Research at Intuitive, shares her insights on the medical device product development cycle from the perspective of "The Engineer."

Drawing from her unique background in military tech and auto tech and her extensive experience in medtech, Dr. Rieger shares insights into how engineers influence the essential stages of the medical device product development cycle.

In the episode, Dr. Rieger emphasizes the rigorous nature of verification and validation processes in medtech, underlining the importance of document control and thorough testing to ensure device safety and functionality. She also highlights the role of clinical studies in pre-market validation, underlining the significance of balancing safety considerations with regulatory compliance. Additionally, Dr. Rieger discusses the growing role of AI and machine learning in optimizing development processes while prioritizing user needs and safety.

TL;DR - Key takeaways:

1. Integrating user experience and safety is crucial in medical device development.
2. A multidisciplinary approach to medtech product development is key.
3. Effective collaboration and communication are critical to successful product launches.

Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support.

aptyx.com
catalyzehealthcare.com
confluentmedical.com
cretex.com

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

Thank you for supporting MedtechWOMEN Talks!

How do I design, verify and validate a medical device? With Kathryn Rieger, Intuitive

In the latest episode of MedtechWOMEN Talks, Nicole Osmer, Founder & CEO at Health+Commerce, shares her expertise on the role of branding, media relations, and public relations in the medical device product development cycle from the perspective of “The Publicist.”

In the episode, Osmer shares the significance of establishing a strong brand right from a company's inception. Attention to detail in messaging, brand presence, and even the subtleties like an area code on a contact page are pivotal. A central theme revolves around structuring communication effectively through traditional and emerging media channels to make significant market impacts. Osmer's insights on press releases, direct media outreach, and the role of digital platforms offer valuable takeaways on modern medtech marketing. The episode covers not only the 'what' but also the 'how' of successful medtech communications.

TL;DR – Key takeaways:
1. Establishing a strong brand from the early stages and maintaining it throughout the lifecycle of a medtech company is crucial for lasting success.
2. Clear, concise messaging and being prepared for media opportunities with key story elements is essential in PR and branding.
3. Press releases remain a relevant tool for communication, especially when they are concise, impactful, and include a compelling headline.
4. Collaboration across various company functions such as marketing, clinical teams, and investor relations is integral to a coherent communication strategy.

Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support.

https://aptyx.com/ 
https://catalyzehealthcare.com/ 
https://confluentmedical.com/
https://www.cretexmedical.com/

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

How do I get a medical device in front of the right people? with Nicole Osmer

In this episode of MedtechWOMEN Talks, Christina Hawley, Sr. Director, of Clinical Operations at May Health helps to unravel the clinical trial process for medical devices, emphasizing the non-linear path from early feasibility to pivotal trials and post-market studies; and delves into the meticulous process of gaining FDA approval and even the nuanced differences between clinical affairs and regulatory affairs.
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TL;DR – Key takeaways:
- Close collaboration with cross-functional teams, including R&D, regulatory, quality, and marketing, is key to the success of clinical trials.
- Clinical trials must consider the specific regulatory requirements of the targeted geographical markets.
- There is no standardized approach to any of the different clinical trials, each must 

Tune in to gain insights into the complex and surprisingly creative world of clinical research in the medical device industry.

Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical!
https://aptyx.com/ 
https://catalyzehealthcare.com/ 
https://confluentmedical.com/
https://www.cretex.com/

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

Thank you for listening to MedtechWOMEN Talks!

How do I navigate the clinical affairs process effectively? with Christina Hawley, May Health

In the latest episode of MedtechWOMEN Talks, Rebecca Whitney, SVP, Global Spine President, ZimVie dives deep into what it takes to bring innovative medical solutions to market in a large medtech OEM, weighing the benefits of internal product development against strategic external partnerships.
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The episode shines a light on the diligent process behind medical device product development, taking into consideration global market nuances, regulatory challenges, and the balance between in-house innovations and external collaborations. Whitney underscores the value of rigorous review stages, which sometimes require difficult decisions like ceasing investment in long-term, costly projects.

Key Takeaways:
- Tough decisions, like halting a project, are necessary for the betterment of patient care and resource allocation.
- Product development incorporates feedback from patients, surgeons, and salesforces to ensure that solutions are practical and market-appropriate.
- Strategic external partnerships can optimize development by leveraging outside expertise, allowing large medtechs like ZimVie to focus on their core strengths.

Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical!

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

Thank you for listening to MedtechWOMEN Talks!

How does the internal medical device development process work at large medtechs?

In the final episode of MedtechWOMEN Talks season one, we are joined by YJ Oh, SVP US Sales, Marketing and Commercial Operations at Edwards Lifesciences, who takes us through the intricate process of medical device commercialization. Starting with her unique entry into the medtech industry, YJ shares her comprehensive journey from sales to global marketing, emphasizing the significant role of upstream marketing in shaping product development and downstream efforts in executing commercial strategies.

In the discussion, YJ highlights the criticality of understanding market needs right from the inception of a product idea, ensuring that every development phase aligns with customer insights and real-world applicability. She provides a glimpse into the key collaborations across various departments and touches on the essential feedback mechanisms in place, ensuring devices meet the stringent requirements and expectations set forth by both regulatory bodies and the end-users, primarily physicians. Her insights extend into the strategic considerations for global market penetration, discussing how different regulatory landscapes affect the accessibility and success of medical devices across borders.

TL;DR – Key Takeaways:
- The integration of market insights from the beginning is crucial for successful medical device commercialization.
- Collaborative efforts across various functions are vital to address the comprehensive demands of product development.
- Strategic global considerations are imperative to navigate varying regulatory and market conditions effectively.

Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical!

https://aptyx.com/ 
https://catalyzehealthcare.com/ 
https://confluentmedical.com/
https://www.cretex.com/

Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode.

Thank you for listening to MedtechWOMEN Talks!

How do I take an approved medical device to market? with YJ Oh, Edwards Lifesciences

The DeviceTalks Podcast Network delivers news, insights and commentary from MedTech industry leaders, primarily from the largest OEMs in healthcare. Our podcasts will inspire MedTech professionals to create better MedTech devices and companies.

Explore the DeviceTalks Podcast Network, home to more than 11 podcasts:

• DeviceTalks Weekly
• AbbottTalks
• Boston Scientific Talks
• DeviceTalks AI
• IntuitiveTalks
• MedtechWOMEN Talks
• MedtronicTalks
• Neuro Innovation Talks: J&J MedTech Neuro
• Structural Heart Talks: Edwards Lifesciences
• Ortho Innovation Talks: Zimmer Biomet
• StrykerTalks

WATCH our video podcasts on www.youtube.com/@DeviceTalks

Connect with the hosts:
Tom Salemi, Editorial Director, DeviceTalks https://www.linkedin.com/in/tom-salemi-7118948/
Kayleen Brown, Managing Editor, DeviceTalks https://www.linkedin.com/in/kayleenbrown/

Learn more about DeviceTalks - Podcasts • Conferences • Webinars - www.devicetalks.com

New tracks tagged #MedtechWOMENTalks