**Season Two has rebranded to "Women in MedTech With Kayleen Brown**

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:

1. The integration of market insights from the beginning is crucial for successful medical device commercialization.

2. Collaborative efforts across various functions are vital to address the comprehensive demands of product development.

3. 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!

Thank you for listening!

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Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode.

Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** 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. ​ 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! 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. Thank you for listening!

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Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode.

Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe

**Season Two has rebranded to "Women in MedTech With Kayleen Brown**

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. ​

TL;DR – Key takeaways:

1. Close collaboration with cross-functional teams, including R&D, regulatory, quality, and marketing, is key to the success of clinical trials.

2. Clinical trials must consider the specific regulatory requirements of the targeted geographical markets.

3. 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!

***

Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode.

Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe