Episode 56 · January 30, 2026 · 30m listen · 4,684 words · ~23 min read
The Hidden Reason Medtech Products Get Recalled (It's Not Quality Issues) with William Jin | Ep. 55 - Full Transcript | The Med Device Cyber Podcast
Read the complete, searchable transcript of Episode 56 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.
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Episode summary
In this episode of The Med Device Cyber Podcast, hosts Trevor Slatterie and Christian Espinosa, joined by special guest William Jin, delve into the often-overlooked cybersecurity challenges that lead to medical device recalls and hinder market expansion. William Jin, with over 30 years in the medtech industry and experience at companies like Medtronic and Stryker, offers a unique perspective on navigating both the Chinese and US/European markets. The discussion highlights crucial differences in cybersecurity regulations between the NMPA (China) and the FDA (US), emphasizing that NMPA requirements are not just stringent but uniquely divergent, often necessitating two separate product builds for compliance. A significant focus is placed on the impact of early design decisions, such as cloud platform selection (e.g., Google Cloud versus Amazon China), on market viability and the costly ramifications of not considering target markets from the outset. The episode underscores the increasing frequency of cybersecurity-related recalls, exemplified by the Baxter Life 2000 ventilation system, and stresses the critical importance of integrating cybersecurity throughout the entire product lifecycle, from design to disposal, to prevent costly setbacks and ensure product success in a globalized medtech landscape.
Key takeaways from this episode
Medical device companies must consider target markets like China, the US, and Europe from the initial design phase to avoid costly redesigns and ensure market viability.
The NMPA in China has unique and stringent cybersecurity requirements, often necessitating a completely separate product build and regulatory filing compared to FDA requirements.
Choosing a cloud platform, such as Google Cloud, without considering its compatibility with specific markets like China, can lead to significant barriers to market entry.
Cybersecurity-related medical device recalls are increasing, as evidenced by the Baxter Life 2000 ventilation system recall, highlighting the critical need for proactive cybersecurity measures.
Integrating cybersecurity through the entire product lifecycle, from design to disposal, is essential to prevent recalls, ensure regulatory compliance, and safeguard financial resources.
Staying informed about evolving cybersecurity regulations and market-specific requirements is crucial for success in the rapidly changing global medtech industry.
Chinese medical device companies face challenges in entering US/European markets due to a lack of cybersecurity awareness and commercial knowledge, in addition to IP concerns.
US and European companies face challenges entering the Chinese market due to longer registration times, data exchange restrictions, and the incompatibility of certain platforms like Google Cloud with Chinese regulations.
You don't want to spend all of this time, spend all of this money creating a product that you're not actually going to be able to sell in really valuable markets for you. There are 1.5 million companies in China in the medtech space. The Chinese market very quickly moved its way up to the second largest medical market in the world, and it is showing no signs of slowing down. When I'm talking to a lot of Chinese companies in med areas, I get the feeling that a lot of companies are not ready to get to a US market or European market. We always say cybersecurity should be considered from design to disposal of the product, the entire lifecycle.
Hello and welcome back to The Med Device Cyber Podcast. I'm your co-host Trevor Slatterie, joined with our other co-host Christian Espinosa. And today we have a very special guest: William Jin. We're going to dive into talking about some of our typical North Star with cybersecurity and then looking a little bit into some of these differences that we see between the US market as well as the Chinese market.
Now, before we dive in too far, I'll turn it over to you, William, to give a little bit of an introduction of yourself, a bit of background, and then we can jump right in. Yeah, I was educated as a medical doctor in Shanghai, China, and then I moved into the industry for more than 30 years, working for companies like Medtronic and Stryker. So, right now, I'm pretty much focused on helping overseas medtech companies outside of China, especially with innovative products, enter the China market, as well as supporting Chinese medtech companies if they are willing to go abroad.
Awesome. So you're helping kind of both directions: Chinese companies try to get to the United States as an example, and US companies trying to get into the Chinese market. Is that correct? Yes, yes. I started with helping the overseas get into the China market. But now there are more and more Chinese companies finding their way to go to the US and Europe market.
But I found the latest data from the China statistic data that Chinese export to Europe and the US, the data actually to North America, decreased in 2025 versus 2024 by about 5%, but to Europe, it increased by about 11%. So, it seems although overall Chinese medtech companies want to go abroad, it's not reflected in the numbers for North America. That lines up with the new tariffs coming in on just about everything imported to the US. So I can't say I'm surprised to hear that.
Yeah, I think this is one of the reasons, the tariffs. But I still, when I'm talking to a lot of Chinese companies in med areas, I get the feeling that a lot of companies are not ready to get to a US market or European market. I think not only from an IP perspective—I think that's always the issue about IPs—and also coupled with the commercial knowledge: how to launch your product into another market, especially in a more mature market, and do you have the talent, do you have the knowledge?
But right now, like our discussion, I think a lot of medtech products are getting into wireless, getting into iCloud, getting into data, you know, algorithms. Most of them are not ready or fully aware about the cybersecurity and what kind of requirements are outside of China. So, I think all these are the barriers or the challenges for a Chinese medtech company if they are planning to go to the US or Europe.
And what are some of the challenges with, let's say, a United States-based company going into China? What are some of the main challenges you see from that angle? From the US to China, right? Mhm. On the market factors, it will be like you understand the local market, you have a local talent. And also the registration time is much longer than in the US and Europe. It takes like 3 to 5 years based on your category: class two or three.
Most recently, I feel I have two cases about the data because, for example, you know, some of medtech products are developed under the Google platform. Mhm. So all the associated products are built up on the Google platform, but the Google platform is not allowed in the China market. It's not allowed by the Chinese government. So this product cannot sell the similar exactly the same product in the China market because Google is actually not allowed.
And then you need to develop everything from scratch only from some local platforms like Alibaba or maybe Amazon, if available. So you need to do everything from scratch. So this is the biggest challenge for that particular company because they are using algorithms to collect the data. And from this perspective, I think the other challenge is that the Chinese government has very strict rules regarding the exchange of data, patient information, and some other data: how you can transfer it abroad. So some algorithms will not work outside of China.