Interview with Minghua Chen, Business Development Manager APAC

We would like to get you all acquainted with our Business Development Manager of APAC. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!

Let's start with a small introduction, could you tell me something about yourself?

I’m the business development manager of Qserve Group APAC, responsible for planning and executing business development and sales activities, including presenting new solutions and services to clients, brand building, PR and partnership development.I work at the head office in China. 

What is your main area of expertise?

My personal focus is the global regulations and its impact on the industry. As a BD manager, I have the opportunity to talk with different parties, including various manufacturers, consultant experts, laboratories, notified bodies, industry associations & regulators of different areas. This gives me a broader view of the industry and some extend of understanding of the specific topics.Because of my broad knowledge regarding implementations, I can also take on some other roles, such as the role of atrainerand the role of project manager where I facilitate cooperation’s. 

Could you also tell me something about your experience before you joined Qserve?

Before I joined Qserve, I worked for 13 years at the Notified Body (BSI UK, 0086). I mainly focused on Healthcare business, including CE Marking, ISO 13485, FDA 3rd party review, CMDCAS, NMPA 3rd party inspection etc. I have held various positions within BSI, the last role was as Healthcare China’s National Sales Manager, responsible for the business development and the sales team management. For many years, I worked as the coordinator of the China regional team & the global healthcare team. Where I acted as the key contact for local clients to make sure projects were going smoothly. 

Which part of your job do you like the most?

The greatest and most interesting part of my job is to face various challenges together with our international teams, help medical device manufacturers to improve the product quality and shorten their time to market. We learn quickly about the global regulations, which are changing very fast  past years; we learn to understand gradually the cultural differences so we can enhance the efficiency of internal and external communication; we review, summarize & share the best practices to our team members, our clients and partners.

How does a normal workday look like?

Communications will always be the theme of my workday as BD manager. I first talk to external parties, such as our clients, partners and regulators to understand their needs. Then talk to my colleagues to find out the proper resources & solutions for our clients. Thanks to internet, IT tools & social medias, I could keep frequent communications in an efficient way even during the Covid-19 pandemic period.

Do you prefer a specific type of medical device?

There’s no preferred type of medical devices as I believe each device exists to help patients. But those innovative devices & high risk devices are always impressive as they normally bring in the biggest challenges.

Which trends are topic at the moment?

MDR & IVDR together with its enhanced requirements, such as CER & PMCF, UDI & EUDAMED etc. are always the hot topics. As the new EU regulations will have a big impact on not only EU market, but also the other markets which use CE Marking as their importation registration basis. Due to the Covid-19 pandemic, EUAs for those urgent needed products draw much attention from the industry & the public. We can also see the obvious trend for enthusiastic discussions of the new challenges that the new technology (such as AI) will bring to the regulatory world.

How do you stay up to date with everything that is happening in the MedTech-world?

I’d like to subscribe to trusted resources & the blogs/articles from KOLs. For important information, I will always check the wordings from original sources (e.g. regulations/standards or authorities’ official website etc.) to avoid mis-understanding. I hope our clients enjoy reading our newsletters, blogs/vlogs that we prepared for them. 

What is your advice/message for our customers?

For those who need to be compliant with MDR/IVDR before the DoA, take actions ASAP as time is very limited considering the big amount of additional workloads ahead & limited internal & external resources (Notified Bodies’ capacity for example). Keep learning new published regulations, standards and guidance’s, stay tuned with experts’ interpretations. And don’t forget to share those information you’ve collected with team members & keep the broader team well informed of the project progress, keep in mind that MDR/IVDR project implementation will be definitely a team work instead of one man’s task.

Would you like to know more about Minghua? Click here for her full profile.

Minghua Chen
Post date: June 24, 2020
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