MEET THE CHINA MED DEVICE TEAM
Grace Fu Palma
Founder and CEO
Grace Fu Palma founded CMD in 2011. She brings 20+ years of industry experience to the medical device industry. Grace has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception.
Grace Fu Palma is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.
Yi Elaine Wang,
Director of China Funding
Yi Elaine Wang brings 15+ years of extensive scientific background as well as business experience from medium size to startup companies at Richard Franklin & Company, Cell Signaling Technology, and Incyte Pharmaceutica. She has solid knowledge of PE, financial and business modeling, and developing pipeline of M&A and licenses. Her scientific background has enabled her to develop quantitative and statistical methods for cell signaling technology and help with R&D, marketing, product development, patent office to develop automation solutions. In addition, she led the analysis and human genome sequencing to address a wide range of scientific questions and the establishment of SOP process and documentations. Has publications and presentations at national and international conference presentations.
Yi Elaine Wang is originally from Beijing, China and graduated with Ph.D. in Biophysics, MBA from Brandeis and BA, Chemical Biology from Rensselaer Polytechnic Institute.
Tony Liu has more than ten years of CFDA regulatory experience from premarket approval to post-market surveillance and quality compliance. He was mentored by a top CFDA review chief. His career spans from R&D engineer to CFDA regulatory manager and supervisor at Beijing JR Technology Company, Philips Healthcare and Brady Regulatory Services Tech. His technical knowledge combined with his seasoned wide range of regulatory practical experience has enabled him to not only successfully obtained many CFDA approvals for the most complex class III medical devices but also to have established GMP approved facilities with clean rooms in China. Tony is leading a team of 20 regulatory professionals in Beijing focusing on CFDA medical device/IVD regulatory services in the following areas: Premarket: registration, clinical evaluation and trial, QMS establishment and audit, CFDA manufacturing license. Post-market: distribution license, adverse event and recall, labelling and manual, CFDA advertisement approval. GMP and regulatory compliance assessment and audit preparation.
Tony received BS from Northern Industrial University with joint degree in Physics and English.
Supporting and Analysts Team
CMD Boston office has 3 support and analysts staff. All of them received MBA degrees from the leading U.S. universities and BA/BS from universities in China. In addition to our U.S. based staff, we partnership office in Beijing, Shanghai and Nanjing to support our China commercial, regulatory and funding activities.
In my twenty years of Class Ill medical device experience, I have not had the pleasure of working with a Chinese regulatory firm as talented and knowledgeable. As CFDA is increasing their technical and clinical review, it is one of the few companies staffed to assist medical device companies in this area. Their focus and dedicated support has exceeded our expectations. In my search for a strategic partner in China, they exceeded the other companies in all areas. While they have a very experienced Regulatory and Marketing team, their technical engineering, clinical, and international project management expertise place them above other companies in this area.
Vice-President, Global Regulatory/Clinical Affairs
China Med Device (CMD) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in China. Specifically we have gained a much better understanding of the ins and outs of the China medical device market and choices of business models. CMD has walked us through the very complicated process CFDA registration guiding us not only from regulatory documentation and testing perspectives but also how the process will impact the reimbursement downstream
Vice President of Finance
I had the opportunity to work with China Medical Device Group on a research project to inform our portfolio and regulatory strategy for entering the Chinese Marketplace. Grace's extensive experience in medical device has enabled her to independently and efficiently evaluate our product portfolio and assess our needs. They exceeded my expectations on quality and amount of data they were able to collect and we now have a strategy that has been informed by real data that will ultimately ensure our business success in the years to come.
Director of Marketing
Regenerative and Orthopedic Company, CA, USA
China Med Device (CMD) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in China. Specifically we have gained a much better understanding of the ins and outs of the China medical device market and choices of business models. CMD has walked us through the very complicated process CFDA registration guiding us not only from regulatory documentation and testing perspectives but also how the process will impact the reimbursement downstream ...
Vice President of Finance
On the fund raising front, what sets CMD apart is their understanding of the China market and key needs of Chinese investors. Their detail to preparation is second to none. Within a few months after our market access study, CMD was able to introduce us to solid investment sources.
We have been very impressed with CMD’s deep understanding of the medical device industry and investment landscape.