Chunnan Chen
Freelance Consultant
Experience
Jan 2021 - Present
3 years 6 months Aschaffenburg, Germany
Freelance Consultant
Chen International Consulting
- Medical devices
- Clinical evaluation under EU MDR
- Risk-based biological evaluation
- Post-Market Surveillance System incl. Post-Market Clinical Follow-up
- Product development and clinical & regulatory strategy of novel medical technologies
- Life Sciences & MedTech
- Fundraising incl. research & innovation funding program, from project conceptualization and proposal writing phase to implementation and project exploitation
- Market research; technology evaluation; marketing & sourcing in Taiwan
Jan 2013 - Dec 2021
9 years Aschaffenburg, Germany
Manager/ Investorangelegenheiten/ Key Account Manager
emka MEDICAL GmbH (formerly CGS Sensors GmbH) combined with MI Medical Innovation GmbH
- Joined as co-founding partner of the German start-up MedTech company CGS Sensors in Aschaffenburg (later renamed to emka MEDICAL) in March 2013, with Prokura from then on to November 2020;
- Spearheaded clinical application development of innovative medical sensor technologies, based on scientific literature together with intensive brainstorming with KOLs;
- Spearheaded fundraising with successful EU and Bavarian fundings secured under MI Medical Innovation & emka MEDICAL respectively;
- Spearheaded market research and regulatory strategic planning;
- Spearheaded clinical evaluation (acc. MEDDEV 2.7/1 rev 4) & biological evaluation (acc. ISO 10993-1:2018) procedure development and implementation under the EU MDD & MDR;
- Participated in R&D of novel and innovative medical technologies.
- CorLog Probe 1P – invasive intracardiac blood pressure monitor for mobile patients in cardiopulmonary applications (Class III under MDR) – market research, R&D (device intended uses and indications, polymer material analysis, biological evaluation, clinical evaluation), clinical and regulatory strategical planning, custom-made devices in clinical use
- Bayerisches Forschungsprogramm „Medizintechnik“ (BayMED): “Drucksensorkatheter mit Konnektivität zur mobilen Überwachung von Patienten mit Herzinsuffizienz” (Nov 2016 - Nov 2018)
- CorLog – key and major grant writer of Seal-of-Excellence awarded EU Horizon 2020 SMEi Phase 2 project: No. 718249: “Clinical validation and new business creation for a novel biomarker panel measuring central venous pressure, central venous and right atrial oxygen contents, for remote monitoring of heart failure” (Nov. 2015)
- Sniff-Nose – sole grant writer and executor of granted EU Horizon 2020 SMEi Phase 1 feasibility study project – Sniff-Nose: A novel double-point intravascular diagnostic probe with continuous monitoring of the biomarker panel, dual oxygen tension PcvO2 and PcsO2, for clinical assessment of heart failure (Sep 2015 - Oct 2015)
- Medical app – Cor/log View, (Class IIa under MDD) software as a Medical Device (SaMD) – market research, R&D (vital parameters presented, device intended uses and indications, clinical evaluation), clinical and regulatory strategical planning
- Invasive pulse wave velocity (PWV) sets (Class IIa under MDD) – market research, R&D (in vivo/ ex vivo PWV measuring technologies, device intended uses and indications, biological evaluation, clinical evaluation), clinical and regulatory strategical planning
- Medical thermometer patch (Class IIa under MDD) – market research, R&D (device intended uses and indications, clinical evaluation), clinical and regulatory strategical planning
- Non-invasive EIS biomolecule monitor (EIS Reader + EIS Cell/ EIS Wristband) (Class I under MDD)– market research, R&D (preclinical evaluation of EIS on measuring biomolecules in comparison with enzymatic measurements, device intended uses and indications, clinical evaluation), clinical and regulatory strategical planning, PMCF study
Jan 2009 - Dec 2013
4 yearsInvestment Manager
LAFA LifeTech, Inc.
- Lead technical, clinical & market analysis of MedTech & life science start-up companies, with deals from both the US, China and Taiwan;
- Responsible for international business development of two German companies, MHM Harzbecher Medizintechnik GmbH and CGS Sensors GmbH, with the focus in Taiwan and China;
- Participated in negotiation of Joint Venture between CGS Sensors GmbH (Germany) and WEGO (Shangdong Weigao Group, China);
- Responsible in co-founding the German start-up MedTech company, CGS Sensors GmbH;
- Offered consulting service to the industries for Taiwan government grant funding and participation in European research and innovation projects.
Jan 2008 - Dec 2009
2 years Taiwan, Province of China
Special Assistant to the President
TaiMed Biologics Inc.
- Participated in establishing R&D pipeline projects of drug development for viral infection diseases;
- Successfully licensed anti-H1N1 compounds from Academia Sinica;
- R&D project management, and outsourcing contracts;
- Participated in planning and establishing the biopharmaceutical research laboratory;
- Assisted executive management and leadership in developing and executing strategic government affairs;
- Participated in governmental grant fund-raising, including proposal.
- Ibalizumab (TMB-355) clinical development project, the first humanized monoclonal antibody (mAb) developed for the treatment of HIV-1 infection by blocking viral entry
- Tamiphosphor preclinical anti-H1N1 pharmaceutical development project
Jan 2004 - Dec 2009
4 years Taiwan, Province of China
Specialist & Visiting Officer
Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), Taiwan (ROC)
- Governmental outsourced project management at the Food & Pharmaceuticals Sector in the areas of life science, medical devices and food
- Participated in execution and planning of the industrial policy of Taiwan on medical devices & aging-related industries;
- Coordinated sector business of the Food & Pharmaceutical Sector;
- Participated in MOEA IDB project management of Taiwan's participation in international APEC Life Science Innovation Forum.
Jan 2003 - Dec 2009
6 years Taiwan, Province of China
Assistant Project Manager
Medical & Pharmaceutical Industry Technology & Development Center
- Responsible for executing “Project of Healthcare and Medical Devices Industrial Technology Development and Promotion” contracted by the Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), Taiwan. This project ran from March 2003 to February 2008.
- Responsible in international cooperation.
- Approached Taiwanese and foreign medical device companies to facilitate match-making collaboration cases for bilateral industrial cooperation between Taiwan and foreign countries.
- Served as the Taiwan contact window at the medical device sector in Industrial Cooperative Conference of Taiwan and the Czech Republic.
- Served as Representative for the bilateral cooperation in medical device industries in the 2004 Taiwan Official Industry Delegation to the Czech Republic and Hungary; and in the 2006 Economic Delegation to the Czech Republic, Poland, and Slovakia.
- Organizing conferences.
- Key member in coordinating international medical devices regulatory seminars and conferences sponsored by Department of Health, Taiwan.
- Spearheaded business development to establish collaborations on herbs between herbal companies in the Czech Republic and Poland, and Medical & Pharmaceutical Industry Technology & Development Center.
Summary
Experienced professional with more than 19 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations; expertise in corporate operation, governmental affairs, financing, R&D, product development, pre-clinical and clinical evaluation, external research collaborations; familiar with medical device regulations related to marketing products in EU, US and Taiwan.
Languages
Chinese
Native
German
Native
English
Advanced
Education
Oct 1993 - Jun 1997
National Tsing Hua University
Life Science · Taiwan, Province of China
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