SINGAPORE MEDICAL DEVICE SCHOOL EXPERIENCE

Continuing education is very much important these days in a medical device industry that is growing really fast on top of regulations that are ever changing and I was fortunate enough for the opportunity given by PAMDRAP to be able to attend the first run of the Singapore Medical Device School that would be an annual event starting next year. The first day was very exhausting for me as I need to find where the venue was which was Biopolis, I thought it was Temasek Polytechnic but I was able to locate Biopolis later without much delay. The very first of the lectures was on understanding the regulatory landscape globally and how it affects Asia, it thought the participants the key organizations involved in affecting the regulatory framework globally and the importance of taking part into molding the global regulations. This was followed by a comprehensive report on the medical device regulatory requirements and updates per member country in the ASEAN which is actually a run through of the reports from the last AMDC in Manila. A panel discussion took place after the tea break with the medical device KOLs in Asia including a representative from RAPS. Challenges on the regulatory requirements were discussed in the afternoon session in selected markets/economies, including that of China, Taiwan ROC, India, Japan, USA (includes 510k and QSR), Australia and New Zealand. The schedule was tightly packed everyday day, it starts at 8:30AM and extends up to 6:30 to 7:00PM, the topics discussed were very important though like further in the afternoon session of the first day, medical device reimbursement process in Australia was discussed, product and process changes was also tackled in a global perspective, the difference between a device and an IVD was also a topic. A very lengthy discussion was allotted to CE marks covering general requirements, IVD-CE and MDR-CE, emerging regulatory controls on radiation and wireless medical device was also among the topics, the day was concluded on a lecture on Med tech start-ups which admittedly bridged the gap between regulatory processes and the client needs to provide innovative technologies to the public.

Day 2 started with a very interesting lecture that showcases the support of Singapore to the Med tech industry, the Singapore Biodesign. What is good with the Medical Device School training program is that it shows not only the regulatory aspect but also the details on how an invention comes to life in a very complicated market and in a highly regulated industry. QMS was the main focus of the AM session covering the quality aspect of the entire product life cycle including ISO 13485 and ISO 14971, more importantly, the lecture also gives the participants a peak on how the certification body thinks. The lecture on Singapore Biodesign earlier in the morning was further supplemented by the designing process of new and innovative medical device (really cool!) A heavy regulatory affairs topic concludes the rest of the day including – the IEC requirements both for electrical and electromagnetic testing as well as software validation; cybersecurity and data protection was also added as a supplementary to the IEC discussion; biocompatibility including toxicology of the device were discussed; sterilization and packaging validation was detailed; QMS of production, warehouse and distribution was the highlight of the day followed by a separate QMS set-up discussion, which completes not just the regulatory understanding of QMS but how to bring QMS to the SMEs; the QMS set-up was only the beginning, a series of discussions dedicated to start-ups in the Med tech industry followed including physical set-up of the plant, contract outsourcing and even collaboration opportunities and setting up a clinical strategy for the medical device clinical trial. Another topic that highlighted the supremacy of Singapore as a leader in the ASEAN region for Med tech is being showcased through its National Health Innovation Center lecture where a sound support by the Singaporean government may be availed to improve Med tech. The day was concluded through a panel discussion on the clinical aspect of medical device.

Day 3 is more on a managerial crash course on the management of a medical device start-up company. I appreciate the topics very much as we hear regulatory details everyday as regulatory professionals but we seldom hear about what goes beyond regulatory like how to ensure business continuity, marketing strategies and pitching a product to investors. The day started with a discussion on medical device market trend and opportunities, a need-based approach from the patients was repeatedly emphasized. The barriers and appropriate strategies were also provided by the roster of expert speakers but the strategies presented are not just suggestions, they actually are help that may be provided by the Singaporean government via the MedtechBOSS eNetwork, at this point in the training, one can feel how proud Singaporeans are of the help their government provides and how everybody wished they are from Singapore. The next topic talks about healthcare softwares and e-commerce including the apps that are getting so much attention these days. A lot of soft skills were discussed throughout day 3 including standard hospital procurement of medical devices, code of ethics in the medical device industry, human resources management in medical device companies, fund raising and pitching to support new and innovative products as well as awareness of funds and support from both private and government sectors. Minor regulatory topics were also given attention like patents, trademarks and liabilities; labelling; UDI barcode requirements and updates; PMS in medical devices including handling complains, post-market clinical follow-up and FSCA; and GDP for importers and distributors.

Finally the 4^th day came so fast and this day was purely dedicated to Med tech innovation at the laboratory level. A refresher on the medical device development was made but with a touch of engineering, the next lecture was on genetic engineering and tissue engineering which was further broaden to stem cells discussion, clinical chemistry aspects was also a topic and later in the afternoon, advanced topics like 3D printing and microfluidics wrapped up the classroom setting. A plant visit concluded the day where the class went to JTC Med tech hub’s manufacturing sites and were able to keep in touch with actual SMEs of Med tech that started up in Singapore. The event was very enriching professionally, I hope that more people will be able to experience what I experienced as at the end of the day, I went home to the Philippines inspired of how much potential is just waiting to be nurtured onwards growth in the local med tech industry.