NHIC organised Regulatory and Product Engineering workshops on 17 January 2018 targeted at clinicians and innovators developing their medtech innovations. The workshops spread over two half-day sessions were attended by project teams from all three healthcare clusters - SingHealth, NUHS and NHG.
The participants were provided with insights into significance and process of developing regulatory strategy, design specifications and product risk assessment along with hands-on exercises for their respective innovations. Teams also benefitted from NHIC engaged specialist consultants’ expertise and facilitator initiated discussions.
The Regulatory workshop, conducted by Ms May Ng, Managing Director of ARQon emphasized the importance of understanding regulatory bodies’ requirements, approval timelines, quality management system, documentation preparation including building a compliant design history file with applicable standards as essential milestones in medical device innovation. Teams subsequently worked on developing a regulatory strategy and completed a design control exercise for their respective innovations.
The Product Engineering workshop, conducted by Mr S C Cheong, Managing Director of Mdesign Solutions, touched upon ideation, conception, prototyping and potential pitfalls in medical device development. Participants were given insights into translation of product features into technical specifications, assessing prototyping vendors, conceptual costing estimation and risk control in product development. Participants were actively involved during the hands-on exercise on design output and risk assessment for their respective innovations.
Positive and encouraging feedbacks were received from the participants with strong recommendations that NHIC should organise more such workshops for clinicians and innovators. Do stay tuned for the next workshop to be held in the second half of 2018.
“Excellent interactive workshop highlighting the importance of regulatory and engineering design aspects for clinician-driven innovations”.
- A/Prof Sng Ban Leong, Head & Senior Consultant, KK Women's and Children's Hospital.
“I’m glad that there was time for team discussion and hands-on - it was most beneficial as it allowed our team of clinicians and engineers to discuss in greater detail on our regulatory strategy specific to our innovation”.
- Dr Liu Yuchun, National Dental Centre Singapore.
“The Regulatory and Engineering workshop organized by NHIC offered useful information on Quality Management System and Product Development. It can be very helpful for start-ups that spun off from research institutes”.
- Jane Wang, CEO, Roceso Technologies.
“The workshop serves as a great introduction on the cycle of a new medical device. I also learnt about the things I should be informed and equipped with for proper documentation of product’s efficacy”.
- Janet, TTSH.