Additive Manufacturing of Medical Devices worldwide regulatory status and latest developments in industrial standards

11:30-12:00

【Profile】

Great inventions require great product development! Enora is a Mechanical Engineer passionate about helping inventors develop their concept into successful commercialized products. She specializes in identifying and addressing early-stage product factors for success.
She has over 30 years’ working as an R and D Engineer, Principal Engineer, and Manager at companies such as Johnson and Johnson and Dow Corning. After starting her company in 2007 she began consulting for various mid-size and start-up companies.
Additive Manufacturing (AM), also known as 3D printing, is an essential new manufacturing method. Enora is currently engaged with companies providing state-of-the-art solutions. She is a member of leading organizations driving standardization and advancement of this industry.
Degrees and Certifications: SB SM Mechanical Engineering, Massachusetts Institute of Technology, Certified Reliability Engineer (ASQ), Additive Manufacturing Certificate (SME). Licensed Professional Engineer, State of Florida, United States.
Memberships: ASTM International F42 Additive Manufacturing Committee Member, F04 Medical Devices Committee Member, ASQ (American Society for Quality)

【Abstract】

Additive Manufacturing (AM) technologies have transformed medical device manufacturing in such areas as dental procedures, prosthetics, and even implantable devices. Globally, adoption of devices produced using AM are increasing exponentially. This growth is enabled by the development of industrial standards that address the quality and safety risks introduced with AM. First, this presentation will cover how AM medical devices are characterized by various countries leading the way in adoption. Second, an overview of how standards have played a role in establishing best practices for utilizing and specifying materials, processes, product, and manufacturing operations.

Construction of a decentralized medical device development platform utilizing AM technology

12:00-12:30

【Profile】

Social Activities:
Fellowship Director, Hiroshima Biodesign
Adjunct Faculty, Center for Biomedical Eng. (CBME), Indian Institute of Technology Delhi (IITD)
Adjunct Associate Professor, The University of Tokyo

Major Professional Backgrounds:
2017-18 All India Institute of Medical Sciences (AIIMS), New Delhi, School of International Biodesign (SiB), iFellow

Educational Backgrounds:
1995-2002 Hiroshima University, Faculty of Medicine, Japan
2009-13 Hiroshima University Graduate School of Biomedical & Health Sciences, Department of Cardiovascular Medicine
2013-16 Harbor-UCLA Medical Center, Respiratory & Critical Care Physiology & Medicine, UCLA

【Abstract】

Hiroshima University has developed Biodesign program in collaboration with Government of India as part of Prefectural medical-related industry cluster formation. In US and India, they have raised the solutions of "Silicon Valley type value chain" and "emerging country type innovation driven by lean startup", respectively. Based on learning from India Biodesign, we aim to realize frugal innovation by taking technological advantage and reliability of Japan in developing medical devices at affordable price. COVID-19 pandemic required medical resource optimization. In order to promote medical technology (MedTech) development even under stagnant logistic situation, we proposed "Decentralized Platform among Local Core Institutions" with Japan Agency for Medical Research and Development (AMED) support and Hiroshima Prefectural Government. We report our experience from the viewpoint of biomedical engineering as an optimal solution promoting MedTech demonstrating resilience.

Development of heat exchanger for Inter Proto Series Engine

We are developing a heat exchanger with additive manufacturing. We will ask Mr. Masanori Sekiya to provide opportunities for testing of the Interproto, aiming to improve the oil cooling capacity.

12:30-13:00

【Abstract】

Interproto's oil cooler was originally set to be equipped only with a water-cooled heat exchanger. It was close to the limit when the outside temperature was high in the summer.
After that, due to the model change of the machine, both the water temperature and the oil temperature became higher than the old model, so the engineer added an air-cooled oil cooler to all cars.
The new model aims for a water temperature of 85 ° C and an oil temperature of 110 ° C while driving at an outside air temperature of 30 ° C.

A novel design framework for therm-fluids devices by combining additive manufacturing and optimization technologies

13:00-13:30