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Summer Solstice, the longest day of the year is soon here for the Northern hemisphere. It has been marked by festivals and rituals throughout the world since prehistory.
This month’s MedTech Gateway from Access-2-Healthcare will send you into the latter half of the year, full of advances in medical device technology. |
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The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023.
Guidance on the transition to new manufacturer evidence for IVD medical devices will be published soon.
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Phase out of ISO 13485 certificates for IVD medical devices |
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Guidelines for entering application documents for classification and definition of medical devices (draft) released is |
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The Center for Medical Device Standardization Administration (NPMA) has released guidelines for entering application documents for classification and definition of domestic and foreign medical device products.
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NEC Thailand to build digital health platform for supporting elderly and patient care
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NEC Corporation (Thailand) Ltd. (NEC Thailand), has signed a Memorandum of Understanding (MoU) with Chiang Mai Municipality to develop smart city solutions and transform Chiang Mai into a smart city, starting with a digital platform for the district’s healthcare system. The system will support healthcare facilities in Chiang Mai that are housing the elderly and chronically-ill patients. The MoU will also explore the feasibility of utilizing other applications within the community under the “Smart Hospital” theme.
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Medical Radionuclide Innovation Programme |
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Under the Department for Energy Security and Net Zero, this Programme will support development of technologies that may enable future access to medical radionuclides. The Innovation Project Workstream is now open for applications.
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Scivita Medical’s Headquarters, R&D and Manufacturing Plant Officially Opened
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Scivita Medical’s headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP). This momentous occasion marks a significant milestone for Scivita Medical as it consolidates its key operations, encompassing R&D, production, marketing, doctor training, product display, and experiential activities. The establishment of the plant will serve as a strong foundation for Scivita Medical to enhance its R&D capabilities as well as sales capabilities, further upgrade its production capacity and improve product competitiveness. It reflects Scivita Medical's commitment to its core strategy of “globalisation”
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Korea-Sweden partnership to address radiologist shortage with AI-powered mammography analysis
Lunit, a leading global provider of AI-powered cancer diagnostic solutions, today
announced the signing of a supply and license agreement with Capio S:t Göran Hospital (Stockholm), Sweden’s largest private hospital with over 2,300 medical staff. Under the agreement, Lunit will provide S:t Göran Hospital with Lunit INSIGHT MMG, an AI solution for mammography analysis, for the next three years.
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Ideas vs Concepts, Mockups vs Prototypes |
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When we have contact with the researchers or doctors that have the next big idea in MedTech, sometimes the word ‘idea’ and ‘concept’ may be used interchangeably. In truth, is there any difference between them?
Idea – could be seen as a hypothesis that’s not yet user validated. It could be some thoughts being put together and presented as a possible solution. A concept is considered a structured solution where the clinical workflow and it needs to be user validated for the development work to continue.
This is quite similar to the difference between a “mockup" and a "prototype” – where a mockup is putting together some existing items or components to create the proposed solution, and the prototype comes from creating parts or modules (that are not verified or minimally verified) from technical drawings or software architecture.
Why it is important to distinguish between them? It is important to determine when the appropriate moment is to proceed towards proof of concept – which is to validate the value of the proposed solution. It is also a point to determine when the appropriate method is to request for funding. Ideas and mockups are usually too early, whilst concepts and prototypes especially after 1 iteration may be suitable for seed funding.
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Although summer holidays are coming, get ready for the second half of the year with these MedTech events! |
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