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Dear Access-2-Healthcare Community,
We’re thrilled to present our December newsletter, filled with insights, updates, and events in medical device world. Join us on a journey through the latest happenings in the industry. As we wrap up 2023, we extend our heartfelt thanks for being an integral part of the Access-2-Healthcare family. May this festive season bring you joy, and may the coming year be filled with continued growth and prosperity.
Warm regards,
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Guidance - MDCG endorsed documents and other guidance
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New guidance documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. |
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MFDS updates IVD clinical performance testing institutions list |
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The MFDS released the list of designated IVD clinical performance testing institutions (list in Korean). Notably, this list now includes 107 IVD clinical performance institutions following the designation of a new institution.
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EU4Health grants €4 million to improve healthcare for Ukrainian refugees and displaced persons under temporary protection |
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The European Commission is launching today a project backed by €4 million from the EU4Health program, to help improve access to healthcare for Ukrainian refugees and displaced persons benefitting from temporary protection in Bulgaria, Czechia, Estonia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, and Slovakia.
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On the 14th of December, the Infrastructure and Medical Device Administration (IMDA) - Ministry of Health and Medical Devices Diagnostics Sector Committee under The European Chamber of Commerce in Vietnam (EuroCham) signed a Memorandum of Understanding.
With the consent of the leaders of the Ministry of Health and related units, the sign-ing ceremony between IMDA and the Medical Devices Diagnostics Sector Committee under The European Chamber of Commerce in Vietnam (EuroCham) in the coming time will continue to enhance effectiveness and achieve many important results, contribute to the growth of the Vietnamese medical device market. |
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2nd Vice-Minister of Health and Welfare Park Minsoo attended the 16th Tripartite Health Ministers' Meeting, which was held on Sunday, December 3, in Beijing, China, to discuss ways of strengthening cooperation in healthcare, including joint responses to infectious diseases, under the theme of “Work together for a healthier and safer future”. At the first face-to-face meeting in four years, the representatives of the three countries confirmed their commitment to strengthening bilateral and tripartite strategic cooperation in the area of healthcare, including health security for peace and security in the Asia-Pacific region.
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Brain-machine interfaces… coming soon to a cerebrum near you |
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Smartbrain technology may be common by the 2040s, says a leading UNSW Sydney biomedical engineering academic. It might seem like something out of Star Trek, but people controlling so-called ‘smartbrains’ with their own thoughts could happen sooner than you think. A smartbrain is a more common term for what biomedical engineers refer to as a brain–machine interface (BMI) – that is, a direct communication pathway between electrical activity in the brain and an external device such as a computer or a robotic limb.
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Beta Bionics integrates iLet bionic pancreas with Dexcom G7
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Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced today the nationwide launch of the iLet Bionic Pancreas automated insulin delivery system with the Dexcom G7 Continuous Glucose Monitoring (CGM) System planned for December 18, 2023. With a firmware update, users will be able to update their iLet to integrate with Dexcom G7 without any additional cost for new hardware.
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Meet the musical robot breaking down barriers for people with disabilities
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Researchers at the University of Nottingham have developed a musical robot that can help musicians with disabilities to improvise and access instruments in a way that hasn’t previ-ously been possible. Jess+ has been developed as part of the DigiScore project, which is the first large-scale col-laboration between the university’s Department of Music, Orchestras Live, and Sinfonia Viva. The AI robot helps musicians with disabilities to collaborate as part of a mixed en-semble and to improvise in the creation of live scores where dexterity can be a barrier.
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From the other side of the fence – Distributors |
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“I would like to have a wing-to-wing approach to market entry” “A one stop service is preferred”
These are some of the statements from manufacturers who on one hand feel that they have a great product offering (which oftentimes is true), and therefore “we have to be careful to select the best distributors to represent our product”
Have manufacturers thought about the risks and investment that distributors have to consider?
1. Product-market-fit – if the manufacturer had no idea, then it is up the distributor to decide if there is indeed one. Sometimes without sufficient product knowledge from the manufacturer it is a shot in the dark, or worse, over-promise from the manufacturer.
2. Exclusivity – with investment, the last thing a distributor wants to hear is that they are not exclusive to this market. Yes, perhaps there are good reasons why it is needed to ensure more than one channel (large country coverage, for example) but seriously you would start with one, albeit restricted to one area of the country, then expand as needed, either with the same distributor, or to add another.
3. Various costs: marketing and promotion, business development and sales re-source, regulatory approvals. These would easily run to tens of thousands of USD. There would be some things that a distributor will very much appreciate – for example, sharing some of the market promotion costs. Yes, manufacturers all want the distributors to have ‘skin in the game’, what about the manufacturers themselves?
4. Product support – even in the early phases, product knowledge, training, and especially in-market presence are all part of the manufacturer showing commitment to the market, especially to understand actual market sentiment. This is something the distributor would appreciate very much but oftentimes it is all left to the distributor to ‘sort it out’. After the product enters the market, whether if it is a service job or a product return, some manufacturers aren’t the most supportive because they had done so many spot deals that it be-comes out of control (for example, one export manager or service manager to manage 80 countries running from South America to Australia!)
Yes, there are also (large or bogus) distributors that would take manufacturers for a ride. Therefore, this mutual lack of trust still occurs today. There would be some ways that Access-2-Healthcare can help, either with independent license holding, or distributor due diligence / monitoring, or even supporting the manufacturer to set up their own local entity and providing human resources (email us for more information). But it starts with each party all willing to put in some effort to really benefit patients in the market, and not hope something sticks on the wall to make a quick buck.
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27th GHWP Annual Meeting/TC Meeting in Shanghai, China |
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On November 29, 2023, the 27th Global Harmonization Working Party (GHWP) was held in Shanghai, China with 600+ participants from 25 countries taking part. From personal experience, this is one of the larger GHWP annual meeting as the National Medical Products Administration (NMPA) have put on a great show along with the local industry and its association in great support. See more about the meeting in this blogpost.
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The holiday seasons are here, so get packing and visit some of these MedTech events! |
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