Asia PharMed&HealthCare Thailand Digital Issue.4

ISSUE NO.4 www.ipriasia.com

Medical Technology - Equipment & Device - Pharmaceutical - Manufacturing - Health Care & Technology Information

Medical & Device

Zero-Contact Medical Station for a Safe and Rapid PCR Covid-19 Testing

COVID-19 Update

How COVID-19 vaccines are regulated for safety and effectiveness

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MEDICAL TECHNOLOGY PHARMACEUTICAL

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As the world faces challenges due to Covid-19, which has disrupted lifestyles of people regardless of their race or skin color, all across the world. And as the digital technologies, the upcoming 5G network have provided people with fast and broad access to information, helping to connect people across borders. Increasing production efficiency in the manufacturing sectors, thanks to the full speed and unlimited connectivity, making the world a smaller place like one could never have imagined before.

This edition of Digital Magazine for industrial sector of Pharmaceutical, Medical Equipment & HealthCare that you are now reading the latest updates on modern technologies for the manufacturing industry of Pharmaceutical, Medical Equipment & HealthCare so that everyone can access latest technologies from the manufacturers and for the manufacturing industry instantly and with efficiency. It also allows you to access to information in digital format enable you can easily forward and share the information to those that are relevant.

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Lavene S. Taypin

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CONTENTS COVID-19 Update

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Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness

Healthcare & Technology Swisslog Healthcare Supports Correctional Health Care Advancement Through Donation to National Commission on Correctional Health Care Foundation Inspiring Women’s Healthcare: Mindray Unveils Nuewa I9, a New OB/GYN Diagnostic

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Health innovation Council on the Economics of Health For All issues brief on equitable health innovation

manufacturing

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MEDICAL TECHNOLOGY

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MEDICAL & Device NEWS

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Two Component Molding Solves Medical Design Challenges and Reduces Costs Zero-Contact Medical Station for a Safe and Rapid PCR Covid-19 Testing

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The Philippines Unveils Unique Advantages in Covid-critical PPE and Medical Supplies Manufacturing at Japanese Business Event

INDUSTRY ASSOCIATION Launch National wide COVID-19 Vaccination rollout at Bangsue Central Vaccination Center, Thailand NSTDA converts Sirindhorn Science Home to a COVID-19 field hospital for people with disabilities

September 1-3, 2021 EH 102-104, BITEC, Bangkok

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COVID-19 Update

By WORLD HEALTH ORGANIZATION

Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization Healthcare professionals and public health authorities have a central role in discussing vaccination against COVID-19 with their patients. Vaccines play a critical role in preventing deaths, hospitalisation caused by infectious diseases. Emerging data on effectiveness indicates that licenced COVID-19vaccines are contributing to controlling the spread of the disease. Until widespread vaccination has been achieved, both vaccinated and unvaccinated people need to be aware of the additional protective behaviours required to control the pandemic locally.

The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines.

This includes a focus on the development of vaccines and their regulatory review and safety monitoring. Much of this coverage has taken place through mass and social media. Reports of adverse events (side effects) have led some people to express concerns about getting vaccinated, delay getting vaccinated or even be strongly opposed to

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vaccination. There are also differences in individual confidence in national safety monitoring systems. Another challenge in communicating the importance of COVID-19 vaccination is that younger adults are typically less clinically affected by COVID-19 infection and so may see limited value in getting vaccinated, including until further data confirms that vaccines prevent transmission and that vaccines are effective against variants. Clear and consistent communication is therefore essential to support people in making the choice to be vaccinated.

We appreciate that you, your colleagues and your patients may have a number of questions around the development, regulatory review and ongoing safety monitoring of COVID-19 vaccines. healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety is closely and continually monitored after approval.

Vaccination has been shown to contribute to reducing deaths and severe illness from COVID-19, and to reduce the transmission of COVID-19. Vaccinating as many people as possible and reducing the spread of disease is important. Vaccination of a significant proportion of the population also protects vulnerable people, including those who cannot receive vaccines, or the small proportion of people who might remain at risk of infection after vaccination. Failure to vaccinate widely also enables continued circulation of the virus and the generation of variants, including some that may pose a greater risk. Widespread vaccination will help prevent people from having to go to hospital and contribute to fewer people getting sick, ultimately alleviating the burden of COVID-19 on healthcare systems. It will also help allow a return to normal societal functioning and the re-opening of economies.

Vaccines and the regulatory process How do regulatory authorities evaluate COVID-19 vaccines?

Regulators rigorously evaluate scientific and clinical evidence provided by vaccine manufacturers. Vaccine manufactures are legally obliged to follow defined standards in the data they provide, and their clinical research and manufacturing operations are subject to regulatory oversight. Either full or summary data from clinical trials is made available following vaccine evaluation. Each vaccine is thoroughly assessed for safety, efficacy and pharmaceutical quality to determine whether it can be approved for use. Regulators use available scientific evidence from preclinical laboratory research, human clinical trials, and manufacturing information to assess benefits and risks of candidate vaccines.

Regulators may seek additional expert advice from independent scientific advisory committees to help inform their decision on whether to approve a vaccine. These committees are made up of experts in science, medicine (including infectious diseases) and public health, and often include consumer and healthcare professional representatives.

Public health agencies have a different role than regulatory authorities. They develop and deliver vaccination programmes, often working with their expert immunisation technical advisory committees. This includes prioritising and designating populations for vaccination with specific vaccines, issuing additional recommendations and providing information more broadly about vaccines and immunization.

They also collaborate with regulators to monitor the safety of vaccines after they are approved for use.

Globally, the public can have confidence in the rigour of the process used to scientifically evaluate the safety, efficacy and quality of vaccines before they are approved for use in the wider population.

Safety evidence prior to potential regulatory authorisation: Safety evidence is an essential part of each regulatory submission for a COVID-19 vaccine. It is gathered during all phases of the vaccine development process. Robust assessment of safety is carried out in the clinical trials and submitted to regulators for review as part of the approval process.

All adverse events need to be examined and reported in the regulatory submission by the companies for a marketing licence. Typically, regulators will require that participants in clinical trials have been followed for at least 1-2 months after receiving their final vaccine dose. Generally, based on previous experience with vaccines, most adverse events occur within such timeframes, though rare adverse events might not be recognised until after wide population use.

There will also be longer-term (for example for 6-12 months or more) follow-up of those who participated in the earlier phases of the clinical trials of each vaccine. Many trial participants will also be followed for at least one year to assess the duration of protection and longer-term safety of individual vaccines, and safety data from these longer-term trials will be carefully reviewed by regulators as part of post-approval monitoring of safety.

Efficacy: Apart from information on the types of immune responses induced by the vaccine, companies must submit data from well-designed clinical trials to regulators to demonstrate that the vaccine prevents COVID-19. The data showed there were sufficient numbers of people included in the clinical trials receiving the vaccine so that the efficacy of the vaccine can be accurately measured (generally at least 10 000 and usually 15 000 or more people who receive the vaccine, in addition to those in the control arm). Populations in clinical trials should include a range of age groups and people with co-morbidities. Given the disproportionate impact of COVID-19 on older people, COVID-19 vaccine clinical trials have included significant numbers of older participants.

Vaccine clinical trials for a new candidate vaccine showed that vaccines very significantly reduced COVID-19 in people who were vaccinated, compared to a control group of

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COVID-19 Update

By WORLD HEALTH ORGANIZATION people who did not receive the vaccine, through a reduction in numbers of laboratory confirmed SARS-CoV-2 infections.

Quality: Any COVID-19 vaccine that receives regulatory authorisation must be manufactured according to internationally accepted stringent regulatory standards of good manufacturing practices (GMP). Regulators review data to confirm that the manufacturing process at each production site is well-controlled and consistent. This will include data on the composition and purity of the vaccine and its potency, as well as data on every step of manufacturing and on the controls used to ensure that each batch of vaccine is consistently of a high quality. Data on vaccine stability must also be provided before a vaccine can be approved.

After approval, batches may also undergo evaluation by individual national regulatory authorities to ensure they meet national requirements, before they can be supplied.

Monitoring safety and effectiveness after vaccine approval: After a vaccine is approved for use, regulators conduct robust effectiveness monitoring as well as monitoring of safety and risk minimisation activities (pharmacovigilance).

They need to continuously monitor vaccine safety to ensure that the benefits of the vaccine continue to outweigh the risks. Regulators do this by: Reviewing and analysing adverse events reported by healthcare professionals and consumers and requiring industry vaccine companies (sometimes called “sponsors”) to report to regulators on adverse events received both within the regulator’s home country and globally ; Many regulators will implement enhanced passive surveillance systems. These include systems to rapidly compare numbers of suspected side effects reported with vaccines to the numbers of events expected to occur by chance, and include access to near real-time data on vaccine usage in different settings. Several regulators also implemented traceability systems for different vaccine brands and batches; Taking rapid action to mitigate risks, also considering the information about emerging safety issues shared among regulators and researchers through international collaboration ; Reviewing medical literature and other sources of new safety information ; Requiring vaccine manufacturers to continue safety surveillance from the ongoing clinical trials of their products; and Many regulators also require vaccine manufacturers to have risk management plans describing how they will monitor and minimise risks, including further epidemiological studies, associated with their vaccines.

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It is very important that healthcare professionals not only diligently report any adverse events they see in their patients, but also encourage people who are vaccinated to immediately report adverse events to their healthcare professionals or to the medicines regulator in countries where direct reports from members of the public are accepted by the regulator. Reporting all relevant events helps regulators assess the possible role of the vaccine in causing the adverse event and assists in identifying safety issues relating to newly introduced vaccines.

As part of the safety monitoring and review of all suspected side effects reporting for vaccines, regulators have developed lists of “Adverse Events of Special Interest”. These lists include some events that have been associated with other vaccines (for example anaphylaxis). Others are included on these lists because they are serious events that are important to monitor extremely closely, even though there is no evidence that they are causally associated with specific vaccines. Having information on the background rates of these events that would be expected in people who have not received a vaccine will help ensure that any increased reporting of these events can be quickly detected and thoroughly investigated by regulators.

The widespread use of COVID-19 vaccines, including in the elderly and in patients with underlying health conditions, will unfortunately mean that there will be deaths and serious illnesses that are purely coincidental and unrelated to vaccinations. The job of each regulator, together with the relevant medical experts and vaccine manufacturers is to determine causality. There will be a special focus on monitoring safety in some groups of people, such as pregnant women, persons with severe pre-existing illness, older people, children, and in people also receiving vaccines for prevention of other diseases.

Regulators, often in collaboration with public health authorities, are able to take decisive action if a safety issue is identified. These actions might include: issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions such as restriction of vaccine authorisation to a particular subgroup of the community or revocation of authorisation.

Commonly reported adverse events The most commonly-reported events with COVID-19 vaccines are expected vaccine side effects, such as headache, fatigue, muscle and joint pain, fever and chills and pain at the site of injection. The occurrence of these adverse events is

consistent with what is already known about the vaccines from clinical trials.

Adverse events of special interest Regulators approve and maintain an approval of a vaccine only if they determine that the known and potential benefits of the vaccine outweigh its known and potential risks.

Anaphylaxis is a very rare side effect that may occur with any vaccine. There have been some other reported adverse events which include facial weakness, seizures, loss of sense of taste or small and cardiac events, but none are confirmed to be causally related to the vaccines. mRNA vaccines The major adverse event of special interest reported for these vaccines, which include the Pfizer and Moderna vaccines is anaphylaxis. Regulators carefully review the reports of possible anaphylaxis to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Anaphylaxis reports remains very rare (in the order of 10 cases per million vaccinated).

Guidance on the management of possible anaphylaxis is included in the Product Information/Label for these vaccines.

Routine vaccination procedures include keeping people under observation for at least 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed. These vaccines should not be given to people with a known history of a severe allergic reaction to any of the vaccine components. A second dose of mRNA vaccine should not be given to those who have experienced anaphylaxis to the first dose.

There have been some other reported adverse events, which include unusual bleeding and blood clotting disorders, facial weakness, seizures, loss of sense of taste or smell and cardiac events. Regulators monitor and carefully review if there is a causal relationship between the vaccines with those adverse events, and, if appropriate, they will be included in Product Information / Product Label of vaccines of concern.

Adenovirus vector vaccines These include the AstraZeneca, Janssen, Gamaleya and CanSino Biologics vaccines. Internationally, the AstraZeneca and Janssen COVID-19 vaccines have been associated with a very rare and unusual clotting syndrome involving thromboembolic events (blood clots) with thrombocytopenia (low blood platelet count). This condition has been termed Thrombosis with Thrombocytopenia Syndrome (TTS).

Medicines regulators are meeting regularly to share information about cases to better characterise this risk and understand this syndrome. Less information is available internationally about adverse events following the Gamaleya and CanSino Biologics vaccines.

The overall number of reports received of blood clots in the veins or arteries (including venous thrombosis or venous thromboembolism) occurring without thrombocytopenia is no higher than the expected background population rate for the more common type of blood clots in most countries.

The spontaneous reporting rates of thromboembolic events with thrombocytopenia vary by country and the precise incidences are difficult to estimate, but for the AstraZeneca vaccine, based on substantial use in Europe and the UK, the frequency of such events is very rare. Available estimates are of the order of 10-15 per million people vaccinated (note that for some countries this statistic is based on the numbers of reports of suspected cases of TTS rather than numbers of confirmed cases). Thromboembolic events with thrombocytopenia have also been reported in the United States for the Janssen vaccine, at a rate of about 2-3 per million doses administered. National regulators are continuing to monitor the issue closely and to publish up to date information on the numbers of cases reported and the latest estimates of the incidence.

The cases of thromboembolic events with thrombocytopenia after vaccination were mainly reported for younger rather than older individuals. This, together with the risk of serious illness or death associated with COVID-19 being much higher in middle-aged and older people, has led public health authorities in some countries to recommend that vaccination with the Astra Zeneca vaccine not be initiated in younger individuals.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia as well as coagulopathies after vaccination as TTS requires specific management. Vaccinated individuals should be instructed to seek immediate medical attention if they develop symptoms such as a severe or persistent headache, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain or unusual skin bruising and/or petechiae (tiny purple, red, or brown spots on the skin) mostly occurring within around 4-20 days after vaccination, although some cases have been reported later than 20 days post vaccination. This information is in the Product Information / Product Label of the vaccines as approved by regulators.

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HEALTH CARE & TECHNOLOGY INFORMATION

By Swisslog Healthcare

Swisslog Healthcare

Supports Correctional Health Care Advancement Through Donation to National Commission on Correctional Health Care Foundation Swisslog Healthcare supports the NCCHC mission to progress correctional health care.

Swisslog Healthcare is pleased to announce today that they have made a gift to the National Commission on Correctional Health Care (NCCHC) Foundation, making Swisslog Healthcare a Bronze Partner in the foundation’s Partners in Correctional Health Annual Giving Society.

The NCCHC Foundation’s mission is to champion the correctional health care field and serve the public by supporting research, professional education, scholarships and patient reentry into the community. Swisslog Healthcare is committed to lead change for better care, transforming medication management for correctional facilities and pharmacies, by delivering an automated medication packaging and dispensing technology that saves valuable employee time and ensures accuracy in medication administration.

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“We are deeply grateful to Swisslog Healthcare for their partnership. Their trust in the NCCHC Foundation helps demonstrate the importance of corporate leadership and supports our mission,” said Jennifer Riskind, Director, NCCHC Foundation.

“As a market leader in corrections pharmacy automation technology solutions, Swisslog Healthcare is excited to partner with the NCCHC Foundation to support their mission to champion the correctional health care field as it aligns with our mission to lead change for better care,” said Mike Carmody, Vice President of Long-Term Care at Swisslog Healthcare. “It is important to us to support health care development for correctional facilities and ensure effective population health management.”

Over the last year, correctional facility clinicians not only provided typical health care and medication needs for inmate patients, but also were challenged with learning how to provide care in a pandemic and treat numerous inmates infected with COVID-19. Meeting the medication needs of inmate populations has become increasingly more challenging, especially since most correctional facilities are facing inadequate staffing levels.

For nurses, the corrections environment demands a high level of flexibility and efficiency as they move between performing intake exams, performing medication calls and dealing with emergency situations such as serious injuries or psychological trauma. Furthermore, the nationwide nursing shortage means fewer nurses must cover more ground with less time. Some nurses are required to do mandatory overtime due to not enough staff to meet the facility’s needs. This contributes negatively to retention and employee health. Additionally, as COVID-19 cases rise some facilities are using nurses to perform law enforcement duties due to existing correctional officer staffing shortages, which furthers issues of nursing staff leaving. One study on nurse retention in a correctional facility detailed that, after a period of three years, only 20% of nursing staff remained employed.

searching for medication management automation solutions to ensure accuracy and efficiency.”

A leading provider of in-facility packaging and dispensing systems, Swisslog Healthcare offers medication automation solutions to correctional facilities enabling them to simplify medication administration, provide down-to-the-dose accountability, reduce waste and decrease avoidable drug spend. Swisslog Healthcare’s InSite® In-Facility Medication Packaging and Dispensing System transforms the process of medication dispensing from a tedious, error prone set of tasks to an efficient, automated workflow.

Correctional professionals can see a demonstration of the InSite System in the Swisslog Healthcare virtual booth at the Spring National Commission on Correctional Health Care Conference on April 27-28.

For more information on Swisslog Healthcare or packaging and dispensing automation, visit swisslog-healthcare.com/corrections.

To minimize the impact of these challenges, correctional facilities are streamlining medication management processes by using automation technology to package and dispense medications on demand. In-facility medication packaging and dispensing systems can help by eliminating time consuming, tedious processes for correctional nursing personnel and freeing up more time for higher value tasks.

This enables better adherence to recommended therapies, ultimately leading to a healthier population.

Through in-facility packaging, medications are organized into labeled, individual pouches for each inmate by their location. This not only increases medication accuracy but significantly speeds up the medication administration process, providing a smoother, more organized medication call line. One Swisslog Healthcare customer reported it previously took 4 nurses, in one facility, 3 hours each to set up their medications and then pass their medications.

Now, with the medication packager, they can deliver medications for their entire facility in less than 30 minutes.

“In the past, health care technology adoption has been gradual for correctional facilities,” said Mike Carmody.

“However, today, the challenge of staffing issues is contributing to facilities changing their mindset and expediently

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Healthcare & Technology

By Mindray

Inspiring Women’s Healthcare:

Mindray Unveils Nuewa I9, a New OB/GYN Diagnostic Ultrasound System

Mindray (SZSE: 300760), a global leading developer and provider of medical devices and solutions, has introduced the Nuewa I9, its latest cart-based ultrasound system and tailored solution for Obstetrics and Gynecology (OB/GYN).

Committed to inspiring women’s healthcare, Mindray’s Nuewa I9 elevates scanning capacity to new levels by combining innovative design and exceptional imaging quality with the latest technologies.

“Nuewa I9 offers an unrivaled ultrasound scanning experience in its class. Each feature and innovation have been deliberately designed to address the daily challenges of OB/GYN clinicians. The result is a full-stack smart solution for extraordinarily efficient care, which covers the entire continuum from pre-pregnancy to obstetrics and postpartum,” said He Xujin, General Manager of Mindray Imaging System Division.

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Nuewa I9 boasts a well-thought-out design for the ultimate convenience. Its foldable height and compact body allow the system to easily pass through doors for quick access across departments. Meanwhile, the breakthrough examspecific iConsole control panel is optimized to adapt to different clinical scenarios, and its E-ink keys can be easily customized for the most frequently used functions.

The entire solution is powered by Mindray’s revolutionary ZST+ platform, which overcomes traditional trade-off limitations to deliver exceptional image quality for infinite imaging solutions with non-stop improvements. Nuewa I9 is also packed with automated tools to improve workflow and efficiency in women’s and neonatal care, such as Smart-VTrace, Smart Pelvic and Smart Hip.

One of the biggest innovations featured in Mindray’s Nuewa I9 is Smart Scene 3D, a scenario-oriented volume scan technique that enables the automatic identification of tissue characteristics and provides an organ-specific diagnosis. The technology supports the whole examination procedure starting with auto clinical scenario identification, then harnesses automation at every point from imaging optimization to plane acquisition, quantification, and the creation of an automated workflow. As a result, Nuewa I9 alleviates the workload of manual operation; reduces scanning time for individual patients; and delivers atruly easy, accurate and fast diagnosis.

Nuewa I9 also makes 3D/4D interactions extremely intuitive with reduced knob adjustments. Clinicians need only to click and choose their desired effect for different application scenarios, such as Routine, iLive, Bone, Tissue, and Follicle. Preset imaging settings have been integrated in the system for optimal volume imaging effects, and support ease of use in every possible clinical scenario for OB/GYN. For more information visit : https://www.mindray.com/en/index.html

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MEDICAL TECHNOLOGY Article BY Freudenberg Medical

Two Component Molding Solves Medical Design Challenges and Reduces Costs

Device manufacturers count on their supply chain partners for answers. What processes can be adjusted to add value and reduce cost? What methods can be used to streamline manufacturing processes, reduce SKUs, and improve part quality? One way is by moving from single component molding to two-component molding.

What is Two-Component Molding Two-component molding is a method of combining parts that require different characteristics or material properties that one material alone cannot provide. It is a sophisticated injection molding process that requires specialized equipment and a high level of engineering beyond single material injection molding.

Resins with different properties are combined in a single part often to improve functionality, product differentiation, aesthetic appeal, or marketability over traditional designs.

The process is commonly referred to as two-shot, 2K or 2C molding and often involves the combination of hard ther 14

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moplastics and a soft thermoplastic elastomer (TPE). In some applications the material properties of TPEs are not sufficient so thermoplastics are utilized alongside a silicone elastomer.

One example of a product produced using a two-component method is a medical device housing. A housing requires material that is durable to ensure the protection of interior components but also requires material that will deliver aesthetic appeal. A device handpiece is another example, a product that needs to be rigid or sturdy, but at the same time requires material to provide good grip and handling to facilitate user control.

Combining multiple materials can provide enhanced physical properties, such as resistance to certain media, UV shielding, and resistance to drug migration into the outside wall. With hard-soft two-component molding, the hard component provides the strength (typically the base or substrate), while the soft component acts as a sealant, insulation, or generates good haptics.

Advantages of Two-Component Molding The two-component injection molding process adds value for the device manufacturer because they do not have to spend the capital to build and validate two different molds. This process also reduces assembly or eliminates it altogether while reducing the amount of part numbers, which further simplifies the overall manufacturing process.

Advantages of Two-Component Molding The two-component injection molding process adds value for the device manufacturer because they do not have to spend the capital to build and validate two different molds. This process also reduces assembly or eliminates it altogether while reducing the amount of part numbers, which further simplifies the overall manufacturing process.

Other advantages include: • Lower costs with fewer steps, fewer parts, less assembly, and less manual labor • Higher quality due to fewer defects, as manual labor leads to defects ‑and potential contamination • Reduction in waste • Improved quality, aesthetics, and functionality by combining different materials with different physical properties • Reduction in cycle time provides faster manufacturing and throughput • Combining multiple part performance into one component The overall cost with two-component molding is lower because there are fewer steps involved in manufacturing a product. If the right materials are selected the components will form a strong chemical bond to the underlying surface which eliminates the need and associated costs for some secondary finishing operations such as priming,

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MEDICAL TECHNOLOGY Article BY Freudenberg Medical painting, or coating. When these steps are combined into a single injection molding process, it increases part quality, reduces waste, boosts throughput, and decreases overall production costs.

Medical device manufacturers understand the need to provide aesthetic appeal in order to help their products stand out against the competition. TPEs are a good way to improve aesthetics since they come in a wide range of colors and can be tinted to provide visual appeal or engineered with a custom finish.

Medical applications ideal for two-component molding include: • Sealings or gaskets integrated into a housing or the outer case of a part • IVD cartridges, e.g.,TP with integrated seal • Luer connectors with strain relief • Stem connectors or manifolds for pharmaceutical filling lines • Housings with TPE for aesthetics, feel, or haptic sensation • Syringe piston seals • Hubs and connectors with a kink resistant portion

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• Soft touch handle grips and components with ergonomic and aesthetic features • Multicolor parts • Parts with molded seals, flexible hinges, or movable components • Technical parts that reduce vibration, dampen noise The Two-Component Molding Process Two-component injection molding is achieved by molding one material over or onto another material. The process of overmolding combines multiple materials into one molded part. It typically consists of two materials, a rigid substrate covered in whole or in part by a more pliable material such as a thermoplastic elastomer or thermoplastic polyurethane. This two-component injection molding process is the most efficient method to produce parts with two plastic materials, which gives the designer multiple functions in one design or in one part.

Technically a two-component part can be realized with two machines. A component is produced in machine 1 and then loaded into machine 2 to mold the second component.

This process duplicates the effort with the use of two

machines and two molds. A more sophisticated two component process utilizes one machine with rotating cavity plates or sliders or a combination of the two. Machines with up to six barrels are the latest evolution in multicomponent technology and can deliver even more functionality to a medical device designer. These machines can incorporate multiple resins with unique performance properties or colors.

• Choose materials that are compatible with each other • Modify one component to improve compatibility with the second component • Choose materials that have similar surface energies • Use mechanical interlocks, where a component is designed to flow around the injected component.

• Use surface treatments such as plasma activation • Use wet chemical treatments to apply a primer layer

For additional cost saving benefits, a hot runner system or systems can be added to the molding operation to eliminate runner waste. The addition of a hot runner system decreases cycle time and results in better process control and ultimately

Some applications make specific use of components that do not bond to each other. By using incompatible polymers, designs can be assembled in-mold during the molding process. With this approach parts can be produced with a hinge, pivot point, or sliding element without the need for additional assembly or downstream processing steps.

Material Selection Choosing the right material is essential to a device’s success in its application and in the marketplace. When it comes to selecting materials for a two-component application, the most critical factor is making sure the materials are compatible. Materials must bond together both chemically and physically in order to produce a strong finished part with a long service life. If materials are not compatible the result may be component deformation or other bonding failures like delamination, in which the different material layers fall apart.

TPEs are typically used for the overmolded soft-touch layer and they represent a rapidly evolving segment of material science. Advanced TPEs have been developed that expand the capabilities for bonding high-performance thermoplastic resins to hard plastic substrates and their performance, appearance and functionality are constantly improving. The higher-bonding properties between TPEs and substrate base materials give two-component molding a manufacturability advantage over standard single material injection molding, broadening the range of applications and design possibilities. However, a complete understanding of how the selected materials interact at all stages during the process is essential for high-quality, efficient production.

The Role of Bonding Some material combinations are compatible for bonding while others require pretreatment such as an additional coating layer that is compatible with both materials in order to forge the bond. Other materials are not compatible and require bonding which can be achieved by a variety of methods or a combination of methods listed below:

A working example of this would be a stopcock made of two dissimilar materials. The substrate is typically a hard thermoplastic such as a polycarbonate, which does not typically bond to a number of different TPE’s. This twocomponent manufacturing step would result in a handle able to turn to operate the stopcock without the secondary operation of assembly.

Conclusion The two-component molding process is an efficient and cost-effective way to provide custom plastic parts using two or more resins or colors in one operation. As a supply partner it is important to make customers aware of advanced manufacturing techniques and deliver innovative ideas so that they can leap ahead of their competition. A good supplier will advise the customer on the best processing methods and the most cost-efficient solutions to achieve their goals while enabling the customer to focus on the application and regulatory aspects.

Medical device manufacturers will save money by working with contract manufacturers that embrace two-componentmolding and other innovative ideas to reduce manufacturing costs. The end result is higher quality, less waste, simplified validation, and a streamlined process with fewer parts in the final device. Ultimately, it results in an improvement in the overall customer experience.

This article was written by Lars Gerding, Director of Technology, and Tom Diaz, Manager, Engineering and New Product Development at Freudenberg Medical.

For more information visit www.FreudenbergMedical.com

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MEDICAL & Device NEWS

By Proclinical

Zero-Contact Medical Station for a Safe and Rapid PCR Covid-19 Testing

Brain Navi Biotechnology Co., Ltd., a brain surgery robotic company, is launching “zero-contact” medical stations in hospitals across Taiwan, fully protect medical staff and patients from the cross-infection of “highly contagious diseases.” The biggest risk of infection for medical staff is during intubation, nasal swabbing, and personal protective equipment (PPE) removal, says Dr. Jerry Chen, the Brain Navi CEO. He adds that “Since the SARS crisis in Asia 17 years ago, there was no advancement in the protection technology for medical staff. How could medical staff protect us if they are not well protected in the first place?”.

As a physician himself with a full understanding of the frontline medical staff’s anxiety, this motivates Dr. Chen to reimagine testing for infectious diseases using robotics, enabling zero-contact between medical staff and patients.

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The Zero-Contact Medical Station with robotics technology is creating a new normal of Covid-19 testing in Taiwan.

Medical staff and patients stay in an isolated chamber with safety features, including HEPA filter, UVC lamps, a ventilation system, and a negative 8 Pa air pressure. Under medical staff’s control and supervision, a Nasal Swab Robot performs the nasopharynx specimen collection.

This allows the medical staff to achieve nasal swabbing without patient contact and eliminates the need to wear a PPE. Nasal Swab Robot just obtained the CE mark with Class I. The Zero-Contact Medical Station achieves zero-contact swabbing and pipetting tasks for lab technicians.

After swabbing, an automated robot will then pipette the collected specimen and prepare an essay for PCR diagnosis. The robotic systems are integrated with Roche’s RT-PCR device allowing automatic and efficient process. The entire testing process from robot’s collection to result generation can be done in 25 minutes.

Through robotics automation and consolidation of PCR lab and diagnosis in one medical station, the Zero Contact Medical Station protects medical staff and minimizes precious staffing, improves lab testing capacity, and reduces transport and reporting time.

The zero-contact features and rapid PCR testing with minimal staffing make this station an ideal solution for large-scale testing at public venues such as cruise ships, stadiums, and airports, allowing your country to reopen the economy or commence the travel bubble with safety measures. To find out more about the Zero-Contact Medical Station, please visit our website https://brainnavi.com/zerocontactstation/.

For More Information : www.brainnavi.com

DIGITAL ISSUE NO.04 : JUL 2021

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health innovation

By Pharmaceutics International, Inc

Council on the Economics of Health For All issues brief on equitable health innovation

Leading economists and health experts call for a health innovation ecosystem governed by “the common good” The WHO Council on the Economics of Health for All, which comprises leading economists and health experts from across the globe, today called on governments, the scientific and medical community and private sector leaders to re-design the health innovation ecosystem toward delivering health technologies for the common good.

In the Council’s first brief, its members called on the public and private sectors to work collaboratively to deliver needed vaccines, therapeutics, diagnostics, and other essential health supplies that are available equitably to those who can benefit.

The Council Brief recommends both immediate and longterm action, urging all stakeholders to work towards creating

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a health innovation ecosystem characterized by purposedriven and symbiotic public-private partnerships that put the common good front and center.

Mobilizing money to throw at solutions that fail to address the underlying causes of longstanding structural problems will not be sufficient,” according to the Council Brief. “We all must look forward towards reimagining health innovation as part of a new economic ecosystem that can deliver Health for All.” The Council has made clear that just patching up the existing system will not work. Deep change is needed on how intellectual property rights are governed to drive collective intelligence, how corporate governance is structured, and how the benefits of public investments are shared to avoid the current dynamic of sharing risks but privatizing rewards.

To build an inclusive end-to-end health innovation ecosystem able to deliver the appropriate medical technologies required to achieve Health for All equitably, the following building blocks are critical: Creating purpose-driven innovation through a missionoriented approach.

Reshaping knowledge governance to nurture collective intelligence.

Reforming corporate governance to be more long-term and purpose-oriented.

Seventy-fourth World Health Assembly and the G20 Global Health Summit co-hosted by Italy and the EU earlier this month.

Building resilient manufacturing capacity and infrastructure.

Introducing conditionalities for public investments to build symbiotic public-private partnerships.

Strengthening the capacity of the public sector on both the supply and demand side.

In the short-term, the Council, in its brief, adds its voice to the growing calls for urgent action in four areas:

The Council, which was established by the World Health Organization in November 2020, is chaired by noted economist Professor Mariana Mazzucato, Professor of the Economics of Innovation and Public Value and Founding Director in the Institute for Innovation and Public Purpose at University College London.

Its patron is H.E. Sanna Marin, Prime Minister of Finland.

Available vaccine doses should be redistributed immediately, not as acts of charity, but as a shared imperative for pandemic control and inclusive, equitable and sustainable access.

In addition to Professor Mazzucato, members of the council are Professor Senait Fisseha, Professor Jayati Ghosh, Vanessa Huang, Professor Stephanie Kelton, Professor Ilona Kickbusch, Dr Zélia Maria Profeta da Luz, Kate Raworth and Dame Marilyn Waring. Dr Vera Songwe will join as a special guest.

Technology transfer and building manufacturing capacity must be supported and financed, not as the responsibility or property of any single actor, but as a collective responsibility towards building health greater health security and resilience in all regions, governed as common goods.

Inaugural council member Linah K Mohohlo, the former Governor of the Bank of Botswana (1999-2016), passed away on 1 June 2021.

Knowledge should not be kept as privatized intellectual property under monopoly control but considered collective rewards from a collective value creation process to be openly shared and exchanged.

For More Information : https://www.who.int/news/item/ 09-06-2021-council-on-the-economics-of-health-for-allissues-brief-on-equitable-health-innovation

Existing mechanisms set up to address the above aspects, including COVAX, ACT-Accelerator, and the Covid Technology Access Pool, should be utilized and strengthened, not as an approach to fix market failures, but as turning points for creating market-shaping approaches.”

The Council’s brief came ahead of the G7 Leaders’ Summit under the U.K.’s Presidency, which aims to build back better from the COVID-19 pandemic, including by strengthening resilience against future pandemics; and following the

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MANUFACTURING The Philippines Unveils Unique Advantages in

Covid-critical PPE and Medical Supplies Manufacturing at Japanese Business Event

Today, the Philippine government in partnership with the Japan Hygiene Products Industry Association (JHPIA) organized an online briefing with JHPIA members to promote investment opportunities in the Philippines for manufacturers of PPE, hygiene products and medical supplies based in Japan. The webinar showcased the competitive advantage of the Philippines as a manufacturing base for companies not only from Japan but also from neighbouring markets such as Taiwan, South Korea and Malaysia.

The Philippines currently has an active and productive PPE manufacturing sector, with 300 businesses engaged in the textile and garments industry and a highly skilled workforce of 510,000 capable of efficiently producing PPEs. On a monthly basis the Philippines is now producing over 80 million face masks, 10.2 million pieces of medicalgrade coveralls and 65,700 face shields.

The Philippines also has a large and well-established chemical and chemical products sub-sector, the second largest contributor to manufacturing GVA with a value

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of $8.6 billion and employing over 200,000 people. The medical supplies industry in the Philippines is estimated to contribute at least $165 million in sales annually. With the sudden increase in demand for disinfectants, including rubbing alcohol, hand sanitizers and cleaning materials, local companies which have been traditionally engaged in the production of alcoholic beverages, personal care, and food manufacturing transformed their facilities to produce sanitizers, disinfectants and similar products.

With the high global demand for PPE, hygiene products and medical devices amid worldwide shortages caused by the Covid-19 pandemic, the Philippine Government has developed programs to provide financing support and additional fiscal and non-fiscal incentives to assist companies, which include the unhampered movement of goods and personnel and reduced corporate income tax.

To date, 42 production lines including textile factories, garment plants and yarn spinning mills have been repurposed to manufacture PPE, and over 1.5 million litres of alcohol, sanitizer and hand spray are now produced monthly in the Philippines.

Lanie Dormiendo, OIC Director of the Philippines’ Board of Investments said: “Our large population, rich talent pool and access to key markets open up various opportunities for Japanese manufacturers of PPEs, hygiene and other related products as they explore business expansion or diversification. Our country can serve both as their market and manufacturing base for exports. Throughout this unprecedented global health emergency, the Philippines has proven itself as a manufacturing hub for PPE and other medical supplies vital to fighting the pandemic.

We did not impose import or export restrictions and even assisted foreign manufacturers and exporters including Japanese firms at the height of the lockdowns enabling them to continue their factory operations.”

Ferdinand Ferrer, Vice Chairman of the Coalition of Philippine Manufacturers of PPE (CPMP) adds: “Heeding the call of the government to repurpose manufacturing to produce medical grade PPE products and fabric, CPMP was established to strengthen the growth of our local PPE manufacturers and sustain our supply chain. We are open to partnerships and investments from our Japanese counterparts to explore more opportunities and further develop our capabilities.”

The Japanese face mask manufacturer Yokoisada is one of several international businesses to successfully set up operations in the Philippines.

Yuki Yokoi, CEO of Yokoisada comments: “The strategic location of the Philippines has been a great advantage for our company because our main markets are in East Asia and ASEAN. There is also available a skilled and English-speaking workforce. During the lockdown, the DTI-BOI has assisted us in the transit of our employees, movement of cargoes, and sourcing of raw materials. Encouraged by the support from the Philippine government, our company recently decided to expand and double our current production capacity with the financial assistance we received from the Japan’s government subsidy for its supply chain diversification program.”

The BOI together with the Philippine Trade and Investment Centers in Tokyo and Osaka will host two other industry-focused webinars for businesses considering expansion or relocation to the Philippines: a multi-sector business-to-business event which will take place on 29 March, followed by a pharmaceutical industry event on 20 May. For further information about the events and other support available from BOI visit: www.philippines.business.

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INDUSTRY ASSOCIATION

bY WHO THAILAND

Launch National wide COVID-19 Vaccination rollout at Bangsue Central Vaccination Center, Thailand Thailand’s Prime Minister and Minister of Public Health, in the presence of multiple ministers, senior government officials and the WHO Representative launched the national wide COVID-19 vaccination rollout at Bangsue Central Vaccination Center. This is the biggest vaccination center in Thailand, and will provide approx. 10,000 jabs per day – a major contribution to achieving Thailand’s goal of providing 96 million doses of COVID-19 vaccine in the next 200 days.

As of today, there are 993 vaccination centers in Thailand, at least 25 centers in Bangkok, 25 centers operated by social security offices, 11 centers operated by universities, and 10 central vaccination centers such as Bang Sue Central Station, Rajanukul Institute, Srithanya Hospital, Bang Rak Medical Center, etc. All vaccination centers in provinces are providing standardized vaccination services.

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H.E. Mr Anutin Charnvirakul, Deputy Prime Minister and Minister of Public Health, mentioned that “Everyone living in Thailand who wants to be vaccinated will be vaccinated free of charge” Dr Daniel A. Kertesz added that “Today, Thailand took a big step in its fight against COVID-19. Vaccines against COVID-19 work – they have saved thousands of lives around the world and they will do the same in Thailand. All adults in Thailand should get vaccinated as soon as they can.”

For More Information : https://www.who.int/thailand/news/detail/07-06-2021launch-national-wide-covid-19-vaccination-rollout-atbangsue-central-vaccination-center-thailand

INDUSTRY ASSOCIATION

bY National Science and Technology

NSTDA converts Sirindhorn Science Home

to a COVID-19 field hospital for people with disabilities As the COVID-19 infection cases continue to rise, field hospitals have been established for asymptomatic COVID cases and those with mild symptoms. However, most, if not all, of these field hospitals cannot accommodate patients with disabilities. With the cooperation of Sirindhorn National Medical Rehabilitation Institute (SNMRI) and the Department of Empowerment of Persons with Disabilities, NSTDA has turned Sirindhorn Science Home to a field hospital to treat COVID-19 patients with disabilities aged between 15 and 65.

Located at the Thailand Science Park, Sirindhorn Science Home was designed to serve as a permanent science camp, fully equipped with facilities for training workshop and exhibition, including houses for visiting professors, student dormitory, exhibition hall, lecture and workshop rooms and basketball court and swimming pool.

Scheduled to open on 1 June 2021, the Sirindhorn Science Home Field Hospital for Disabled Persons will occupy the dorm rooms located on the 5th to the 10th floor of the building with a total of 224 beds. 11 assistive technologies and innovations developed by NSTDA and its partners will used in the hospital. These include mobile robot for transport and delivery of material, UV sterilization robot, Thai Telecommunication Relay Service (TTRS) supporting

people with hearing impairment and negative pressure isolation and transport chamber. SNMRI will provide medical staff to treat patients and the Department of Empowerment of Persons with Disabilities will provide social workers to assist patients and their families on social issues.

On 26 May, NSTDA welcomed a visit of Deputy Prime Minister Jurin Laksanawisit, MHESI Minister Anek Lao thamatas, Deputy Minister of Public Health Satit Pitutecha and Permanent Secretary of Ministry of Social Development and Human Security Patcharee Arayakul to inspect the facility, meet with team preparing for the field hospital operation and view COVID-19 response innovations on display.

For More Information : https://www.nstda.or.th/en/news/news-years-2021/1372nstda-converts-sirindhorn-science-home-to-a-covid-19field-hospital-for-people-with-disabilities.html

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Event calendar NSTDA converts Sirindhorn Science Home 02 - 05 Sep 2021 BITEC

West Africa Pharma & HealthCare Show 21 - 23 Jul 2021

http://careexpothailand.com/en/

www.westafricapharmahealthcare.com

www.healthandsafetyevent.com

WegVoraus

Nineteen Events Ltd

BEST ORGANIZER CO., LTD

Healthcare & Medical Cosmetology Expo

Medicall Chennai

https://www.chanchao.com.tw

30 Jul - 01 Aug 2021 hennai Trade Centre, Chennai, India https://www.medicall.in

Chan Chao International Co., Ltd

Medexpert Business Consultants Pvt. Ltd.

22 - 25 Jul 2021 Taipei Nangang Exhibition Center

PharmaTech Expo 19 - 21 Aug 2021 (GUCEC), Ahmedabad, India https://pharmatechexpo.com PharmaTechnologyIndex.com Pvt. Ltd.

Warsaw Dental Medica Show 09 - 11 Sep 2021 PTAK WARSAW EXPO, Poland https://dentalmedicashow.pl/en/

Ptak Warsaw Expo 26

Accra International Conference Center

ASIA PHARMED & HEALTHCARE THAILAND

Expo Med 01 - 03 Sep 2021 Centro Citibanamex, Mexico https://www.expomed.com.mx Informa Markets - Mexico

Cosmofarma Exhibition 09 - 12 Sep 2021 bologna fiera, Bologna, Italy www.cosmofarma.com/it/ Bologna Fiere

The Health & Safety Event 07 - 09 Sep 2021 NEC, Birmingham, UK

Vietnam Medi-Pharm Expo 12 - 14 Aug 2021 Saigon Exhibition and Convention Center http://hcm.medipharmexpo.com/en

Vietnam Nation Trade Fair & Advertising Company

Medical Fair China 09 - 11 Sep 2021 Suzhou International Expo Center http://www.medicalfair.cn/en/ Messe Dusseldorf (Shanghai)

MAGHREB PHARMA Expo 28 - 30 Sep 2021

CIC Algiers, Algiers, Algeria www.maghrebpharma.com Easyfairs Brussels (Global)

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