Take advantage of local manufacturing opportunities-Medical Plastics News

2021-11-25 08:01:23 By : Mr. Victor Wang

Thomas Bontempi, head of medical business development at Husky Injection Molding Systems, said that with the emergence of new opportunities, medical injection molding can shift to local production and integrated systems.

Brian Pieters @ Brian Pieters Corporate Vision

According to industry observers, as the global demand for medical devices increases, medical injection molding continues to maintain strong growth. As the industry expects the compound annual growth rate of the medical device industry to exceed 10%, new business opportunities are emerging globally.

Increasing prevalence of chronic diseases and an aging population are the main market drivers. In addition, healthcare expenditures in emerging economies with higher GDPs are also increasing. Another major impact is the COVID-19 pandemic, which has stimulated an explosive growth of laboratory consumables used for testing, vaccinations and other diagnostics. Growing business opportunities include pipette tips and blood collection tubes, which use integrated manufacturing methods to ensure the highest level of certainty, scalability and the fastest time to market.

Localized production is the top priority during a major epidemic, the surge in demand for medical devices caused supply disruptions. One issue that has surfaced again during the COVID-19 outbreak is the realization that 85% of the world's countries rely on imported medical equipment and components. Supply imbalances existed before, but the pandemic has accelerated demand and raised concerns about a global shortage of medical products-many of which are critical to fighting the virus.

In order to deal with the uncertainty of the future and ensure supply, many political and government initiatives have made the establishment of a local supply chain a top priority. According to McKinsey & Company, more than 90% of medical technology multinational companies (MNC) expect to achieve greater localization in the industry after the outbreak. At the same time, about 60% of medical technology multinational companies believe that local manufacturing is beneficial to their success. This scenario provides profitable opportunities for existing participants and new entrants. The looming question is whether manufacturers are ready to seize these new business opportunities.

Obviously, processors and end users are ready to take advantage of potential growth applications. Choosing the right application means balancing risks and opportunities. Conducting a risk/reward assessment is very important for selecting business opportunities that have a reasonable level of risk and complexity combined with high capacity to achieve rapid returns. During the pandemic, the production of pipette tips, blood collection tubes, and prefilled syringes has become a high-growth area that can expand the scope of penetration.

Pipette tips-used to dispense medical fluids and liquids-are a high-volume application that is expected to reach a compound annual growth rate (CAGR) of 9.7% by 2025. COVID-19, nationalization, and the demand for high-quality parts are driving growth opportunities. There are several key quality standards for pipette tip design, including dimensional tolerances, part filling (especially wall thicknesses below 0.5 mm), and concentricity (Outflow or outflow), internal and external flash and insert parting line positioning. 

Another promising application is blood collection tubes, which have seen significant growth due to the need for epidemic-related products. They consist of PET tube, HDPE cover and rubber stopper. The test tube is ready to be used when delivered to the end user, used for specific sample analysis, and has the functions of labeling, vacuum sealing to extract a specific volume and pre-filled reagents. Key design requirements include dimensional accuracy, non-brittleness, transparency, oxygen permeability, vacuum maintenance, water vapor permeability and gate quality.

Another growth area is prefilled syringes, which have become one of the fastest growing options for unit-dose drugs, driven by the increasing popularity of self-care equipment and the high demand for improved injection safety. More and more pre-filled syringes are made of plastic because they are more resistant to breakage than glass and can be manufactured for specific sizes, inner diameters and finger flange designs while maintaining strict tolerances during the production process. 

Integrated molding system brings major advantages

In order to meet the requirements of these high-volume applications, processors and OEMs are increasingly turning to integrated manufacturing systems to provide better quality, eliminate human barriers between suppliers, and accelerate time to market. Medical device manufacturing can be very complex, and the process of self-assembly of different devices can be time-consuming, costly, and inefficient. Manufacturers need to check whether they own this luxury. 

The integrated solution not only provides the highest part performance, but also provides precision and repeatability in the high-altitude manufacturing process, bringing proven medical parts to the market at an unimaginable speed and quantity. This is achieved while minimizing waste and increasing the bottom line. The goal is to combine the sub-components of the injection molding system so that they are not simply integrated together, but are designed and operated as a system. 

Husky has transferred its extensive experience and expertise in turnkey PET systems for packaging into the medical field. The company, together with its subsidiary Schöttli, is a leading manufacturer of medical molds, providing integrated systems for high-volume medical applications, such as pipette tips, blood collection tubes, and prefilled syringes. Husky provides injection molding machines, hot runners, controllers and auxiliary equipment, while Schöttli provides medical mold design and mold manufacturing expertise. Together, they provide a complete system solution that has a single source of responsibility and is specifically configured for the application.

For pipette tips, a typical fully integrated work cell is used for 2 to 128 cavity applications, combining Husky's injection machinery and Schöttli's mold components. It also includes automation equipment from third-party suppliers, such as shelves, visual controls, filter assembly, packaging, and sterilization. The system reduces complexity, reduces risk, and accelerates time to market. The Schöttli mold solution adopts a compact design to achieve high altitude and is built around the concept of an eight-cavity cluster. It also includes star-shaped nozzle hot runner technology, component accessibility for the main parting line, and efficient cooling for faster cycles. Concentricity and quality are achieved through the design concept of adjustable core and mold. For a 200 μL pipette tip, the estimated cycle time is 4.9 seconds.

For blood collection tubes, Husky's Ichor integrated system is based on the proven PET platform, providing high performance, low risk and fast time to market. The working unit includes injection molding machine, hot runner, auxiliary machine, controller and cold half mold. It provides a cycle time of 5.4 seconds and an overall system efficiency of 97%. Downstream automation can achieve various levels of IMM integration, including removal of equipment, inspection, labeling and packaging. A typical integrated system runs in an ISO 8-9 clean room and includes downstream automation from third-party suppliers.

Husky's integrated system also features Advantage Elite, a remote monitoring service with active troubleshooting capabilities that enables early detection and traceability. It analyzes the operating system and tracks changes in subsystems and hardware components. This capability is achieved through an in-depth understanding of all the building blocks of an integrated solution, as they are all provided by Husky as a single-source supplier.

Syringe startup rapidly expands in Russia                                                                               

A successful case study involving a Russian manufacturer illustrates how integrated production systems can achieve business success. Husky helped Pascal Medical (one of Russia's leading medical device suppliers) headquartered in Moscow to quickly scale up to produce high-quality products, and quickly became an industry leader. Pascal Medical hopes to reverse the import trend by establishing local production of disposable PET syringes to meet local and international standards from scratch in a short time. 

Pascal Medical is looking for technology that will enable them to produce the highest quality syringes in Russia. They lacked the preliminary ability to establish such an operation, so they recruited Husky to develop a turnkey system. Pascal Medical relies on Husky to guide them in the right way to build their injection molding capabilities.

In this case, Husky provided multiple integrated injection systems, including molds, injection machines and hot runners, to inject large quantities of disposable syringes. The company is now the largest Russian supplier of these products, producing 450 million disposable syringes annually.

As processors and end users hope to take advantage of these future business opportunities, they are keenly aware of the challenges posed by COVID-19. They saw the urgent need to establish a local manufacturing industry to avoid being hindered by dependence on imports. Integrated or turnkey production is expected to play a key role, as processors and original equipment manufacturers aim to work with partners who can provide the necessary technical expertise and expertise to effectively scale up operations and quickly bring final products to market.

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