medical – Asia Pacific Metalworking Equipment News | Manufacturing | Automation | Quality Control

Precision In Medical Practice — Machining Medical Device Components

Christellee — Fri, 18 Oct 2024 00:29:14 +0000

Annika Langéen, Vice President Offer Management and R&D Sandvik Coromant, explains how small part machining supports precise, accurate medical device component manufacturing.

In the intricate world of medical device manufacturing, where precision is paramount and innovation saves lives, a strong production process is key. From crafting tiny bone screws to fabricating complex hip replacement parts, there is high demand for accuracy, reliability and efficiency.

The medical device industry encompasses a wide array of products designed to diagnose, monitor and treat medical conditions. From diagnostic equipment to implantable devices, the industry caters to the evolving needs of healthcare professionals and patients worldwide.

Today, there are an estimated two million different kinds of medical devices on the global market, categorised into more than 7,000 device groups, according to the World Health Organisation (WHO).

Challenges In Medical Device Manufacturing

Manufacturing components for medical devices presents unique challenges that demand advanced machining solutions. End-users rely on these devices being manufactured to the highest quality, as any products that do not meet quality standards can cause huge disruption. Entire operations could be paused, products recalled, organisational reputation damaged and patients’ lives at risk.

Additionally, regulatory requirements are stringent in this field. There are international standards around quality management — such as ISO 13485, risk management and ISO 14971 — as well as regional regulations such as 21 CFR and FDA for the US and EU MDR for the European Union, which all devices must meet.

The requirement for such high accuracy means manufacturers cannot risk even a millimetre of differentiation between components, so having a robust machining setup is paramount.

Read more in our Digital Edition —> https://shorturl.at/KJVFw

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Research Reveals Almost Half Of FDA-Approved AI Medical Devices Lacked Clinical Validation

Christellee — Tue, 10 Sep 2024 08:33:26 +0000

An article on Nature Medicine disclosed a thorough analysis of clinical validation data for 500+ medical AI devices, approximately half of the tools authorised by the U.S. Food and Drug Administration (FDA) lacked reported clinical validation data.

Source: Medical Xpress

While the world ravels at the wonders of Artificial intelligence (AI) being the cornerstone of prognosis breakthroughts, a multi-institutional team of researchers at the UNC School of Medicine, Duke University, Ally Bank, Oxford University, Colombia University, and University of Miami have been on a mission to build public trust and evaluate how exactly AI and algorithmic technologies are being approved for use in patient care.

Together, Sammy Chouffani El Fassi, a MD candidate at the UNC School of Medicine and research scholar at Duke Heart Center, and Gail E. Henderson, Ph.D., professor at the UNC Department of Social Medicine, led a thorough analysis of clinical validation data for 500+ medical AI devices, revealing that approximately half of the tools authorized by the U.S. Food and Drug Administration (FDA) lacked reported clinical validation data.

AI has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumour removal accuracy. Despite their potential benefit to doctors and patients alike, these tools have been met with skepticism because of patient privacy concerns, the possibility of bias, and device accuracy.

“Although AI device manufacturers boast of the credibility of their technology with FDA authorization, clearance does not mean that the devices have been properly evaluated for clinical effectiveness using real patient data,” said Chouffani El Fassi, who was first author on the paper.

“With these findings, we hope to encourage the FDA and industry to boost the credibility of device authorization by conducting clinical validation studies on these technologies and making the results of such studies publicly available.”

Since 2016, the average number of medical AI device authorisations by the FDA per year has increased from two to 69, indicating tremendous growth in commercialisation of AI medical technologies. The majority of approved AI medical technologies are being used to assist physicians with diagnosing abnormalities in radiological imagining, pathologic slide analysis, dosing medicine, and predicting disease progression.

AI is able to learn and perform such human-like functions by using combinations of algorithms. The technology is then given a plethora of data and sets of rules to follow, so that it can “learn” how to detect patterns and relationships with ease.

From there, the device manufacturers need to ensure that the technology does not simply memorise the data previously used to train the AI, and that it can accurately produce results using never-before-seen solutions.

Regulation During a Rapid Proliferation Of AI Medical Devices

Following the rapid proliferation of these devices and applications to the FDA, Chouffani El Fassi and Henderson et al. were curious about how clinically effective and safe the authorised devices are. Their team analysed all submissions available on the FDA’s official database, titled “Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices.”

“A lot of the devices that came out after 2016 were created new, or maybe they were similar to a product that already was on the market,” said Henderson. “Using these hundreds of devices in this database, we wanted to determine what it really means for an AI medical device to be FDA-authorised.”

Of the 521 device authorisations, 144 were labeled as “retrospectively validated,” 148 were “prospectively validated,” and 22 were validated using randomized controlled trials. Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data.

A few of the devices used “phantom images” or computer-generated images that were not from a real patient, which did not technically meet the requirements for clinical validation.

Furthermore, the researchers found that the latest draft guidance, published by the FDA in September 2023, does not clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

Types Of Clinical Validation And A New Standard

In the realm of clinical validation, there are three different methods by which researchers and device manufacturers validate the accuracy of their technologies: retrospective validation, prospective validation, and a subset of prospective validation called randomized controlled trials.

Retrospective validation involves feeding the AI model image data from the past, such as patient chest X-rays prior to the COVID-19 pandemic. Prospective validation, however, typically produces stronger scientific evidence because the AI device is being validated based on real-time data from patients.

This is more realistic, according to the researchers, because it allows the AI to account for data variables that were not in existence when it was being trained, such as patient chest X-rays that were impacted by viruses during the COVID pandemic. Randomised controlled trials are considered the gold standard for clinical validation. This type of prospective study utilises random assignment controls for confounding variables that would differentiate the experimental and control groups, thus isolating the therapeutic effect of the device.

For example, researchers could evaluate device performance by randomly assigning patients to have their CT scans read by a radiologist (control group) versus AI (experimental group).

Because retrospective studies, prospective studies, and randomised controlled trials produce various levels of scientific evidence, the researchers involved in the study recommend that the FDA and device manufactures should clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

In their Nature Medicine publication, Chouffani El Fassi, Henderson and others lay out definitions for the clinical validation methods which can be used as a standard in the field of medical AI.

“We shared our findings with directors at the FDA who oversee medical device regulation, and we expect our work will inform their regulatory decision making,” said Chouffani El Fassi.

“We also hope that our publication will inspire researchers and universities globally to conduct clinical validation studies on medical AI to improve the safety and effectiveness of these technologies. We’re looking forward to the positive impact this project will have on patient care at a large scale.”

Algorithms Can Save Lives

Chouffani El Fassi is currently working with UNC cardiothoracic surgeons Aurelie Merlo and Benjamin Haithcock as well as the executive leadership team at UNC Health to implement an algorithm in their electronic health record system that automates the organ donor evaluation and referral process.

In contrast to the field’s rapid production of AI devices, medicine is lacking basic algorithms, such as computer software that diagnoses patients using simple lab values in electronic health records. Chouffani El Fassi says this is because implementation is often expensive and requires interdisciplinary teams that have expertise in both medicine and computer science.

Despite the challenge, UNC Health is on a mission to improve the organ transplant space.

“Finding a potential organ donor, evaluating their organs, and then having the organ procurement organization come in and coordinate an organ transplant is a lengthy and complicated process,” said Chouffani El Fassi.

“If this very basic computer algorithm works, we could optimize the organ donation process. A single additional donor means several lives saved. With such a low threshold for success, we look forward to giving more people a second chance at life.”

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Bioprinting Adoption To Propel Additive Manufacturing Market

Christellee — Mon, 05 Aug 2024 03:39:56 +0000

Increased demand for personalised and customised medical solutions like bioprinting is driving the 3D printing medical devices sector to rise by US$7.07 billion until 2028 at a CAGR of approximately 25.2%.

Source: Manufacturing Asia

“The potential applications of 3D printing in medicine are vast, from surgical planning and dental restoration to remote patient monitoring and telemedicine,” according to Technavio, quoted by Manufacturing Asia revealed. Meanwhile, a trend towards the field of bioprinting serves as another growth factor.

Additionally, findings from MarketsandMarkets Research revealed the global 3D printing bioprinting market vlued at US$1.3 billion in 2024, is expected to reach US$2.4 billion in 2029, growing at a compound annual growth rate (CAGR) of 12.7%. This growth is driven by advancements in 3D bioprinting technology, increased public-private partnerships, and its integration into pharmaceutical and cosmetic industries.

Key market drivers include adopting 3D bioprinting for precise tissue and organ fabrication, facilitating drug testing and personalised medicine. Opportunities lie in the rising demand for organ transplants, while biocompatibility issues and stringent sterilisation protocols present challenges.

Unlike traditional 3D printers that use plastics or metals, bioprinters utilise a computer-guided pipette to deposit living cells, known as “bioink,” to produce artificial living tissues. This capability has notable implications for organ replacement, potentially addressing donor shortages and reducing rejection risks by creating organs fit for specific needs.

Moreover, the market is also witnessing advances in other areas, including prosthetics, implants, and surgical equipment. Solutions such as stereolithography (SLA) and digital light processing are widely used in the production of customised medical devices, including orthopaedic implants and wearable medical devices.

Furthermore, the fields of dentistry and orthodontics benefit from 3D printing, which can be utilised for dentures, bone scaffolds, and hearing aids.

“Complex medical procedures, such as implantable and non-implantable medical devices, drug testing, and organ and tissue production, are also being revolutionised by this technology,” the report added.

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Thailand Auto Parts Makers Can Bounce Back If They Diversify

Christellee — Tue, 25 Jun 2024 00:00:09 +0000

Despite transitioning to Electric Vehicles, Thailand auto parts businesses can be resilient with a little push from the government to diversify — with auto parts making to medical devices.

Currently, steel and metal industries are hit hardest in Thailand as production costs remain high and cheap Chinese goods flow into the market. Thailand had 561 factories shutting down this year, primarily in the steel and metal industries. The Federation of Thai Industries (FTI) warns that if production costs, including energy, transportation, and interest rates, remain high, more closures are likely.

The FTI is urging the government to take immediate measures to support businesses. ML Peekthong Thongyai, the federation’s Vice Chairman, said the FTI is closely monitoring the ongoing trend of factory closures. According to data from the Department of Industrial Works, 561 factories closed between January and May, resulting in 15,342 job losses, averaging about 3,000 jobs per month.

These included 12 plastic factories, 11 metal factories, and 8 wood processing factories. Continuing high production costs, including interest rates, are raising concerns that more closures may follow.

The FTI is urging the government to implement additional measures to support business operators. However, businesses must also adapt and find ways to reduce costs. Over the past two years, low-priced goods have flooded the market, intensifying competition.

In spite of economic trials and tribulations, Thailand is certainly not backing down without a fight. Local auto parts manufacturers are being urged to adapt to the technological disruption caused by electric vehicles (EVs) and transition to the production of medical devices, which are expected to have a promising business future, the Federation of Thai Industries (FTI) added.

The Nation quoted FTI that auto parts makers familiar with internal combustion engines (ICE) are struggling to adapt to electric mobility technology, as many of their products are no longer required by EV makers.

“We will discuss this shift with the government and hope to create new product champions in the medical field,” said Isares Rattanadilok Na Phuket, vice-chairman of the FTI. “This can become another effort to stimulate the economy.”

Transition To Medical Devices

The Nation added a cluster under FTI Mobility-ONE, which is a new unit under the federation, believes auto parts producers can transition to manufacturing medical products, including some single-use devices such as test kits to diagnose illnesses, and durable items such as wheelchairs and hospital beds. Known as CFM-ONE, this cluster was established last year to support the development of Thailand’s automotive industry and help car and auto parts companies cope with challenges in their businesses.

Up to 1,700 auto parts makers are members of the FTI. Most of them are small or medium-sized original equipment manufacturers, clkassed as Tier 2 and 3 in the auto parts supply chain. Auto parts producers in Tier 1 are usually subsidiaries of global car companies.

Manufacturers in the second and third tiers, skilled in plastic stamping and tasks involving rubber and electronics-related manufacturing processes, have the potential to pivot their operations towards the production of medical devices. According to Krungsri Research, Thai medical device manufacturers are expected to enjoy solid rates of growth from 2023 to 2025, with the value of goods distributed domestically and internationally forecast to expand by an annual average of 5.5-7.0% and 6.5-7.5%, respectively.

Markets will be lifted by a number of factors, including the aged society and the accompanying rise in rates of illnesses, the threat of newly emerging diseases, rising interest in preventive healthcare in the post-pandemic era, and growth in demand for medical tourism.

According to Krungsri Research, Thailand is recognised globally for its high quality of care and low costs. CFM-ONE said it would cooperate with global car manufacturers to assist local auto parts makers who want to continue businesses in the automotive industry in shifting to producing parts for EVs.

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Thailand May Be The Next Manufacturing Base With Japan’s Support

Christellee — Sun, 12 May 2024 23:30:05 +0000

Thailand Commerce Ministry invited members of the Japan Business Federation, also known as “Keidanren”, to invest in manufacturing medical equipment, railway, aircraft, innovation, and clean-energy industries.

Source: The Nation Thailand

The event highlighted the kingdom’s suitability as manufacturing base under modern global trends. Thai trade delegates led by Deputy PM and Commerce Minister Phumtham Wechayachai met with executives of Keidanren, led by Suzuki Jun, chair of Japan-Thailand Trade and Economic Committee at Imperial Hotel in Tokyo.

During the meeting, Phumtham underscored Japan was Thailand’s third-largest trade partner last year, while accumulated investment amount from Japanese corporations made up for 25% of the kingdom’s total foreign investment, more than any other country.

He invited Japanese business leaders to invest in Thailand as well as visit the country to witness its potential. The Thai government has facilitated this by exempting visa requirements for Japanese visiting Thailand for up to 30 days since 1 January 2024, he added.

Phumtham said Thailand possesses readiness to be a manufacturing and exporting bases for various industries, adding that the government has prepared and promoted Thai entrepreneurs for new global trends that focus on green business, sustainable manufacturing, low-carbon emission and the use of renewable energy.

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High Accuracy And Absolute Repeatability For Medical Technology

Christellee — Tue, 05 Sep 2023 03:08:01 +0000

Micro-mechanical tools for endoscopy, laparoscopy (in general minimally invasive surgery) as well as implantable devices, which must provide guaranteed functionality.

Article by BalTec AG / SEA@baltec.com

In the course of technical progress, the medical devices used in surgery for minimally invasive procedures and implantable devices have become smaller and more complex. This development has also increased the need for reliable specialty tools that do not sacrifice accuracy and precision despite their ever-decreasing dimensions and associated small tolerances. For producing bone cutters, clamps, needle holders, forceps and scissors, or implantables including heart valves, gastric stimulators, cochlear implants, cardiac defibrillators, or pacemakers, the tools must be reliably produced and assembled to withstand the extreme conditions encountered during laparoscopy.

As BalTec, we have already proof in various projects that our devices can meet the most stringent requirements for such surgical devices and medical products. Check out the success.

CONSULTATION

BalTec core competence lies in the execution and development of intelligent solutions in the field of joining technology – Industry 4.0 ready. To find the optimal solution for your individual requirements, BalTec AG performs feasibility studies, the first one at no cost to you. We determine a suitable process (radial, orbital, tangential, roller forming), machine size, and necessary accessories to meet your specific requirements regarding quality and productivity—our knowledge results from over 50 years of experience in joining and assembly technology.

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How Optical 3D Measurement From Cairnhill Improves Quality Processes

Christellee — Wed, 31 May 2023 04:00:43 +0000

Optical 3D measurement technology has become an indispensable tool in various industries, from chips and electronics to automotive and medical devices. One leading manufacturer is Bruker Alicona, which offers high-precision measurement solutions for a wide range of applications with help from Cairnhill.

The accuracy of the optical measuring devices from Bruker Alicona is achieved by using Advanced Focus-Variation technology. Based on this technology, the Bruker Alicona optical 3D measuring systems by Cairnhill Metrology close the gap between classical dimensional metrology and surface roughness measurement.

The core competence is the measurement of dimension, position, shape and roughness of complex components of different shapes, sizes and materials. Furthermore, measuring steep flanks with angles larger than 87° is not a problem at all, and even surfaces with strongly varying reflection properties and greatly varying roughness are measurable.

Advanced Focus-Variation also allows measuring samples with smooth and highly polished surfaces. Plus, users benefit from repeatable, robust and stable measurements, also in production.

Where tactile methods fail, Bruker Alicona comes into the game with its optical 3D measurement technology. Users can measure both GD&T features and roughness parameters robustly, accurately, traceably and in high repeatability by using only one optical sensor. The product portfolio includes high-resolution optical measuring solutions for the shop floor and the laboratory.

Highest Precision For Electronic Components

In the field of chip and electronics manufacturing, the use of optical 3D measurement technology gained importance. The miniaturization of electronic components has made it difficult to measure and inspect their geometries with traditional measurement methods.

Bruker Alicona’s measurement solutions allow for the precise measurement of the dimension, position, shape and surface roughness of electronic components, such as PCBs, microchips, and MEMS devices.

Read more here —–> https://t.ly/rIfAU

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Improved Orthopaedic Quality Control In Medical Knee Joint Production

Christellee — Mon, 29 May 2023 01:35:42 +0000

On-machine measurement with an Absolute Arm and 3D laser scanner is making the production of innovative medical orthopaedic both more accurate and easy to achieve. Hexagon Manufacturing Intelligence demonstrates in this case study.

G&G Präzisionstechnik GmbH, located in Süßen near Göppingen, is a young and dynamic company offering high-quality industrial manufacturing of precision parts made of different materials. The business takes on projects of various sizes, from individual parts to small series, and across and range of industries including aerospace, medical technology and racing.

Secret To Success

The business’ uncompromising selection of the highest quality production materials, using the most modern working machines, guarantees production quality at the highest level across a huge selection of small-to-medium-sized parts. Powerful and precise machines are for G&G the basic prerequisite for reliable and high-quality products.

Michael Nonnengässer, Master Orthopaedic Technician and Managing Director of Nonnengässer Orthopedie Technik in Donzdorf, contacted Martin Gabriel, Founder G&G Präzisionstechnik, with a very special request in the field of orthopaedics. The company is a leading provider in the field of orthopaedic technology in the region, and in their daily work, they treat many patients with varus and valgus gonarthrosis, commonly understood as knee mal-alignment.

“We were dissatisfied with the results of the long-term correction of the orthoses that are on the market and we started looking for a partner who could develop our own joints that would meet our expectations,” recalls Nonnengässer.

Read more here —–> https://t.ly/OjWK

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The post Improved Orthopaedic Quality Control In Medical Knee Joint Production appeared first on Asia Pacific Metalworking Equipment News | Manufacturing | Automation | Quality Control.

Changing Times Of Healthcare Investment In ASEAN

Christellee — Fri, 14 Apr 2023 02:01:06 +0000

Aditya Agarwal, Principal of Life Sciences and Healthcare from Roland Berger looks at ASEAN’s investment developments in healthcare.

The classic rules of road of investing in large brands, pursuing value creation with rigour, developing solutions that payers or patients shall be willing to pay for shall continue to hold true. However, with these new trends, investment themes and portfolios in SEA will likely be far more cohesive in their value proposition rather being a mosaic of assets serving short term financial objective.

Increased Demand, Focused On Domestic Middle Class

Pre-COVID, ASEAN’s healthcare investment landscape was heavily focused on traditional models like super specialty hospitals and distribution of high-end medical products. These investments largely were on assets focusing on a premium play such as hospitals serving cash rich patients and medical tourists.

With shift in government priorities, maturing universal coverage across markets, post-pandemic hyper-awareness and adoption of digital health tools – the investment landscape and priorities are shifting towards a more value based approach. From our recent conversations and deal support we see the emergence of a few themes: Despite the major decline in patient volumes in outpatient and elective surgeries, financial performance of non-medical tourism super-specialty hospitals was healthy in 2020-2021.

While medical tourism volumes are eventually expected to return, hospitals with a healthy mix of universal coverage patients and focusing on the needs of the middleclass, have become relatively more attractive. Improved universal coverage payment cycles and reimbursement rates have encouraged private hospital groups to increase focus on the middle-of the pyramid.

Read on for more —–> https://t.ly/VGUmN

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Cutting Tools For Orthopedic Medical Components

Christellee — Mon, 27 Mar 2023 04:00:08 +0000

ISCAR illustrates new solutions to contend with machining parts for the medical industry.

Machining continues to be a main process for the production of medical parts. The medical industry is a major consumer of cutting tools.

What are the specific features of the industry from the tool manufacturer’s point of view? Which medical components are most challenging to the machine?

Which cutting tools are common today for machining medical parts? Why are tools for machining orthopedic components at the forefront of technology? What are the cutting tool trends for tomorrow?

Complexity Of Medical Equipment

The medical industry specialises in producing a wide range of healthcare equipment. These equipment are intended for solving a broad spectrum of health protection problems and it contains numerous parts that vary in dimensions, accuracy, material, and shape complexity. To make these parts, the medical industry utilises diverse technological processes in which machining still plays an essential role.

The general principles of machining healthcare equipment parts do not differ from similar parts of non-medical mechanisms. However, there are components that require intricate machining processes.

These processes are challenging and require process planning, essential machinery, and selecting the right cutting tools. Cutting tool manufacturers contend with developing unique tools to assure effective productivity and profitability solutions for medical parts production.

Read more here —–> https://t.ly/G7xW

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