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Demographics aren’t changing. Key drivers in the medical device manufacturing sector consist of the demand from adults aged 65 and older. OK Boomer! Additionally, you can add age-related disorders such as diabetes, neurology, hypertension, and osteoarthritis combined with chronic disease and toss in the rising costs of healthcare. Altogether that sets up the global medical devices market size, valued at $597.4 billion in 2023, to grow at a compound annual growth rate (CAGR) of 6.2% through 2032 to reach $ $1.025 trillion by 2032.
When winnowing down to just the U.S. market, Fortune Business Insights
Supporting growth in U.S. medtech is an outlook from Cleveland Research Company as Jim Rutan, president, ARCH Medical Solutions
Further indicating these moves toward ASCs were topics of discussion at the recent J.P. Morgan Healthcare Conference
Yet this growth can come with some challenges. Beyond OEMs needing to be prepared for increasing orders, a study by the American Academy of Orthopedic Surgeons (AAOS)
The population-based study used national data from the National Inpatient Sample (NIS) and Association of American Medical Colleges (AAMC) to determine the number of TJAs and active orthopedic surgeons from 2010 to 2020. To determine growth trends, researchers used arthroplasty-to-surgeon ratios (ASRs) and an arthroplasty surgeon growth indicator (ASGI). The ASR values estimate the average annual output of total hip arthroplasty (THA), total knee arthroplasty (TKA), or TJA procedures performed by an orthopedic surgeon in a given year. ASGI values were calculated using the 2017 ASR values as the standard point of comparison.
Results show:
Annual volume of primary TJAs will grow 70% to 2,257,326 Higher growth in demand for THAs compared to TKAs (1,219,852 THAs vs. 1,037,474 TKAs by 2050) Active orthopedic surgeons is projected to decrease 14% by 2050 In 2017, the average primary TJA caseload per active orthopedic surgeon was 65.2 procedures while the projected TJA-ASRs for 2050 is 139.4. The number of TJAs performed per surgeon will double by 2050 to meet the projected demand Increasing the number of orthopedic surgeons by 10% every five years could ensure the caseload per surgeon remains similar to the 2010 to 2017 numbers Additionally, as we enter 2024, AdvaMed President and CEO Scott Whitaker called on the Biden Administration to ensure the medtech industry is considered as it implements policies to strengthen domestic supply chains, recommending:
Immediate, long-term prioritization of medtech needs in programs such as CHIPS to ensure enough critical components – in addition to semiconductor chips, circuit boards, monitors, resins, polymers, medical grade packaging, helium in magnetic resonance imaging (MRI) machines, and the materials needed for sterilization – among industries competing for supplies. Supporting greater diversification of supply chains to reduce barriers to the flow of goods, with public-private partnerships to enhance resiliency and agility and reduce over-reliance for any aspect of manufacturing or supply. The new U.S. Department of Commerce Supply Chain Center and the Indo-Pacific Economic Framework for Prosperity, including the United States and 13 regional partner nations, are among key initiatives for this work. Further areas of growth moving forward will be artificial intelligence (AI) and data interoperability, which form the basis for effective digital health strategies, supporting the shift toward value-based care – the best, cost-effective health outcomes for patients.
These indicators for increased orthopedic surgeries, growing ASCs, and embracing digital health will have machine tool builders seeing more demand for high-efficiency equipment as job shops and contract manufacturers produce more implants, bone screws, plates, and the surgical tools required to complete each procedure. Automation will continue its growth in manufacturing as lack of skilled workers remains a challenge but the reshoring of medtech manufacturing will demand more efficient operations.
About the author: Elizabeth Engler Modic is editorial director for GIE Media’s Manufacturing Group of magazines and can be reached at 216.303.0264 or emodic@gie.net .
Boost efficiency, reduce costs PHOTOS COURTESY OF RESPECTIVE COMPANIES UNLESS OTHERWISE NOTED.
INDEX Cris Taylor, President & CEO
Overall, there are significant reasons for optimism concerning U.S. manufacturing. The expected reshoring trend has continued to manifest, with investment in the construction of new manufacturing facilities up 61.9% year-over-year. In the first half of 2023, the Reshoring Initiative reported companies announced 406,000 new manufacturing jobs in the U.S., nearly 4x the total created in 2019.
That said, good news for the whole of manufacturing may create challenges for the medical segment. Much of the current and future growth is being driven by government investment in key sectors, including semiconductors, transportation, defense, and energy. Steady and continued increase in demand will keep medical growing, albeit at a slower pace than some of these other areas, but the big-picture growth across manufacturing may lead to increased costs for skilled labor and materials.
U.S. medical manufacturers may also be impacted by regulatory actions taken domestically and in Europe. The EU and UK have been expected to implement new medical device regulations in 2024, making the U.S. a more appealing option for smaller companies and start-ups. At the same time, with healthcare costs significantly higher than peer countries, the U.S. has been moving toward greater transparency in pricing and may take more concrete actions to bring costs down.
The above factors point toward higher pressure on medical manufacturers to further boost efficiency and reduce costs. The industry has already experienced some significant consolidation within medical, with mergers and acquisitions (M&As) leading to larger players that can reduce costs through scale and standardization of best practices. We expect to see that trend continue. At INDEX, we’ve already seen it lead to increased demand for CNC multi-spindles from medical manufacturers seeking to slash cycle times for medium-to-large quantities of parts. Overall, the current conditions bode well for high-end machine tool builders as well as providers of automation systems and other complementary equipment.https://www.index-group.com/en_us
Robotics and automation transform the medtech industry FANUC America Jerry Perez, Executive Director – Global Accounts
As we begin 2024, key indicators show the medtech industry is poised for profound growth, and as the executive director of global medtech accounts, I’m keenly aware of the pivotal role our technologies can play in the transformation of medical device manufacturing.
The recent influx of medical device manufacturers moving production onshore, coupled by increasing global demand, is prompting medtech companies to consider automation versus traditional labor-intensive methods.
In this dynamic environment, our focus extends to where robotic automation will help medtech companies streamline their production processes and overcome significant challenges such as increasingly strict regulatory requirements, and the growing labor shortage.
Much like major corporations, medtech startups are looking to break into the market to gain a foothold in this very competitive industry. Again, those that embrace robotics and automation will be better equipped to launch innovative new products quickly and cost-effectively.
With robotics and automation, the domestic medtech industry will experience changes in their go-to-market strategies in capacity utilization, controlling production processes, and minimizing quality concerns. The innate flexibility of automation technologies helps companies scale production according to market fluctuation and keep operating costs under control.
In today’s business climate of intensifying global competition, the time is right for medtech companies to take the next steps to automate in 2024 and beyond. https://www.fanucamerica.com
Challenges in medtech manufacturing Platinum Tooling Preben Hansen President
Medical parts manufacturing is challenging in many ways, due to the materials used and requirements for high accuracy and exceptional finish. Most of this work is produced on Swiss-style turning centers, as the parts are usually very small.
Materials used in medical parts manufacturing are also often difficult to machine. The size of the parts and the cutting tools needed to machine the features many times require speeds higher than the machine’s rpm capability. In these cases, the customer must consider the tooling choices available to achieve proper speed and feedrates for optimal production. Using live tools with a 1:4 gear ratio, capable of running at the higher rpm’s required, can benefit many applications.
Since medical components have stringent tolerance requirements, the customer must pay close attention to the quality and accuracy of the guide bushing selected for machining. Ultra-precision guide bushings are available for these applications.
Materials commonly used in medical parts manufacturing, such as stainless steel, titanium, and platinum present processing challenges on Swiss-style machines. In many cases, the material tends to load up on the guide bushings which could score the material or make it difficult to feed. In this case, the customer needs to consider alternative guiding materials such as bronze, ceramic, or Meehanite, or in the case of unground material, an adaptive guide bushing system may be useful in adjusting for material variance.https://platinumtooling.com
Medical manufacturing requires machine data Mazak USA Dan Janka President
Connecting CAD/CAM software to a machine tool can increase the confidence factor when it comes to machining complex medical parts. When these systems are paired with Mazak’s advanced SMOOTH control technology, users gain valuable real time data at the machine and can generate more accurate part program simulations, tremendously increasing a shop’s odds of producing a good first part which minimizes prove-out time.
When shops run a simulation on a Mazak machine, they get confidence because the simulation uses all the machine’s data as provided by the original equipment manufacturers (OEM) – what happens in the simulation will happen the same way on the machine as long as the tool data is accurate.
Nowhere is this level of confidence more important than when running complex medical parts. Shops have invested considerable expense in machine tools needed to run equally expensive parts, so the program must be right.
When it comes to optimizing part program simulations, OEMs have tried to shoehorn CAM systems into machine controls for decades with little success because machine control computers lack the power and shops don’t want operators or programmers spending time working at a machine’s control on the shop floor. So, it makes more sense to provide CAM systems with some type of seamless integration to a machine’s control – more in line with a shop’s best interest.
While more powerful machine controls are possible, doing so would increase a control’s cost considerably. Anyone could purchase a computer for about $6,000 that’ll run CAM, but when you try to incorporate that computer into a machine control, the huge amounts of customization needed increases costs. This is because a machine’s control must fit the NC side and the PC side, which must then work together. Plus, with future software updates, it’s not feasible to add a new control to a machine every time the software technology changes.
Instead, Mazak provides an Application Programming Interface (API) that allows CAM software to seamlessly access data from its machine controls. The CAM software then uses that data to generate extremely accurate part program simulations.
To make this interface effective, Mazak essentially provides all the same information used in its machines to the CAD/CAM suppliers. They in turn have the software engineers, the time, and the computing power to make the simulation graphics much sharper and more precise, then tie them directly into their CAM system. Equally important, the interface keeps machine controls affordable and cost effective.
The connection between the CAM software and the machine control allows shops to produce programs that take into consideration the specifics of the machine being used and how it operates – capabilities, kinematics, tooling, and range limits. Without this exact machine data, programmers often guesstimate when it comes to the machine’s true range capabilities.
For example, a programmer will select the necessary tooling and produce a part program. The program is then loaded into the machine. But what if a 4.000" diameter tool was specified in the program when the tool in the machine actually measures 3.99" in diameter? The program would produce the part, but it would be a much more accurate part if the CAM program knew exactly what the tool size was. Now, instead of working in a theoretical world, the interface between CAM systems and machine controls allows shops to work in an actual world with real data.
This removes huge amounts of guesswork when programming a machine tool. But most importantly, it gives shops the confidence to push the cycle start button, know a program will run exactly as it did in the simulation, and produce a good part the first time. This is especially beneficial when running complex 5-axis parts common in medtech or anytime operators can’t see inside the machine to watch a part run. https://www.mazakusa.com
Predictions, recommendations for 2024 Full Spectrum Matt Eisendrath, President and Chief Commercial Office
In the dynamic landscape of medtech, the fervor for artificial intelligence (AI) investment is palpable, and we expect the robust investment in AI technologies to continue, even though the meaningful impact will not materialize until beyond 2024. Though there are some noteworthy exceptions to this, such as in diagnostic imaging, the broader industry will have to wait longer for AI’s tangible use cases to drive a strong return-on-investment (ROI). A cautionary parallel is drawn from an over-enthusiastic investment in data analytics – leading to some significant localized wins, but a lot of generalized frustration in the CFO office. Keeping abreast of the developments in AI is clearly important, but keeping some financial powder dry for clearer opportunities to crystallize, use cases to unfold, and genuine value to be articulated might be warranted.
Amidst the AI buzz, we see strategic-thinking medtech companies are focused on a more immediate challenge – cybersecurity. 2024 marks a pivotal shift, with the first full year of FDA’s new, heightened focus and stringent guidance on cybersecurity for medical devices. Acknowledging the increased requirements, and liability, companies recognize failure to meet these evolving standards can lead to costly fines, reputational damage, and the reality of significant delays in bringing products to market.
The imperative to prioritize cybersecurity isn’t merely a regulatory compliance issue; it’s a business necessity. As cyber threats continue their evolutionary process, forward-thinking medtech firms understand proactive cybersecurity measures are critical. In the face of today’s real and tomorrow’s mounting risks, focusing more of limited budgets on cybersecurity in 2024 is paramount for both more practical and strategic players. While AI promises significant impact, it’s the judicious attention to immediate concerns such as cybersecurity that may set the foundation for sustainable success in the medtech landscape. https://fullspectrumsoftware.com
Keeping pace, thriving in medtech Propel Software Chuck Serrin VP of MedTech and Life Sciences Industry Marketing
For medtech companies, fast product launches and compliance are pivotal for success. In an ever-changing medtech landscape, the increasing integration of technology into patient care has accelerated innovation, prompting a rapid transformation. This shift encompasses the optimization of long-standing manual procedures, the development of novel diagnostic devices, and the infusion of software solutions into patient care, all contributing tangibly to enhancing patients’ quality of life.
In the current environment, medtech companies are leveraging cutting-edge technologies to foster quicker and more efficient engagement with patients. They’re enhancing traditional devices and introducing entirely new products, significantly impacting the industry and patient outcomes. The imperative for medtech enterprises lies in their ability to adapt swiftly to innovation, launching new products promptly, and expanding into new markets with agility. The key to achieving this is in prioritizing speed to market.
The secret weapon in navigating this accelerated landscape is a streamlined solution seamlessly connecting business, product, and quality processes onto a single platform. By adopting such a system, medtech companies can effectively manage integrated change processes and facilitate cross-functional collaboration throughout the entire product lifecycle. Compliance is more easily achieved and maintained including resolving product quality issues faster, robust document and training management, and secure supplier controls. This modern approach is essential for keeping pace with industry leaders, ensuring companies survive and thrive in the competitive landscape by rapidly bringing innovative products to market and seamlessly extending their reach into new global markets.https://www.propelsoftware.com
Predictions 2024 AcuityMD Michael Monovoukas CEO & Co-founder
Prediction #1: Artificial intelligence (AI) will turn windshield time into work time
The result is a wide dispersion of surgeries, requiring reps to spend more time driving long distances and adding to their already 2+ hours a day in transit. Artificial intelligence (AI) and large language models (LLMs) will help reps make better use of this dead time by enabling hands-free audio productivity. When they’re driving, reps can listen to their AI-based system to prepare for their upcoming meeting, respond to email requests, and more. The top-performing reps will leverage LLMs to be dramatically more efficient and make the most of their longer travel stretches.
Looking beyond 2024, AI can also bring a similar audio experience into the operating room, audibly guiding surgeons what screens to view when, and capturing surgical context that can be automatically transcribed into notes for highly individualized post-operative care.
Prediction #2: Medtech will return to demanding a return on investment
Prediction #3: Consolidated healthcare will demand empowered quarterbacks at medtech companies
Prediction #4: Breakthrough obesity drugs will change healthcare supply-and-demand dynamics
Today, the blazing success of Wegovy and Mounjaro has electrified the pursuit of new treatments for obesity. Novo Nordisk and Eli Lilly are leading the market with injectable drugs that target receptors of the GLP-1 hormone to mimic the hormone’s effects of helping people feel full. As these weight loss drugs flood the marketplace, 2024 will start to see their impact on related healthcare interventions for obesity, diabetes, and orthopedics, among others. We may not need bariatric surgery at all someday soon. How we treat diabetes – and the sheer volume of diabetic patients – is likely to drop. And, there’ll be a significant impact on orthopedic interventions without the strain on joints from obesity.
We work in an exciting industry at an equally exciting time with scientific breakthroughs such as Wegovy and technology innovations like AI and I expect this year to bring more of the same.https://acuitymd.com
6 trends impact medtech in 2024 Sky Medical Technology Bernard Ross, CEO
The healthcare industry is fast-moving with evolving healthcare needs, staffing shortages, and rising demands all increasing the pressure to deliver timely and effective care. To keep up, healthcare organizations are increasingly looking toward innovation for solutions to make treatments more time- and cost-effective, while improving patient outcomes.
While most of the headlines in 2023 were dominated by artificial intelligence (AI), other technologies such as wearable devices, Internet of Things (IoT), and telemedicine have played a crucial role in advancing healthcare.
In previous years, the healthcare industry has been criticized for being too slow to adopt the latest innovations and breakthroughs – largely due to the many barriers such as regulatory hurdles and data collection that make innovation adoption a long process. However, 2024 will see the latest technologies more commonly and effectively deployed across a variety of different practices. The healthcare industry is on the brink of transformative change, and these are the six trends that are expected to be at the forefront of this transition.
1. AI is here to stay
With AI still in its infancy years and rapidly evolving, we can expect to see the technology more commonly used on a much wider scale, supporting health services with data-driven tasks. As a result, staff will receive more training on how to get the most out of AI and how to do so safely.
2. The rise of wearable devices Already we’re seeing more patient monitoring devices and sensors being tested and implemented in the medical setting to track and analyze patient data in real-time, such as heart rates, sleeping patterns, and blood pressure to provide more accurate insights into patient wellbeing. For patients, this information is particularly useful for self-monitoring and will help them proactively make any necessary adjustments to their lifestyle and give them more independence.
Medical devices that can transfer this data directly to healthcare professionals will provide patients with peace of mind and reduce the need for unnecessary hospital or community nurse visits. Combining such devices with AI capabilities will prove invaluable in 2024, allowing for faster and more accurate data collection, helping to save time, money, and resources.
3. Personalized approach With strains on resources, healthcare services can be time short and not provide a treatment plan suitable to the unique needs of each patient. As AI and medical technology combine, healthcare will be able to increasingly adopt more personalized treatment plans best suited to the individual. Through the analysis of medical history and health assessments, AI can formulate more personalized treatment plans. This will be further supported by new services such as virtual healthcare assistants that can answer medical queries, questions, and assist with appointments and scheduling.
New treatments are also considering differences in people’s genes, environments, and lifestyles – known as precision medicine. By considering these characteristics, the most effective treatment can be given and enables doctors to easily determine the efficacy of medications, along with the likelihood of adverse effects. 2024 will see more patient-centric treatments as these technologies and considerations are further implemented into care pathways.
4. Advancing telemedicine During the pandemic, telemedicine facilitated the use of remote consultations and was an invaluable tool for delivering non-urgent patient care. Post-pandemic, telemedicine has enabled the adoption of a hybrid model, combining in-person visits with online appointments. This enabled flexibility and convenience for patients and healthcare professionals.
As healthcare services prioritize tackling backlogs and waiting lists in 2024, telemedicine will continue to support the delivery of non-urgent care and remains an effective alternative to in-person visits. As telecommunication platforms advance, these services will improve patient satisfaction, help deliver timely care, and facilitate the rollout of virtual wards, allowing patients to receive the care they need safely and conveniently at home.
5. The fight against cybercrime Despite the countless benefits of innovation adoption in healthcare, risks to safety and security remain a leading threat. Cyber-attacks can compromise patient data and cause significant reputational and financial damage. A critical insight report revealed 40 million people have been affected by healthcare data breaches – the highest number recorded in the reports since it began. Healthcare provides a lucrative target for cybercriminals due to the vast amount of personal data it stores.
The rise of medical devices and telemedicine being integrated within healthcare networks has only exacerbated this threat due to the increase in the number of entry points for criminals to attack. As a result, healthcare organizations are becoming a lot more vigilant. In response, we can expect to see more investment from healthcare organizations in their cyber defenses.
6. Prioritizing sustainability
Reduced dependency on single-use plastics, embracing energy-efficient technologies, and the use of telemedicine to reduce the distance traveled to hospitals, will all contribute to reducing the impact on the environment.
A brighter future https://skymedtech.com
