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Orthopedics hasn’t always been known for its speed and agility in adapting to new technology. However, the industry has reached new heights with advancements in manufacturing and expansion into enabling and digital technology. Those advancements are only expected to continue in the wake of COVID-19 as healthcare and medical device companies strive for greater efficiencies in the way they work.
Enter Industry 4.0. While the Fourth Industrial Revolution isn’t new, today’s market forces will require companies to digitize crucial operations and new products. Experts say a more profound and enduring pivot to Industry 4.0 is vital for companies to compete in the modern orthopedic device industry.
“Ultimately, the question of Industry 4.0 is not if, but when,” said Jeff Richardson, Industry Solution Director at Critical Manufacturing, a provider of MES and IoT Data Platforms. “While it may seem like a strange new world with many challenges to overcome, the benefits are attainable and, arguably, essential for orthopedic device manufacturers to meet increasing and changing demands in the marketplace.”
What is Industry 4.0?
When asked to define Industry 4.0, Richardson first described the three industrial revolutions that proceeded it. There was a dramatic shift in the balance of social power from aristocrats to business leaders to the advent of the Information Age, which was defined by the proliferation of electronic devices, Information Technology (IT) and Operational Technology (OT) systems, and automation. Industry 4.0 isn’t some far-off trend that industries might collectively experience at a later date.
“We are living through it now,” Richardson said. “Rapidly changing technology, increased interconnectivity, and smarter automation are blurring the lines between physical and digital worlds.”
Industry 4.0 entails the four themes of interconnection, information transparency, technical assistance and decentralized decisions.
How does that correlate to orthopedics? In a wealth of ways. Think Internet of things (IoT) platforms, additive manufacturing, smart sensors (be they in manufacturing or devices), data collection and analytics of advanced processes and ecosystems, robotics on the manufacturing floor and in the operating room, artificial intelligence and augmented reality.
How is it Used in Orthopedics?
Industry 4.0 will resonate differently with orthopedic companies based on their size, product lines and outsourcing plan. But it is primarily considered a savvier and more innovative way to work. We found that orthopedic companies of all sizes are incorporating these cutting-edge ideas.
DePuy Synthes recently received a coveted Lighthouse designation for its use of Industry 4.0 technologies. The company leverages image-based and artificial intelligence algorithms in a platform called Advance Case Management (ACM) to predict which set of instruments and implants should be used during joint replacement surgeries. The ACM platform boasts an accuracy rate of nearly 90% in most cases. Additionally, it has resulted in a 60% reduction in instrument-sterilization costs and instrument trays needed for procedures.
DePuy Synthes facilities in China and Ireland have also received Lighthouse designations due to improved interconnectivity and manufacturing efficiencies. DePuy Synthes’ Suzhou location improved siloed technologies by leveraging digital analytics to optimize productivity, enhance prediction of customer demand and make the supply chain more agile. The facilities’ productivity increased by 15% after implementing new measures. DePuy Synthes also opened a new distribution center that accelerates the site’s supply of 3D-printed implants to the Chinese market.
Carlsmed embraces Industry 4.0 with Corra, a system that draws on predictive analytic technology to build patient-specific surgical plans and 3D-printed implants for spinal surgeries. According to Carlsmed’s CEO and Co-Founder, Mike Cordonnier, Corra produces implants that are tailor-made to a patient’s unique anatomy, which saves surgeons from having to adapt the plans themselves. The startup’s patient-specific interbody device technology, aprevo, received FDA Breakthrough Designation and 510(k) clearance in 2020.
Zimmer Biomet’s Persona IQ tibial extension smart implant for total knee replacement records a patient’s range of motion, step count, walking speed and other gait measures and sends the data directly to surgeons. The device’s ability to track passive data gives surgeons a clearer picture of how patients are faring without relying exclusively on reported experiences. Zimmer Biomet partnered with Canary Medical on the sensor technology, which is expected to be expanded to other implants. This is one example of how Industry 4.0 delivers precise, consistent data that could improve outcomes collection.
Adapting to Industry 4.0
Orthopedic companies stand to greatly benefit from adapting to Industry 4.0, because the industry faces sweeping and complex challenges ranging from turbulent supply chains to the need to accommodate products that are becoming increasingly complex and connected.
Numerous tools are available to assist companies with Industry 4.0 integration. Take manufacturing, as an example.
“Industry 4.0 leverages software, such as Manufacturing Execution Systems (MES), that help orthopedic device manufacturers improve efficiency, enhance quality, and reduce waste while enabling cost-efficient production of high mix products,” Richardson said. “It enables them to produce devices to help meet the demands in a new world of Value-Based Care. Connectivity means increased data collection from all previously disparate data sources, enabling complete traceability, analytics and closed-loop automatic control for higher efficiencies and enhanced quality.”
A modernized MES can deliver a comprehensive set of Industry 4.0 benefits when it comes to manufacturing. These could be enhancements in the quality of products and production efficiency, and even the ability to validate its own implementation through modern automated validation tools, an asset that can significantly reduce the burden of meeting regulatory requirements. While acknowledging the challenges that heavy regulation posed for companies pivoting to Industry 4.0, Richardson noted that changes are underway aimed at helping companies adapt to new technologies.
“The orthopedic device market is already heavily regulated, but these regulations are poised for change,” he said. “Although some manufacturers delayed previous phases of automation due to uncertainty around existing regulations and kept manual systems and Device History Records in place, regulatory bodies want manufacturers to be able to adopt technology more freely. Why is this? Automation of manual systems reduces the risk of human error, and the latest Industry 4.0 technology also builds quality into processes and products and enables continuous process improvements.”
Richardson firmly believes that orthopedic device companies should not fear or procrastinate in implementing Industry 4.0 digitization upgrades. However, he pointed out challenges that industry leaders routinely face, such as ensuring the reliability of digitized communication networks, cybersecurity concerns and the essential need for a skilled, technologically savvy workforce. Noting that adapting to Industry 4.0 will undoubtedly take work for some leaders, Richardson said companies shouldn’t go through the shift alone.
“Some may conclude that the journey to Industry 4.0 is just too difficult,” Richardson said. “However, the benefits simply cannot be ignored, and can you be sure your competitors are not already leveraging the advantages on offer? Reach out to others who already have experience and learn from them. Talk to a consulting partner or software provider and gather as much information as possible. Most importantly, start with just one step. Identify where you will gain the most value from Industry 4.0 and focus there. This will help you to understand and realize the benefits more quickly and overcome any trepidation that this is the right path to follow.”
Making the Transition
Every transition to Industry 4.0 is unique and comes with its own particular challenges. Orthopedic companies can’t begin to benefit from fully digitizing their operations until they’ve put in the work to pivot. This significant change is best facilitated with thoughtful planning under the guidance of experts and contemporaries who have successfully adapted themselves.
“Some organizations struggle to know where to start and to understand how big the overall effort should be,” Richardson said. “Break up the whole Industry 4.0 program into phases, rank them by the value and start with the highest.”
For example, Phase 1 might involve adopting an MES. Companies should start with one facility or the highest valued production line. They should also set clearly defined goals so that they can measure their success throughout the process.
Richardson noted that the changes companies face when modernizing far transcend daily operations.
“Industry 4.0 is also a cultural change. Be prepared for this,” he said. “Help frontline workers prepare and let them have a say in the process.
Train your workforce on how to use the software and show them why it is valuable for the business. This collaborative approach will encourage adoption and facilitate the beneficial outcomes you are seeking.”
Richardson concluded by highlighting ways that Industry 4.0 is likely to benefit orthopedic companies. He noted how adapting to the industrial revolution that is currently underway will help to prepare for the next one.
“Adopting Industry 4.0 strategies and solutions today will also help manufacturers be ready for Industry 5.0, which many believe will be focused on even higher levels of product personalization and quality,” he said. “The consensus is that Industry 5.0 will lead to complete waste elimination and an increase in collaboration between humans and machines. There is also conjecture on how quantum computing can be brought to bear on manufacturing or other technologies like cognitive computing through enhanced artificial intelligence. Just as we are being introduced to self-driving cars, will self-manufacturing work cells or plants be more common for manufacturers? Time will tell. In the meantime, we can establish the foundation needed through Industry 4.0 tools like Manufacturing Execution Systems or IoT Data Platforms and deliver higher quality products with more efficiency today, making patients healthier and customers happier.”
