Medical devices engineering has undergone significant changes in recent years due to advancements in technology, changes in regulatory requirements, and evolving customer demands. These changes have led to a shift in the design, development, and manufacturing processes used by companies in practice. In this article, we will explore some key changes and their impact on the industry.
Paweł Zieliński – Head of Marketing, Consonance
Changing design, development and manufacturing processes in the medical device industry
Design is an essential aspect of the medical device industry, and advances in technology have revolutionized the way products are designed. Computer-aided design (CAD) and simulation tools have made it possible to create highly detailed and accurate 3D models of products, which can be tested and refined before any physical prototypes are made. This approach reduces development costs and speeds up the time-to-market for new products.
In addition to technology, changing customer needs have also influenced the design process. There is a growing demand for personalized medical devices that are tailored to group or individual patients’ needs. This trend has led to the development of modular and customizable products that can be adjusted to meet the unique requirements of each patient.
Meanwhile, the development process hasn’t stayed intact. Regulatory bodies have implemented more stringent requirements for safety and efficacy (MDR and FDA), which has increased the time and cost of bringing new products to market. To meet these requirements, companies must conduct extensive testing and verification throughout the development process.
To reduce development costs and streamline the process, medical devices engineering services are shaped with an approach which emphasizes collaboration, flexibility, and rapid prototyping, allowing teams to respond quickly to changes and adjust their approach based on feedback from customers and stakeholders.
With a number of unpredicted global events like Covid-19 pandemic, broken logistic chains and Russian invasion in Ukraine, the manufacturing process for medical devices has also evolved. Project managers, procurement specialists and engineers had to adapt a new approach to development and purchasing procedures to bypass these difficulties. Demand for advances in automation, robotics, and additive manufacturing can’t stay unmatched if we want to keep up the pace of MedTech novelties.
In addition to technology, changing regulatory requirements have also impacted the manufacturing process. The introduction of the Medical Device Regulation (MDR) in the European Union has increased the documentation and reporting requirements for manufacturers. This has led to a greater emphasis on quality management systems and supply chain management to ensure that products meet the required standards. However, some sort of relief for manufacturers came in the recently passed extension of the introduction of the MDR legislation by the European Parliament until 2028. Why? Because, faced with problems, too many devices could disappear from the market, increasing the danger of equipment shortages in healthcare facilities or even in private homes.
Application of new technologies in the production and design of medical devices
More reliable? Less expensive or simply prettier? You can choose the key result of the change. But no matter which one you pick, advancements in MedTech are unprecedented and lead to cutting-edge medical products. But how to enhance their functionality, efficacy, and safety? What really turns engineers on most today, and what are they working on?
3D Printing
This technology allows for the creation of complex and personalized devices that are tailored to individual patient needs. 3D printing enables the production of medical implants, prosthetics, and other devices with a high level of accuracy and precision.
Nanotechnology
Nanotechnology is another emerging field that has significant potential in the medical device industry. It involves the use of materials and structures at the nanoscale level, which can have unique properties and applications. Nanotechnology has been used to develop new materials for medical devices, such as coatings that improve the biocompatibility and durability of implants. With nanotechnology comes yet another gamechanger in the healthcare field: the level of bodies penetration with nano devices revolutionize diagnostics and treatment without using chirurgic tools and allow patients for faster recovery.
Artificial Intelligence
AI algorithms can analyze large amounts of data and identify patterns that can help in the development of more effective and efficient medical devices. AI can also be used to create predictive models for patient outcomes and to optimize the design of medical devices for specific patient populations.
Robotics
Robotic technology is being used increasingly in the production of medical devices, particularly in the manufacturing process. Robotics can improve the accuracy and precision of the manufacturing process, resulting in higher quality products. But this is just one side of a coin. Robotics like DaVinci can also be used to help perform surgery, automate certain tasks, which can lead to increased efficiency and limited risk of failures.
Internet of Things (IoT)
The Internet of Things (IoT) is a network of connected devices that can share information and data. In the medical device industry, IoT technology is being used to create smart devices that can monitor patient health and provide real-time feedback to healthcare professionals. IoT devices can also be used to track and manage medical devices, improving inventory management and reducing the risk of device failures.
New opportunities for patients and medical staff
From improved patient outcomes to increased efficiency in medical care delivery, new medical technologies are changing the way healthcare is delivered.
New medical technologies have significantly improved patient outcomes in many areas of healthcare. For instance, robotic-assisted surgeries have made procedures less invasive and more precise, leading to faster recovery times and reduced complications. Similarly, the use of telemedicine has made it easier for patients to access medical care, particularly in remote areas.
New medical technologies have also increased the efficiency of healthcare delivery. For example, Electronic Health Records (EHRs) have enabled medical staff to access patient data in real-time, reducing the risk of errors and streamlining administrative processes. Wearable medical devices that monitor vital signs and other health metrics can provide medical staff with real-time information on patient health, enabling them to make more informed decisions and respond more quickly to changes in patient conditions.
The tech advancement brought patient empowerment as we have never seen before. We take control over our own health. Mobile apps and wearable devices that track physical activity, sleep, and other health metrics provide patients with real-time feedback on their health status, enabling them to make informed decisions about their lifestyle choices. Telemedicine has also empowered patients by giving them more control over their healthcare decisions, enabling them to access medical care on their terms.
This also fuels personalized medicine, which tailors medical treatment to the unique needs of individual patients. Genomic sequencing and other diagnostic tests can provide medical staff with a more comprehensive understanding of a patient’s health status, enabling them to develop more targeted treatment plans. This can improve patient outcomes by ensuring that patients receive the most effective treatments for their individual conditions.
Challenges of implementing digitization in the medical sector
The digitization of the medical sector has the potential to revolutionize healthcare delivery, improve patient outcomes, and reduce costs. However, the implementation of digitization also poses several challenges that need to be addressed.
Data Privacy and Security – less paper mess, right? Yet, the digitization of medical records and patient data makes it easier for hackers to access sensitive information, putting patient privacy at risk. It is crucial to have robust data protection measures in place to ensure that patient data is protected from unauthorized access.
Another challenge of implementing digitization in the medical sector is interoperability. Healthcare providers use different systems and technologies, making it difficult to share patient data seamlessly between different providers. This can result in delays in care delivery and can compromise patient safety. Interoperability standards need to be established to enable seamless sharing of patient data between healthcare providers.
I’m sure you’ve noticed already that annual healthcare expenses are increasing each year. Are we getting weaker as humans, or mentioned above trends require investments today to make the future brighter? New hardware, software, and infrastructure to support digitization can be a significant financial burden, particularly for smaller healthcare providers.
The last factor which I want to emphasize is a resistance to change, which is common for most people. We like to stick with known solutions, and it’s hard to convince (especially those who didn’t have a chance to grow up in a computer-technology environment. Healthcare providers need to be involved in the implementation process and provided with the necessary training and support to ensure that they are comfortable with new digital technologies.
In conclusion, the digitization of the medical sector offers significant benefits, but it also poses several challenges that need to be addressed with some effort at various ends of the healthcare ecosystem. Global population growth, new threats from virus and bacteria evolution, civilisation diseases and the aging of populations in highly developed countries give no other direction, but the widest possible implementation of advanced engineering solutions to ensure that health systems are efficient and have the opportunity to respond quickly to variability – as the Covid-19 pandemic proved to all.
Bio:
Pawel Zielinski is a highly skilled marketing professional with a passion for driving business growth in the Medtech industry. With years of experience in marketing, business development, and product management, Pawel is a trusted leader and respected voice in the Medtech community.