Contact us anytime to know more — Kuldeep K., Founder & CEO CISIN
The use of outdated systems and processes can negatively impact corporate resources such as time, money and personnel.
Automation can be used to help eliminate this issue. Medical device manufacturers can reap many benefits from digitalization and smart production.
This transformation not only streamlines work and reduces errors but also saves money and time on mundane or repetitive tasks. It also accelerates the expansion of an organization's product range and meets regulatory requirements. The technical documentation in the medtech sector is interconnected.
If one document is updated, it must also be updated on other documents to maintain accuracy. The conversion of these systems into digital allows for faster updates and easier maintenance in Industrial IoT.
The medical device industry is critical to the growth of healthcare and science because it provides advanced solutions for doctors and patients.
The medical device industry is highly dependent on technology. Therefore, companies in this field need to focus on the most advanced solutions.
Digitalization of processes can also increase end-user security by removing the risks that come with increased traceability.
Design dossiers, also known as design history files, are one of the most important documents that internal and external auditors inspect. A fully traceable and comprehensive design dossier contains all steps and pieces of evidence of processes that were carried out in the design phase.
This enhances regulatory compliance and allows for smooth, transparent internal and external auditors.
It is very difficult to inspect these interconnected design components when they are not digitized.
It takes longer for manufacturers to meet the required requirements, and it diverts financial and human resources away from other tasks. Digitalization is the only way to increase traceability.
Medical device manufacturing has undergone some changes as a result of the new era of automation and intelligent factories.
The smarter future is being ushered in by digitalization, automated production and remote solutions. In the future, medical equipment will be less invasive, more efficient, smaller, connected devices and more personalized.
Manufacturers must still adhere to certain regulatory standards in order to create safe devices, as patient safety is a priority.
Medical Manufacturing Standards
Medical device manufacturing and design is a vital industry where conformity to product standards is essential.
Medical devices can be used to identify and treat diseases as well as improve health. Engineers and manufacturers are therefore required to ensure the safety of the devices that they design. Medical equipment is vital for healthcare as it has a direct impact on the public's health and quality.
Medical device standards are important for both healthcare professionals and patients.
Medical Devices: Common Standards
Medical manufacturing devices are subject to a number of management standards. ISO is an international organization that sets global standards for quality and risk management for many Smart Connected Products and businesses.
Medical device manufacturing standards are primarily:
- ISO 9001 is a standard for quality management systems in business. ISO 9001 is a standard for quality management systems in business. It involves the management of medical device manufacturers. This helps save costs, promotes responsibility, allows responsible expansion and simplifies regulatory compliance.
- ISO 13485 is a standard of quality management systems designed specifically for manufacturers of medical devices. It is now explicitly recognized as a "harmonized norm" in the EU Medical Device Regulation. ISO 13485 compliance helps in quality control, risk management, traceability and process validation. ISO 13485-certified manufacturers will be able to sell more products on the global market because they have more efficient procedures, more successful business operations, and are less risk-averse.
- ISO 45001 specifies requirements for management systems that address occupational safety and health in the medical devices industry. Reduces accident rates and liability issues.
- ISO 27001 is a standard that has tools to help assess and manage cybersecurity risk in organizations. It's important for security. The standard is based on internationally recognized best practices and does not have any platform or software package-specific requirements.
- ISO 14001 is a standard that helps medical device manufacturers reduce waste, save energy and reduce their carbon footprint.
- ISO 50001, a standard that adds to ISO 14001, provides a structured approach to energy management. This standard allows medical device manufacturers to reduce operating costs and improve overall energy efficiency. It also helps them maintain their reputation by facilitating regulatory compliance.
- IEC 60601 must be used for all medical electrical equipment. It is widely accepted, but it may differ in different countries.
- IEC 62304 is a standard that covers the life cycle criteria of medical software, including embedded software in medical equipment. It also addresses both the maintenance and development of medical device software.
There are many other standards depending on the features of a product and its application.
These standards can help manufacturers to know what they need to do to comply with regulations. As digitization is taking over medical manufacturing, manufacturers can focus on safety by focusing on digitization.
Are you curious how? Continue reading.
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Advanced Technologies And Industry 4.0
The Fourth Industrial Revolution (or Industry 4.0) is the movement towards mass digital and intelligent manufacturing.
It includes:
- Implementation of artificial intelligence. Artificial intelligence in manufacturing is a powerful tool that can assist with decision-making, create countless data points and determine predictability. This allows manufacturers to take proactive measures to minimize errors and increase yield.
- Data analytics. Data analytics.
- Machine learning. Machine learning algorithms are capable of efficiently collecting data and predicting repeated tasks. This improves accuracy and productivity. It can assist with compliance management and inventory management and even help manage your stock.
- Reliance on the Internet of Things Internet of Things has enabled remote monitoring by allowing patient interaction with doctors and is cost-effective. Wearables, home monitoring equipment and medical equipment, can all be tracked in real-time by physicians.
Product life cycle management systems (PLM) are essential for optimizing the use of digitalization.
PLM is a system that manages the life cycle of an entire product, from conception to manufacturing and servicing. Every part of the process which can be digitized improves the individual step. The more steps digitized, the better the outcome.
Manufacturing execution systems (MESs) are a powerful tool that can enhance digital manufacturing.
Software solutions are used to connect production data between different vendors and locations. They also integrate existing business applications and equipment. MESs optimize production, provide control of processes and deliver quality.
A medical device or diagnostic MES should create a paperless environment, reducing human error and increasing regulatory compliance.
R&D Versus Manufacturing
The success of digital and intelligent acceptance and implementation is dependent on the successful integration of medical research and development with manufacturing.
R&D teams, for example, determine the product that should be developed and proceed to develop it while adjusting and optimizing the item along the way. After a decision has been made, the project is transferred to production through a design-transfer process.
Both the R&D team and the manufacturing team must perform their tasks as efficiently and cleanly as possible.
Communication between groups is essential to allow for informed decisions. The manufacturing team will not be able to complete the task satisfactorily without clear directions and specificity.
It is important to communicate and document any challenges that the R&D team may encounter. This will allow them to make the necessary revisions. This process would be inefficient and slow without digitalization.
It could result in significant delays and revenue loss.
Digitized And Automated Medical Production
Medical facilities are becoming more interconnected with the advancement of technology and automation.
In the health sector, we are also in an Industry 4.0 world. Medical device manufacturers can produce more products at lower costs with AI, medical robots and machine learning technologies.
Devices are also becoming smaller, less intrusive, more efficient, and smarter.
Fortune Business Insights estimates that the global medical devices market reached around 425.5 billion US Dollars in the past year.
According to Insights estimates, in the past year, the global market for medical equipment was worth $425,5 billion approx.
Read More: 20 Types of Healthcare Software you can use to take your Medical Business to the next level
Automated Medical Manufacturing
Human error is not allowed in the field of safety and health. Smaller devices, especially those used in medical applications, require a high level of precision.
Automation and Industry 4.0 are brought to the forefront, where manufacturing lines will be filled mainly by robotic arms and wireless devices as they are more accurate than humans. This article contains more information about wireless solutions in manufacturing lines.
The production of high-volume medical devices can be automated and optimized to reduce costs.
Businesses and original equipment manufacturers (OEMs) can also benefit from increased productivity, quality and reduced waste.
Data Collection
Data-driven manufacturing is the foundation of agile and flexible manufacturing techniques.
Devices like Programmable Logic Controllers, Human Machine Interfaces, and robotics are essential to monitor, understand and connect factory plants. In medical device manufacturing, in particular, optimal operating conditions and assurance of quality are essential.
Our selection of PLCs and HMIs includes top-of-the-line products from leading manufacturers.
Find the right HMI or PLC for your application by reading our guide.
SIMATIC HMI human-machine interface is designed to handle increasingly complex processes in your equipment and system.
SIMATIC HMI is able to meet the individual requirements of each customer for a human-machine interface by utilizing open and standardized hardware and software interfaces.
Smart Companies Offer Smart Solutions
At CISIN, we offer highly advanced solutions for Smart Manufacturing.
Electric company is one of our suppliers, and its automation products are the basis for many applications. The applications are diverse, ranging from secondary packaging to processing and even combining robotics and metaphysical processes.
Other applications include controlling the ozone sterilization of medical instruments and manufacturing processes for body parts like replacement hip joints.
HealthCam, their innovative system, combines infrared and visual video images to create a system that can detect heart rate and breathing rate based on small changes in body shape and facial color.
A more advanced version can detect blood oxygenation and other conditions such as choking and aspiration.
EcoStruxure, Schneider Electric's platform for hospitals and other healthcare institutions, is designed to promote sustainability and hyper-efficiency.
Schneider Electric helps its customers anticipate and manage both regular and extraordinary healthcare events.
Robotics
After Industry 4.0, the industrial revolution is now ready to welcome Industry 5.
Many companies have already implemented new solutions because the 5th Industrial Revolution focuses on the cooperation between humans and robotics. This means there will be a greater need for robotic diagnosis and treatment, which in turn requires more medical equipment and parts that are compatible with these systems.
ABB is one brand that shows the benefits of laboratory robot concepts for hospitals. ABB's brand states clearly that the medical devices industry is all about automation, robots and artificial intelligence.
Robots will be used in many areas, including manufacturing, laboratories and hospitals.
They will help clinical staff by taking over certain tasks, such as disinfecting an entire ward, dispensing medicine or caring for the patients. Markets and Marketers predict that the global market for medical robots will grow.
The following are the primary factors driving the robotics industry:
- Benefits of robot-assisted surgery in rehabilitation therapy and robotic-assisted training.
- Technological advancements in robotic systems.
- reimbursement scenarios.
- Increased adoption of surgical robots.
- Increased funding for robotic medical research.
The list of medical robots is growing. We have written about them in the past, but it continues to grow.
The da Vinci Surgical System is an industry-changing device. It can't be showcased at all, but it is definitely the most innovative.
Robots are also used in other areas of medicine, such as mental health. The PARO Therapeutic robot, for example, is a gadget that interacts like an animal.
It was designed to provide the benefits of animal therapy without using actual animals. PARO improves the quality of life for people who have undergone surgery or treatment for mental illness or depression.
Discover other robotic pets who are helping people with Alzheimer's disease by watching the video below.
Read More: Importance Of Medical Software Development
Sensors For Healthcare
Wearable, digestible, and implantable sensors can collect health metrics or vital signs anywhere patients or caregivers need them.
Sensors in healthcare are becoming more common, particularly in AI devices that monitor and inform patients about their health. The integration, customization, and miniaturization of multiple sensors into a single device allow for the collection of more data.
Touch sensors are used in many different areas of medicine. In minimally invasive surgeries (MIS) that incorporate the sense of touch, such sensors allow doctors to "feel" the inside of the human body using the smallest of initial incisions.
These sensors are also used in artery finders, which can detect pressure from the femoral arterial when it is placed against the skin of the patient. Sensors in prostheses would deliver electrical impulse signals to the brain whenever the prosthesis touched something.
Sensors are also used in the treatment of diabetic neuropathy. Patients with severe forms of diabetes can use them to replace their sense of touch.
Remote Monitoring Of Patients
Remote monitoring allows patients and healthcare professionals to track their health easily without having to make unnecessary visits to hospitals and clinics or undergo invasive tests.
Remote devices send data to a mobile or computer device where it can be analyzed. Healthy reading parameters for automated warnings, when the patient becomes ill can also be set. Discover medical applications by Moxa if you're curious about how devices are connected.
Medical personnel can monitor patients remotely, outside of traditional clinics.
This allows patients to maintain their freedom while still receiving healthcare. It provides daily assurance and peace of mind. Serial Ethernet/Wireless LAN can be used to perform remote monitoring.
For example, it could connect to a patient monitor. These device servers can be used to remotely monitor a patient's physiological signals. The Wi-Fi Serial Server from Moxa is recommended.
The NX Series I/O includes both conventional and high-speed Digital I/O. Analogue I/O provides information about encoder inputs and pulse outputs.
Medical 3D Printing For Prototyping And Medical Applications
Medical applications could be a huge benefit of 3D printing, as it allows for custom-made devices and items.
3D printing can be used to provide highly personalized healthcare. This includes the production of products such as prosthetics limbs, orthopedic implants like dental crowns or hips and legs, as well as cranial implants.
Radiologists and surgeons can use anatomical models to plan and teach surgery and visualize complex pathologies and anomalies before they operate.
By creating 3D models based on scans, medical personnel can better consult with patients by showing them how the surgery will be done and clarifying their concerns. Medical students can also benefit from 3D models to illustrate and teach anomalies like fractures, lesions, and tumors.
Bioprinting, one of many forms of 3D printing used in the medical industry, allows parts to be built that look like natural tissues, blood vessels, and bones in the body.
Bio-printed 3D organs are also useful for clinical trials, as the efficacy of medications can be tested on bio-printed tissue before they are used on humans. Medical equipment and PPE (personal protective equipment) are also made using 3D printing. Many companies offer a wide range of 3D printers, both assembled and unassembled.
Our webshop also offers 3D printer filaments under our exclusive RND label.
Tips For A Digital And Smart Manufacturing Plan's Successful Implementation
It is impossible to avoid challenges in any new process, but they can be minimized through careful planning and awareness.
Researching potential problems before implementing any plan can help an organization to be prepared. Companies can avoid the issue of moving too quickly by developing a plan that identifies which systems to improve first and which processes are easy to digitalize.
Some legacy products and processes are not upgradeable because they use outdated technology or documentation. Implementation plans for processes that are upgradeable should be staggered. Replacement is the only solution for legacy products or systems that cannot be upgraded.
This can be costly. The cost increases if multiple processes are upgraded.
Companies can reduce costs by determining which systems they need to upgrade. They should then compare these systems with the digitalized systems that are easily available to determine where there is overlap.
Then companies can start with one solution and continue as funds permit.
Follow these five steps for a successful implementation of your digital and smart manufacturing plans:
- Assess the current state of your business by conducting a gap analysis.
- Before moving forward, perform a feasibility/risk analysis to determine the viability of the plan. Include all stakeholders in the process.
- Create a data configuration plan and a transfer plan, if necessary, with modifications.
- Validate, verify, evaluate and process data in an environment of training before launching your product.
- Install a tracking system and go live with the implementation to verify its effectiveness and identify opportunities for improvement.
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Future Of Digitalization And Smart Manufacturing In Medical Device Manufacturing
The COVID-19 pandemic taught us that digitalization and remote work are unavoidable.
Organizations can better meet the ever-changing demands of consumers by taking action now to move manual processes into a smart manufacturing system such as Smart Supply Chain. Manufacturers need to hire or designate coordinators that are responsible for researching and implementing digitalized systems.
Even if a company has upgraded its processes, there are always new technologies that can be used to upgrade or replace older ones. To ensure a company continues to grow and succeed, it is important to be vigilant and open to change.
Many companies are now relying on automation and digitization. Organizations can improve and monitor devices by implementing advanced technologies such as AI, robotics and 3D printing.
These smart manufacturing solutions help the medical device industry to digitize its processes. This allows them to reduce time-to-value, increase efficiency, optimize asset usage, and build a product that meets safety criteria.
It is important for medical device manufacturers to adopt new technologies and meet the appropriate standards.
