Blogs

28 Nov, 2023
A Leaders Guide In the modern workplace, leaders must be aware of the subtle cues that signal an employee disengaging – a behaviour referred to as "silent" or "quiet" quitting. Unlike an obvious resignation, silent quitting occurs when employees mentally check out, disheartened by various factors that reduce their commitment to the company. In the era of remote work, leaders face an extra challenge in identifying signs of silent quitting among their distributed teams. The absence of physical presence makes it imperative for leaders to be attuned to subtle cues that may indicate disengagement. Here’s what to look out for: Decreased Visibility An obvious reduction in putting their camera on or offering opinion Refusing to go into the office when the rest of the team are in  Decreased Initiative Observable decline in proactivity and initiative Minimal or no contribution beyond routine responsibilities Withdrawal from Social Activities or Collaboration Reluctance to participate in team discussions or collaborative projects Limited interaction with colleagues, both professionally and socially Lack of Innovation Diminished enthusiasm for proposing and implementing new ideas A decline in creativity and problem-solving efforts Deteriorating Quality of Work Noticeable decrease in the quality and thoroughness of completed tasks. Frequent errors or oversights in work that was previously meticulous. Increased Absenteeism Unexplained absences or a rise in the frequency of sick leave Disengaged employees may use time away as a form of escape Negative Attitude A shift in demeanor marked by increased cynicism or pessimism Lack of enthusiasm for company goals or achievements Strategies to Reignite Engagement More Open Communication Encourage regular feedback sessions to address concerns Create an environment where employees feel comfortable expressing their thoughts Offer Enhanced Professional Development Invest in continuous learning and skill development Show a commitment to employees' long-term growth within the company Acknowledge and Reward Contributions Recognise and celebrate individual and team achievements Implement a rewards system that reinforces positive behaviors Offer More Responsibility Assign exciting, larger projects to try and re-engage employees Assign tasks with added visibility in the company to make the employees feel valued Promote Work-Life Balance Support flexible work arrangements when feasible Recognise the importance of employees' well-being beyond work Clarify Expectations Clearly communicate roles, responsibilities, and expectations Ensure employees understand how their contributions align with overall company Address Issues Promptly Respond swiftly to signs of dissatisfaction or disengagement Work collaboratively to find solutions to underlying problems Cultivate a Positive Company Culture Encourage a culture of trust, respect, and inclusivity Encourage a sense of belonging and shared purpose among the team Recognising the signs of silent quitting requires an astute leadership. By addressing these indicators quickly and implementing strategies to boost engagement, leaders can create a workplace where employees feel valued, motivated, and committed to achieving shared goals.
19 Oct, 2023
Introduction The field of Medical Technology (MedTech) is on the brink of a transformative era. As we approach 2024, it's becoming increasingly clear that this sector is set to redefine healthcare as we know it. With innovations spanning from AI-driven diagnostics to personalized treatments, the Medtech industry is at the forefront of medical breakthroughs. In this blog, we'll take a closer look at the exciting developments expected in the MedTech landscape in 2024 and beyond. 1. Innovative Technologies The year 2024 promises to be a pivotal moment for the integration of cutting-edge technologies in healthcare. Artificial Intelligence (AI) and machine learning will continue to play a central role in the industry, revolutionizing diagnostics, and treatment planning. Through data analysis and pattern recognition, AI-powered systems can assist healthcare professionals in making more accurate and timely decisions, ultimately improving patient outcomes. 2. Personalized Medicine One of the most significant trends in Medtech is the rise of personalized medicine. Thanks to advancements in genomics and precision medicine, treatments are increasingly tailored to the individual. Genetic information, combined with a patient's medical history, will allow healthcare providers to offer therapies that are not only more effective but also less likely to cause adverse reactions. 3. Wearable Health Tech Wearable devices, such as smartwatches and fitness trackers, are becoming integral to healthcare. In 2024, these wearables will continue to evolve, providing real-time health data to users and their healthcare providers. From tracking vital signs to monitor chronic conditions, wearable health tech is empowering individuals to take charge of their well-being. 4. Telemedicine and Remote Monitoring The COVID-19 pandemic accelerated the adoption of telemedicine, and it's here to stay. In 2024, telemedicine will become a standard component of healthcare delivery, offering convenient and accessible options for patients. Remote monitoring, enabled by IoT devices, will enable healthcare providers to keep a close eye on patients' health, especially those with chronic conditions. 5. Regulatory Changes The Medtech industry is subject to rigorous regulations to ensure patient safety. In 2024, we can expect to see new guidelines and standards to keep pace with the evolving landscape. Regulatory agencies like the FDA will continue to adapt to technological advancements, streamlining approval processes for innovative medical devices. 6. Cybersecurity Concerns As Medtech becomes more interconnected, cybersecurity will become a paramount concern. Protecting sensitive patient data and ensuring the security of medical devices will be a top priority. The industry will invest in robust cybersecurity measures to safeguard against potential threats. 7. Market Trends The Medtech market will continue to experience growth, driven by emerging technologies and increasing demand for healthcare solutions. Startups and innovation hubs will play a pivotal role in driving industry growth by developing groundbreaking solutions and attracting investment. 8. Global Health Initiatives 2024 will witness a continued focus on global health initiatives. Collaborations between Medtech companies and organizations working to address global healthcare challenges will accelerate the development and distribution of life-saving technologies worldwide. Conclusion The future of MedTech in 2024 holds promise and potential. From AI-powered diagnostics to wearable health tech and personalized medicine, the industry is poised to reshape healthcare in ways we can only begin to imagine. As these innovations become a reality, the world can look forward to improved patient outcomes, increased access to healthcare, and a brighter and healthier future for all. Stay tuned for more exciting developments in the world of MedTech as we embark on this transformative journey. 
13 Oct, 2023
Introduction In recent years, the healthcare landscape has witnessed a significant shift towards providing care in the comfort of patients' homes. The widespread use of medical devices designed for home healthcare settings has made this evolution possible. While these devices offer many benefits, they also have a crucial responsibility: ensuring compliance with regulatory standards. In this blog, we will explore the importance of medical device compliance in home healthcare settings, the regulatory framework, and steps to ensure that medical devices meet the requirements. The Rise of Home Healthcare The rise of home healthcare has revolutionized the way patients receive medical attention. Patients can now manage chronic conditions, receive post-surgical care, and monitor their health from the convenience of their own homes. Advancements in medical technology have sped up this shift, which has resulted in a wide range of medical devices being designed specifically for home use. Types of Medical Devices in Home Healthcare Medical devices used in home healthcare settings encompass a broad spectrum of products. These include but are not limited to: Monitoring Devices: Blood pressure monitors, glucose meters, and pulse oximeters. Therapeutic Devices: Like home ventilators, nebulizers, and infusion pumps. Diagnostic Devices: Such as home pregnancy tests, thermometers, and home test kits for various medical conditions. Assistive Devices: Including mobility aids, home care beds, and lift chairs. The Regulatory Framework Ensuring the safety and effectiveness of medical devices is paramount in home healthcare. To achieve this, regulatory agencies around the world have established stringent guidelines for the development, manufacturing, and distribution of medical devices. In the United States, the Food and Drug Administration (FDA) plays a central role in regulating medical devices. In the European Union, the European Medicines Agency (EMA) and the Conformity Europeans (CE) marking are vital authorities. Critical Steps for Medical Device Compliance in Home Healthcare Settings Product Classification: Determine the appropriate regulatory class for your medical device. This classification will dictate the level of scrutiny and requirements your device must meet. Categories range from Class I (low-risk) to Class III (high-risk). Quality Management System (QMS): Establish a robust QMS compliant with relevant quality standards such as ISO 13485. This system ensures consistent quality control throughout the device's lifecycle. Clinical Evaluation: Conduct clinical evaluations to assess the safety and performance of your medical device. This involves gathering and analyzing clinical data to show its effectiveness. Labeling and Documentation: Ensure that labeling, instructions for use, and all accompanying documentation are clear, accurate, and compliant with regulatory requirements. This information is crucial for end-users. User Training: Provide training to end-users and healthcare professionals on the proper use and maintenance of the device. This can help prevent misuse and potential safety issues. Risk Management: Implement a comprehensive risk management process to identify, assess, and mitigate potential risks associated with your medical device. This is critical for patient safety. Post-Market Surveillance: Establish a system for monitoring the device's performance and collecting user feedback. This information can make improvements and address any issues. Compliance Testing: Conduct testing and verification to ensure your device meets all relevant safety and performance standards. This may include electrical safety, electromagnetic compatibility, and biocompatibility testing. Regulatory Submission: Prepare and submit a regulatory dossier to the appropriate regulatory agency. This submission should include all necessary documentation and data to support the safety and efficacy of your device. Maintain Vigilance: Stay informed about updates and changes in regulatory requirements. Continuously assess and improve your device's compliance to ensure long-term success in the home healthcare market. Conclusion Medical device compliance in home healthcare settings is a multifaceted process that demands careful planning, adherence to regulatory standards, and an unwavering commitment to patient safety. As the home healthcare industry grows, the need for compliant medical devices will only increase. By following the steps outlined in this blog and staying vigilant in your commitment to compliance, you can contribute to the well-being of patients and the success of your home healthcare device in the market. Compliance isn't just a legal requirement; it's a fundamental aspect of providing safe and effective healthcare at home.
29 Sep, 2023
Overview of Biomedical Engineering: Biomedical engineering is the application of engineering principles to the development and advancement of healthcare. It is an interdisciplinary field that combines engineering, biology, and medical principles to develop solutions that improve patient care and quality of life. The history of biomedical engineering dates to the 1800s when physiologists and engineers began collaborating to study the human body's electrical signals. The field has since evolved to include the development of medical equipment, prosthetics, and implants and the use of technology to study and analyze biological systems. There are several fields within biomedical engineering, including biomaterials, biomedical imaging, medical device design, and tissue engineering. Each of these fields focuses on a specific area of healthcare and uses engineering principles to develop solutions to unique challenges. In summary, biomedical engineering is an interdisciplinary field that combines engineering, biology, and medical principles to develop innovative solutions that improve patient care and quality of life. The field has a rich history and is continually evolving to meet the changing needs of the healthcare industry. Biomedical Engineering Careers and Salaries: 1. Biomedical Research Scientist: Biomedical research scientists work on the cutting edge of scientific discovery, conducting experiments and studies to understand diseases, develop new treatments, and improve medical technologies. They might work in academic institutions, research laboratories, or pharmaceutical companies. Salaries for biomedical research scientists can vary widely, depending on factors such as experience, location, and the specific organization. Entry-level salaries might start around $50,000 to $60,000, while experienced scientists can earn well over $100,000 annually. 2. Clinical Engineer: Clinical engineers bridge the gap between medical practice and technology. They are for managing, maintaining, and ensuring the safety of medical equipment in healthcare facilities. This role involves collaborating with healthcare professionals to integrate technology into patient care effectively. The salary for clinical engineers can range from $60,000 to $90,000 or more, depending on experience and location. 3. Medical Device Designer: Medical device designers create and develop innovative medical technologies, ranging from diagnostic tools to surgical instruments. They combine their engineering skills with medical knowledge to create devices that meet the unique demands of the healthcare industry. Salaries for medical device designers can start at around $70,000 and reach over $100,000 with experience. 4. Biomechanical Engineer: Biomechanical engineers focus on understanding how the human body moves and functions, often working on projects related to prosthetics, orthotics, and ergonomic design. Their work contributes to advancements in rehabilitation and mobility help. The salary range for biomechanical engineers typically starts around $60,000 and can go up to $90,000 or more. 5. Biomaterials Engineer: Biomaterials engineers develop materials that are compatible with the human body for applications like implants, tissue engineering, and drug delivery systems. They play a critical role in enhancing medical treatments and interventions. Salaries for biomaterials engineers can start around $70,000 and rise with experience to around $100,000 or more. 6. Regulatory Affairs Specialist: Regulatory affairs specialists ensure that medical devices and technologies meet legal and safety standards set by regulatory authorities. They navigate the complex landscape of regulations and approvals required for new medical products. Salaries for regulatory affairs specialists can vary but often start around $60,000 and can reach $100,000 or more with experience. 7. Biomedical Data Scientist: Biomedical data scientists analyze large datasets to derive insights and patterns that contribute to medical research and decision-making. They use their expertise in data analysis and interpretation to drive advancements in personalized medicine and clinical research. Salaries for biomedical data scientists can range from $80,000 to $120,000 or more, depending on the level of experience and the industry.  It's important to note that salaries can vary significantly based on factors such as location, educational background, level of experience, and the specific employer. The field of biomedical engineering is continually evolving, creating new opportunities and roles that might not have existed just a few years ago. As you consider your career path in biomedical engineering, keep in mind that the field's impact on healthcare and patient outcomes is immense, making it a rewarding choice for those passionate about both science and technology.
20 Sep, 2023
Technology in healthcare is advancing, and that's a good thing. The AMA claims that doctors are using digital tools more frequently, including remote care technology, and that they are eager to employ emerging technologies like artificial intelligence. In the end, doctors want to provide better care for their patients and are aware that they may do so by utilising both current and emerging technologies to provide more comprehensive alternatives and services to people seeking specialised care as well as better insight into diagnosis and treatment. Here are 9 technological trends that are influencing both the present and future of patient care so that you can stay on top of what's new and developing: Increasing Use of AI-Optimized Medical Devices: Medical gadgets collect a lot of data, which artificial intelligence helps process and analyse better. Companies employ AI to spot diseases or the beginning of medical disorders using patient-specific health data. Furthermore, AI makes predictive analysis possible and tracks therapy effectiveness. To facilitate robotic surgery and speed up diagnostics, medical device manufacturers are using AI technology like computer vision. Automation and optimisation of industrial operations are other areas where AI is useful. Growing Use of Miniature Medical Devices: In the medical industry, smaller gadgets with more advanced features are becoming more popular. Medical gadgets that are portable and small use less room and energy. Also, they help patients monitor their own health concerns, such as blood sugar and heart rate. More mobility is made possible by such lightweight, portable equipment, particularly when it comes to ambulatory care and patient transport. The Philips Healthcare Heart Start automatic external defibrillator is a compact, portable device that analyses cardiac rhythm and encourages the operator to administer a defibrillation shock when necessary. A portable oxygen concentrator that combines pulse-dose delivery with continuous flow is now available from Philips Respironics. The smallest portable heart-lung support system in the world, called Cardio help, can track various blood values, such as venous oxygen saturation, haemoglobin, haematocrit, arterial, and venous blood temperature. Soon, it might alter how patients manage their medical requirements. Increasing Acceptance of Wearable Medical Devices: Wearable medical gadgets provide medical monitoring while being worn on the user's body. Either as an ornament or as part of clothing, these gadgets are worn. They offer data on the following: heart rate, motion, direction, glucose, blood pressure, oxygen saturation, weight, respiration, temperature, hydration, and brain activity. One of the most well-liked types of wearable technology is head-mounted displays (HMDs), which include smartwatches. Internet of Medical Things (IoMT): The Internet of Medical Things (IoMT) is a collection of medical software and hardware that may be linked to networks in order to access healthcare IT systems. It establishes a line between patients and their doctors and permits the transmission of medical information across a secure network, lessening the need for unneeded hospital stays and the strain on the healthcare infrastructure. IoMT examples include tracking patient medication orders, identifying patients admitted to hospitals, and remotely monitoring patients with long-term or chronic medical illnesses. Patients may also wearable medical devices that communicate information to caretakers. Adoption of 3D Printing of Medical Devices: Dental restorations, surgical equipment, and orthopaedic and cranial implants are among the medical items created via 3D printing. Medical gadgets and implants built via 3D printing may be more successful than mass-produced ones because they are made specifically for a patient's physiology or even a particular procedure. Surgeons have discovered that personalised surgery using patient-specific 3D-printed equipment and implants expedite recovery and lessen patient pain levels in knee surgery. With 3D printing, there is a significant opportunity to raise the quality of products used in dental and orthodontic procedures. Cybersecurity, Data Breaches, Hacking, and Lawsuits: In the first half of 2022 compared to 2021, the number of cybersecurity assaults on U.S. healthcare companies doubled. A CyberMD analysis found that small and midsize hospitals are most vulnerable to intrusions. The absence of cybersecurity knowledge among employees is the cause. Because of this, manufacturers of medical devices must continue to exercise caution when creating user-friendly healthcare items that are properly protected against cybersecurity threats. The networking of medical equipment inside a hospital is another aspect of cybersecurity. A medical network is increasingly vulnerable to attack danger the larger it becomes. With more web-connected and mobile tools in use, a cyberattack can easily and quickly spread to the other devices on the network, greatly expanding its scope. A cyberattack often originates from a single device. 5G Technologies: Physicians, surgeons, and radiologists now have relatively simple access to patient information with the arrival of 5G technology in the medical device industry. Real-time data transmissions are made easier by 5G networks, which is crucial for a quick and precise diagnosis. The possibilities for remote patient monitoring have generally increased thanks to 5G networks. Since this technology is aimed at populations who prefer to get healthcare in their homes as well as populations who live in remote locations with poor connectivity. Also, outlying hospitals that lack specialist knowledge routinely use 5G technology to link to metropolis clinics. With such instruments, surgeons can get immediate feedback. Medical Robotics: Medical equipment businesses in industrialised nations started to create robots to assist nurses in carrying out their duties as the global nursing shortage grew. The demand for additional help has grown as a result of the pandemic. According to research, nurses were considering leaving their positions due to stressful workloads and burnout. Many nations likewise experience this. Robotics in healthcare facilities frees staff members from repetitive duties including venepuncture, vitals monitoring, getting elderly patients out of bed, sanitising patient rooms, and protocolling. In 2022, Worcester Polytechnic Institute created a remote-controlled medical robot with the goal of treating patients who were placed in home quarantine. These virtual assistants safeguard medical staff from the possibility of patient infection. Moreover, physiotherapy is using a lot of robotics technology to assist patients in their injury recovery. Medical Waste Management The problem with waste is getting worse as medical equipment and accessories are used more frequently. The disposal of medical devices is mostly in the hands of the manufacturers. For usage in biomedical applications, for instance, entrepreneurs are producing high-quality materials like recyclable electronics. Some solutions track medical waste and pinpoint techniques for recycling or reusing medical equipment. FAQ's:
11 Sep, 2023
Wearables: The development of numerous wearables, including ECG monitors, biopatches, smart eyewear, psychological monitoring gadgets, etc., is made possible by advancements in circuit miniaturisation. They gather user health and vital statistics needed for better healthcare delivery and better health management. Additionally, this enables medical professionals to monitor a patient's health while also delivering remote treatments. Wearable medical technologies therefore offer non-invasive diagnosis and boost the effectiveness of prognosis for medical situations. Medical Robots: For better targeting and patient safety, surgical robots are replacing traditional procedures. For instance, robot assistance during laparoscopic procedures guarantees that patients have smaller incisions, less blood loss, and quicker recovery times. However, compared to traditional laparoscopy, improved ergonomics and dexterity are advantageous to the surgeon. Robotic cleaners are being used in hospitals and clinics, freeing up healthcare professionals to concentrate on patient involvement. Finally, the use of micro- and nano-bots to deliver treatments that are targeted. Telemedicine: The idea of telemedicine was first introduced in the 1920s, when clinics on ships received medical advice via radio. In the 1950s and 1960s, when radiology images and patient records were discussed over the phone, this medium was enhanced. In the 1990s, the internet led to a further expansion of this. In the 2000s, telemedicine as we know it was used in the military; recent technological advancements include triage bots and expanded video connectivity for patients and physicians. Telemedicine can be divided into three categories: real-time, store-and-forward, and remote patient monitoring. The advantages of employing telemedicine include improved convenience, improved access to care for patients in rural areas, and improved provider productivity. Immersive Technologies: Medical gadget advancements result in higher resolution photos and movies, yet they are still static. Immersive technologies get over this restriction and offer a first-person viewpoint. To enhance product design, startups are using virtual reality (VR), augmented reality (AR), and extended reality (XR) in the manufacturing of medical devices. These technologies also enhance the delivery of care while enhancing engagement and rehabilitation. Immersive technology help doctors make better decisions. 3D Printing: Anatomical and pathological structures can be more effectively included into the design of medical equipment with 3D printing or additive manufacturing. For instance, this improves how well body components and implants fit together. Better training and planning scaffolds for surgeries are also provided by additive fabrication. On the other hand, it makes it possible to produce medical devices with high cost-effectiveness and patient-specificity. Additionally, rapid prototyping enables producers to produce medical devices quickly, thereby bridging the supply-demand gap. Artificial Intelligence: A key area of the biological sciences now involves the application of algorithms and machine learning in the detection, diagnosis, and treatment of disease. It has been dubbed the biggest healthcare revolution of the twenty-first century by some. Compared to traditional methods, AI may diagnose illnesses earlier and with more accuracy. AI is making it possible to review mammograms 30 times faster and with nearly 100% accuracy in breast cancer, which eliminates the need for biopsies. Smart bandages: American researchers have created a bandage that has sensors to track the healing of wounds. It encourages quicker wound healing, boosts fresh blood flow to wounded tissue, and speeds up skin recovery by considerably minimising the creation of scars. Temperature sensors that keep an eye on a wound are built into a thin electrical layer on the bandage. They can initiate further electrical stimulation if necessary to quicken tissue closure. Cybersecurity: One of the main targets of hostile hackers is healthcare facilities. Furthermore, the industry is more susceptible to cyberattacks as a result of the adoption of cloud-based and connected medical devices. Startups now provide cybersecurity options made specifically for medical equipment. With the aid of these technologies, manufacturers, medical facilities, and patients may quickly spot any network or device irregularities and reduce risk. Cybersecurity solutions shield medical equipment from purposeful malfunction, preventing risks to patient life. Minimally Invasive Devices: The problems of invasive surgery—risks of infection, noticeable scarring, and lengthier healing times—are addressed by minimally invasive surgery. Smaller incisions can now be made during treatments like endoscopy, laparoscopy, and robot-assisted operations thanks to new methods and tools. Startups are incorporating tiny sensors in the tips of tools that provide the operating doctor input, like haptic vibrations. Additionally, minimally invasive techniques lessen pain and discomfort for patients as well as infections, hospital expenses, and recovery times. IoT and Wearables in Healthcare: Their potential in the healthcare sector has significantly increased as wearables and IoT technologies gain popularity. The Internet of Medical Things is the term used by many to describe uses of telemedicine and telehealth technologies. At the beginning of 2023, there were 11.3 billion connected IoT devices. According to projections, the market for IoT medical devices will grow from USD 26.5 billion in 2021 to USD 94.2 billion in 2026. IoT cannot be overlooked because of how connected the healthcare sector is becoming as a result of these technologies. FAQ's 
11 Aug, 2023
What is Software as a Medical Device (SaMD)? SaMD, is a software that complies with the definition of a device and is intended for use for one or more medical purposes without being part of a hardware device." These criteria are a wonderful place to start, but there is a lot of complexity in what SaMD is and how to tell whether your product is SaMD. Let's examine what software as a medical device is, what it isn't, and how to determine whether your product satisfies the criteria. How Do I Know if My Product is SaMD? Since FDA is a participant in the IMDRF, it is obvious that both definitions of SaMD have structural similarities. For software to qualify as SaMD, it must accomplish two requirements that are outlined in the criteria provided by the FDA and IMDRF. We must first decide if the software can even be referred to as a medical device. The IMDRF just indicates that it must be "intended for one or more medical purposes". Anything—including a component, part, or accessory—that is an instrument, equipment, implement, machine, contraption, implant, in vitro reagent, or other similar or related product, and that is: Listed in the official National Formulary, the United States Pharmacopoeia, or any addition to either of those two publications Intended for use in treating, preventing, or curing disease in humans or other animals, or in the diagnosis of disease or other disorders Intended to influence the composition or any bodily function of humans or other animals, and not accomplished primarily by chemical activity within or on the human or animal body. which is not dependent on being metabolised for the accomplishment of its primary intended goals and which does not achieve its primary intended purposes through chemical activity within or on the body of a man or another animal. Software functions that are disallowed under section 520(o) are not included in the definition of "device". You must specify the intended purpose and usage instructions for your product in order to use this definition properly. Just a reminder: Intended use: Your device's intended usage is its purpose. It is what will be done with your device. Indications for use: The diseases or ailments that your gadget will diagnose, treat, prevent, cure, or alleviate are known as indications for use. Indications for use specify who and why your gadget will be used. Is My Software Considered SaMD or SiMD? Consider the case when you have found that your product satisfies the criteria for a medical device. The second half of the IMDRF and FDA's SaMD criteria must still be considered. According to the IMDRF definition, software must fulfil its functions "without being a part of a hardware medical device." The FDA nearly exactly uses the same words when it declares that SaMD "is intended to be used for one or more medical purposes without being part of a hardware device." SaMD's reach is once more constrained by this. The requirements for SaMD are not met by software that is used to drive or power hardware. As opposed to that, this kind of software is referred to as SiMD, or "software in a medical device." Simply simply, a medical device's software is any programme that aids in the operation of its hardware, such as by generating a graphical user interface or powering its mechanics. Here are a few instances: Software that regulates a blood pressure cuff's expansion or contraction A programme that regulates the insulin delivery on an insulin pump Computer programmes for pacemaker closed-loop control. If you hear the terms "embedded software," "firmware," or "micro-code" used to describe this kind of software, remember that these refer to SiMD rather than SaMD. What are Some Examples of SaMD? Real-world examples are frequently simpler to understand than theoretical ones. Below mentioned are a few examples of SaMD. Software that enables viewing of diagnostic pictures from an MRI, ultrasound, or X-ray on a mobile device Image processing software for breast cancer detection Software that analyses data from a smartphone's tri-axial accelerometer to determine a condition. Real-time patient data collection software that is overseen by a medical expert and utilised to create treatment recommendations. How is SaMD Regulated around the World? Even though there are other medical device markets throughout the world, the US and the EU are by far the biggest; therefore, in this section, we will concentrate on these markets. Start off by saying that a SaMD product is still considered a medical device and is subject to the same regulations as such. A quality management system (QMS) will be necessary to get started. You must abide by the FDA's Quality System Regulations (QSR) in the US. The EU MDR (or EU IVDR if it's an in vitro diagnostic equipment) will also apply to your SaMD in the EU. The regulations that apply in each market will still be applied to your device's classification. Basically, it's important to keep in mind that even if your SaMD may differ greatly from a conventional, hardware medical device, you still need to adhere to the same rules that apply to all other medical devices. Considering this, let's discuss some of the specifics of the SaMD regulatory environments in the US and EU. What You Need to Know about SaMD Regulation in the US & UK? Recently the FDA is aware that the standards for medical devices were created with traditional medical devices in mind, they have recently issued guidance guidelines that are specifically for software in areas like premarket filings. Its initial guidance on SaMD premarket submissions was released in 2005. You are correct if you believe it to be a little dated. Because of this, the FDA revised its premarket submissions guidance for SaMD in 2021. The hard part comes at this point. The paperwork you must submit is listed in both the draught guidance and the current guideline according to the intended usage of your SaMD. The current recommendations, which date from 2005, categorise SaMD into three "levels of concern" based on the seriousness of injury that could result from a device failure or design flaw: Minor: Latent design defects or breakdowns are unlikely to result in any harm to the patient or operator Moderate: Failures or hidden design defects could cause mild injuries to the patient or operator as a direct outcome, either through the provision of delayed or inaccurate information or through provider actions. Major: failures or latent design defects could directly cause patient or provider death or serious injury, including through the provision of inaccurate or delayed information or through provider actions. The current advice document then describes the supporting documentation you must provide based on the level of concern that applies to your device. Please be aware that "level of concern" differs from the risk class assigned to your device. Let's now examine the draught guidance. In this instance, two layers of documentation have taken the place of the three degrees of concern: Basic Documentation Enhanced Documentation  What You Need to Know about Medical Device Software Regulation in the EU? The EU's regulation of SaMDs is comparable to that in the US in that it does not differ from the regulation of conventional medical devices. All pertinent requirements of the EU MDR and EU IVDR must still be followed. However, it's significant to note that EU rules do not make use of the phrase "software as a medical device." Instead, they refer to it as "medical device software" or simply MDSW. Fortunately, the European Commission (EC) has released a number of directives that apply to SaMD producers. MDCG 2021-24 - Guidance on classification of medical devices MDCG 2020-1 - Guidance on clinical evaluation and performance evaluation of medical device software MDCG 2019-16 - Guidance on cybersecurity for medical devices MDCG 2019-11 - Qualification and classification of software How is SaMD Classified across Global Regulatory Markets? We have already heard about the SaMD-related rules, recommendations, and worldwide standards. Unfortunately, the IMDRF and IEC 62304 both include techniques for classifying SaMD in addition to the fact that the US and the EU have separate risk categories for medical devices. This can soon become confusing, so let's utilise this part to explain each class and category and how they are related to one another. SaMD Risk Class and “Levels of Concern” The US approach for classifying SaMD comes first. The FDA categorises SaMD using the same risk classes—Class I, Class II, and Class III—as it does for conventional medical devices. Just to emphasise, your risk class is not determined by the "level of concern" you select for your pre-market submission to the FDA. Simply put, the level of concern informs you of the supporting materials your pre-market submission will need. Your level of concern is not considered when determining the risk class for your device, even though it may be significantly connected with it. Medical Device Software Risk Class and “Rule 11” in the EU There is no MDSW-specific risk classification in the EU, like the US. Class I, class IIa, class IIb, and class III risk categories are used for medical device software in the same way as they are used for conventional medical devices. However, Rule 11 of the EU MDR provides guidance on how to identify your medical device software risk class. Rule 11 of the EU MDR's Annex VIII reads as follows: Software that is designed to give data required to make judgements for diagnosis or treatment purposes is classed as class IIa, unless those decisions may: Class III refers to death or an irreparable decline in a person's health Class IIb refers to a substantial decline in a person's health or a surgical procedure Software meant to track physiological processes is categorised as class IIa, unless it's meant to track vital physiological parameters, in which case it's categorised as class IIb because variations in those parameters have the potential to put patients in immediate danger. All other software is categorised as class I. In MDCG 2021-24 and MDCG 2019-11, the EC goes into more detail on Rule 11 and its classification procedure. Most medical device software will, however, be categorised as at least class IIa under the regulation, as you may have noted after reading regulation 11. SaMD Categorization according to IMDRF: The IMDRF has also released guidelines for classifying SaMD. When reading this paper, you'll note right away that the IMDRF categorization includes four rather than three possible categories and needs a table to help you determine which category your device belongs to. Due to the two-dimensional nature of this table, it is necessary to identify both the scenario or condition and the importance of the data supplied by the SaMD. Software Safety Classification according to IEC 62304: The worldwide standard on software lifecycle procedures, IEC 62304, also classifies software safety. There are three categories in the IEC 62304 categorization system based on the seriousness of the harm that a software failure could result in: Class A: No harm Class B: Non-serious injury Class C: Severe harm or death Software Development for SaMD: If you start bringing up software development in the context of medical devices, you'll probably get a lot of sharp opinions. The main cause of this is straightforward. Many laws, including the FDA's QSR, were drafted with the use of conventional, hardware-based medical devices in mind. As a result, they presumptively follow a relatively linear method of product development, where each task is finished before moving on to the next. This is commonly referred to as the waterfall process, which creates a lot of frustration among software engineers because it is how rules and standards like IEC 62304 are established. Most developers today work with an agile methodology, a more adaptable strategy built on an ongoing cycle of iteration. Additionally, a lot of young SaMD businesses don't originate in the traditional medical device industry. Because of the current laws, many of these teams believe it is difficult to use an agile methodology in the development of medical devices. Cybersecurity and SaMD: Safety is always of utmost importance when it comes to medical technology. And to create safe SaMD, you must take cybersecurity into account. The necessity of cybersecurity measures should be obvious by this point, regardless of your background in the software development or medical device industries. In the past ten years, the healthcare sector has experienced several high-profile hacks, and new vulnerabilities are always being found. In fact, one of the sectors with the highest risk of cyberattacks is the healthcare sector. Because of everything said above, device manufacturers can no longer afford to ignore cybersecurity or attempt to incorporate it into a finished product. In order to ensure the security of the users of your device, you must take the dangers seriously because they are actual. Postmarket Requirements for SaMD: It is important to reiterate that software as a medical device is still subject to the same rules as hardware medical devices, despite the subtleties and additional concerns that come with SaMD (such as cybersecurity). This indicates that your SaMD is still subject to all postmarket obligations from laws like the FDA's QSR, the EU MDR, or the IVDR. Additionally, your software maintenance process and software problem resolution process will assist you meet some of these postmarket standards if you have been using IEC 62304 for software development. Check out some of the postmarket-related guides, podcasts, and webinars in our collection of free medical device resources for a more thorough knowledge of these rules. After that, let's discuss some of the characteristics of SaMD that call for a distinct strategy during the postmarket phase of a medical device's lifecycle. Final Thoughts on Software as a Medical Device: In the upcoming years, it will be necessary to resolve the remaining unclarified areas in the SaMD laws and guidelines. Around topics like cybersecurity, there is still a lot of work to be done. Additionally, both software developers and medical device manufacturers must undergo a challenging learning curve. However, there is also a tonne of opportunity and excitement in this field. There is no reason why your organisation can't provide high-quality SaMD that enhances the quality of life for millions of patients if you have the greatest resources and expert counsel at your disposal. FAQ's
08 May, 2023
What is medical device? Any tool, apparatus, machine, implant, or other similar item designed for use in the identification, therapy, or prevention of illness or other disorders requiring medical attention is referred to as a medical device. From basic tongue depressors and bedpans to complex pacemakers with programmable features and closed-loop artificial pancreas systems, medical equipment comes in all shapes and sizes. Additionally, IVD products like reagents, test kits, and blood glucose metres are included in the category of medical devices. Other electronic devices that emit radiation but have a medical use or make medical claims are considered medical devices. These include, for instance, x-ray machines, x-ray equipment, and medical lasers. What are medicinal products? A substance or mixture of substances is a medicinal product if it is meant to be used therapeutically, such as to treat, prevent, or lessen the symptoms of a disease or other medical condition. The compounds that give medicines their therapeutic effects are known as their active ingredients, and medicinal goods may contain one or more of these. Excipients are additional components that medicinal goods may contain in addition to the active ingredients. Excipients helps in stabilising the active ingredient, boost its potency, or improve its absorption. Pharmaceuticals may be offered over-the-counter (OTC) or solely by prescription. Unlike over-the-counter (OTC) medications, which can be bought at a pharmacy or other retail location without a prescription, prescription-only medications need a prescription from a qualified healthcare provider. Medicinal products & medical devices: The creation of new pharmaceuticals and medical device is growing steadily as a result of research and technical advancement. The federal government controls the use of medicinal items to protect both human and animal health. User safety: It is important to utilise therapeutic products sparingly and for the intended purpose only. Product safety: Only superior, efficient medicinal items may be made available for purchase and use. Security of supply: The entire nation must have access to a dependable and well-managed supply of medicinal products as well as the required technical knowledge and guidance. Therapeutic products include medicinal products and medical devices: Therapeutic products are used in the diagnosis, treatment, or prevention of illnesses, accidents, and Chemical or biological items with the intent to have—or that are advertised as having—a medical effect on the human or animal organism are referred to as medicinal products. Products that are advertised as having a medical use or that are intended to have a medical use but whose primary impact cannot be achieved with a medicinal product are known as medical devices. They consist of tools, equipment, medical devices for in vitro diagnosis, software, and other products or substances. Types of borderline products: Below mentioned are the borderline products: Cosmetics Food products, including food supplements Herbal products Medical devices Biocides Machinery/laboratory equipment Borderline medicines: A medicinal product is: Any chemical or mixture promoted as having capabilities for preventing or curing sickness in humans. Any medicine or mixture of substances that may be utilised by or provided to humans with the goal of restoring, correcting, or changing a physiological function through the exertion of a pharmacological, immunological, or metabolic effect, or for the purpose of making a medical diagnostic. Food supplements that contain well-known ingredients like vitamins, amino acids, or minerals are often governed by food safety and food labelling laws rather than regulations for medications. The Trading Standards Institute can provide you with guidance on food and cosmetics. The MHRA determines whether the product is deemed to be a medical product based on the claims that are made or the active substance(s) present. A product can still be a therapeutic product even if it contains herbal or "natural" elements. When determining a product's status that contains herbal ingredients, the MHRA takes the same factors into account. How we decide if a product is a medicine: A product is determined to be a medication by the MHRA when: The manufacturer seeks guidance from the MHRA because they are unsure whether their product qualifies as a medicine or not A product is promoted as a medicine but the MHRA gets a complaint that it lacks a marketing authorization, also known as a product licence We examine: The explicit and implicit promises made by the product The substances' pharmacological, metabolic, or immunological effects (including any herbal constituents) The product's main objective and whether any similarly licenced or registered items are currently available in the market How it is advertised and promoted to the general public through labelling, packaging, literature, and commercials FAQ's:
17 Apr, 2023
Marketing custom-made medical equipment can be a challenging procedure that involves several regulatory regulations and high criteria for quality assurance. The main procedures for releasing a specially created medical device onto the market will be covered in this blog, including design and development, testing and validation, regulatory compliance, and marketing and distribution plans. By being aware of these processes, you can make sure that your specially produced medical gadget satisfies all standards and reaches its target market in a secure and efficient manner. Custom-made Medical device definition: A custom-made medical device, also known as a custom device or a made-to-order device, is a medical item created and produced specifically for a single patient. Auricular splints, dentures, orthodontic tools, orthotics, and prosthetics are a few examples of custom-made medical equipment. An individual patient's unique medical needs, which are incompatible with typical off-the-shelf medical devices, are to be met by a custom-made medical device. Custom-made medical devices can enhance a patient's mobility or functionality, help treat medical conditions or injuries for which there may be no other effective treatments, and improve the patient's quality of life by designing and manufacturing a device that is specifically suited to their individual anatomical or physiological characteristics. To improve the patient's results, customised medical gadgets can also be applied during operations or as a component of continuous care. Clarification: A custom-made device is not a normal product; rather, it is a product required by a licensed expert under a written prescription, which is the first thing you need to grasp. You need to clarify the needs and requirements based on which the actual device will be made! Mass-Production: Medical gadgets that are mass-produced are those that are created in big quantities and are designed to be used by numerous patients. Without being customised for specific patients, these devices are made to a standard specification and are intended to fulfil broad medical demands. Is a 3D printed device considered custom-made? If a 3D printed equipment is created specifically for a patient based on their particular anatomical or physiological traits, then yes, it may be said to be custom-made. Medical 3D printing involves creating physical reproductions of anatomical structures in order to create medical equipment directly or indirectly. Using MRI, X-Ray CT, and other 3D imaging techniques, you can create digital models of structures for 3D printing. Recently, this approach has become more widely used for clinical and research-based healthcare activities. With 3D printing, it is possible to produce small batch sizes quickly and affordably, which is a significant benefit. Over the following few years, it is projected that as the cost and accessibility of the technology decline, so will its application in medicine. It is anticipated that this development will lead to increased 3D printing use in clinical and educational settings, better regulatory guidance, and more competition among manufacturers of medical devices. Requirements to register a custom-made device: We can continue when you can attest that your product is indeed a custom-made device. There are two types of specialised equipment: General Custom-made devices Class III implantable Custom-made devices You must adhere to Annex XIII's standards for generic devices. Make a statement Maintain all conformity-demonstrating documentation in the Competent Authority Archive for 10 years and 15 years for implanted devices. Utilise PMCF to monitor the devices' performance. MDCG 2021-3: The MDCG group published a guide for custom-made devices in the form of questions and answers. What makes this blog intriguing is the amount of vocabulary it provides, such as: Adaptable medical equipment Patient match devices We have the following devices within the definition of what constitutes a CMD: Mass-produced items that need to be modified to satisfy the unique needs of any professional user. We refer to these as adaptable gadgets. Devices that are mass-produced using industrial manufacturing techniques, maybe following a written prescription from a qualified individual. The patient match devices can incorporate that. Therefore, take care to ensure that your product does not fall into one of these categories otherwise it will not be regarded as a custom-made item. Podcast: You can explore the world of custom-made medical devices, from design and development to regulatory compliance and patient impact, in several podcast episode available online. The distinction between general custom-made and class III implantable device:
11 Apr, 2023
To significantly improve the quality of patients' lives, innovative medical devices frequently bring disruptive changes to the market. The development cycle of a cutting-edge medical product can take anywhere from 3 to 7 years to get to the point of potential commercialization. According to the data, 90% of new businesses fail within the first five years. Going on, 75% of startups for medical device companies never reach the market. What causes the 25% of people to succeed, then, is the actual mystery. Medical Device Success: A study by MDPI discovered numerous variables that have a significant impact on a medical device company's performance. The most crucial qualities for a highly skilled workforce were technical skills. Yet, elements like marketing expertise, market research, product competitiveness, and growth potential came after the technical skill set. All these factors can be categorised as indicators of the market's actual need for the goods. Your ability to complete the development life cycle quickly and enter the market is crucial because it could have an impact on the demand for your product. The marketability of a cutting-edge medical equipment may be increasingly impacted over time by competition, cyclical tendencies, and economic conditions. This takes us to the realisation that market demands and healthcare trends have a significant impact on the potential of medical device start-ups. List of Medical Device Startups: You'll find 10 outstanding medical device startups on this list, all of them are at various stages of development. Synchron – Brain Computer Interface: It creates a fully implantable brain-computer to help paralysed persons regain their functional freedom. The implanted brain interface enables patients to do daily tasks and improve communication without requiring open brain surgery. BiVacor – Durable Artificial Heart: A long-lasting artificial human heart being developed by BiVacor should last for more than ten years. The lengthy lifespan of the novel medical equipment is made possible by active magnetic levitation and the usage of just one moving part. In contrast to other products on the market, the BiVacor artificial heart functions using a rotating pump rather than mechanical valves and membranes that flex.  TytoCare – Diagnostics at Home: You can avoid the waiting room by using TytoCare, a medical device. The device gathers information about your symptoms and, using that information, advises and schedules medical exams. The findings of these tests are then sent to your doctor, who may propose a course of therapy or write a prescription. InsighTec – Incisionless Operations: For image-guided acoustic surgery, Insightec creates focused ultrasound devices. These products are intended to replace conventional surgery. Without cutting into the body, high intensity focused ultrasound can generate enough heat to target and impact internal tissue. This enables the surgeon to avoid using a scalpel in favour of a computer station and mouse. ReperioHealth – Diagnostics at Home: You can keep track of your health with the help of Reperio Health's FDA-approved health test kit. The health kit performs checks on vital biometric indicators like blood pressure, cholesterol, resting heart rate, and more. It is a diagnostic instrument that enables you to carry out easy health tests at home and, based on the results, suggests a doctor appointment. LegWorks: It is a medical device firm that makes high-quality artificial knees that are also reasonably priced available to everyone. 90% of amputees in underdeveloped nations lack access to prosthetic devices, according to LegWorks. At the age of 18, CEO Brandon Burke lost his leg above the knee. He wanted to provide the world with a variety of functional and realistic knee solutions. ComeBack Mobility: Ukraine-based ComeBack Mobility aspires to make it simple for patient care teams to keep track of the development of the complete recovery procedure following a leg injury. Their Smart Crutch Tips track the amount of pressure a patient applies to their leg when using crutches. The crutch tips instantly alert the patient if they have too much weight on one leg, allowing them to make necessary adjustments. Patients can follow their development in weight bearing by using an app that is compatible with the crutch tips. Proov: Dr. Amy Beckley created Proov's rapid response progesterone test strips as a result of her three years of infertility, two IVF cycles, and seven miscarriages. In order to help other women, detect their progesterone levels and prevent the problems and protracted diagnosis procedure she went through, she discovered that her fertility challenges were caused by low progesterone. As a result, she developed these test strips. Senzo: An amplified lateral flow (ALF) fast antigen self-test for COVID-19 with 100% accuracy is being developed by Senzo, a startup in the UK. In the future, Senzo intends to apply the ALF system to other testing requirements so that people all over the world can benefit from the accuracy of self-testing that was previously only found in laboratories. Polycarbin: Syringes, DNA extraction kits, and other tools used in the life sciences all involve the usage of plastic. According to Polycarbin, which seeks to stop the production of approximately 12 billion pounds of scientific plastic garbage annually, this is the case. The company offers techniques to recycle plastic waste and aids laboratories in lowering carbon emissions. Its mobile app offers data on waste reduction, allows users to schedule recycling pickup, and more. FAQ's:
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