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Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent u

Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices. Agenda Day One Day one sets the stage with an ov

Single-use medical device reprocessing refers to cleaning, disinfection, testing, sterilization, and remanufacturing of a used medical device to be put in service again. The reuse of single-use medical devices first began in the late 1970s. According to the Centers for Disease Control and Prevention (CDC), around 20 to 30% of the U.S. hospitals reported having reused at least one type of single-use device. The reuse of single-use devices involves ethical, regulatory, legal, medical, and economic issues, which have faced controversy in the last two decades. The reuse of single-use medical devices has increased typically due to the COVID-19 pandemic outbreak. In general, there are two categories of products that can be reused: active and inert. Active products are required for making new products, while inert products are used for making old products stronger, newer, longer-lasting, and more effective. The useful products that are generated are called inert products. These are products that have a certain amount of value because of their function. They are available in different forms like paper, paperboard, metals, plastic, etc. These products can either be reclaimed from the environment, or produced by industries and used for manufacturing purposes. The mobile devices that need to be recycled for single-use medical device reprocessing include diagnostic devices, sterilization equipment, biopsy instruments, blood glucose analyzers, blood pressure monitors, disposable gloves, medical imaging devices, and many more. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/single-use-medical-device-reprocessing.html

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Patient warming devices come in many forms, each designed for a specific purpose. For example, some devices are made for offices that are out of the way or for doctor offices that are smaller in size. In addition, these applications are very easy to operate and can be used without requiring a great deal of training on the part of the patient or the medical professional using the device. However, there are certain devices that are extremely efficient and are recommended by both practitioners and medical associations across the country. An increasing number of surgical procedures is expected to drive the growth of the global patient warming devices market. According to the National Health Statistics Reports, in 2017, around 48.3 million surgical and nonsurgical procedures were performed in the U.S. with around 25.7 million ambulatory surgery procedures being performed in hospitals, while 22.5 million being performed in ambulatory surgery centers (ASCs). Patient warming devices are widely used in surgical procedures, which cover before and after surgery. As a result of this, the demand for patient warming devices has increased significantly. Hence, these factors are expected to drive growth of the global patient warming devices market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/patient-warming-devices-market-is.html

A hearing protection device, more commonly known as an HPD, is an ear protective device worn on or behind the ears to help avoid noise-induced hearing impairment, especially noise caused by construction, aircraft, machinery, and some home appliances. An HPD works by reducing background noise and blocking out high-frequency noise that's typically emitted from machinery, or other loud noises. An HPD usually blocks out more than 90 percent of the noise in a room, and often can't be bought by most people because they are typically a bit bulky, which makes them more expensive than traditional earplugs. One of the most common reasons why an HPD is recommended for workers exposed to noise above 200 hertz is because they protect the worker's ears by reducing the amount of time that they're exposed to damaging radiation. Most workers who wear hearing protection devices are not exposed to as much noise as they would be with no protection, so they tend to retain more of their hearing after extended exposure to loud sounds. This keeps them healthier overall and prevents the onset of hearing loss that normally occurs after long-term exposure to high levels of noise. The main factor driving the growth of the hearing protection devices market is stringent rules made by governmental bodies all over the world for workers' safety. Increased hours of working in factories with heavy machinery emitting sounds can result in temporary or permanent deafness. Keeping in mind this issue, rules have been made for factory workers across the world to wear safety devices such as hearing protection devices to work. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-hearing-protection-devices.html

The term "portable diagnostic device" (or PDD for short) refers to a wide range of medical devices that are either made for external use (that can be used in the field) or for internal use in the doctor's office. They are designed to be used quickly and easily by any patient and also provides continuous and non-invasive monitoring of health parameters. Moreover, they also provide real-time information to a healthcare provider through connectivity. Growing advancement in the field of medical device such as smart wearable's and image-guided therapy systems is predominantly fueling the growth of the portable diagnostic device market. For instance, in January 2019, Royal Philips announced Azurion with FlexArm, to set a new standard for patient imaging and positioning flexibility for image-guided procedures. Rising awareness regarding the advantage of portable medical devices is again anticipated to foster market growth. Increasing the manufacturer's focus on the development of compact, wireless, and user-friendly is again projected to foster the growth of the portable diagnostic device market. Growing advancement in the field of embedded systems, sensors, and electronics is contributing to market growth over the forecast period. Also, the growing geriatric population is increasing the prevalence of chronic diseases such as diabetes and cancer which is again driving demand for portable diagnostic devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/are-smart-wearable-and-image-guided.html

Surgical drain cleaning equipment plays an integral part in ensuring maximum productivity in the healthcare industry. These devices are meant to evacuate fluid and prevent the buildup of air at the surgical site. This is done with the use of vacuum or wall suction. Majority of these devices use negative pressure therapy to drain fluid from the surgical site. Demand for such medical devices has increased at a rapid pace due to their various advantages which make them highly useful. Increasing prevalence of chronic diseases such as cancer, cardiovascular disease, and kidney disease is expected to drive growth of the global surgical drainage devices market during the forecast period. According to the World Health Organization (WHO), in 2018, around 9.6 million deaths were attributed to cancer across the globe. According to the same source, around 70% of deaths from cancer occur in emerging economies. Moreover, according to the WHO, around 17.9 million people die from cardiovascular diseases each year globally. According to the same source, in 2010, around 2.3-3.7 million people were suffering from end-stage kidney disease. These above-mentioned diseases require significant surgical procedures and hence, it is boosting the demand for surgical drainage devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/surgical-drainage-devices-market-is.html

Enteral feeding devices technological advanced medical device used to deliver nutrition food directly to the stomach to the bedridden patient suffering from chronic diseases such as cancer and neurological disorder. The increase in the cases of malnutrition and premature birth cases around the globe is a prime factor driving growth of the enteral feeding devices market. Moreover, the growing prevalence of chronic diseases such as cancer and cardiovascular disease is another key factor fostering the market growth of the enteral feeding devices. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths occur due to cancer. Around 70% of deaths from cancer occur in low- and middle-income countries. Furthermore, increasing global expenditure on the healthcare sector for improving the patient care is further projected to augment the growth of the enteral feeding devices market. From the geographical perspective, North America is projected to gain significant growth over the forecast period and this is attributed to the high presence of the geriatric population prone to chronic disease that leads to digestive ailments. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/enteral-feeding-devices-to-gain.html

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html

Endoscopy is a procedure that has been developed to assist in the removal of endometriosis from the human body. Endoscopy is also being used to help in the treatment of gallstones, cholecystitis, and gastric reflux disease among a number of other conditions. The recent developments in this industry have been driven by changes in government regulation and legislation. The increase in the number of malignancies and the introduction of fiscal policy in the region has resulted in political will on the part of the governments to strengthen public health services. Rising product approval for endoscopy devices by regulatory authorities is expected to drive growth of the global endoscopic stricture management device market during the forecast period. For instance, in January 2020, Pentax Medical received the U.S. Food and Drug Administration (FDA) approval for its Imagina Endoscopy System, which will be used in performing gastrointestinal procedures, digital image enhancement system with Pentax i-Scan. This endoscopy machine is equipped with an LED touch-screen interface, which removes the need for periodic bulb replacement. Besides, it is far more cost-efficient than the GI endoscopy system such as video endoscopy. Thus. These factors are expected to drive growth of the global endoscopic stricture management device market during the forecast period. Furthermore, increasing incidence of bleeding during surgical procedures combined with growing number of endoscopic procedures is expected to boost the global endoscopic stricture management device market growth over the forecast period. However, the lack of skilled healthcare professionals to perform surgical procedures, especially in emerging economies combined with complications related to endoscopic procedures such as bleeding and infection is expected to hamper the global endoscopic stricture management device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/end

Cast saw devices are efficient, versatile power tool used primarily to remove orthopedic cast plaster. Unlike a regular circular saw with an adjustable blade designed to cut wood, a cast saw utilizes a straight, sharp blade spinning or vibrating quickly back and forth across a narrow angle to cut hard material. The blades are most often used with an orthopedic cast spreader attached to the machine. With the cast spreader attached to the machine, the operator simply places the cast in the center of the spread and begins the vibrating action. The speed and depth of the material being cut vary according to the operator's preference. Modern cast saw devices date back to the plaster cast cutting saw. Homer H. Stryker, an orthopedic surgeon in the U.S. submitted the patent for this device in April 1945. The cast saw consists of a blade and a cutting block. To cut materials without using vibrations, the blade must be slightly bent. An arbor blade assembly provides for a stable framework on which the blade of the saw blade can be placed. Power corded models of cast saw devices require a separate power cord to operate. This cord usually plugs into a standard wall outlet. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/electric-cast-saw-devices-offer-various.html

Patient Lateral Transfer Devices (PLDs) have been a mainstay of patient care in the healthcare industry. In this new age of technology, devices are quickly replacing traditional medical procedures. These devices are changing the way we do things and the way we move from one location to another. The introduction of PLDs has brought along with the changes and advancements in how we transfer our patients from one floor of a hospital to another. As this transition continues to happen, more changes will come forth along with it. The number of people using and accessing these services has increased drastically and the number of people who use these services is expected to continue growing. It is projected that within the next two years, there will be a majority of individuals who use the services provided by patient lateral transfer devices to move from their beds to waiting areas of the hospital. Patient lateral transfer includes the clinical settings that involve transporting an injured or ill patient to a medical facility. It can also include transferring an individual from a medical facility to a hospital in another location for treatment. When the patient is moved, it could include transporting the patient to the operating room or to another treatment facility. These services are very popular and serve as a huge industry. There are several different reasons why individuals are enticed to become part of this segment. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/patient-lateral-transfer-devices.html

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

PET-CT Scanner devices are highly advanced devices that help physicians make a correct diagnosis of the disease earlier, reducing unnecessary suffering to patients. They are widely used in a number of applications in the healthcare industry. One such medical application is in the field of diagnosing certain diseases, wherein the scanning of the body tissues, the positron emission tomography or PET-CT is used as a diagnostic tool. By using the ionization technique, scientists are able to locate and map the location of the abnormalities in a patient's body. This technology is a boon to mankind as it has helped in reducing the number of deaths caused by various diseases due to their early detection. The growing prevalence of cancer, HIV, and cardiovascular disease is driving the PET-CT scanner device market growth. Out of these chronic diseases, cancer held the highest share in the market. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. According to the U.S. Department of Health & Human Services, an estimated 36,400 new HIV infections occurred in the United States in 2018. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/pet-ct-scanner-devices-gaining-traction.html

"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.

Deep brain stimulation is a non-invasive neurosurgical treatment involving the placement of an electronic device called a simulator that emits electronic pulses, into the brain. These pulses are delivered to the area where there is the greatest need for stimulation, in the area known as the cerebral cortex. The purpose of this treatment is to increase brain function and improve brain function. This treatment is often used in conjunction with other procedures and is also very successful when it is used alone. Increasing prevalence of Parkinson's disease is expected to propel growth of the global deep brain stimulation devices market. For instance, according to the study, 'Prevalence of Parkinson's disease (PD) across North America", published in July 2018 in the journal Nature, the number of people suffering from PD is expected to reach 930,000 in 2020 and 1,238,000 in 2030. Increasing number of clinical trials for deep brain stimulation devices is expected to offer lucrative growth opportunities for players in the global deep brain stimulation devices market. For instance, in January 2021, Medtronic plc announced the first enrollment in ADAPT-PD, a trial evaluating the safety and efficacy of adaptive deep brain stimulation in patients with Parkinson's disease. Similarly, in October 2020, Keck Medicine of USC announced to enroll individuals in an international phase 3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer's. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/increasing-prevalence-of-parkinsons.html