Wk 5 Team
Nies6ha
HCS490_W5_Presentation1.pptxHealth care consumer – medical device Manufacturer
Learning Team 3
HCS/490
July 5, 2021
Dr. Teresita Rodriguez
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Agenda
Introduce
Introduce medical device and company information
Understand
Understand the importance of sharing information
Identify
Identify the impact of outside agencies
Discuss
Discuss the effect of regulations in health care
Explain
Explain the changing market and how the company plans to respond
“Elite Prosthetics” Company
Here at EP, we are driven to make sure those who experience our products are satisfied and safe in doing so. Our passion is the relentless pursuit of premier performance and patient comfort. Our health care professionals employ the most advance prosthetics techniques while delivering comfort and performance. Our company takes the proper steps in assuring our customers are comfortable, safe, and satisfied with all our prosthetic products.
Above Knee
Below Knee
Knee Disarticulation
Hip Disarticulation
Health care workers and administration at Elite prosthetics understands that it can be difficult to adjust and get around comfortably without having all limbs especially if you recently lost one due to an accident or medical condition. We offer counseling to help cope along with a limited amount of physical therapy sessions to get you started and prepared for daily living and activities. Here at Elite prosthetics, we take ever thing we do seriously including our team. We have certified practitioners on board that are experienced adept in the most advanced procedures and advanced technological prosthetic care available today. It is important to us that our patients understand how our products works and will benefit them now and, in the future. Leveraging video technology, each of our patients receives a thorough review and analysis from our team of expert clinicians located statewide.
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Our Value “Elite Prosthetics”
We value everything about our patients. Their stories, their daily lives and activities, making sure they are satisfied with all services and products received. Our staff must believe that patients come first. Their comfortability with the products , their safety, and well being. All of our products are safely tested and approved. Any time a manufacturing is changed for a particular reason, the product is retested to assure its best for use. We use top tier metal for our products that are API(active pharmaceutical ingredient) approved. To make sure our products are tested properly we have QC chemists, QC laboratory management and
Quality Assurance personnel on board. Assessment of compendial verification data is needed to ensure potential technical and safety issues are identified.
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Respect- At EP we value our patient’s backgrounds, stories, and viewpoints. We treat everyone including our staff, patients and suppliers with respect.
Calling- Patient care is a calling and not just a job. We are passionate about seeing our patients satisfied and leaving our company happy and comfortable. We are excited to by pursuing the best outcome with our prosthetics care for all patients.
Teamwork- to deliver the best results, we must work together as one and stay involved. Working as one has the best out outcome for patients.
Integrity- We encourage all our health care workers to share their opinion and views with the patients.
Sharing Health Information
There are various ways to share and obtain information such as:
Medical information guides at physicians' offices
In person support groups
Virtual support groups
Trusted online organizations
There are various ways to share and obtain information about new products, medication, and trials. Physician offices and surgical facilities typically have areas where there is pamphlets and posters containing information on various new studies, new medications that are available and new services available. These are designed for the reader to take into consideration and ask their specialist for more information or to visit the website to sign up for more information. There are also different types of support groups. These are not only good for one’s mental health, but they are also a great way for people who are experiencing similar situations to share new information as well. People can talk about new medications that they have tried and if they did or did not help them as well as various studies that they have tried and/or heard about. Support groups can also be found online through different forums and on various social media platforms. Another great way to find information is through trusted organizations online such as https://www.amputee-coalition.org.
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Sharing Health Information (Cont’d)
Modern methods of communication that physicians and pharmacies utilize include but are not limited to social media, websites, television ads, and word of mouth. Social media is a great way to communicate new trials, services, medications and more. Not only can the physicians’ office or pharmacy inform their followers of the new services, they can also purchase advertisements as well to reach various potential patients with similar interests or search results that signify that they may be interested in the content. Television ads are a great way to reach the public and inform them of new services. This can reach a larger population as well as a broader population. Not everyone is able to use social media or the internet in the most efficient manner. These days nearly every pharmacy and physician office has their own website. This helps patients stay informed with new information as well as allows for possible new patients or clients to reach out and contact the facility for a number of reasons. Adding a section to the home page making new services known as well as providing links to their social media can allow for more interaction. The most common method of communication is word of mouth. Word of mouth can spread faster than anything posted on the internet. Physicians and pharmacists informing patients during visits and pointing them in the direction of more information leads to the patients talking to their friends as well. This works for both positive and negative information.
People love to communicate and feel like they are making a difference. This leads to spreading information through word of mouth, blogging, and the use of social media. Through social media services such as Facebook and Instagram, people are encouraged to share information, their experiences as well as photos to accompany the information. This is a great way for those who are comfortable enough to show off their new medical devices and talk about them. With social media, it’s easier than ever to bring attention to, and spread awareness about various diseases, disabilities and more. Blogging is another way that consumers spread information. This allows for the writer of the blog to also provide links to support the information that they are sharing as well as photos.
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Physicians and pharmacies often communicate in ways such as:
Social Media
Television
Websites
Word of mouth via visits
Consumers communicate in ways such as:
Social Media
Blogging
Word of mouth
Impact of Outside Agencies
Federal R&D programs date back as far as World War 2, that is when the R&D support of the federal government became one of the major functions in government. Federal R&D support has grown and began embracing domestic concerns which has led to government and the private sectors supporting development and innovation (Institute of Medicine, 1991).
The medical device manufacturers association or MDMA is a national trade association based in Washington DC. This organization takes a proactive role in healthcare by helping shape policies that will ultimately affect medical device innovators and the healthcare ecosystem. The MDMA can do this by working with key members of congress, the FDA and CMS. The prime mission of the MDMA sets out to create innovation in research driven medical device technology (MDMA).
Believe it or not the CMS also plays a role in medical device manufacturing but maybe not in the way you think. The CMS plays more of a role in the availability of medical devices. With recent changes to their policies and rules the CMS has accelerated Medicare’s coverage and payments for FDA approved devices. This is their efforts to get needed medical devices to the consumer quicker and more efficiently (Euhus, 2020).
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Federal R&D Programs
Medical Device Manufacturers Association (MDMA)
Centers for Medicare & Medicaid Services (CMS)
Impact of Outside Agencies (Cont’d)
Food & Drug Association (FDA)
MedWatch
Center For Devices and Radiological Health (CDRH)
The FDA plays a multiple roles in how they effect the medical device manufacturing industry. First, the FDA as a whole regulates any and all sales of medical device products in the U.S. and monitors the safety of al regulated medical products. Without the approval of the FDA it is not legal for any devices to be sold in the United States (FDA, 2018).
MedWatch is the FDA’s safety information and adverse event reporting program. With this program in place the FDA allows the device manufactures, healthcare professionals as well as the consumers to report any adverse or serious issues that are directly related to the use of the medical devices. This can also be used as a tool because they have a section used to search for previously reported medical device problems (FDA, 2018).
The FDA is broken up into other centers, one of them is the CDRH. The CDRH is directly responsible for the regulation of any firms that manufacture, import medical devices that are sold in the United States as well as repackaging and relabeling. Whether the manufacture be domestic or foreign, in order for the importers to have the medical devices distributed in the U.S. they must first have their establishments registered and approved by the FDA (FDA, 2020).
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Anticipating the Changing Market
Team Linchpin (2021). Trends transforming the medical device industry outlook in 2021. Retrieved from https;//linchpinseo.com/trends-medical-device-industry/
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In 2020, the amount of medical data obtained will begin to increase by 100% about every 73 days.
When collecting data for the purpose of medical research, studies show that 40 percent of patients are willing to share their personal information.
By 2025, the use of extended reality devices is expected to reach $5.1 billion.
It’s anticipated that growth in the IoMT market will continue by 30.8 percent annually, reaching $159.1 billion by 2022.
Until 2024, it’s anticipated that growth in the medical device industry will average 5.6 percent. This is based on a compound annual growth r
Anticipating the Changing Market (Cont’d)
Artificial intelligence will help guide medical device industries drive better and earlier diagnosis of diseases, help treat more precisely and help engage patients more efficiently.
The internet of medical things are computing, mechanical and digital devices and machines, and they have the ability to transfer data over the network without requiring external interaction.
Medical robotics assist surgeons in the operating room, automate research lab processes, and assist medical emergencies by making them cheaper and more readily available.
Wearable technology are devices such as pedometers, heart rate monitors or blood pressure cuffs that can send statistics directly to physicians for remote patient care.
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Artificial Intelligence
Internet of Medical Things (IoMT)
Medical Robotics
Wearable Technology
Conclusion
Presented the company information and the metal alloy prosthesis
Analyzed the importance of sharing consumer information
Identified the impact outside agencies have on health care companies
Reviewed the critical role that regulations have on the health industry
Discussed the changing health care market and how the company can be adaptable to it
REFERENCES
Euhus, R. (2020). CMS Proposed Rule on Breakthrough Medical Devices Builds on a Flawed System. https://www.arnoldventures.org/stories/cms-proposed-rule-on-breakthrough-medical- devices-builds-on-a-flawed-system//
FDA. (2018). FDA's Role in Regulating Medical Devices. https://www.fda.gov/medical-devices/home-use- devices/fdas-role-regulating-medical-devices
FDA. (2020). Overview of Device Regulation. https://www.fda.gov/medical-devices/device-advice- comprehensive-regulatory-assistance/overview-device-regulation
REFERENCES
Institute of Medicine. (1991). Roles of Government and Industry in Medical Technology Research, Development, and Use. https://www.ncbi.nlm.nih.gov/books/NBK234438/
MDMA. (2021). About MDMA. https://www.medicaldevices.org/page/AboutMDMA
Team Linchpin (2021). Trends transforming the medical device industry outlook in 2021. https://linchpinseo.com/trends-medical-device-industry/
