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    [title] => Medtech & Health IT Joint Security Plan Addresses Cybersecurity Threats
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    [summary] => The plan aims to incorporate strong cybersecurity into existing design control, quality systems, and product release processes.
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    [body] => A medical technology and health IT task force of medical device manufacturers, trade associations, FDA representatives and other health industry stakeholders—operating as part of the Healthcare Sector Coordinating Council (HSCC)—unveiled the Medical Device and Health IT Joint Security Plan (JSP) to address challenges the healthcare industry faces when securing and protecting itself against cybersecurity incidents, both intentional and unintentional.
 
The JSP responds to and puts into effect recommendations and action items set forth in the June 2017 Health Care Industry Cybersecurity (HCIC) Task Force Report, which identified a need to increase the security and resilience of medical devices and health IT products.
 
The JSP provides a voluntary framework that should be considered during the entire product lifecycle, and to assist medical device manufacturers and healthcare information technology vendors to incorporate strong cybersecurity into existing design control, quality systems and product release processes. Various participants of the JSP drafting committee organizations commented on the JSP release:
 
“AdvaMed congratulates the Healthcare Sector Coordinating Council on release of the Joint Security Plan,” said committee member Zach Rothstein, AdvaMed vice president, technology and regulatory affairs. “The JSP provides a voluntary framework to assist medtech manufacturers, health IT vendors, and others to continue to maintain the strongest cybersecurity practices for the benefit of patients everywhere, in a continuously evolving cybersecurity environment,” Rothstein said.
 
“The collaborative approach on the JSP demonstrates the healthcare sector’s ongoing commitment to address cybersecurity challenges throughout the product lifecycle and across the healthcare delivery system,” said Rob Suarez, director of product security for BD, who served as industry co-chair for the working group that developed the JSP. “Developed in collaboration among the healthcare community—including medical device manufacturers, healthcare IT vendors, healthcare delivery organizations, related trade associations, independent security researchers and federal government representatives—the JSP is an important, foundational piece of the collective effort to help make medical devices and IT solutions more secure from potential hacking risks.”
 
“MITA is encouraged by the engagement and collaboration among stakeholders and FDA to develop solutions for reducing medical device cybersecurity risks,” said Michael McNeil, global product security and services officer for Royal Philips and chair, MITA, Cybersecurity Committee. “As an increasingly important part of the modern health delivery infrastructure, it is important for medical device stakeholders to work together to share the responsibility of cybersecurity to ensure patient safety, privacy, and security.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-29 08:45:00 [updated_at] => 2019-01-31 10:11:04 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305694","292106","306032","305643","305426","304505","304021","303430","301013","301011","306356","305612","305313","305056","304107","303306","302016","300334","300250"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2019-01-29/medtech-health-it-joint-security-plan-addresses-cybersecurity-threats/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 292106 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Children’s National Health System","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 172818 [primary_image_old] => 107160 [slider_image_id] => 172818 [banner_image] => 0 [title] => A Call for Pediatric Cardiovascular Devices: $100K Competition Now Accepting Proposals [short_title] => [summary] => Pediatric Device Innovation Symposium’s pitch competition to address unmet need for children. [slug] => a-call-for-pediatric-cardiovascular-devices-100k-competition-now-accepting-proposals [body] => Children’s National Health System is now accepting proposals for its annual “Make Your Medical Device Pitch for Kids!” competition. New this year, the competition is focused on pediatric cardiovascular devices to address a significant unmet need for children. The competition will be held on Sept. 23 in Philadelphia at the Sixth Annual Pediatric Device Innovation Symposium. For the second year, the one-day symposium is co-locating in a joint effort with The MedTech Conference powered by AdvaMed.
 
Children’s National invites proposals from innovators with pediatric cardiovascular medical devices that have potential for commercialization. Competition finalists will pitch their device to a panel of judges and as many as four innovations will be awarded $25,000 each. In addition to the prize money, winners will receive consultation services from experts at Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland’s A. James Clark School of Engineering. This year, the competition is funded by the Children’s Hospital Foundation. The deadline to apply is Sept. 10. For additional competition details and to apply, click here.
 
“There is a profound need for cardiovascular devices made specifically for children, especially the younger subpopulations of children under 18 years of age, so we decided to focus this year’s competition on this one particular need with the emphasis on also testing these novel devices on the younger kids,” says Kolaleh Eskandanian, Ph.D., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “We are seeking devices that can make a life-saving difference for thousands of children each year.”
 
Over the last five years, Children’s National and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) have awarded $1.425 million to 31 companies. Past awardees include CorInnova, Green Sun Medical, Maternal Life, PhotoniCare, Prapela, Procyrion, Rebion, Velano Vascular and X-Biomedical, to name a few.
 
The one-day Symposium, which will be held at the Pennsylvania Convention Center, brings together key leaders in the device space to stimulate pediatric device innovation and bring solutions to market faster for the benefit of children everywhere.
 
This year’s theme is “Using Real-World Evidence to Drive Pediatric Innovation,” recognizing that, on Aug. 31, 2017, the U.S. Food and Drug Administration (FDA) issued the finalized guidance for medical device developers’ use of real-world evidence (RWE) and real-world data (RWD) to gain approval for medical devices. At the symposium, stakeholders from industry, government, academia and patient groups will discuss how best to use RWE to drive pediatric device innovation. The panels include RWE discussions related to the payors’ perspective, policy and regulatory perspectives, and the digital revolution (artificial intelligence and machine learning). The symposium will close with an update from the FDA.
 
“We are very pleased to co-locate our symposium and competition with The MedTech Conference again this year,” says Eskandanian. “Joining forces with AdvaMed for last year’s event proved to be invaluable in reaching new players in the space that could help further pediatric device development.” She adds that any company interested in testing a pediatric version of their device or looking to get into the pediatric market should plan to come one day early to The MedTech Conference to learn more at this very interactive gathering.
 
A pre-symposium reception for competition finalists and panelists will be hosted by Children’s National and Drexel University. As one of founders of the Philadelphia Pediatric Medical Consortium and a member of the Coulter Translational Research program, Drexel has been a driving force for research and development of pediatric medical technology in the region. This event will give finalists an opportunity to celebrate their achievement and provide them with an opportunity to network with a wide range of pediatric innovation experts attending the symposium.
 
To register for the symposium, visit www.themedtechconference.com. For the symposium agenda and additional event details, visit www.pediatric-device-symposium.org.
 
Children’s National Health System, based in Washington, D.C., has served the nation’s children since 1870. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is the seventh-highest NIH-funded pediatric institution in the nation. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-08-14 09:06:00 [updated_at] => 2018-08-14 09:24:36 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282939","272547","275054","278237","281299","280635","277744","274327","272544","282688","279015","283697","270967","283580","278216","277952","282663","279447","279174","287341","283630","284113"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300250 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176247 [primary_image_old] => [slider_image_id] => 176247 [banner_image] => 0 [title] => FDA Approves New DNA-Based Test to Determine Blood Compatibility [short_title] => [summary] => ID CORE XT Test streamlines blood compatibility testing, provides an additional alternative to testing blood with antisera. [slug] => fda-approves-new-dna-based-test-to-determine-blood-compatibility [body] => The U.S. Food and Drug Administration approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.
 
“The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise—to provide more informative, accurate and cost-effective methods that can enhance patient care.”
 
Human blood can be classified into different groups based on the antigens on the surfaces of red blood cells. In addition to the ABO blood group antigens, the presence or absence of other specific blood group antigens can be important when matching blood for transfusions since some people develop antibodies to non-ABO antigens. People who receive repeated blood transfusions, such as individuals with sickle cell disease, are more likely to develop these antibodies. If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in a transfusion recipient.
 
Traditionally, red blood cell antigens have been identified using serological methods that involve the use of antisera, a blood serum that contains antibodies for testing. Serologic testing presents limitations and certain antisera may be scarce or unavailable.
 
A study was conducted to compare the typing results of the ID CORE XT Test with licensed serological reagents, the first FDA-approved molecular assay, and DNA sequencing tests. The results demonstrated comparable performance between the methods.
 
The approval of the ID CORE XT Test was granted to Progenika Biopharma S.A., a Grifols company. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-16 11:21:00 [updated_at] => 2018-10-16 11:25:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289792","299761","299382","298924","297561","297183","296568","296302","296232","294745","293411","285570","283697","289912","282081","291998","289348","299650","294573","283843","290449"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300334 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176324 [primary_image_old] => [slider_image_id] => 176324 [banner_image] => 0 [title] => FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats [short_title] => [summary] => Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center. [slug] => fda-and-dhs-begin-partnership-to-address-medical-device-cybersecurity-threats [body] => As part of the Administration’s ongoing efforts to strengthen cybersecurity in healthcare, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
 
“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”
 
“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS. “DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country. DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”
 
The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.
 
The two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
 
Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
 
The agreement formalizes a long-standing relationship between the FDA and DHS. Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices. 
 
The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations, and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market. 
 
The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-17 10:27:00 [updated_at] => 2018-10-17 10:37:49 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279504","282390","284256","283867","294745","299278","297561","292699","280635","300250","299761","299382","298924","297183","296568","296302","296232"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301011 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Walt Maclay, President and Founder, Voler Systems","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176933 [primary_image_old] => [slider_image_id] => 176933 [banner_image] => 0 [title] => Prototypes Enable a Wearable Hypothesis Investigation [short_title] => [summary] => Securing data from a prototype device can present challenges for medical device manufacturers. [slug] => prototypes-enable-a-wearable-hypothesis-investigation [body] => The human body gives off billions of data points everyday. Imagine if we could collect that data and make sense of it. We could provide health recommendations to patients based upon it. That’s exactly what medical researchers and clinical care professionals are clamoring for. Medical researchers and clinical care professionals want to gather physiological data related to a condition or complication to refine diagnosis or therapy, or they want to detect new conditions earlier.
 
To gain a competitive advantage, some equipment manufacturers want to develop a wearable device to complement their main product by collecting additional sensor data. Others see untapped opportunities based on new data.
 
A Prototype Review
Prototypes are an important part of the hardware development process. At the simplest level, a prototype is an initial or preliminary model of the product. A prototype is fabricated to test key assumptions about the product. Further, they can be used to test feasibility risks and desirability. A prototype can be handed to a customer for them to manipulate to answer questions regarding how well the product satisfies the market’s requirements.
 
Rapid Prototypes Save Time and Money
Prototyping tools provide a useful method for quickly developing a functioning prototype. Developers can rapidly develop fully functional working prototypes, saving 75 percent of prototype development time. Furthermore, being able to develop prototypes more quickly and less costly allows a development team to place the product into the user's hands earlier, test assumptions, and gather data. Through the feedback the prototype receives, the developers can better understand the user and product purpose or use case. The marketing and engineering teams can use prototypes to secure necessary feedback, test the use cases, and ultimately, build a better product.
 
Not All Prototypes Are the Same
The type of prototype needed will be identified by the current stage of development and the type of data required. In early stages, spreadsheets, illustrations, storyboards, wireframes, paper prototypes, and other low fidelity prototypes may be sufficient to generate the feedback necessary for initial buy-in. Later product decisions may require a functional prototype or proof of concept. For example, alternative ways to solve a problem may be explored by prototyping a few solutions and putting them in the hands of the user to observe the interaction. A prototype could be used to test and measure how the design affects power consumption or Wi-Fi range. Alternatively, the prototype may be employed to test the behavior of a sensor in a wearable device where the contact to the skin or motion of the person creates a challenge in capturing the required measurement.
 
The more information and data that can be captured from the prototype prior to manufacturing, the more likely a product is developed that satisfies the use case. Also, the less likely the development team makes product decisions that would be too costly to reverse.
 
There are many challenges involved in new product development. The first and foremost is ensuring accurate data is being utilized. Arguably, the greatest challenge with sensors used directly on the body is the collection of clean, valid data. If not captured correctly, there can be false or missing data, making diagnosis difficult. Additionally, for wearable devices, the need to manage power consumption and wireless data transmission can introduce additional complexity. The result may be inconsistent collection or unreliable data, which makes assessing the impact of a clinical intervention virtually impossible.
 
In some cases, the data may only be needed for the trial and it will be gathered by an adjunct unit. In other cases, it may be integrated directly into the device or incorporated into a treatment protocol. There is a temptation for researchers to press graduate students into a product development role—to hack something together quickly to support the primary research but this often leads to other problems.
 
A Quick, Cloud-Based Solution
Voler’s Universal Health-Sensor Platform is a pre-engineered solution for wearable medical devices. It provides a rapid pathway to capturing and transmitting accurate patient data. The pre-engineering prototype platform is small enough to be worn, and provides wireless data transmission so developers can access the data in the cloud. The company can quickly add the right type of sensor for an specific application and ensure it is collecting quality data.
 

Walt Maclay is the president and founder of Voler Systems, an electronic design firm in Silicon Valley. His company is committed to delivering quality electronic products that are easy to manufacture. Voler Systems specializes in designing wearable and IoT devices by implementing its expertise with sensors, wireless technology, and power management. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-26 15:22:00 [updated_at] => 2018-10-26 15:25:24 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301013","298924","291771","283630","279703","299785","282676","296469","296460","283982","115096","281126","298721","299792","299952","299129","284685","281665","290454","284246"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301013 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176935 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Regulating the Practice of Medicine [short_title] => [summary] => Sean Fenske and Mike Drues discuss the FDA's regulation of healthcare (or lack thereof) and if changes need to be made. [slug] => mike-on-medtech-regulating-the-practice-of-medicine [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the October issue of MPO, Regulating the Practice of Medicine (click to read that Letter). In it, I pose several scenarios regarding the industry’s direction and whether the FDA’s mission needs to be altered such that it would ultimately regulate the practice of medicine to some degree. This is primarily based upon a comment from a reader who offered feedback based on my Editor’s Letter in MPO’s sister publication, ODT. That comment is shared and Mike and Sean discuss it, along with several other points brought up in the October MPO Letter.

Listen to this episode and see what you think regarding the FDA’s oversight should be within the healthcare environment. Are you for it or against? In either case, If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-26 15:35:00 [updated_at] => 2019-08-15 15:26:10 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => {"video_url":{"video_url":"Video URL","value":"https://players.brightcove.net/73033050001/default_default/index.html?videoId=5854032310001"},"image_url":{"image_url":"Image URL","value":"http://rodpub.com/email/mpo/images/1400x1400.jpg"},"video_id":{"video_id":"Video ID","value":"5854032310001"}} [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["320011","319679","319180","318935","318889","318858","318706","317769","317622","316570","316351","316297","315502","315274","315263","311437","311395","310103","309296"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 292106 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Children’s National Health System","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 172818 [primary_image_old] => 107160 [slider_image_id] => 172818 [banner_image] => 0 [title] => A Call for Pediatric Cardiovascular Devices: $100K Competition Now Accepting Proposals [short_title] => [summary] => Pediatric Device Innovation Symposium’s pitch competition to address unmet need for children. [slug] => a-call-for-pediatric-cardiovascular-devices-100k-competition-now-accepting-proposals [body] => Children’s National Health System is now accepting proposals for its annual “Make Your Medical Device Pitch for Kids!” competition. New this year, the competition is focused on pediatric cardiovascular devices to address a significant unmet need for children. The competition will be held on Sept. 23 in Philadelphia at the Sixth Annual Pediatric Device Innovation Symposium. For the second year, the one-day symposium is co-locating in a joint effort with The MedTech Conference powered by AdvaMed.
 
Children’s National invites proposals from innovators with pediatric cardiovascular medical devices that have potential for commercialization. Competition finalists will pitch their device to a panel of judges and as many as four innovations will be awarded $25,000 each. In addition to the prize money, winners will receive consultation services from experts at Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland’s A. James Clark School of Engineering. This year, the competition is funded by the Children’s Hospital Foundation. The deadline to apply is Sept. 10. For additional competition details and to apply, click here.
 
“There is a profound need for cardiovascular devices made specifically for children, especially the younger subpopulations of children under 18 years of age, so we decided to focus this year’s competition on this one particular need with the emphasis on also testing these novel devices on the younger kids,” says Kolaleh Eskandanian, Ph.D., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “We are seeking devices that can make a life-saving difference for thousands of children each year.”
 
Over the last five years, Children’s National and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) have awarded $1.425 million to 31 companies. Past awardees include CorInnova, Green Sun Medical, Maternal Life, PhotoniCare, Prapela, Procyrion, Rebion, Velano Vascular and X-Biomedical, to name a few.
 
The one-day Symposium, which will be held at the Pennsylvania Convention Center, brings together key leaders in the device space to stimulate pediatric device innovation and bring solutions to market faster for the benefit of children everywhere.
 
This year’s theme is “Using Real-World Evidence to Drive Pediatric Innovation,” recognizing that, on Aug. 31, 2017, the U.S. Food and Drug Administration (FDA) issued the finalized guidance for medical device developers’ use of real-world evidence (RWE) and real-world data (RWD) to gain approval for medical devices. At the symposium, stakeholders from industry, government, academia and patient groups will discuss how best to use RWE to drive pediatric device innovation. The panels include RWE discussions related to the payors’ perspective, policy and regulatory perspectives, and the digital revolution (artificial intelligence and machine learning). The symposium will close with an update from the FDA.
 
“We are very pleased to co-locate our symposium and competition with The MedTech Conference again this year,” says Eskandanian. “Joining forces with AdvaMed for last year’s event proved to be invaluable in reaching new players in the space that could help further pediatric device development.” She adds that any company interested in testing a pediatric version of their device or looking to get into the pediatric market should plan to come one day early to The MedTech Conference to learn more at this very interactive gathering.
 
A pre-symposium reception for competition finalists and panelists will be hosted by Children’s National and Drexel University. As one of founders of the Philadelphia Pediatric Medical Consortium and a member of the Coulter Translational Research program, Drexel has been a driving force for research and development of pediatric medical technology in the region. This event will give finalists an opportunity to celebrate their achievement and provide them with an opportunity to network with a wide range of pediatric innovation experts attending the symposium.
 
To register for the symposium, visit www.themedtechconference.com. For the symposium agenda and additional event details, visit www.pediatric-device-symposium.org.
 
Children’s National Health System, based in Washington, D.C., has served the nation’s children since 1870. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is the seventh-highest NIH-funded pediatric institution in the nation. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-08-14 09:06:00 [updated_at] => 2018-08-14 09:24:36 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282939","272547","275054","278237","281299","280635","277744","274327","272544","282688","279015","283697","270967","283580","278216","277952","282663","279447","279174","287341","283630","284113"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300250 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176247 [primary_image_old] => [slider_image_id] => 176247 [banner_image] => 0 [title] => FDA Approves New DNA-Based Test to Determine Blood Compatibility [short_title] => [summary] => ID CORE XT Test streamlines blood compatibility testing, provides an additional alternative to testing blood with antisera. [slug] => fda-approves-new-dna-based-test-to-determine-blood-compatibility [body] => The U.S. Food and Drug Administration approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.
 
“The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise—to provide more informative, accurate and cost-effective methods that can enhance patient care.”
 
Human blood can be classified into different groups based on the antigens on the surfaces of red blood cells. In addition to the ABO blood group antigens, the presence or absence of other specific blood group antigens can be important when matching blood for transfusions since some people develop antibodies to non-ABO antigens. People who receive repeated blood transfusions, such as individuals with sickle cell disease, are more likely to develop these antibodies. If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in a transfusion recipient.
 
Traditionally, red blood cell antigens have been identified using serological methods that involve the use of antisera, a blood serum that contains antibodies for testing. Serologic testing presents limitations and certain antisera may be scarce or unavailable.
 
A study was conducted to compare the typing results of the ID CORE XT Test with licensed serological reagents, the first FDA-approved molecular assay, and DNA sequencing tests. The results demonstrated comparable performance between the methods.
 
The approval of the ID CORE XT Test was granted to Progenika Biopharma S.A., a Grifols company. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-16 11:21:00 [updated_at] => 2018-10-16 11:25:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289792","299761","299382","298924","297561","297183","296568","296302","296232","294745","293411","285570","283697","289912","282081","291998","289348","299650","294573","283843","290449"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300334 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176324 [primary_image_old] => [slider_image_id] => 176324 [banner_image] => 0 [title] => FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats [short_title] => [summary] => Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center. [slug] => fda-and-dhs-begin-partnership-to-address-medical-device-cybersecurity-threats [body] => As part of the Administration’s ongoing efforts to strengthen cybersecurity in healthcare, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
 
“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”
 
“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS. “DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country. DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”
 
The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.
 
The two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
 
Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
 
The agreement formalizes a long-standing relationship between the FDA and DHS. Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices. 
 
The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations, and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market. 
 
The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-17 10:27:00 [updated_at] => 2018-10-17 10:37:49 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279504","282390","284256","283867","294745","299278","297561","292699","280635","300250","299761","299382","298924","297183","296568","296302","296232"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301011 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Walt Maclay, President and Founder, Voler Systems","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176933 [primary_image_old] => [slider_image_id] => 176933 [banner_image] => 0 [title] => Prototypes Enable a Wearable Hypothesis Investigation [short_title] => [summary] => Securing data from a prototype device can present challenges for medical device manufacturers. [slug] => prototypes-enable-a-wearable-hypothesis-investigation [body] => The human body gives off billions of data points everyday. Imagine if we could collect that data and make sense of it. We could provide health recommendations to patients based upon it. That’s exactly what medical researchers and clinical care professionals are clamoring for. Medical researchers and clinical care professionals want to gather physiological data related to a condition or complication to refine diagnosis or therapy, or they want to detect new conditions earlier.
 
To gain a competitive advantage, some equipment manufacturers want to develop a wearable device to complement their main product by collecting additional sensor data. Others see untapped opportunities based on new data.
 
A Prototype Review
Prototypes are an important part of the hardware development process. At the simplest level, a prototype is an initial or preliminary model of the product. A prototype is fabricated to test key assumptions about the product. Further, they can be used to test feasibility risks and desirability. A prototype can be handed to a customer for them to manipulate to answer questions regarding how well the product satisfies the market’s requirements.
 
Rapid Prototypes Save Time and Money
Prototyping tools provide a useful method for quickly developing a functioning prototype. Developers can rapidly develop fully functional working prototypes, saving 75 percent of prototype development time. Furthermore, being able to develop prototypes more quickly and less costly allows a development team to place the product into the user's hands earlier, test assumptions, and gather data. Through the feedback the prototype receives, the developers can better understand the user and product purpose or use case. The marketing and engineering teams can use prototypes to secure necessary feedback, test the use cases, and ultimately, build a better product.
 
Not All Prototypes Are the Same
The type of prototype needed will be identified by the current stage of development and the type of data required. In early stages, spreadsheets, illustrations, storyboards, wireframes, paper prototypes, and other low fidelity prototypes may be sufficient to generate the feedback necessary for initial buy-in. Later product decisions may require a functional prototype or proof of concept. For example, alternative ways to solve a problem may be explored by prototyping a few solutions and putting them in the hands of the user to observe the interaction. A prototype could be used to test and measure how the design affects power consumption or Wi-Fi range. Alternatively, the prototype may be employed to test the behavior of a sensor in a wearable device where the contact to the skin or motion of the person creates a challenge in capturing the required measurement.
 
The more information and data that can be captured from the prototype prior to manufacturing, the more likely a product is developed that satisfies the use case. Also, the less likely the development team makes product decisions that would be too costly to reverse.
 
There are many challenges involved in new product development. The first and foremost is ensuring accurate data is being utilized. Arguably, the greatest challenge with sensors used directly on the body is the collection of clean, valid data. If not captured correctly, there can be false or missing data, making diagnosis difficult. Additionally, for wearable devices, the need to manage power consumption and wireless data transmission can introduce additional complexity. The result may be inconsistent collection or unreliable data, which makes assessing the impact of a clinical intervention virtually impossible.
 
In some cases, the data may only be needed for the trial and it will be gathered by an adjunct unit. In other cases, it may be integrated directly into the device or incorporated into a treatment protocol. There is a temptation for researchers to press graduate students into a product development role—to hack something together quickly to support the primary research but this often leads to other problems.
 
A Quick, Cloud-Based Solution
Voler’s Universal Health-Sensor Platform is a pre-engineered solution for wearable medical devices. It provides a rapid pathway to capturing and transmitting accurate patient data. The pre-engineering prototype platform is small enough to be worn, and provides wireless data transmission so developers can access the data in the cloud. The company can quickly add the right type of sensor for an specific application and ensure it is collecting quality data.
 

Walt Maclay is the president and founder of Voler Systems, an electronic design firm in Silicon Valley. His company is committed to delivering quality electronic products that are easy to manufacture. Voler Systems specializes in designing wearable and IoT devices by implementing its expertise with sensors, wireless technology, and power management. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-26 15:22:00 [updated_at] => 2018-10-26 15:25:24 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301013","298924","291771","283630","279703","299785","282676","296469","296460","283982","115096","281126","298721","299792","299952","299129","284685","281665","290454","284246"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301013 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2720 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Sean Fenske","title":"Editor-in-Chief"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176935 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Mike on Medtech: Regulating the Practice of Medicine [short_title] => [summary] => Sean Fenske and Mike Drues discuss the FDA's regulation of healthcare (or lack thereof) and if changes need to be made. [slug] => mike-on-medtech-regulating-the-practice-of-medicine [body] => In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the October issue of MPO, Regulating the Practice of Medicine (click to read that Letter). In it, I pose several scenarios regarding the industry’s direction and whether the FDA’s mission needs to be altered such that it would ultimately regulate the practice of medicine to some degree. This is primarily based upon a comment from a reader who offered feedback based on my Editor’s Letter in MPO’s sister publication, ODT. That comment is shared and Mike and Sean discuss it, along with several other points brought up in the October MPO Letter.

Listen to this episode and see what you think regarding the FDA’s oversight should be within the healthcare environment. Are you for it or against? In either case, If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other podcasts.
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