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    [title] => Phillips-Medisize Expands FDA Compliant Medical Manufacturing Capacity 
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    [summary] => Firm recognizes need to support growing customer requirements.
    [slug] => phillips-medisize-expands-fda-compliant-medical-manufacturing-capacity
    [body] => Phillips-Medisize, a Molex company, has announced the Little Rock, Ark. facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA. The facility is FDA 21 CFR part 820 compliant. As a result, this 380,000-square foot facility enhances Phillips-Medisize’s medical manufacturing services with capabilities around molding, stamping, plating and assembly which allows for vertical integration of manufacturing, electronics and connected device solutions all in one site. The facility also leverages existing dedicated white space along with Class 8 cleanroom space for medical manufacturing.
 
For decades, Phillips-Medisize has been designing, developing, and manufacturing drug delivery devices. Phillips-Medisize’s current end-to-end capabilities serve pharmaceutical, diagnostics and medical device companies with a wide range of solutions for both mechanical and connected devices. Customers benefit from effective quality systems, risk management approaches and dedicated clinical build sites, as well as the ability to produce drug delivery devices and combination products, including electronic PCBA manufacturing at facilities around the globe.
 
“We believe most drug delivery devices will benefit from being part of a connected health system. For that reason, we diligently pursue opportunities for lowering the cost of adding connectivity modules to drug delivery devices,” said Matt Jennings, CEO and president of Phillips-Medisize.
 
As a new FDA compliant manufacturing site, the Little Rock facility combines the innovative solutions and knowledge of Molex’s existing electronics production operations with Phillips-Medisize’s proven platform of drug delivery and medical device expertise. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-04-24 13:56:00 [updated_at] => 2019-04-24 13:57:14 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["115218","302207","302159","308063","312814","312374","311673","311491","311395","311006","310992","310355","309564","309243"] [is_show_company_name] => [created_at] => 2019-04-24 13:50:32 [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/2019-04-24/phillips-medisize-expands-fda-compliant-medical-manufacturing-capacity/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302159 [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":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177841 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Phillips-Medisize Partners With InterSystems in Connected Health Platform [short_title] => [summary] => Union offers a data-sharing, analytics platform foundation designed for connected drug delivery devices, bio sensors. [slug] => phillips-medisize-partners-with-intersystems-in-connected-health-platform [body] => Phillips-Medisize, a Molex company, has joined forces with InterSystems, a global leader in healthcare software technology, to develop the third-generation Connected Health Platform. The integration of InterSystems HealthShare offers an information-sharing and analytics platform foundation designed for connected drug delivery devices, bio sensors and regulated Mobile Medical Applications (SaMD/MMA).
 
“Our collaboration with InterSystems brings together the information that matters—connecting pharmaceutical companies, providers, patients, and payers on the Phillips-Medisize Connected Health Platform through a unified healthcare medication record and powerful analytics that span the care continuum,” said Matt Jennings, CEO and president, Phillips-Medisize.
 
An estimated 50 percent of medications for chronic diseases are not taken as prescribed. A 2017 Annals of Internal Medicine review reports that an estimated 125,000 deaths and 10 percent of U.S. hospitalizations are linked to patient non-adherence to prescribed medications, which results in over $290 billion dollars to U.S. healthcare annually.
 
Phillips-Medisize was the first company to develop a U.S. Food and Drug Administration-approved combination Connected Medicine solution to support patients and develop a deeper understanding of how they take their medication. The company has applied this experience to the development of its third-generation platform, built on InterSystems HealthShare, for the pharmaceutical delivery environment. The platform will enable pharmaceutical companies to connect medication and diagnostic information across their drugs and therapy areas on a single, unified platform at an exceptional scale.
 
Data collected by connected devices using the Phillips-Medisize Connected Health Platform can be shared securely to inform the patient and their healthcare provider when medications have been administered and can be combined with data from diagnostic devices and biometric sensors to generate further insights. Pharmaceutical companies working with Phillips-Medisize will receive an exclusive, secure private cloud.
 
“Poor medication adherence currently yields unnecessary human suffering and significantly reduced patient health around the world. The collaboration between InterSystems and Phillips-Medisize aims to change that paradigm with a highly scalable platform to securely connect and aggregate data from rare diseases to many millions of patients across global geographies; encouraging patients in the most effective use of prescribed medications to improve outcomes,” adds Don Woodlock, head of the HealthShare business unit at InterSystems.
 
Phillips-Medisize LLC, a Molex company, is an end-to-end provider of development and manufacturing solutions to the pharmaceutical, diagnostics, medical device market segments. Backed by the combined global resources of Molex and its parent company Koch Industries, Phillips-Medisize’s core advantage is the knowledge of its people to integrate design, molding, electronics, and automation, providing innovative, high-quality manufacturing solutions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-12 11:03:00 [updated_at] => 2018-11-12 11:19:16 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289553","179477","300913","296453","300474","289748","284685","289789","294053","297145","300535","302068","302198","288422"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302207 [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] => 2698 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Staff","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177898 [primary_image_old] => 112105 [slider_image_id] => 177927 [banner_image] => 0 [title] => Images from Medica/Compamed 2018, Day 2 [short_title] => [summary] => The showcase of happenings viewed within the halls of Medica and Compamed during the 2018 event continues. [slug] => images-from-medicacompamed-2018-day-2 [body] => [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-13 10:09:29 [updated_at] => 2018-11-14 04:22:49 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289553","302159","302278","302102","301013","291771","300014","298406","296460","302307","282671","289745","296568","289741","282656","282673","299785","282845","302261","302323","299790","302310"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 308063 [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":"Phillips-Medisize","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 183103 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Phillips-Medisize Celebrates Groundbreaking of St. Croix Meadows Manufacturing Facility [short_title] => [summary] => Construction of state-of-the-art manufacturing facility will support hiring of over 250 new employees ranging from skilled manufacturing to engineering. [slug] => phillips-medisize-celebrates-groundbreaking-of-st-croix-meadows-manufacturing-facility [body] => Phillips-Medisize, a Molex company, has announced the groundbreaking of a new state of the art manufacturing facility located in the St. Croix Meadows development in Hudson, Wis. This site is expected to support at least 230,000 sq. ft. of manufacturing space for FDA-regulated products.
 
Hosted by the City of Hudson, Mayor Rich O’Conner welcomed esteemed community and company representatives to the groundbreaking ceremony held on February 15, 2019.
 
“The St. Croix Meadows redevelopment is aimed at transforming the riverfront community, said Hudson Mayor Rich O'Connor. "By creating employment opportunities with Phillips-Medisize, I hope to encourage young people to stay in Hudson.”
 
Other presenters at the groundbreaking included Klint Klaas, representative of the developer, who initiated and shaped the vision of the new St. Croix Meadows re-development project. Representing Phillips-Medisize, Dave Thoreson, vice president and general manager of North America Medical, graciously acknowledged the developer and the City of Hudson planning teams for their invaluable roles in advancing the project. The event culminated in the ceremonial turning of the soil marking the official launch of construction of the Phillips-Medisize St. Croix Meadows facility slated for completion in the late 2019 to mid-2020 timeframe.
 
“We are proud to invest in growing Phillips-Medisize’s manufacturing presence in our founding state of Wisconsin,” stated Matt Jennings, CEO and president, Phillips-Medisize. “Hudson has been home to Phillips-Medisize for the past 36 years, so we are excited to reinforce our commitment to the vibrant community with our St. Croix Meadows facility. We expect to support over 250 employment opportunities for area residents in jobs, ranging from skilled manufacturing to engineering. It also reaffirms our commitment to better serve customers as a global end-to-end provider of innovation, development and manufacturing solutions.”
 
Founded in the town of Phillips, Wis., over five decades ago, Phillips-Medisize currently employs more than 5,500 people at 26 manufacturing sites around the world. This new Phillips-Medisize facility will be situated on a 34-acre site in St. Croix Meadows development, representing the company’s single largest operation in Wisconsin with opportunity to expand.
 
The Phillips-Medisize St. Croix Meadows manufacturing facility will be FDA-registered, adhering to clean room practices, and featuring state-of-the-art equipment to meet quality production standards. Investment in a new facility of this size and scope underscores the company’s commitment to its people, processes and facilities necessary for long-term success. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-02-19 08:48:00 [updated_at] => 2019-02-19 08:56:08 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["115218","302207","302159","298716","299790","297835","300024","298776","306423","302063","306566","304427","302309","306622","308051","304362","304253","299131"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309243 [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":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 184307 [primary_image_old] => [slider_image_id] => 184307 [banner_image] => 0 [title] => Saranas' Early Bird Bleed Monitoring System Gains De Novo Clearance [short_title] => [summary] => First and only device for real-time detection and monitoring of endovascular bleed complications. [slug] => saranas-early-bird-bleed-monitoring-system-gains-de-novo-clearance [body] => Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System.
 
According to a recent study of over 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database, one in five patients experienced a bleed complication. A 2017 report in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters.
 
“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said Saranas President and CEO Zaffer Syed. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
 
The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from vessel injury which may occur during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100 percent sensitivity and 100 percent specificity.1
 
“Bleeding remains an Achilles' heel of advancing minimally-invasive, catheter-based procedures,” said Dr. Dimitrios Karmpaliotis, Director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”
 
“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” stated Saranas chief medical officer Dr. Philippe Généreux. "I firmly believe the Early Bird Bleed Monitoring System will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”
 
The Early Bird Bleed Monitoring System is currently being piloted in multiple centers to assess the versatility of the Early Bird to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans to commercially launch the device in select centers of excellence across the U.S.
 
Reference
1 Data on file, included in device’s Instructions for Use (IFU). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-03-06 09:44:00 [updated_at] => 2019-03-06 09:47:02 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305056","305313","306421","302883","300402","309187","308446","308217","308074","308066","307999","306356","305612"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309564 [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] => 184576 [primary_image_old] => [slider_image_id] => 184576 [banner_image] => 0 [title] => FDA to Closely Examine Surgical Stapler Risks [short_title] => [summary] => The agency is aware of an increasing number of reports associated with surgical staplers for internal use and implantable surgical staples. [slug] => fda-to-closely-examine-surgical-stapler-risks [body] => The U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and to provide updated recommendations to help reduce risks associated with their use. The letter also includes information about additional actions the agency is planning in the coming months to address the devices’ safety, including issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.
 
“As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health. “As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective. The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk. We are asking providers to be aware of the new information and implement the recommendations we’re outlining today to help improve the safe use of these devices. Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”
 
Surgical staplers and staples may be indicated for use in a wide range of surgical applications, including gastrointestinal, gynecologic, and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures. These devices facilitate surgical procedures and may shorten surgical procedure time compared to manual suturing. Currently, surgical staplers are regulated as Class I medical devices, which do not require a premarket submission to the FDA. Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.
 
The agency has issued previous communications about the risks involved with surgical staplers and implantable staples and has been conducting an ongoing assessment of medical device reports (MDRs) filed with the agency. The agency’s analysis shows that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions. The FDA continues to evaluate the MDRs for these devices.
 
The most commonly reported problems in these adverse event reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue). Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
 
In today’s communication, the FDA is reminding providers to review labeling instructions and indications for use for surgical staplers and implantable staples, such as choosing the appropriate staple size for the patient’s tissue type and thickness. The letter to healthcare providers also suggests considering alternative options if the patient’s tissues are swollen, prone to bleeding, or dead (necrotic). The FDA further provides recommendations on how to recognize and manage device malfunction.
 
For patients, it is important to understand that when used correctly, surgical staplers and staples can be beneficial surgical tools. These devices are regularly used in many types of surgical cases, and enable a surgeon to perform a less invasive operation, which may reduce postoperative pain and shorten recovery time. The types of adverse events observed with surgical staplers and staples may similarly occur with hand sewn alternatives. The purpose of the letter to healthcare providers is to remind them of the importance of appropriate selection and use of surgical staplers and staples to mitigate risk.
 
In addition to the letter to healthcare providers, the agency is taking steps to address the safety of these devices.
 
The FDA intends to issue a new draft guidance for public comment this year, which will describe proposed recommendations for manufacturers of surgical staplers and staples for internal use about information to include in their product labeling, which will help healthcare providers better understand the appropriate use and the risks of these products.
 
In light of the identified risks of surgical staplers, the agency also intends to hold a public meeting of the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee this year to discuss whether the current pathway for manufacturers to market surgical staplers is appropriate. As part of the panel meeting, the FDA will present a comprehensive analysis of all the MDRs received for surgical staplers and staples for internal use, as well as other relevant information, and will seek panel input on whether reclassifying surgical staplers for internal use is appropriate. Reclassifying surgical staplers for internal use from Class I to Class II would allow the FDA to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension (assessing user’s ability to properly select and use the device according to the labeling), and specific labeling elements supporting the safe use of the device.
 
The FDA will announce the meeting, including details about how to participate, on the FDA Advisory Committee calendar webpage and in a Federal Register notice at a future date.
 
The communication issued today reflects the agency’s commitment to advancing policies that enhance the FDA’s oversight of medical device safety. As part of the Medical Device Safety Action Plan, the FDA has alerted the public when safety issues are identified, such as duodenoscopes, breast implant-associated anaplastic large cell lymphoma, and unsafe silicone injections. The agency is also working with stakeholders to develop patient registries, including the National Evaluation System for health Technology, to provide more complete evidence in clinical areas to enhance the agency’s ability to identify and act upon safety issues with medical devices.
 
As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with surgical staplers and implanted staples. We will keep the public informed if significant new information becomes available. We encourage patients, providers and healthcare facilities to report adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-03-11 10:12:00 [updated_at] => 2019-03-11 10:16:24 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["309243","309187","308446","308217","308074","308066","307999","306356","305612","305313","307067","308969","301664","304965","305699","308121","307598","303306","304467","304107"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302159 [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":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177841 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Phillips-Medisize Partners With InterSystems in Connected Health Platform [short_title] => [summary] => Union offers a data-sharing, analytics platform foundation designed for connected drug delivery devices, bio sensors. [slug] => phillips-medisize-partners-with-intersystems-in-connected-health-platform [body] => Phillips-Medisize, a Molex company, has joined forces with InterSystems, a global leader in healthcare software technology, to develop the third-generation Connected Health Platform. The integration of InterSystems HealthShare offers an information-sharing and analytics platform foundation designed for connected drug delivery devices, bio sensors and regulated Mobile Medical Applications (SaMD/MMA).
 
“Our collaboration with InterSystems brings together the information that matters—connecting pharmaceutical companies, providers, patients, and payers on the Phillips-Medisize Connected Health Platform through a unified healthcare medication record and powerful analytics that span the care continuum,” said Matt Jennings, CEO and president, Phillips-Medisize.
 
An estimated 50 percent of medications for chronic diseases are not taken as prescribed. A 2017 Annals of Internal Medicine review reports that an estimated 125,000 deaths and 10 percent of U.S. hospitalizations are linked to patient non-adherence to prescribed medications, which results in over $290 billion dollars to U.S. healthcare annually.
 
Phillips-Medisize was the first company to develop a U.S. Food and Drug Administration-approved combination Connected Medicine solution to support patients and develop a deeper understanding of how they take their medication. The company has applied this experience to the development of its third-generation platform, built on InterSystems HealthShare, for the pharmaceutical delivery environment. The platform will enable pharmaceutical companies to connect medication and diagnostic information across their drugs and therapy areas on a single, unified platform at an exceptional scale.
 
Data collected by connected devices using the Phillips-Medisize Connected Health Platform can be shared securely to inform the patient and their healthcare provider when medications have been administered and can be combined with data from diagnostic devices and biometric sensors to generate further insights. Pharmaceutical companies working with Phillips-Medisize will receive an exclusive, secure private cloud.
 
“Poor medication adherence currently yields unnecessary human suffering and significantly reduced patient health around the world. The collaboration between InterSystems and Phillips-Medisize aims to change that paradigm with a highly scalable platform to securely connect and aggregate data from rare diseases to many millions of patients across global geographies; encouraging patients in the most effective use of prescribed medications to improve outcomes,” adds Don Woodlock, head of the HealthShare business unit at InterSystems.
 
Phillips-Medisize LLC, a Molex company, is an end-to-end provider of development and manufacturing solutions to the pharmaceutical, diagnostics, medical device market segments. Backed by the combined global resources of Molex and its parent company Koch Industries, Phillips-Medisize’s core advantage is the knowledge of its people to integrate design, molding, electronics, and automation, providing innovative, high-quality manufacturing solutions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-12 11:03:00 [updated_at] => 2018-11-12 11:19:16 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289553","179477","300913","296453","300474","289748","284685","289789","294053","297145","300535","302068","302198","288422"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302207 [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] => 2698 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Staff","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177898 [primary_image_old] => 112105 [slider_image_id] => 177927 [banner_image] => 0 [title] => Images from Medica/Compamed 2018, Day 2 [short_title] => [summary] => The showcase of happenings viewed within the halls of Medica and Compamed during the 2018 event continues. [slug] => images-from-medicacompamed-2018-day-2 [body] => [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-13 10:09:29 [updated_at] => 2018-11-14 04:22:49 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289553","302159","302278","302102","301013","291771","300014","298406","296460","302307","282671","289745","296568","289741","282656","282673","299785","282845","302261","302323","299790","302310"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 308063 [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":"Phillips-Medisize","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 183103 [primary_image_old] => [slider_image_id] => 0 [banner_image] => 0 [title] => Phillips-Medisize Celebrates Groundbreaking of St. Croix Meadows Manufacturing Facility [short_title] => [summary] => Construction of state-of-the-art manufacturing facility will support hiring of over 250 new employees ranging from skilled manufacturing to engineering. [slug] => phillips-medisize-celebrates-groundbreaking-of-st-croix-meadows-manufacturing-facility [body] => Phillips-Medisize, a Molex company, has announced the groundbreaking of a new state of the art manufacturing facility located in the St. Croix Meadows development in Hudson, Wis. This site is expected to support at least 230,000 sq. ft. of manufacturing space for FDA-regulated products.
 
Hosted by the City of Hudson, Mayor Rich O’Conner welcomed esteemed community and company representatives to the groundbreaking ceremony held on February 15, 2019.
 
“The St. Croix Meadows redevelopment is aimed at transforming the riverfront community, said Hudson Mayor Rich O'Connor. "By creating employment opportunities with Phillips-Medisize, I hope to encourage young people to stay in Hudson.”
 
Other presenters at the groundbreaking included Klint Klaas, representative of the developer, who initiated and shaped the vision of the new St. Croix Meadows re-development project. Representing Phillips-Medisize, Dave Thoreson, vice president and general manager of North America Medical, graciously acknowledged the developer and the City of Hudson planning teams for their invaluable roles in advancing the project. The event culminated in the ceremonial turning of the soil marking the official launch of construction of the Phillips-Medisize St. Croix Meadows facility slated for completion in the late 2019 to mid-2020 timeframe.
 
“We are proud to invest in growing Phillips-Medisize’s manufacturing presence in our founding state of Wisconsin,” stated Matt Jennings, CEO and president, Phillips-Medisize. “Hudson has been home to Phillips-Medisize for the past 36 years, so we are excited to reinforce our commitment to the vibrant community with our St. Croix Meadows facility. We expect to support over 250 employment opportunities for area residents in jobs, ranging from skilled manufacturing to engineering. It also reaffirms our commitment to better serve customers as a global end-to-end provider of innovation, development and manufacturing solutions.”
 
Founded in the town of Phillips, Wis., over five decades ago, Phillips-Medisize currently employs more than 5,500 people at 26 manufacturing sites around the world. This new Phillips-Medisize facility will be situated on a 34-acre site in St. Croix Meadows development, representing the company’s single largest operation in Wisconsin with opportunity to expand.
 
The Phillips-Medisize St. Croix Meadows manufacturing facility will be FDA-registered, adhering to clean room practices, and featuring state-of-the-art equipment to meet quality production standards. Investment in a new facility of this size and scope underscores the company’s commitment to its people, processes and facilities necessary for long-term success. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-02-19 08:48:00 [updated_at] => 2019-02-19 08:56:08 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["115218","302207","302159","298716","299790","297835","300024","298776","306423","302063","306566","304427","302309","306622","308051","304362","304253","299131"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309243 [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":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 184307 [primary_image_old] => [slider_image_id] => 184307 [banner_image] => 0 [title] => Saranas' Early Bird Bleed Monitoring System Gains De Novo Clearance [short_title] => [summary] => First and only device for real-time detection and monitoring of endovascular bleed complications. [slug] => saranas-early-bird-bleed-monitoring-system-gains-de-novo-clearance [body] => Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System.
 
According to a recent study of over 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database, one in five patients experienced a bleed complication. A 2017 report in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters.
 
“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said Saranas President and CEO Zaffer Syed. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
 
The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from vessel injury which may occur during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100 percent sensitivity and 100 percent specificity.1
 
“Bleeding remains an Achilles' heel of advancing minimally-invasive, catheter-based procedures,” said Dr. Dimitrios Karmpaliotis, Director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”
 
“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” stated Saranas chief medical officer Dr. Philippe Généreux. "I firmly believe the Early Bird Bleed Monitoring System will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”
 
The Early Bird Bleed Monitoring System is currently being piloted in multiple centers to assess the versatility of the Early Bird to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans to commercially launch the device in select centers of excellence across the U.S.
 
Reference
1 Data on file, included in device’s Instructions for Use (IFU). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-03-06 09:44:00 [updated_at] => 2019-03-06 09:47:02 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305056","305313","306421","302883","300402","309187","308446","308217","308074","308066","307999","306356","305612"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309564 [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] => 184576 [primary_image_old] => [slider_image_id] => 184576 [banner_image] => 0 [title] => FDA to Closely Examine Surgical Stapler Risks [short_title] => [summary] => The agency is aware of an increasing number of reports associated with surgical staplers for internal use and implantable surgical staples. [slug] => fda-to-closely-examine-surgical-stapler-risks [body] => The U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and to provide updated recommendations to help reduce risks associated with their use. The letter also includes information about additional actions the agency is planning in the coming months to address the devices’ safety, including issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.
 
“As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health. “As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective. The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk. We are asking providers to be aware of the new information and implement the recommendations we’re outlining today to help improve the safe use of these devices. Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”
 
Surgical staplers and staples may be indicated for use in a wide range of surgical applications, including gastrointestinal, gynecologic, and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures. These devices facilitate surgical procedures and may shorten surgical procedure time compared to manual suturing. Currently, surgical staplers are regulated as Class I medical devices, which do not require a premarket submission to the FDA. Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.
 
The agency has issued previous communications about the risks involved with surgical staplers and implantable staples and has been conducting an ongoing assessment of medical device reports (MDRs) filed with the agency. The agency’s analysis shows that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions. The FDA continues to evaluate the MDRs for these devices.
 
The most commonly reported problems in these adverse event reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue). Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
 
In today’s communication, the FDA is reminding providers to review labeling instructions and indications for use for surgical staplers and implantable staples, such as choosing the appropriate staple size for the patient’s tissue type and thickness. The letter to healthcare providers also suggests considering alternative options if the patient’s tissues are swollen, prone to bleeding, or dead (necrotic). The FDA further provides recommendations on how to recognize and manage device malfunction.
 
For patients, it is important to understand that when used correctly, surgical staplers and staples can be beneficial surgical tools. These devices are regularly used in many types of surgical cases, and enable a surgeon to perform a less invasive operation, which may reduce postoperative pain and shorten recovery time. The types of adverse events observed with surgical staplers and staples may similarly occur with hand sewn alternatives. The purpose of the letter to healthcare providers is to remind them of the importance of appropriate selection and use of surgical staplers and staples to mitigate risk.
 
In addition to the letter to healthcare providers, the agency is taking steps to address the safety of these devices.
 
The FDA intends to issue a new draft guidance for public comment this year, which will describe proposed recommendations for manufacturers of surgical staplers and staples for internal use about information to include in their product labeling, which will help healthcare providers better understand the appropriate use and the risks of these products.
 
In light of the identified risks of surgical staplers, the agency also intends to hold a public meeting of the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee this year to discuss whether the current pathway for manufacturers to market surgical staplers is appropriate. As part of the panel meeting, the FDA will present a comprehensive analysis of all the MDRs received for surgical staplers and staples for internal use, as well as other relevant information, and will seek panel input on whether reclassifying surgical staplers for internal use is appropriate. Reclassifying surgical staplers for internal use from Class I to Class II would allow the FDA to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension (assessing user’s ability to properly select and use the device according to the labeling), and specific labeling elements supporting the safe use of the device.
 
The FDA will announce the meeting, including details about how to participate, on the FDA Advisory Committee calendar webpage and in a Federal Register notice at a future date.
 
The communication issued today reflects the agency’s commitment to advancing policies that enhance the FDA’s oversight of medical device safety. As part of the Medical Device Safety Action Plan, the FDA has alerted the public when safety issues are identified, such as duodenoscopes, breast implant-associated anaplastic large cell lymphoma, and unsafe silicone injections. The agency is also working with stakeholders to develop patient registries, including the National Evaluation System for health Technology, to provide more complete evidence in clinical areas to enhance the agency’s ability to identify and act upon safety issues with medical devices.
 
As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with surgical staplers and implanted staples. We will keep the public informed if significant new information becomes available. We encourage patients, providers and healthcare facilities to report adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program. 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