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    [title] => Insulet Assumes Direct Operations of its Omnipod Line in Europe 
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    [summary] => Firm will provide sales, distribution, customer support, and product services for its system.

    [slug] => insulet-assumes-direct-operations-of-its-omnipod-line-in-europe
    [body] => Insulet Corporation, a provider of tubeless insulin pump technology via its Omnipod Insulin Management System, has announced as of July 1, it has assumed direct commercial operations in Europe to provide sales, distribution, customer support, and product services for its Omnipod System. Insulet has established a dedicated Customer Care team, committed to providing best-in-class support to its large European customer base.
 
“We are thrilled to directly support the diabetes community across Europe now and into the future,” said Patrick Sullivan, chairman and chief executive officer. “We have a very accomplished team in place whose sole focus is to deliver an exceptional customer experience and we are deeply committed to bringing customized innovation to the local European markets.”
 
Since July 2017, when Insulet announced its intention to assume the distribution, sales, marketing, training, and support activities for the Omnipod System across Europe, the company has established a highly-talented European team of over 100 employees with extensive diabetes knowledge and expertise within the European markets. In addition, Insulet now has 24/7 customer care and product support for over 140,000 Podders worldwide.
 
“Insulet has always been committed to putting the patient first and direct operations in Europe is a big step forward for all Omnipod users,” said Professor Eric Renard, professor of endocrinology, Lapeyronie University Hospital, Montpellier, France. “Insulet is making a significant, long-term commitment to the diabetes community in Europe and I’m excited they plan to bring new innovations to market that best serve the local European customers.”
 
For more information on the Omnipod System, visit the company’s Omnipod website.
  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-07-02 10:14:00 [updated_at] => 2018-07-02 10:15:51 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282647","283095","277337","279550","271580"] [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/2018-07-02/insulet-assumes-direct-operations-of-its-omnipod-line-in-europe/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 271580 [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":"Medtronic plc","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162696 [primary_image_old] => [slider_image_id] => 162696 [banner_image] => 0 [title] => Additional FDA Approval for Medtronic’s ‘Artificial Pancreas’ [short_title] => [summary] => New arm indication for Guardian Sensor 3 enhances MiniMed 670G Hybrid Closed Loop experience. [slug] => additional-fda-approval-for-medtronics-artificial-pancreas [body] => Medtronic plc, a global supplier of medical technology, has announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm—delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7 percent following typical calibration methods used with the MiniMed 670G system. The Guardian Sensor 3 is Medtronic's newest and most accurate CGM to-date and is the only sensor FDA approved to control automated insulin delivery via a hybrid closed loop system - the MiniMed 670G system.
 
"The performance of the Guardian Sensor 3 has been extremely impressive and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs," said Bruce Bode, M.D., FACE, a specialist with Atlanta Diabetes Associates and a clinical associate professor at Emory University. "These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimizing outcomes through technological advancements - that can prove to be just as meaningful for quality of life." 
 
The Guardian Sensor 3 is currently available in the U.S. for use with the MiniMed 670G system, which is approved for people with Type 1 diabetes 14 years old and above. The system features the company's most advanced SmartGuard algorithm, which helps to increase Time in Range by automatically adjusting basal insulin delivery every 5 minutes based on real-time data delivered by the Guardian Sensor 3. The sensor incorporates diagnostic technology that continuously monitors sensor health to ensure the consistent and reliable performance that is critical for powering a hybrid closed loop system. 
 
"We are steadfast in our commitment to delivering both best-in-class clinical outcomes as well as best-in-class experiences for our customers," said Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic. "We are inspired by the many voices in the diabetes community who continue to shape our offerings in a meaningful way as we work to address the wide spectrum of needs within the community. We are very pleased to offer this added flexibility for those who rely on our therapies for their diabetes management needs."
 
Time in Range 
Time in Range refers to the percentage of time people with Type 1 diabetes spend in the optimal glycemic range of 70-180 mg/dL. The goal with diabetes management is to increase time spent in this healthy range and to minimize high and low sugar levels, which can lead to both immediate and long-term complications such as damage to blood vessels—increasing the risk of coronary artery disease, heart attack, and stroke. Damage to blood vessels can also lead to loss of vision, kidney disease, and nerve problems. Increasing the "Time in Range" over the long-term can best be accomplished by using advances in diabetes therapies, like the MiniMed 670G system with SmartGuard technology, that automates basal insulin.
 
  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-26 08:56:00 [updated_at] => 2018-02-26 08:59:57 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271646","271575","271372","269375","269237","268098","265796","263655","260163","259792","261191","259387","255490","262272","261080","262288","264451","267660","270967","262289"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277337 [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] => 165565 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Augmenix Opens New U.K. Regional Headquarters [short_title] => [summary] => New facility includes a warehouse with a customer care and logistics team. [slug] => augmenix-opens-new-uk-regional-headquarters [body] => Augmenix Inc., a worldwide developer of hydrogel spacing solutions which reduces toxicity associated with radiation therapy, has opened a new U.K. company headquarters, Augmenix U.K. Ltd., in Corby, Northamptonshire, England.
 
This new headquarters includes a warehouse with a customer care and logistics team, providing a strong base for Augmenix UK Ltd. to support the growing number of clinicians who are using SpaceOAR hydrogel to help reduce the unnecessary side effects of radiation for prostate cancer.

More information about SpaceOAR hydrogel is found in the video below:

 

"We are very pleased about the opening of this new office in Corby and the fact that it will give us a flexible base to support our new and existing customers throughout the U.K. and Ireland,” said Stephen McGill, vice president and general manager of Augmenix International. “This U.K. facility will provide our customers with a dedicated customer care team focused on providing premier support and service. With this increased capacity, we are committed to providing our customers with next-day delivery service on orders received before 12 noon. We are looking forward to working with more clinicians to improve the outcomes of prostate cancer radiotherapy with SpaceOAR hydrogel and making a real difference in the lives of men.”
 
Augmenix Inc. is a privately held company based in the Boston, Mass., that develops and commercializes radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, its next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR hydrogel, the company’s lead product, is a registered trademark of Augmenix Inc. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-10 10:05:00 [updated_at] => 2018-04-10 10:17:29 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["276301","270619","264694","262090","260084","272532","276264","276405","273366","276739","267466","268836","276445","265481","262114"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279550 [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":"Rachel Mele, General Manager, Vennli","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166775 [primary_image_old] => [slider_image_id] => 166775 [banner_image] => 0 [title] => Create a Customer-Centric Marketing Strategy in Four Steps [short_title] => [summary] => Grow your medical device business by discovering your customers’ drivers and keeping in contact. [slug] => create-a-customer-centric-marketing-strategy-in-four-steps [body] => Obtaining and retaining customers is critical, especially in highly competitive markets like the medical device industry. Differentiating your organization with an exceptional customer experience can help your firm to stay ahead. According to a McKinsey survey, more than 70 percent of buying experiences are based on how the customer feels they’re being treated. Now more than ever, the customer’s satisfaction needs to be at the top of focus for companies seeking to excel. In order to aid medical device marketers, I’ve outlined four steps to creating a customer-centric marketing strategy to help grow their businesses.
 
Step 1: Determine who your customers really are.
First, start by learning the basics about your customers. The data you gather will ensure you’ll employ the right tactics to reach your audience with a powerful marketing strategy. Analyze who is buying your product by demographics—job title, location, number of years the customer has been in the business, education level, etc.
 
After gathering the basics, dig deeper. Inspect purchase drivers, how they discovered your company, and why they continue to buy. In what ways do they interact with your company’s website? Are they frequently looking for resources? What makes them choose you?
 
Creating buyer personas from this data will also help align your marketing and sales teams to create effective strategies for maximum impact.
 
Step 2: Discover how your company fits into the competitive landscape.
Getting to know who your customers are is just the first step in creating an effective customer-centric marketing strategy. To chip away at a competitor’s share in the market, medical device companies need to have an objective look at where they stand versus competitors. To do this, turn the tables on your customers. Survey them to find out where they see your company fitting into the competitive landscape. Yes, you might have an idea of where your strengths lie, but your customers may have an entirely different idea.
 
With a survey, you also have the opportunity to discover attributes that are most important to a customer when purchasing. You might think that device durability is a strong purchase driver, but your customers may say that positive patient outcomes are actually their number one purchase driver.
 
Once you analyze survey results, you will understand how your company is perceived in the marketplace and where your company needs to focus efforts to grow market share. Using data and the key metrics gathered from this data will highlight opportunities to differentiate your medical device.
 
Step 3: Create powerful messaging with your results.
With deeper customer insights on your organization’s strengths, your next step is to act on those results and create a compelling message for your brand based on top purchase drivers. Then, examine areas of opportunity for your organization beyond messaging, whether they be improvement in current offerings, new offerings, or a combination of both.
 
With the right marketing messaging, there are a plethora of ways to address top product features as named by customers (in your survey). Trust in the results of your survey to guide your marketing messaging, honing in on the top purchase drivers to guide your content.
 
Step 4: Keep the customer engaged.
Updated marketing materials and messaging to reach your customer can lead to a positive impact on inquiries and sales. That said, your job doesn’t stop once you get the sale. You must work to keep your customer engaged.
 
Ensure your customer’s success by providing educational materials, guiding their use of your product, as well as tips and best practices for their jobs. Don’t let your communication with them stop—stay in touch. See how your product is working out for them. They rewarded you by choosing your business; now it’s your job to make their lives easier and loyal to your brand.
 
Conclusion
It sounds simple but keeping customers as the focus of your business is a full-time job. By truly learning about and listening to your customers and applying their needs to your marketing strategy, your company will cut through the noise and resonate with customers. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-05-01 11:04:00 [updated_at] => 2018-05-01 11:07:03 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271902","262272","266057","265690","276287","279074","272959","276270","270595","269490","279455","268839","264931","264790","270281"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 282647 [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] => 168734 [primary_image_old] => [slider_image_id] => 168734 [banner_image] => 0 [title] => FDA OKs Insulet's Omnipod DASH Insulin Management System [short_title] => [summary] => Features handheld personal diabetes manager, Bluetooth connectivity, waterproof tubeless pump, and mobile app. [slug] => fda-oks-insulets-omnipod-dash-insulin-management-system [body] => Insulet Corporation, developer of tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), today announced FDA 510(k) clearance of the Omnipod DASH Insulin Management System (Omnipod DASH). This clearance lays the foundation for a steady cadence of innovation that furthers Insulet’s mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology.
 
“Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, Chairman and CEO. “Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”
 
Omnipod DASH was built to be simple, discreet and easy-to-use. The system features Bluetooth wireless technology for connectivity between the color touch-screen Personal Diabetes Manager (PDM), tubeless waterproof pump (Pod), and is optimized for use with the CONTOURNEXT ONE Blood Glucose (BG) Meter for the seamless transfer of blood glucose readings to the PDM’s bolus calculator. Bluetooth functionality also provides connectivity to the Omnipod DISPLAY and Omnipod VIEW apps. The DASH PDM will be offered at no cost with the purchase of Pods.
 
The Omnipod DISPLAY and Omnipod VIEW apps will provide users and their caregivers quick and easy access to their insulin therapy information on their smartphones. Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones along with other Podder-inspired features including “Find my PDM”. Omnipod VIEW allows parents and caregivers to monitor their loved ones’ diabetes more easily and with greater peace of mind. The iOS Today View widget allows users and their care teams to see their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.
 
“I’m thrilled with the new Omnipod DASH System,” said Tessa Mellinger, a college student with Type 1 diabetes who was part of the DASH user testing and development. “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”
 
Insulet would like to thank the Centers for Devices and Radiological Health (CDRH) branch of the FDA for its collaborative efforts, timely review and ultimate clearance of the Omnipod DASH Insulin Management System submission. Insulet looks forward to working with Captain Alan Stevens and his team as the Company continues to work on its robust innovation pipeline.
 
Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while today’s clearance allows Insulet to commercialize this product in the United States, the Company is taking a measured approach through a limited market launch to ensure an ideal user experience at full market release. Full market release is estimated to begin in early 2019 in the United States.
 
*The Pod has a waterproof IPX8 rating for up to 25 feet for 60 minutes. The PDM is not waterproof. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-06-04 09:02:00 [updated_at] => 2018-06-04 09:30:28 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279358","282390","281299","280635","279504","279103","279015","278641","278237","278234","277967","267882","268532","273244","269947","282664","282388","271580","282687","274877","265012"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 283095 [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] => 169019 [primary_image_old] => [slider_image_id] => 169019 [banner_image] => 0 [title] => Insulet Forges Two Commercial Partnerships to Support its European Expansion [short_title] => [summary] => Theras Group and Nordic Infucare to provide sales, marketing and customer support for Omnipod System users. [slug] => insulet-forges-two-commercial-partnerships-to-support-its-european-expansion [body] => Insulet Corporation, developer of tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), has entered into partnerships with two highly-experienced diabetes distributors, Theras Group and Nordic Infucare, to provide full-service distribution of the Omnipod System in Italy and the Nordic markets beginning July 1. These partnerships are key milestones for Insulet’s transition to direct operations in Europe to fully support its Omnipod System.
 
“There are considerable commercial opportunities for the Omnipod System in Italy and the Nordics and we are thrilled to work with these two highly-experienced and respected diabetes medical device companies that have provided support to the local diabetes communities for many years,” said D.J. Cass, general manager, Europe. “Establishing these partnerships is another critical step forward to ensure Insulet’s smooth transition to direct operations in Europe and provides a platform for long-term growth and an exceptional customer experience.”
 
“Omnipod is a perfect fit within our existing diabetes portfolio and we are excited to partner with Insulet to provide support to Omnipod System users in Sweden, Norway, Denmark and Finland and to continue building awareness and knowledge of this unique insulin pump across our region,” said Mats Durvall, general manager, Nordic Infucare.
 
“We are also delighted to add the Omnipod System, the leading tubeless insulin pump technology, to our diabetes portfolio so we can offer greater options and support for people living with diabetes in Italy,” said Cristiano Ferrari, president of Theras Group.
 
Under the agreements, Theras Group and Nordic Infucare will provide sales, marketing and customer support for Omnipod System users and healthcare professionals.
 
The Omnipod Insulin Management System is a continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The Omnipod System's innovative design and features allows people living with diabetes to live their life—and manage their diabetes—with unprecedented freedom, comfort, convenience, and ease. The Omnipod System consists of two components: (i) a Pod that stores and delivers insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly programs the user's personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in blood glucose meter. The small, light-weight Pod can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower back and, because it is waterproof (IPX8), there is no need to remove when showering, swimming or performing other activities. This means that Omnipod can provide up to three days of non-stop insulin delivery, without the need to disconnect a tube set or manually inject insulin. The Pod and PDM communicate wirelessly to offer precise, personalized and continuous insulin delivery with customizable basal and bolus delivery options, as well as important safety checks. The Pod's auto-cannula insertion is quick, simple, and virtually pain-free. Users never have to handle a needle. The user simply pushes a button on the PDM and the Pod's automated insertion system inserts the cannula beneath the skin and begins delivering insulin according to the user's programmed basal rate.
 
The Omnipod System is the world's first commercially available tubeless insulin delivery system that allows users to live untethered by tubing and without the stress and anxiety of multiple daily injections. By breaking down the barriers to insulin pump therapy, the Omnipod System offers freedom for users to live life on their own terms and with the ease of use they deserve.
 
Insulet Corporation, headquartered in Massachusetts, has developed the Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod, by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across multiple therapeutic areas. Founded in 2000, more than 140,000 users across the globe rely on Insulet’s Omnipod Insulin Management System to bring simplicity and freedom to their lives.
 
*Starting July 1, Insulet will assume direct distribution of its Omnipod Insulin Management System in Europe, including sales, marketing, training and customer support activities. This will allow Insulet to be closer to the diabetes community and identify opportunities to support European customer needs over the long-term, as it already does in the United States and Canada. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-06-08 07:39:00 [updated_at] => 2018-06-08 07:50:40 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282647","279358","282080","269891","273191","280491","268090","270375","269560"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 271580 [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":"Medtronic plc","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162696 [primary_image_old] => [slider_image_id] => 162696 [banner_image] => 0 [title] => Additional FDA Approval for Medtronic’s ‘Artificial Pancreas’ [short_title] => [summary] => New arm indication for Guardian Sensor 3 enhances MiniMed 670G Hybrid Closed Loop experience. [slug] => additional-fda-approval-for-medtronics-artificial-pancreas [body] => Medtronic plc, a global supplier of medical technology, has announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm—delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7 percent following typical calibration methods used with the MiniMed 670G system. The Guardian Sensor 3 is Medtronic's newest and most accurate CGM to-date and is the only sensor FDA approved to control automated insulin delivery via a hybrid closed loop system - the MiniMed 670G system.
 
"The performance of the Guardian Sensor 3 has been extremely impressive and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs," said Bruce Bode, M.D., FACE, a specialist with Atlanta Diabetes Associates and a clinical associate professor at Emory University. "These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimizing outcomes through technological advancements - that can prove to be just as meaningful for quality of life." 
 
The Guardian Sensor 3 is currently available in the U.S. for use with the MiniMed 670G system, which is approved for people with Type 1 diabetes 14 years old and above. The system features the company's most advanced SmartGuard algorithm, which helps to increase Time in Range by automatically adjusting basal insulin delivery every 5 minutes based on real-time data delivered by the Guardian Sensor 3. The sensor incorporates diagnostic technology that continuously monitors sensor health to ensure the consistent and reliable performance that is critical for powering a hybrid closed loop system. 
 
"We are steadfast in our commitment to delivering both best-in-class clinical outcomes as well as best-in-class experiences for our customers," said Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic. "We are inspired by the many voices in the diabetes community who continue to shape our offerings in a meaningful way as we work to address the wide spectrum of needs within the community. We are very pleased to offer this added flexibility for those who rely on our therapies for their diabetes management needs."
 
Time in Range 
Time in Range refers to the percentage of time people with Type 1 diabetes spend in the optimal glycemic range of 70-180 mg/dL. The goal with diabetes management is to increase time spent in this healthy range and to minimize high and low sugar levels, which can lead to both immediate and long-term complications such as damage to blood vessels—increasing the risk of coronary artery disease, heart attack, and stroke. Damage to blood vessels can also lead to loss of vision, kidney disease, and nerve problems. Increasing the "Time in Range" over the long-term can best be accomplished by using advances in diabetes therapies, like the MiniMed 670G system with SmartGuard technology, that automates basal insulin.
 
  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-26 08:56:00 [updated_at] => 2018-02-26 08:59:57 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271646","271575","271372","269375","269237","268098","265796","263655","260163","259792","261191","259387","255490","262272","261080","262288","264451","267660","270967","262289"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277337 [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] => 165565 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Augmenix Opens New U.K. Regional Headquarters [short_title] => [summary] => New facility includes a warehouse with a customer care and logistics team. [slug] => augmenix-opens-new-uk-regional-headquarters [body] => Augmenix Inc., a worldwide developer of hydrogel spacing solutions which reduces toxicity associated with radiation therapy, has opened a new U.K. company headquarters, Augmenix U.K. Ltd., in Corby, Northamptonshire, England.
 
This new headquarters includes a warehouse with a customer care and logistics team, providing a strong base for Augmenix UK Ltd. to support the growing number of clinicians who are using SpaceOAR hydrogel to help reduce the unnecessary side effects of radiation for prostate cancer.

More information about SpaceOAR hydrogel is found in the video below:

 

"We are very pleased about the opening of this new office in Corby and the fact that it will give us a flexible base to support our new and existing customers throughout the U.K. and Ireland,” said Stephen McGill, vice president and general manager of Augmenix International. “This U.K. facility will provide our customers with a dedicated customer care team focused on providing premier support and service. With this increased capacity, we are committed to providing our customers with next-day delivery service on orders received before 12 noon. We are looking forward to working with more clinicians to improve the outcomes of prostate cancer radiotherapy with SpaceOAR hydrogel and making a real difference in the lives of men.”
 
Augmenix Inc. is a privately held company based in the Boston, Mass., that develops and commercializes radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, its next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR hydrogel, the company’s lead product, is a registered trademark of Augmenix Inc. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-10 10:05:00 [updated_at] => 2018-04-10 10:17:29 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["276301","270619","264694","262090","260084","272532","276264","276405","273366","276739","267466","268836","276445","265481","262114"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279550 [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":"Rachel Mele, General Manager, Vennli","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166775 [primary_image_old] => [slider_image_id] => 166775 [banner_image] => 0 [title] => Create a Customer-Centric Marketing Strategy in Four Steps [short_title] => [summary] => Grow your medical device business by discovering your customers’ drivers and keeping in contact. [slug] => create-a-customer-centric-marketing-strategy-in-four-steps [body] => Obtaining and retaining customers is critical, especially in highly competitive markets like the medical device industry. Differentiating your organization with an exceptional customer experience can help your firm to stay ahead. According to a McKinsey survey, more than 70 percent of buying experiences are based on how the customer feels they’re being treated. Now more than ever, the customer’s satisfaction needs to be at the top of focus for companies seeking to excel. In order to aid medical device marketers, I’ve outlined four steps to creating a customer-centric marketing strategy to help grow their businesses.
 
Step 1: Determine who your customers really are.
First, start by learning the basics about your customers. The data you gather will ensure you’ll employ the right tactics to reach your audience with a powerful marketing strategy. Analyze who is buying your product by demographics—job title, location, number of years the customer has been in the business, education level, etc.
 
After gathering the basics, dig deeper. Inspect purchase drivers, how they discovered your company, and why they continue to buy. In what ways do they interact with your company’s website? Are they frequently looking for resources? What makes them choose you?
 
Creating buyer personas from this data will also help align your marketing and sales teams to create effective strategies for maximum impact.
 
Step 2: Discover how your company fits into the competitive landscape.
Getting to know who your customers are is just the first step in creating an effective customer-centric marketing strategy. To chip away at a competitor’s share in the market, medical device companies need to have an objective look at where they stand versus competitors. To do this, turn the tables on your customers. Survey them to find out where they see your company fitting into the competitive landscape. Yes, you might have an idea of where your strengths lie, but your customers may have an entirely different idea.
 
With a survey, you also have the opportunity to discover attributes that are most important to a customer when purchasing. You might think that device durability is a strong purchase driver, but your customers may say that positive patient outcomes are actually their number one purchase driver.
 
Once you analyze survey results, you will understand how your company is perceived in the marketplace and where your company needs to focus efforts to grow market share. Using data and the key metrics gathered from this data will highlight opportunities to differentiate your medical device.
 
Step 3: Create powerful messaging with your results.
With deeper customer insights on your organization’s strengths, your next step is to act on those results and create a compelling message for your brand based on top purchase drivers. Then, examine areas of opportunity for your organization beyond messaging, whether they be improvement in current offerings, new offerings, or a combination of both.
 
With the right marketing messaging, there are a plethora of ways to address top product features as named by customers (in your survey). Trust in the results of your survey to guide your marketing messaging, honing in on the top purchase drivers to guide your content.
 
Step 4: Keep the customer engaged.
Updated marketing materials and messaging to reach your customer can lead to a positive impact on inquiries and sales. That said, your job doesn’t stop once you get the sale. You must work to keep your customer engaged.
 
Ensure your customer’s success by providing educational materials, guiding their use of your product, as well as tips and best practices for their jobs. Don’t let your communication with them stop—stay in touch. See how your product is working out for them. They rewarded you by choosing your business; now it’s your job to make their lives easier and loyal to your brand.
 
Conclusion
It sounds simple but keeping customers as the focus of your business is a full-time job. By truly learning about and listening to your customers and applying their needs to your marketing strategy, your company will cut through the noise and resonate with customers. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-05-01 11:04:00 [updated_at] => 2018-05-01 11:07:03 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["271902","262272","266057","265690","276287","279074","272959","276270","270595","269490","279455","268839","264931","264790","270281"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 282647 [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] => 168734 [primary_image_old] => [slider_image_id] => 168734 [banner_image] => 0 [title] => FDA OKs Insulet's Omnipod DASH Insulin Management System [short_title] => [summary] => Features handheld personal diabetes manager, Bluetooth connectivity, waterproof tubeless pump, and mobile app. [slug] => fda-oks-insulets-omnipod-dash-insulin-management-system [body] => Insulet Corporation, developer of tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), today announced FDA 510(k) clearance of the Omnipod DASH Insulin Management System (Omnipod DASH). This clearance lays the foundation for a steady cadence of innovation that furthers Insulet’s mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology.
 
“Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, Chairman and CEO. “Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”
 
Omnipod DASH was built to be simple, discreet and easy-to-use. The system features Bluetooth wireless technology for connectivity between the color touch-screen Personal Diabetes Manager (PDM), tubeless waterproof pump (Pod), and is optimized for use with the CONTOURNEXT ONE Blood Glucose (BG) Meter for the seamless transfer of blood glucose readings to the PDM’s bolus calculator. Bluetooth functionality also provides connectivity to the Omnipod DISPLAY and Omnipod VIEW apps. The DASH PDM will be offered at no cost with the purchase of Pods.
 
The Omnipod DISPLAY and Omnipod VIEW apps will provide users and their caregivers quick and easy access to their insulin therapy information on their smartphones. Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones along with other Podder-inspired features including “Find my PDM”. Omnipod VIEW allows parents and caregivers to monitor their loved ones’ diabetes more easily and with greater peace of mind. The iOS Today View widget allows users and their care teams to see their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.
 
“I’m thrilled with the new Omnipod DASH System,” said Tessa Mellinger, a college student with Type 1 diabetes who was part of the DASH user testing and development. “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”
 
Insulet would like to thank the Centers for Devices and Radiological Health (CDRH) branch of the FDA for its collaborative efforts, timely review and ultimate clearance of the Omnipod DASH Insulin Management System submission. Insulet looks forward to working with Captain Alan Stevens and his team as the Company continues to work on its robust innovation pipeline.
 
Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while today’s clearance allows Insulet to commercialize this product in the United States, the Company is taking a measured approach through a limited market launch to ensure an ideal user experience at full market release. Full market release is estimated to begin in early 2019 in the United States.
 
*The Pod has a waterproof IPX8 rating for up to 25 feet for 60 minutes. The PDM is not waterproof. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-06-04 09:02:00 [updated_at] => 2018-06-04 09:30:28 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279358","282390","281299","280635","279504","279103","279015","278641","278237","278234","277967","267882","268532","273244","269947","282664","282388","271580","282687","274877","265012"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 283095 [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] => 169019 [primary_image_old] => [slider_image_id] => 169019 [banner_image] => 0 [title] => Insulet Forges Two Commercial Partnerships to Support its European Expansion [short_title] => [summary] => Theras Group and Nordic Infucare to provide sales, marketing and customer support for Omnipod System users. [slug] => insulet-forges-two-commercial-partnerships-to-support-its-european-expansion [body] => Insulet Corporation, developer of tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), has entered into partnerships with two highly-experienced diabetes distributors, Theras Group and Nordic Infucare, to provide full-service distribution of the Omnipod System in Italy and the Nordic markets beginning July 1. These partnerships are key milestones for Insulet’s transition to direct operations in Europe to fully support its Omnipod System.
 
“There are considerable commercial opportunities for the Omnipod System in Italy and the Nordics and we are thrilled to work with these two highly-experienced and respected diabetes medical device companies that have provided support to the local diabetes communities for many years,” said D.J. Cass, general manager, Europe. “Establishing these partnerships is another critical step forward to ensure Insulet’s smooth transition to direct operations in Europe and provides a platform for long-term growth and an exceptional customer experience.”
 
“Omnipod is a perfect fit within our existing diabetes portfolio and we are excited to partner with Insulet to provide support to Omnipod System users in Sweden, Norway, Denmark and Finland and to continue building awareness and knowledge of this unique insulin pump across our region,” said Mats Durvall, general manager, Nordic Infucare.
 
“We are also delighted to add the Omnipod System, the leading tubeless insulin pump technology, to our diabetes portfolio so we can offer greater options and support for people living with diabetes in Italy,” said Cristiano Ferrari, president of Theras Group.
 
Under the agreements, Theras Group and Nordic Infucare will provide sales, marketing and customer support for Omnipod System users and healthcare professionals.
 
The Omnipod Insulin Management System is a continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The Omnipod System's innovative design and features allows people living with diabetes to live their life—and manage their diabetes—with unprecedented freedom, comfort, convenience, and ease. The Omnipod System consists of two components: (i) a Pod that stores and delivers insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly programs the user's personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in blood glucose meter. The small, light-weight Pod can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower back and, because it is waterproof (IPX8), there is no need to remove when showering, swimming or performing other activities. This means that Omnipod can provide up to three days of non-stop insulin delivery, without the need to disconnect a tube set or manually inject insulin. The Pod and PDM communicate wirelessly to offer precise, personalized and continuous insulin delivery with customizable basal and bolus delivery options, as well as important safety checks. The Pod's auto-cannula insertion is quick, simple, and virtually pain-free. Users never have to handle a needle. The user simply pushes a button on the PDM and the Pod's automated insertion system inserts the cannula beneath the skin and begins delivering insulin according to the user's programmed basal rate.
 
The Omnipod System is the world's first commercially available tubeless insulin delivery system that allows users to live untethered by tubing and without the stress and anxiety of multiple daily injections. By breaking down the barriers to insulin pump therapy, the Omnipod System offers freedom for users to live life on their own terms and with the ease of use they deserve.
 
Insulet Corporation, headquartered in Massachusetts, has developed the Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod, by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across multiple therapeutic areas. Founded in 2000, more than 140,000 users across the globe rely on Insulet’s Omnipod Insulin Management System to bring simplicity and freedom to their lives.
 
*Starting July 1, Insulet will assume direct distribution of its Omnipod Insulin Management System in Europe, including sales, marketing, training and customer support activities. This will allow Insulet to be closer to the diabetes community and identify opportunities to support European customer needs over the long-term, as it already does in the United States and Canada. 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