Growth and Forecasting for next Upcoming Year Until 2025

Trending factors that will influence the progress of the Global Artificial Intelligence in Diabetes Management Market.

Artificial Intelligence in Diabetes Management Market 2019 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. The Market report offers noteworthy data regarding industry’s growth parameters, the current state of the market in terms of analysis of possible economic situations and macroeconomic analysis. This report features competitive scenarios from the recent technology and provides a comprehensive analysis of key growth strategies adopted by key players.

The report has been accumulated through meticulous primary and secondary research, which encompasses interviews, inspections, and observations of experienced analysts, as well as proven paid sources, news articles, annual reports, trade journals, and company body databases. The study also presents a qualitative and quantitative evaluation by analyzing the data collected from industry professionals and market participants across crucial factors in the industry’s value chain. These segments are studied in detail for the market estimates and forecasts at regional and country level.

This report focuses on the Artificial Intelligence in Diabetes Management Market outlook, future outlook, growth opportunities and core and core contacts. The purpose of the study is to present market developments in the US, Europe and other countries. It also analyzes industrial development trends and marketing channels. Industry analysis was conducted to investigate the impact of various factors and to understand the overall appeal of the industry.

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A detailed outline of the Global Artificial Intelligence in Diabetes Management Market includes a comprehensive analysis of different verticals of businesses. North America, Latin America, Asia-Pacific, Africa, and Europe have been considered for the studies on the basis of several terminologies.

To know more https://tinyurl.com/ye572xqv

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The main reason for which many companies were reluctant to adapt the technology.

The FDA has set out requirements for validating all computer systems that handle data regulated by it. These should be in accordance with its guidance on computerized systems, first issued in 1983. The main points of this guidance continue to be consistent today, even with all the changes that technological developments have brought in.

The 1990’s was a decade in which this guidance was revisited for its relevance to the medical device industry. This was because the first issuance was limited to pharmaceuticals.  In 1997, in the context of the move of many FDA-regulated organizations to move into a paperless environment, the FDA issued 21 CFR Part 11, which sought to address electronic records and signatures.

A few changes, such as discretionary enforcement measures, have been brought into this guidance from then, to fashion it to the needs of the industry. Yet, this issuance is rather confusing, although it was intended to help the industry avoid creating a huge regulatory compliance cost, which was the main reason for which many companies were reluctant to adapt the technology.

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What are the current trends in compliance and FDA enforcement?  Technology is a major basis for these trends, although there are other that are based on economics, social media, new diseases, politics, and many other influences.

All these will be discussed in detail at a six-hour learning session from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.  Carolyn Troiano, a senior compliance professional who has worked in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the expert at this webinar, which is being organized on October 28.

Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-trends-for-computer-system-validation-(csv)-compliance-and-enforcement-10310LIVE to enroll for this valuable learning.

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Everything that is required to protect the validity of data that is regulated by the FDA and is stored in electronic format in computer systems will be explained at this webinar. The expert will describe the ways by which to properly validate an FDA-regulated computer system so that security is ensured and data integrity objectives are met.

It is accepted that implementation and adaptation of the System Development Life Cycle (SDLC) methodology is the ideal approach for Computer System Validation (CSV) and for maintaining the system in a validated state throughout its life. Carolyn will explain this aspect in detail at this webinar.

She will also discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The following areas will be explained at this webinar:

Session 1 (90 Mins):

  • FDA Regulatory Oversight
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology

Session 2 (90 Mins):

  • GAMP 5 Software Categorization
  • System Risk Assessment

Session 3 (90 Mins):

  • Requirements
  • Design
  • Testing
  • Requirements Traceability Matrix (RTM)
  • Additional Validation Documentation

Session 4 (90 Mins):

  • FDA Inspection Trends
  • Regulatory Influences
  • Response to Change

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About the speaker: During the over 35 years she has served in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, Carolyn Troiano has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and also collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Medical Device Recalls – How to Handle in a Compliant, Diligent Manner

How to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

A Medical Device Recall (MDR) can be a handful to deal with. It not only indicates that the device has a quality issue; failing to address an MDR rightly can lead to loss of reputation, not to speak of regulatory penal actions from the FDA. It is up to the company whose device has been recalled, to take prompt, prescribed action. Its actions should be proportionate to the level of risk the faulty device poses.

An MDR should be planned well in advance, for it is not something that a medical device can handle hastily, in a piecemeal fashion. The ways by which to prepare for an MDR is thus a matter of crucial importance. GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will offer this valuable learning at a six-hour webinar it is organizing on October 28.

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Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session. To enroll for this webinar, please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-medical-device-recalls—how-to-handle-in-a-compliant,-diligent-manner-10304LIVE

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Even a high degree of preparation by a medical device company cannot completely rule out quality issues that result in a recall. There is no substitute for preparation. The objective of this webinar is to offer learning to its participants on how to prepare for an MDR. Susanne will explain how to decipher signals that could trigger a recall. She will also explain how to face the investigation and what actions are required, what corrective and preventive actions need to be taken, and how to send out notifications to customers and the regulatory bodies.

The expert will give a thorough understanding of the regulatory requirements for dealing with an MDR. She will help understand FDA expectations and regulations, and what to understand and learn from 483s and Warning Letters. The ways of putting robust processes, the basis to efficiently and effectively managing failure investigations, will be explained.

This webinar will also give a proper understanding of recalls, and explain the appropriate corrective and preventive actions that need to be taken. The ways in which these processes link to other aspects of the Quality Management System will be explained. It will give an idea of the best practices for making an MDR efficient. This will help participants prepare for a possible post-recall FDA inspection.

This webinar will have the following agenda:

  • Regulatory Expectations
  • Medical device authority and guidance
  • Complaint Handling, Medical Device Reporting, and Recall requirements
  • Recall Types and Classifications
  • Failure Investigation
  • Difference between a product enhancement and a recall
  • Roles and responsibilities
  • Non-conforming material control
  • Recall strategy and FDA notification
  • Required Communications
  • Firm’s MDR reporting and FDA’s handling of MDRs
  • Lessons learned and enforcement case studies
  • Processes and Procedures
  • Linkages between Complaint Handling, MDRs, Recalls, and CAPA
  • Corrective and Preventive Action
  • Minimize your risk of regulatory actions
  • FDA’s new guidance on risk
  • Preparing for an FDA Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

Cracking the Code to Healthcare Billing, Coding and Reimbursement

A leading provider of professional training for all the areas of regulatory compliance.

Medical billing, coding, and reimbursement are the triumvirate that constitute the heart of a healthcare financial system. These three systems work in tandem with each other; yet, one miss in the cog in the wheel results in utter chaos. The whole system can go into disarray.

A marathon, four-hour session that is being organized on October 17 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will explain all these elements in detail, so that confusions regarding the same can be eliminated.

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At this session, which meets AAPC guidelines for 6.0 Core A continuing education units, Rich Hendriksen, Chief Executive Officer and founder of Nokomis Health, will be the expert. Kindly log on to https://www.globalcompliancepanel.com/virtual-seminar/4-hour-virtual-seminar-on-medical-claims-boot-camp—cracking-the-code-to-healthcare-billing,-coding-and-reimbursement-10309LIVE to register for this valuable session.

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At this course, the expert will explain the fundamentals of medical billing, coding, and reimbursement. He will show how all of these components work with each other. He will demonstrate how to practically apply all the latest industry knowledge and standards. As a result of this learning, those who work with medical claims and claims data stay ahead of the game. They will learn the following:

  • The claim flow process from registration through adjudication and payment
  • How physicians and hospitals set and manage charges
  • Critical data elements on the two major claim forms and what they mean
  • How and why the major coding systems are utilized
  • How various reimbursement methods are used by payors.

The expert will organize the learning in this session into three parts: the life cycle of a claim, coding systems, and reimbursement. He will explain each of these in depth.

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About the expert: Rich has 30 years of experience in healthcare systems, coding, billing, and reimbursement. He has led managed care departments and provider contracting units at a variety of organizations, including hospitals, clinics, and health plans.

Rich has worked with over 70 different organizations, ranging from hospitals and clinics to third-party administrators, law firms, and internet-based companies. As a respected industry expert, he is well known for his unparalleled depth of knowledge in all aspects of healthcare coding, billing and reimbursement.

To understand AI advancements in health care, there are two storylines we must follow

The common thread running through Topol’s books is that medicine is a mess and technology will save it.

If ever there were an industry that could reap the benefits of AI, it is healthcare. The adoption of this technology to actually make medicine better is obvious. However, with this adoption comes a slew of ethical issues.

Let’s start with some numbers: In 2018, the US spent $3.65 trillion on healthcare. That works out to $11,121 per capita, a 4.4% increase over 2017. In addition:

  • Spending on hospitals, doctors, and other clinic services was $2.16 trillion, holding steady at 59% of total health care spending.
  • The spending category that experienced the most substantial year-over-year increase was the general cost of administering health insurance, which rose 7.7% in 2018.
  • Spending on prescription drugs purchased in retail pharmacies went up 3.3% in 2018, higher than the 0.4% rate in 2017.
  • A majority of the more significant spending totals were due to higher overall prices, while the “use and intensity” of health care services played a smaller role.

The per capita spend in western economies, other than Switzerland, which was about 80%, was 50% or less. The worse news is that the US has slipped to 36th in the world in quality of healthcare. (The above data is from Centers for Medicare & Medicaid Services and CIA World FactBook.)

Another lesser-known statistic is the magnitude of iatrogenic disease. From Wikipedia: an iatrogenic disorder occurs when the deleterious effects of the therapeutic or diagnostic regimen causes pathology independent of the condition for which the regimen is advised.

In other words, they are harmed by medical practice. According to a Johns Hopkins study, 251,454 deaths stemmed from a medical error – making it the third leading cause of death in the US, just behind cancer and heart disease.

All industries are facing the problem of which areas to apply AI. In an article in Healthcare IT News, some advice for the healthcare industry was: while AI may have the potential to discover new treatment methods, the report finds strongly entrenched ‘ways of working’ in the healthcare industry that are resistant to change. The authors warn that ‘simply adding AI applications to a fragmented system will not create sustainable change.’ Good advice for any industry.

To continue this: http://bit.ly/2lUwsZj

A Systematic Approach to Implementing Statistical Methodologies

Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, “A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product.”

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ “combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches.” Additionally, the process validation guidance document that “Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.”

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: “After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.” Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.”

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Areas covered by the Instructor:

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who will benefit by this:

  • Process Scientist/Engineer
  • Design Engineer
  • Product Development Engineer
  • Regulatory/Compliance Professional
  • Design Controls Engineer
  • Six Sigma Green Belt
  • Six Sigma Black Belt
  • Continuous Improvement Manager

Click and register for 2 day seminar

Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices. 

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

  • Cite the regulatory requirements for recalls/ field actions regarding medical devices
  • Reference and use medical device recall authority and guidance documents
  • Identify and understand the applicable regulatory standards and guidance documents
  • Identify the different recall types and classifications
  • Explain what types of communications are required
  • Define what effectiveness checks are
  • Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA’s handling of MDR reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls