Sara Bresee and Matt Lowe, MasterControl07.22.21
COVID-19 has been dominating the attention of organizations focused on the development and regulation of medical products. The U.S. Food and Drug Administration (FDA) has largely been in the spotlight, and under enormous pressure. Much like most companies, the agency has needed to adapt on the fly and employ advanced technology to fulfill its core responsibilities—ensuring public health and safety.
Social distancing, travel restrictions, and other circumstances surrounding the pandemic compelled the FDA to suspend foreign and most domestic inspections. The decision was necessary to ensure the safety of FDA staff and the people at the companies they regulate. Meanwhile, the queue for innovative medical devices waiting for regulatory review has steadily grown.
Determined to meet its regulatory obligations of reviewing new medical products and maintaining public safety, the agency turned to technology to circumnavigate the obstacles posed by the COVID-19 pandemic. Primarily, the organization has been plying alternative approaches to reviewing and approving medical products. The FDA’s recently published guidance on remote interactive evaluations outlines the agency’s measures for remotely inspecting drug and biomedical research facilities.1
In the medical device arena, the agency has successfully employed remote interactions and other technology-enabled processes to resume regulatory oversight of mission-critical devices.
Medical Device Oversight During the Pandemic
Personal protective equipment (PPE), COVID-19 test kits, and various other specialized medical devices are among the products that have been needed on the front lines to provide supportive care for sick and hospitalized patients. With many of the products coming in from outside the United States, conducting on-site inspections to get these items approved has not been an option. The FDA has been working closely with the U.S. Customs and Border Protection to clear urgent regulated products—numbering into the thousands—for entry into the U.S. healthcare system.
Automated Screening Tools
To ensure the safety of products coming in from global suppliers, FDA employees are using automated systems to speed the review and admittance of import entries. The agency’s risk-ranking technology tool called Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) electronically reviews entries and flags risky products or entries that are incomplete or contain inaccurate data. It uses various automated processes for determining the potential risks, including data mining, pattern discovery, queries of FDA databases, and the history of the products’ importers and manufacturers. This capability enables the agency to release packages with accurate documentation and shipping contents in minutes rather than days.2
Real-World Evidence
Advances in data collection and management have elevated the potential of real-world data (RWD) in generating robust real-world evidence (RWE), which is the clinical evidence derived from analyzing RWD regarding the usage, benefits, and risks of a medical product. The real-life clinical performance of a medical product can be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.
Commenting on the value of RWE, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said it provides the CDRH with more timely access to a broader and richer set of safety information. It’s useful in bringing new products to market, evaluating the safety and effectiveness of existing products for new uses, and assessing the continued performance and safety of products once on the market. As an example, Shuren mentioned the use of mobile apps as data sources, specifically an automatic external defibrillator. This medical device is designed to analyze a person’s heart rhythm and deliver an electric shock as needed to restore the heart rhythm to normal. Data collected by these devices has been used in premarket applications.3
Remote Reviews of Records and Data
One of the measures the FDA has used to regulate devices during the pandemic is reviewing records and information requested from companies. The agency has also used audit reports gathered from other regulatory agencies showing how companies are in compliance on a global scale. For example, reports from Medical Device Single Audit Program (MDSAP) participants provide essential information on the quality management systems used by device manufacturing firms.
Remotely evaluating companies’ records and data has proven to be an effective part of the regulatory process. The FDA recently published its “Resiliency Roadmap for FDA Inspectional Oversight,” which details the agency’s achievements during the COVID-19 pandemic and how it will continue to meet oversight responsibilities going forward. The FDA’s participation in MDSAP continued during the public health crisis. Leveraging reports from global regulators, the agency conducted 14 regulatory audits at 2,842 medical device manufacturing facilities in 2020. By March of 2021, it had conducted an additional 536 audits.4
Last February, while still under tight COVID-19 restrictions, the FDA approved the first-ever 3D-printed talus implant. The Patient-Specific Talus Spacer is designed to replace the talus (bone in the ankle joint that connects the leg and the foot) to treat avascular necrosis—a rare bone disease. The agency approved the implant from a distance through the Humanitarian Device Exemption after reviewing data from 32 talus replacement surgeries.5
Remote Interactive Evaluations
Travel limitations tethered regulatory auditors to their home offices. While on-site inspections are a key component of compliance, they are one part of a larger, multi-process approach to regulatory oversight. Technology has made remote evaluations a feasible alternative to on-site visits, allowing device manufacturers to achieve or retain regulatory compliance. Using video conferencing and file sharing technology, regulators can complete many of the audits that are typically conducted on-site from a remote location. This allows all audit participants to converse and simultaneously review documents, records, metadata, and audit trails.
Remote evaluations require more planning and preparation to ensure the technology used by inspectors and the host company is compatible and functioning properly. This allows for the auditor to spend more time on the inspection. If a facility tour is necessary, a company rep can walk through the different areas carrying a mobile device using a video-streaming application. One advantage to this is the person can transmit photos of specific areas or items to allow for a more detailed inspection. Auditors can evaluate the company’s quality system, manufacturing, process validation, risk management, etc.
Regulatory Oversight Going Forward
Between the travel restrictions and the all-hands priority given to coronavirus-related activities, the workload of non-COVID-19 device submissions has been building up. In a recent statement, Jeff Shuren said despite staff working around the clock, it’s possible the agency might miss some of its Medical Device User Fee Amendments (MDUFA) performance goals in 2021.
Collectively, the submissions backlog and inspection time frames, along with the advanced medical device technologies that require different types of inspections, have rendered the traditional approach to regulatory oversight ineffective. There are too many innovative medical devices that need to be put on the market, and regulators need to reduce the time-to-decision metric on device submissions. To address this scenario, the FDA is proactively pursuing digitization measures. Shuren asserted the FDA has made significant progress, referring to the creation of the Digital Health Center of Excellence within CDRH. The program is designed to pilot policy and regulatory approaches tailored for fast-growing technologies. “We know we need a different paradigm for these kinds of technologies,” he said.6
Eventually, the FDA will be permitted to travel more frequently and conduct on-site inspections. However, it’s unlikely the industry will fully return to a pre-COVID-19 state. Based on the FDA’s experiences and best practices during the pandemic, remote inspections and other alternatives to on-site reviews will likely be incorporated into the agency’s standard operating model.
The pandemic has fundamentally changed the way products will be developed, manufactured, and regulated. Acting FDA Director Janet Woodcock asserted that “the FDA will continue to leverage and maximize every available tool and resource to meet our inspectional responsibilities while achieving optimal public health outcomes.”
The agency’s current modernization endeavors include transforming its data enterprise platforms. One example is the data standards strategy created by the Center for Drug Evaluation and Research, which is designed to improve the efficiency and effectiveness of regulatory submission reviews. The organization also plans to engage in a more in-depth review of its approaches to regulatory oversight and employ next-generation assessment technologies and improvements.7 Enhancing support for innovation calls for the ability to gather and analyze larger and more complex data sets.
To improve efficiency within its organization as well as across the industry, the FDA is strengthening its understanding of the potential and limitations of artificial intelligence (AI) and machine learning (ML). Areas under consideration include the technical and practical application of AI and ML, new regulatory questions introduced by AI applications, and the impact of AI solutions across the lifecycle of FDA-regulated products.8
More and more innovative medical devices using AI and ML are making their way through the regulatory pathways. The technology has the potential to transform healthcare due to its ability to keep learning upon receiving new data as well as from real-world use. For example, in February 2020, the FDA authorized the marketing of software called Caption Guidance. The software uses AI to capture images of a patient’s heart from different angles to be used in the diagnosis of cardiac conditions. The interactive AI user interface provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality. The AI interface provides real-time feedback on potential image quality. It also captures video clips and automatically saves the best clip acquired from a particular view.9
This is one of several examples of how AI/ML technologies are becoming more mainstream in healthcare. In January 2021, the FDA published its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.” The document explains that with the advancing technology, the agency has an expectation for transparency and real-world performance monitoring by manufacturers that could enable both the FDA and manufacturers to evaluate and monitor a software product from premarket development through postmarket performance, instead of only at various phases of its lifecycle.10
The FDA’s modernization and transformation efforts illustrate how digitization is the direction companies in regulatory environments are heading. Therefore, businesses developing regulated products will find it in their best interest to do what they can on their end to help expedite regulatory approvals.
Digitization: Advantages and Best Practices
Given the availability of advanced technology, regulatory agencies are raising their expectations of what organizations are capable of in terms of product development, manufacturing, and achieving compliance. This trend is compelling more companies developing regulated products to implement a digital quality management system (QMS).
The technology requirements outlined in the new interactive evaluations guidance include provisions for enabling the FDA to remotely review, observe, examine, and evaluate information from the company under review. As part of an inspection process, the FDA commonly requests documents and other information ahead of an inspection—whether on-site or remote. During the inspection, auditors will most likely request additional documents and information. These could include device history records, the data’s history, employee training records, audit trails, etc. The agency expects such requests to be satisfied within a reasonable timeframe.
For companies using paper, these requests can get complicated. Documents need to be scanned to provide in electronic format. Scanned documents must all be reviewed to ensure they are complete, readable, and error free. Companies must ensure all documents and images are a true copy acceptable under GxP regulations for data integrity. Also, the processes for handling electronic documents need to follow the guidelines for electronic signatures specified in 21 CFR Part 11.
Given the effort the FDA is putting into modernization, the agency is in favor of measures to streamline regulatory processes. Medical device companies prevent delays on their end by minimizing quality-related issues such as documentation errors or losses, data integrity nonconformances, mishandled corrective actions, missing audit trails, etc. Quality management is not confined to a single department or role. With a dispersed workforce, organizations lacking connectivity and continuity make the assurance of consistent quality extremely difficult.
Trending Toward Digitization
Currently, digitized quality systems are optional. However, they are quickly becoming necessary, as the tools and methods employed by regulators continue to evolve. Companies that can stay current with technology and modernization trends are in a better position to achieve faster regulatory decisions and compliance approvals.
The fast-paced regulatory environment is invoking companies in the regulated industry to adopt modernization. Businesses can’t afford to prolong the approval process by needing additional review cycles due to nonconformance observations, Form 483s, or warning letters. Manufacturers must demonstrate their capability to consistently produce products that meet the required quality, safety, and efficacy standards. With the ability to integrate all quality tasks, share data across a common platform in real time, and maintain all documents electronically, every business unit within an organization can have an appreciable impact on the product’s quality and successful release.
Planning for Implementation
Sometimes businesses delay adopting new technologies, fearing they are overly complex and require a complicated, multi-year implementation effort. However, digitized systems have come a long way in the past several years. They are purpose-built and currently used by organizations to be more agile, make faster and more confident decisions, and transform their business.
In transitioning to a digitized system, consider the products’ entire lifecycle, identifying where and how digitization will create a competitive advantage. For example, considering the direction regulatory agencies are taking and the prospect of remote inspections becoming more commonplace, paper documents will only become more burdensome for companies to manage and regulatory agencies to accommodate. Participating in a remote interactive evaluation with a paper-based operation presents challenges in managing multiple, disparate electronic systems to allow inspectors to sufficiently view and verify all the documents, procedures, and systems. Scanning documents and transmitting them to an auditor while trying to anticipate which documents will be needed during the audit will only delay regulatory decisions. Switching to a paperless operation, companies almost immediately recognize the cost savings, improved productivity, and faster regulatory cycles. Quality and compliance call for a holistic approach where people, technology, and data work in unison to create innovative, value-add products.
References
Sara Bresee is managing director of APAC at MasterControl. She manages regional GTM planning, sales, marketing, and product P&L. She is charged with increasing market share in China, India, and the rest of the region. She is also responsible for ensuring MasterControl partners worldwide and customers in Asia are well supported. Bresee brings more than 20 years of experience in integrated marketing both on the client side and with the agency. Before joining the agency, Bresee worked for several world-class brands including FranklinCovey, where she repositioned and relaunched The 7 Habits of Highly Successful People curriculum. Additionally, she worked for Intel Corporation and Ford Motor Company. Bresee is a Chicago native and Michigan State University alumna.
Medical device expert Matt Lowe joined MasterControl in 2006. Since then, he has served in a variety of executive leadership positions in global sales, marketing, and product development. In his current role, Lowe is responsible for all aspects of design and development of MasterControl’s software solution. His career includes product development and product management at Ortho Development Corp. and at Bard Access Systems (now BD). Lowe has successfully launched more than a dozen medical devices and he has five patents issued and one pending. He has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.
Social distancing, travel restrictions, and other circumstances surrounding the pandemic compelled the FDA to suspend foreign and most domestic inspections. The decision was necessary to ensure the safety of FDA staff and the people at the companies they regulate. Meanwhile, the queue for innovative medical devices waiting for regulatory review has steadily grown.
Determined to meet its regulatory obligations of reviewing new medical products and maintaining public safety, the agency turned to technology to circumnavigate the obstacles posed by the COVID-19 pandemic. Primarily, the organization has been plying alternative approaches to reviewing and approving medical products. The FDA’s recently published guidance on remote interactive evaluations outlines the agency’s measures for remotely inspecting drug and biomedical research facilities.1
In the medical device arena, the agency has successfully employed remote interactions and other technology-enabled processes to resume regulatory oversight of mission-critical devices.
Medical Device Oversight During the Pandemic
Personal protective equipment (PPE), COVID-19 test kits, and various other specialized medical devices are among the products that have been needed on the front lines to provide supportive care for sick and hospitalized patients. With many of the products coming in from outside the United States, conducting on-site inspections to get these items approved has not been an option. The FDA has been working closely with the U.S. Customs and Border Protection to clear urgent regulated products—numbering into the thousands—for entry into the U.S. healthcare system.
Automated Screening Tools
To ensure the safety of products coming in from global suppliers, FDA employees are using automated systems to speed the review and admittance of import entries. The agency’s risk-ranking technology tool called Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) electronically reviews entries and flags risky products or entries that are incomplete or contain inaccurate data. It uses various automated processes for determining the potential risks, including data mining, pattern discovery, queries of FDA databases, and the history of the products’ importers and manufacturers. This capability enables the agency to release packages with accurate documentation and shipping contents in minutes rather than days.2
Real-World Evidence
Advances in data collection and management have elevated the potential of real-world data (RWD) in generating robust real-world evidence (RWE), which is the clinical evidence derived from analyzing RWD regarding the usage, benefits, and risks of a medical product. The real-life clinical performance of a medical product can be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.
Commenting on the value of RWE, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said it provides the CDRH with more timely access to a broader and richer set of safety information. It’s useful in bringing new products to market, evaluating the safety and effectiveness of existing products for new uses, and assessing the continued performance and safety of products once on the market. As an example, Shuren mentioned the use of mobile apps as data sources, specifically an automatic external defibrillator. This medical device is designed to analyze a person’s heart rhythm and deliver an electric shock as needed to restore the heart rhythm to normal. Data collected by these devices has been used in premarket applications.3
Remote Reviews of Records and Data
One of the measures the FDA has used to regulate devices during the pandemic is reviewing records and information requested from companies. The agency has also used audit reports gathered from other regulatory agencies showing how companies are in compliance on a global scale. For example, reports from Medical Device Single Audit Program (MDSAP) participants provide essential information on the quality management systems used by device manufacturing firms.
Remotely evaluating companies’ records and data has proven to be an effective part of the regulatory process. The FDA recently published its “Resiliency Roadmap for FDA Inspectional Oversight,” which details the agency’s achievements during the COVID-19 pandemic and how it will continue to meet oversight responsibilities going forward. The FDA’s participation in MDSAP continued during the public health crisis. Leveraging reports from global regulators, the agency conducted 14 regulatory audits at 2,842 medical device manufacturing facilities in 2020. By March of 2021, it had conducted an additional 536 audits.4
Last February, while still under tight COVID-19 restrictions, the FDA approved the first-ever 3D-printed talus implant. The Patient-Specific Talus Spacer is designed to replace the talus (bone in the ankle joint that connects the leg and the foot) to treat avascular necrosis—a rare bone disease. The agency approved the implant from a distance through the Humanitarian Device Exemption after reviewing data from 32 talus replacement surgeries.5
Remote Interactive Evaluations
Travel limitations tethered regulatory auditors to their home offices. While on-site inspections are a key component of compliance, they are one part of a larger, multi-process approach to regulatory oversight. Technology has made remote evaluations a feasible alternative to on-site visits, allowing device manufacturers to achieve or retain regulatory compliance. Using video conferencing and file sharing technology, regulators can complete many of the audits that are typically conducted on-site from a remote location. This allows all audit participants to converse and simultaneously review documents, records, metadata, and audit trails.
Remote evaluations require more planning and preparation to ensure the technology used by inspectors and the host company is compatible and functioning properly. This allows for the auditor to spend more time on the inspection. If a facility tour is necessary, a company rep can walk through the different areas carrying a mobile device using a video-streaming application. One advantage to this is the person can transmit photos of specific areas or items to allow for a more detailed inspection. Auditors can evaluate the company’s quality system, manufacturing, process validation, risk management, etc.
Regulatory Oversight Going Forward
Between the travel restrictions and the all-hands priority given to coronavirus-related activities, the workload of non-COVID-19 device submissions has been building up. In a recent statement, Jeff Shuren said despite staff working around the clock, it’s possible the agency might miss some of its Medical Device User Fee Amendments (MDUFA) performance goals in 2021.
Collectively, the submissions backlog and inspection time frames, along with the advanced medical device technologies that require different types of inspections, have rendered the traditional approach to regulatory oversight ineffective. There are too many innovative medical devices that need to be put on the market, and regulators need to reduce the time-to-decision metric on device submissions. To address this scenario, the FDA is proactively pursuing digitization measures. Shuren asserted the FDA has made significant progress, referring to the creation of the Digital Health Center of Excellence within CDRH. The program is designed to pilot policy and regulatory approaches tailored for fast-growing technologies. “We know we need a different paradigm for these kinds of technologies,” he said.6
Eventually, the FDA will be permitted to travel more frequently and conduct on-site inspections. However, it’s unlikely the industry will fully return to a pre-COVID-19 state. Based on the FDA’s experiences and best practices during the pandemic, remote inspections and other alternatives to on-site reviews will likely be incorporated into the agency’s standard operating model.
The pandemic has fundamentally changed the way products will be developed, manufactured, and regulated. Acting FDA Director Janet Woodcock asserted that “the FDA will continue to leverage and maximize every available tool and resource to meet our inspectional responsibilities while achieving optimal public health outcomes.”
The agency’s current modernization endeavors include transforming its data enterprise platforms. One example is the data standards strategy created by the Center for Drug Evaluation and Research, which is designed to improve the efficiency and effectiveness of regulatory submission reviews. The organization also plans to engage in a more in-depth review of its approaches to regulatory oversight and employ next-generation assessment technologies and improvements.7 Enhancing support for innovation calls for the ability to gather and analyze larger and more complex data sets.
To improve efficiency within its organization as well as across the industry, the FDA is strengthening its understanding of the potential and limitations of artificial intelligence (AI) and machine learning (ML). Areas under consideration include the technical and practical application of AI and ML, new regulatory questions introduced by AI applications, and the impact of AI solutions across the lifecycle of FDA-regulated products.8
More and more innovative medical devices using AI and ML are making their way through the regulatory pathways. The technology has the potential to transform healthcare due to its ability to keep learning upon receiving new data as well as from real-world use. For example, in February 2020, the FDA authorized the marketing of software called Caption Guidance. The software uses AI to capture images of a patient’s heart from different angles to be used in the diagnosis of cardiac conditions. The interactive AI user interface provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality. The AI interface provides real-time feedback on potential image quality. It also captures video clips and automatically saves the best clip acquired from a particular view.9
This is one of several examples of how AI/ML technologies are becoming more mainstream in healthcare. In January 2021, the FDA published its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.” The document explains that with the advancing technology, the agency has an expectation for transparency and real-world performance monitoring by manufacturers that could enable both the FDA and manufacturers to evaluate and monitor a software product from premarket development through postmarket performance, instead of only at various phases of its lifecycle.10
The FDA’s modernization and transformation efforts illustrate how digitization is the direction companies in regulatory environments are heading. Therefore, businesses developing regulated products will find it in their best interest to do what they can on their end to help expedite regulatory approvals.
Digitization: Advantages and Best Practices
Given the availability of advanced technology, regulatory agencies are raising their expectations of what organizations are capable of in terms of product development, manufacturing, and achieving compliance. This trend is compelling more companies developing regulated products to implement a digital quality management system (QMS).
The technology requirements outlined in the new interactive evaluations guidance include provisions for enabling the FDA to remotely review, observe, examine, and evaluate information from the company under review. As part of an inspection process, the FDA commonly requests documents and other information ahead of an inspection—whether on-site or remote. During the inspection, auditors will most likely request additional documents and information. These could include device history records, the data’s history, employee training records, audit trails, etc. The agency expects such requests to be satisfied within a reasonable timeframe.
For companies using paper, these requests can get complicated. Documents need to be scanned to provide in electronic format. Scanned documents must all be reviewed to ensure they are complete, readable, and error free. Companies must ensure all documents and images are a true copy acceptable under GxP regulations for data integrity. Also, the processes for handling electronic documents need to follow the guidelines for electronic signatures specified in 21 CFR Part 11.
Given the effort the FDA is putting into modernization, the agency is in favor of measures to streamline regulatory processes. Medical device companies prevent delays on their end by minimizing quality-related issues such as documentation errors or losses, data integrity nonconformances, mishandled corrective actions, missing audit trails, etc. Quality management is not confined to a single department or role. With a dispersed workforce, organizations lacking connectivity and continuity make the assurance of consistent quality extremely difficult.
Trending Toward Digitization
Currently, digitized quality systems are optional. However, they are quickly becoming necessary, as the tools and methods employed by regulators continue to evolve. Companies that can stay current with technology and modernization trends are in a better position to achieve faster regulatory decisions and compliance approvals.
The fast-paced regulatory environment is invoking companies in the regulated industry to adopt modernization. Businesses can’t afford to prolong the approval process by needing additional review cycles due to nonconformance observations, Form 483s, or warning letters. Manufacturers must demonstrate their capability to consistently produce products that meet the required quality, safety, and efficacy standards. With the ability to integrate all quality tasks, share data across a common platform in real time, and maintain all documents electronically, every business unit within an organization can have an appreciable impact on the product’s quality and successful release.
Planning for Implementation
Sometimes businesses delay adopting new technologies, fearing they are overly complex and require a complicated, multi-year implementation effort. However, digitized systems have come a long way in the past several years. They are purpose-built and currently used by organizations to be more agile, make faster and more confident decisions, and transform their business.
In transitioning to a digitized system, consider the products’ entire lifecycle, identifying where and how digitization will create a competitive advantage. For example, considering the direction regulatory agencies are taking and the prospect of remote inspections becoming more commonplace, paper documents will only become more burdensome for companies to manage and regulatory agencies to accommodate. Participating in a remote interactive evaluation with a paper-based operation presents challenges in managing multiple, disparate electronic systems to allow inspectors to sufficiently view and verify all the documents, procedures, and systems. Scanning documents and transmitting them to an auditor while trying to anticipate which documents will be needed during the audit will only delay regulatory decisions. Switching to a paperless operation, companies almost immediately recognize the cost savings, improved productivity, and faster regulatory cycles. Quality and compliance call for a holistic approach where people, technology, and data work in unison to create innovative, value-add products.
References
- bit.ly/mpo210721
- bit.ly/mpo210722
- bit.ly/mpo210723
- bit.ly/mpo210724
- bit.ly/mpo210725
- bit.ly/mpo210726
- bit.ly/mpo210727
- bit.ly/mpo210728
- bit.ly/mpo210729
- bit.ly/mpo210730
Sara Bresee is managing director of APAC at MasterControl. She manages regional GTM planning, sales, marketing, and product P&L. She is charged with increasing market share in China, India, and the rest of the region. She is also responsible for ensuring MasterControl partners worldwide and customers in Asia are well supported. Bresee brings more than 20 years of experience in integrated marketing both on the client side and with the agency. Before joining the agency, Bresee worked for several world-class brands including FranklinCovey, where she repositioned and relaunched The 7 Habits of Highly Successful People curriculum. Additionally, she worked for Intel Corporation and Ford Motor Company. Bresee is a Chicago native and Michigan State University alumna.
Medical device expert Matt Lowe joined MasterControl in 2006. Since then, he has served in a variety of executive leadership positions in global sales, marketing, and product development. In his current role, Lowe is responsible for all aspects of design and development of MasterControl’s software solution. His career includes product development and product management at Ortho Development Corp. and at Bard Access Systems (now BD). Lowe has successfully launched more than a dozen medical devices and he has five patents issued and one pending. He has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.