Kari Miller, IQVIA03.24.22
The medtech industry is currently experiencing a proliferation of regulations, products, markets, and data sources in parallel with intense and steadily growing cost pressures. These trends are not only reinforcing the value proposition for digital transformation that’s begun to take place in organizations. They are also evolving the role of quality management systems (QMS) teams within their organizations.
Due to the increasing regulatory and cost pressures companies face, industry 4.0 technology like artificial intelligence (AI) and machine learning (ML) continues to become embedded into the everyday operations across companies to keep pace. QMS professionals are increasingly expected to find ways to anticipate and proactively prevent issues rather than simply reacting to those that have already occurred.
With these new technologies, in the coming year, we will see a rapid uptick in QMS teams changing their thinking about data validation, verification, and risk-based decision making. In this transformation, automation technology will emerge as a central tool for executing QMS processes. AI, ML, and natural language processing (NLP) will emerge as valuable tools to create signals from social media, identified connections between records, and make sense of unstructured data that might otherwise remain hidden.
In 2022, we will start to see greater convergence of traditionally siloed disciplines enabled by increased adoption of data exchange through connected intelligence. The reach of quality data will expand as more data is reported into and shared with QMS. This development will contribute to the blurring of lines between departments and functional areas. Our traditional definition of quality management will expand dramatically, recognizing this will be critical going forward.
In the coming year, medtech executives will be presented with the challenge of how to accomplish this safely without exposing personally identifiable information or protected health information (PHI). Secure portal capabilities will become increasingly necessary to aid in this endeavor.
Quality groups within medtech organizations have the opportunity to be viewed not as cost centers for the business, but rather as crucial drivers to positively impact patient and business outcomes. Due in large part to the adoption of technology and the breaking down of siloes that technology will enable, QMS teams can ultimately evolve from the historians of their organizations to central fore thinkers. In turn, they can begin making a true difference when it comes to patient outcomes and safety, improving patient quality of life.
As Regulatory and Product Management Leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction, and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. She also is responsible for the Quality Compliance product roadmap, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.
QMS Will Become More Forward Looking
In parallel, we’re seeing how quality management will become more forward looking in view of the expansion of industry 4.0 technologies currently shaping the space.Due to the increasing regulatory and cost pressures companies face, industry 4.0 technology like artificial intelligence (AI) and machine learning (ML) continues to become embedded into the everyday operations across companies to keep pace. QMS professionals are increasingly expected to find ways to anticipate and proactively prevent issues rather than simply reacting to those that have already occurred.
With these new technologies, in the coming year, we will see a rapid uptick in QMS teams changing their thinking about data validation, verification, and risk-based decision making. In this transformation, automation technology will emerge as a central tool for executing QMS processes. AI, ML, and natural language processing (NLP) will emerge as valuable tools to create signals from social media, identified connections between records, and make sense of unstructured data that might otherwise remain hidden.
QMS Will Expand to Incorporate Historically Separate Disciplines within Medtech
The historic siloes between inherently interconnected divisions has likely hampered critical data exchange that can help both do their jobs better and ultimately deliver safer products to market.In 2022, we will start to see greater convergence of traditionally siloed disciplines enabled by increased adoption of data exchange through connected intelligence. The reach of quality data will expand as more data is reported into and shared with QMS. This development will contribute to the blurring of lines between departments and functional areas. Our traditional definition of quality management will expand dramatically, recognizing this will be critical going forward.
QMS Will Extend to Suppliers, Auditors, and Investigators
The virtual way of working that has emerged in the last 18 months is not going away even when the COVID-19 pandemic eventually does. As a result, inclusion of critical third-party stakeholders, including suppliers and extended supply chain, auditors, and investigators will become a norm of quality management.In the coming year, medtech executives will be presented with the challenge of how to accomplish this safely without exposing personally identifiable information or protected health information (PHI). Secure portal capabilities will become increasingly necessary to aid in this endeavor.
Growing Technology Adoption Will Enable Superior Post-Market Surveillance & Continuous Improvement of Medtech Products
In medtech and life sciences at large, the experience of the patient comes above all else. Being able to look at public competitor data and see similar patterns will be extremely helpful to mitigate both quality and safety issues before they’re able to impact their end users: the patients. The growing adoption of technology to address the imminent realities of the space, ultimately offers the opportunity to address much broader challenges. QMS teams will be able to notice new trends in data, identify signals much sooner than has been historically possible, and incorporate predictive analytics. These combined capabilities will enable QMS teams to achieve continuous improvement much more rapidly.Quality groups within medtech organizations have the opportunity to be viewed not as cost centers for the business, but rather as crucial drivers to positively impact patient and business outcomes. Due in large part to the adoption of technology and the breaking down of siloes that technology will enable, QMS teams can ultimately evolve from the historians of their organizations to central fore thinkers. In turn, they can begin making a true difference when it comes to patient outcomes and safety, improving patient quality of life.
As Regulatory and Product Management Leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction, and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. She also is responsible for the Quality Compliance product roadmap, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.
