What should you think about when selecting a software solution to support the development of medical devices while considering the Case for Quality and the EU MDR?
Tech-Clarity’s Medical Device Manufacturers’ Software Selection Guide helps manufacturers identify the right buying criteria for software solutions to support developing, producing, and servicing medical devices. The guide also includes additional considerations for utilizing the Internet of Things (IoT) and other technological advancements such as augmented reality (AR) and 3D printing. Unique needs for medical device companies are also taken into account in the buyer’s guide, including regulatory compliance and support for the FDA’s Case for Quality and the European Union Medical Design Regulation (EU MDR).
Tech-Clarity’s Buyer’s Guides go beyond software functionality to provide a framework of requirements that impact implementation success and long-term ROI, including:
- Software capabilities
- User adoption
- Vendor characteristics / attributes
- Unique business needs
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TABLE OF CONTENTS
- Executive Overview
- Identify Your Challenges
- Transition from Document Centric to Product Centric
- Consider the Complete Lifecycle
- Manage the Product
- Manage Requirements (Customer Needs to Regulatory)
- Support Product Development for Hardware
- Support Software Development
- Enable Smart and Connected Products
- Ensure Regulatory Compliance
- Support Quality Management
- Plan for Manufacturing
- Control Suppliers
- Plan for Service
- Assess Implementation Requirements
- Consider Vendor Attributes
- Identify Specific Needs for your Company
- About the Author
- About the Research
The Opportunity for Medical Device Companies
It’s an interesting time for medical device companies. Initiatives such as the FDA’s Case for Quality and new regulations like the European Union Medical Design Regulation (EU MDR) are shifting the traditional focus of regulatory compliance from a documentation driven approach to one that requires a greater focus on device quality and effectiveness. As discussed in Tech-Clarity’s Preparing for EU MDR – Product Submissions: A Sustainable Approach, while the changes may be challenging in the short term, in the end they can also create opportunity through more efficient processes that result in better devices and improved patient outcomes. In many cases, medical device companies will need to adopt new approaches. These new approaches may be an adjustment, but medical device companies that implement the right technology to support these new methods should find themselves at an advantage. The challenge is figuring out which technology to select.
Let’s start with the fundamental goal for medical device companies. They are in the business of making people’s lives better. As Joel Hembrock, Senior Designer and CAD Administrator at Medtronic says, “Our patients are the people who benefit from our products. Restoring life is our main focus. [We want] to be giving people their lives back, restoring their health, allowing them to actually live again and not have their disease or any other ailment keep them from being able to live.” Technology advancements have opened up new and exciting opportunities that have the potential to further this mission. On top of this, an aging Baby Boomer population will create additional demand for medical devices. Consequently, the industry should see significant growth. In fact, the Evaluate MedTech World Preview 2018, Outlook to 2024  report forecasts a 5.6% growth rate every year for the next five years.
There Are Challenges to Overcome
However, it will be the companies who can overcome the unique challenges in the industry who will be best positioned to take advantage of this growth. With lives at stake, patient safety is of the utmost importance. As such, the industry faces heavy regulations. Compliance is so critical that if medical device companies do not adhere to FDA, EU and other worldwide standards and regulations, they will not be profitable. However, so much time, effort, and cost go into compliance documentation; it takes resources away from innovating and ensuring high quality products. As a result, it is harder to take advantage of opportunities that will boost profitability.
On the other hand, medical device companies who adopt practices focused on high quality devices can expect greater patient satisfaction, improved competitiveness, and higher profits. In fact, McKinsey estimates that firms who embrace quality focused best practices can increase profits by 3% to 4% of revenues. They predict the revenue increase alone could be a $3.5 billion opportunity for the industry  and this doesn’t even factor in the profitability improvements of avoiding costly quality issues.
Unfortunately, for the industry, quality has been getting worse, not better. The FDA’s Medical Device Recall Report FY 2003 to FY 2012 found that recalls nearly doubled over the decade, showing a striking 97% increase in the number of recalls. Since 2012, the Stericycle Recall Index has continued to track regular increases on a quarterly basis in medical device recalls seeing a 39% increase in just four years from 2013 to 2017 . To reverse this trend, medical device companies should adopt new approaches that enable a greater focus on quality.
Shift from Document Centric to Product Centric
One way to achieve this is by shifting from a document centric process to one that is product centric. This shift enables more focus on high quality, innovative products that meet patient needs. The good news is that this is possible with investments in the right software solutions. Software solutions can reduce manual, time intensive reporting processes to a push of a button. Rather than structuring processes around documentation, software solutions can allow you to focus on developing the right products and services that will meet patient needs.
For these reasons, some medical device manufacturers integrate quality processes into their core product lifecycle management activities. By integrating quality processes throughout the product design and delivery lifecycle, companies can improve efficiency. With this approach, instead of wasting efforts searching for compliance supporting documentation and reporting, companies can use that valuable time for quality and innovation. The result will be higher profitability.
Enabling Outcome-Based Healthcare
Other changes in the medical device industry come from recent trends such as the transition to outcome-based healthcare in the US. In some cases, to be compensated, medical professionals must show positive patient outcomes. A way to accomplish this is to take advantage of innovation enabled by the Internet of Things (IoT). For example, IoT combined with software capabilities can be used to meet requirements for Unique Device Identifiers (UDIs) that will provide new levels of traceability and communication to demonstrate device effectiveness. The right software solution must be in place to effectively manage it.
While UDIs present one possible use case for IoT, the potential opportunities for IoT go even further. IoT and other technological advancements such as augmented reality (AR) and 3D printing, create new opportunities for profitable new business models by enabling services that align with customer and patient needs. However, companies stuck following traditional document centric workflows may struggle to find the bandwidth to innovate with these new technologies. Meanwhile, competitors who can devote the resources to innovation will be well positioned to capture a leading market position. This situation makes it an ideal time to invest in a software platform that enables a product centric approach for the entire lifecycle of your device.
Plan for the Right Software Platform
As you evaluate your current needs, think through how your business needs may evolve due to the impact of technological advances in medical devices. For example, designing for connectivity may require new approaches to design. You will now need to consider things like sensors, ecosystems, and new IT development roles that will play a critical part of product development. Ensure your software platform will be able to meet both current and future needs as your product portfolio evolves.
While you consider investments in software solutions, leverage existing systems that are working well. The new solution should use a platform that will leverage and extend the investments made in existing solutions, such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) if you are happy with them. However, the platform should support traceability across all systems to support compliance reporting and so that documentation can be updated once after changes without worrying about conflicting documentation that will put compliance at risk.
Learn More By Downloading the Buyer’s Guide
With so much to consider, how do you select the right software technology to support the lifecycle of your devices? This buyer’s guide will serve as guidance to help you choose the right solution for your company.
This guide consists of four major sections covering software tool functionality required for medical device companies, implementation requirements, vendor attributes, and unique company considerations (Figure 1). Each section includes a checklist of key requirements to investigate when selecting software tools. This guide is not an all-encompassing requirements list. It provides a high-level overview.
 “Evaluate MedTech World Preview 2018, Outlook to 2024,” Evaluate, September 2018 (http://www.evaluate.com/thought-leadership/medtech/evaluatemedtech-world-preview-2018-outlook-2024).
 Ted Fuhr, Katy George, Janice Pai, “The Business Case for Medical Device Quality,” McKinsey Center for Government, McKinsey & Company, October 2013
 “Number of Medical Device Recalls in the U.S. from 2013 to 2017,” Statista, https://www.statista.com/statistics/618125/medical-device-recalls-in-the-us-by-number/
The Cost of Poor Quality
Medical device companies looking to improve profitability should shift their focus from a document centric process to a product centric process that will enable them to concentrate on quality. The cost of poor quality can be significant. In fact, McKinsey estimates that non-routine quality events cost the industry up to $5 billion. On the other hand, companies that focus on high quality enjoy a significant advantage with a potential increase in profits of 3% to 4% of revenues, according to McKinsey. The FDA has also concluded that a greater focus on quality is required. For example, they have found recalls have increased by 97%, with design errors being the leading cause. With the Case for Quality initiative, quality should become an area of heightened focus, which a product centric approach supports. Unfortunately, making this shift, while still meeting regulatory requirements is hard. However, with the right technology, companies can make it much easier.
The Right Solution
The right solution should consider all aspects of the product lifecycle from requirements, through design, testing, manufacturing, and service. It should streamline the regulatory process and automate as much as possible. With traceability across the lifecycle and all deliverables, it will be much easier to provide regulatory compliance documentation. That traceability should also extend to suppliers. The right software solution can make it much easier to bring the right, high quality medical device to market, providing a competitive advantage. This will also support the additional data requirements of the EU MDR for product submissions.
When making such a significant investment, you should also anticipate how your requirements will evolve to remain competitive in the future. Technological advancements such as IoT, AR, and 3D printing create opportunities for very profitable new business models that can increase the quality of patient care considerably. Features such as predictive and remote service offer flexibility around downtime to minimize the impact on patient health. These technologies can help medical device companies advance their mission of making people’s lives better.
Based on industry experience and research for this report, Tech-Clarity offers the following recommendations:
- Identify the top challenges your company needs to solve when bringing medical devices to market.
- Consider a solution that can support the entire lifecycle of your product, from patient needs and requirements to, design, test, manufacturing, and service.
- Look at solutions that will support the Case for Quality. A product centric approach and an integrated PLM and Quality Management System can help keep the focus on quality throughout the entire lifecycle and will also make it easier to comply with the EU MDR.
- Use a vendor who is familiar with medical device regulatory requirements and has the technology to reduce the manual effort required to comply with regulations.
- Ensure you can manage the device and all associated documents, design details, and changes while having traceability across everything.
- Support requirements with a solution that will work across all disciplines and has traceability across all stages and deliverables to support changes and compliance.
- Empower each team member including design, quality, procurement, manufacturing, and service with tools that work for them, while still ensuring a single source of truth for product information.
- Support quality management with traceability from requirements to test and reporting tools to ensure monitoring of trends that impact quality.
- Ensure tight controls on suppliers so as not to put compliance at risk.
- Select a solution that will support manufacturing so that you produce devices as designed and meet regulatory requirements.
- Think about medical device service requirements and use a solution that will support current and future service models such as predictive and remote service.
- Select a vendor who can integrate with your existing solutions while implementing new solutions where needed.
- Consider future needs for potential revenue streams and future needs for technologies such as IoT, 3D printing, and Augmented Reality.
*This summary is an abbreviated version of the research and does not contain the full content. A link to download the full report is available above.
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