2020 has been a year that’s been described as “unprecedented” and “unparalleled” – as well as other descriptors probably best left out of our blog. As we close out this year, it’s hard to say what awaits us in the new one. One thing that we can be sure of is that innovation in medicine, science, and technology shows no sign of slowing down.
As we enter a new year of technological advancements, Jama Software asked select thought leaders – both internal and external – across various industries for the trends and events they foresee unfolding over the next year and beyond.
In Part I of our four-part series, we ask Steven Meadows, Medical Device Solutions Lead at Jama Software, and Founder & CEO, Shawnnah Monterrey at Beanstock Ventures to weigh in on trends they see in the medical device industry for 2021.
From a product perspective, there are a number of areas in the medical space that are set to grow in 2021 and beyond, including robotics nanotechnology, wearable health tech, and extended reality devices.
With more medical devices incorporating software components and connecting to systems, like hospital networks, enhanced cybersecurity is becoming increasingly important. Medical device companies will continue to invest heavily in this area through 2021 and beyond.
There are three primary trends that I am seeing: A shift in initial product launches from Europe to the United States; An increase in Software as Medical Device products; and an increase in IVDs from lab-developed tests.
We are seeing a shift in initial product launches from Europe to the United States, due to the upcoming EU MDR regulations. Typically, US–based companies would launch medical products in Europe first, followed by a US launch shortly after due to the rigor and lag time in receiving FDA approval. CE Mark was typically more straightforward, required less clinical evidence, and was a faster process, especially when companies could self-certify. EU MDR is currently being perceived to be more onerous than the FDA regulatory clearance process and is therefore creating a trend of product launches occurring first in the United States and then in Europe. The cascading impact would therefore be the need for more services providing expertise in regulations to support EU MDR and a need for a more harmonized regulatory strategy.
The second trend we are seeing is an increase in Software as a Medical Device (SaMD).
There have been numerous healthcare, fitness, and consumer products launched into industry recently that were not previously considered a medical device. As a result of the SaMD FDA guidance combined with the EU changes from CE, MDD to EU MDR, many products that were not originally deemed clinical products or medical devices are now falling into that category.
Products that were previously not classified as medical devices were not necessarily held to the same standards that are required to produce a medical-grade product such as quality management, design control, risk management, clinical studies, and post-market surveillance. This shift will cause companies to delay product launches in order to satisfy the regulatory requirements, resulting in an increased need for training, systems, software, and tools to make it easier for companies to make that transition. Since these companies generally lack quality and regulatory expertise, additional support will be required to deliver medical-grade software products.
The last trend we are seeing is an increase in IVDs from lab-developed tests (LDTs), research use only (RUO) and emergency use authorization (EUA). There are numerous laboratory-based tests and associated software that have been developed to support very complex assays that are being used clinically which has recently been deemed outside of the scope of LDT guidance. Products that were covered under CLIA are now required to be cleared with the FDA and EU as an IVD. From a CLIA perspective, the focus is on validation.
Validation is centered on the intended use of the product and workflow. But with medical devices such as IVDs, there needs to be a shift to bringing it down to verification levels – namely design verification. Design verification is quite different than validation, design verification is looking at the design aspects of the product, not from a workflow perspective, but from a design feature perspective.
Design verification occurs at the subsystem and system level, where the subsystem is the breakdown of the system from the architecture. The scrutiny will be from a hazard perspective for the entire system and a failure mode analysis perspective at the subsystem level. Finally, ensuring that there is a full product definition and full verification associated with the product. The impact is that it is going to require taking a different look at the software that has been provided and looking at it differently from a process software perspective to an IVD perspective this might require looking at the architecture and redesigning the system to break apart the items that were allocated to CLIA and the lab system processes versus the actual product that performs the clinical interpretation and the diagnosis.
An overarching impact will be evolving medical device product development from a methodology perspective. Many companies are lean and agile and are performing continuous integration and development of their products. It will be important to set up processes and procedures to still allow for that while continuing to meet the regulations. From a systems perspective, it would be beneficial to take advantage of available tools. There is a myriad of tools in place that can assist in developing quality management systems, manage design control, support requirement and risk management, testing, test automation, and deployment. There is an opportunity for companies to start investing in tools to help with compliance and save time and money while still maintaining their efficiencies.
Software is becoming an increasingly used component in medical devices and we expect this trend to continue. More of our customers are adopting an Agile methodology when developing their software, a shift that has been happening for some time, and will continue to over the next decade.
Over the next decade, I see the use of Artificial Intelligence (AI) supporting the creation of sophisticated data-driven algorithms such as autonomous diagnosis. AI is gaining renewed traction, even though it has been used in medical products since the 2000s. I believe there will continue to be a tremendous amount of investment in the development and understanding AI in the healthcare space and how it could be used to improve clinical outcomes. AI will continue to progress over time as the industry develops an understanding of the utility and how it can contribute to guiding clinical decisions as an autonomous tool. There is FDA draft guidance around AI, however, I think the biggest potential constraint will be how to continuously improve upon the algorithms as new data comes in, without requiring a new regulatory submission.
The other trend I see progressing over the next 10 years is one we are already seeing, cybersecurity. This trend is a bi-product of the increasing numbers of clinical cloud applications that integrate with or use medical devices. As the need for sharing clinical data, advanced computing, remote diagnostics, and accessibility increases, so will the migration of healthcare applications to the cloud. This increased need will be the catalyst that pushes up the demand for securing patient data not only in terms of patient privacy but also in terms of patient safety.
We have seen several instances now where, established medical device manufacturers, medical device cloud software, could be hacked by an unauthorized person and potentially cause adverse side effects to the patient. Such hazards could trigger a class I recall, the most serious type of recall. Not only do these hazards put patients at risk, but they also impact a company’s reputation and financial viability. Occurrences like this will justifiably result in a growing emphasis on creating software systems, processes, and tools to support the industry in maturing standards and guidance around cybersecurity.
In terms of what will remain the same in the medical device industry throughout 2021, I would say that the regulations will remain unchanged. It is unlikely we will see a change in this coming year. To the contrary, we will likely see an increase in the regulation. I previously discussed the potential for harmonization. However, I do not believe that will happen until there is a push for it or until the FDA acts on the overlap between many of the guidance documents. Additionally, there will need to be harmonization on the development methodology across different devices so there is not a need to have different guidance documents. In short, I do not see the regulations changing over the coming year.
In discussing 2021, we should also take a moment to discuss Covid-19. It’s not my belief that things will change from a Covid perspective. The trend that I see continuing involves businesses increasingly going digital, putting pressure on products to focus on cybersecurity. Specialties, such as telemedicine will likely increase, requiring true patient authentication and there will be progress, but a delay in medical device development in areas of selected surgeries.
Regarding development teams, I think Agile is here to stay. I think that development teams will continue to use the agile approach and methodology. The organizational struggle of internal alignment of the quality management system will persist until there is a disruption in the regulatory environment itself. Relative to the need for systems as software tools become more useful and more integrated. The main area I see increasing are the new entrants into the market. There has been a large amount of new investment and I believe that will continue. I think we can assume that there will still be quite a bit of investment opportunities for new players.
As we continue to deal with the new normal, I expect medical device teams to continue to invest in collaborative product development software, enabling their teams to continue bringing new devices to market in a safe and competitive way. Development teams, using legacy product development platforms and Word/Excel need to switch to a modern alternative, in order to be as successful as possible in 2021.
My belief is that development teams are going to need both technology investments and process adjustments to accommodate the changes that are coming. There will be a heavy reliance on technology as the software realm moves more towards focusing on core IP and leveraging the existing software components available. For example, there could be an organization successfully providing cybersecurity packages where other organizations may not have that expertise, so they would be leveraging assets from another organization. In short, software re-use will be important.
My sense is that the industry will shift more towards investing in technology such as AI and mechanisms to improve data sharing. There is an opportunity to really understand the clinical value that the data brings. Currently, the healthcare environment is comprised of disparate systems that will eventually need to come together to be able to fully leverage the data and use the data in unique yet meaningful ways.
We currently see a big shift where the medical device companies and their quality management systems do not satisfy the way in which engineers perform medical device development. For example, software engineers are very agile and tool oriented by nature, while many established companies still utilize a paper-based quality management system or document control system. We’d like to see software teams and the Agile methodologies drive changes to the quality system so that the quality system can be nimbler and more adaptive allowing them to release compliant products faster.
We have observed a hindrance in the companies and auditors themselves to adopt a more progressive and nimble approach that is not necessarily driven by the regulations. Our interpretation is that the intent of the current regulations is to be nimble and still provide safe and effective products. My belief is that if we do not make a change to the current way in which we develop medical devices in the corporate environment, innovation from these larger organizations will be stifled. The innovation gap will ultimately be filled by startups entering the marketplace and experiencing immediate success because the old way of doing things is no longer sustainable or effective. I foresee a trend in an increase in the volume of new, emerging, small players. These players are going to be nimble and will look at the regulations from a different perspective.
Key medical device standards and regulations are constantly changing. Notably, EU MDR is undergoing a number of changes and will need to be fully implemented by May 2025. Key standards like ISO 14971 go through multiple iterations and Jama can help our customers stay current with these changes.
I will say something that ‘should’ happen, not that ‘will’ happen, relative to regulatory changes in the medical device industry over the next decade. Ideally, there would be harmonization across the guidance documents. There are too many guidance documents and many of them are repeating the same requirements but in different ways. With a harmonization effort, it would remove the perceived burden of applying multiple guidance and standard documents. With the current format, there is a need to understand each and every guidance and standard document and to be able to apply them all correctly. With more alignment and more harmonization, it would facilitate adoption and push forward innovation.
The impact of harmonization would certainly be in facilitating development. With one cohesive guidance document and less confusion in applying multiple regulations and guidance documents across development, it would result in more development. If there was more alignment across the agencies to create cohesive processes, it would be easier to get consistency in the application of it. Additionally, the FDA’s time to approve products would be reduced because the FDA would be seeing similar submissions and be able to focus on the critical aspects of the product.
Another regulatory change that I expect to grow over the next decade is with the FDA’s adoption of third-party review organizations. The FDA has begun utilizing third-party vendors to streamline and offload their burden of reviewing Class I & II devices. By working with approved partners to facilitate the review, the FDA can focus on higher risk devices. This allows a company’s submission to get reviewed more quickly. Over the next decade, the FDA will likely become more sophisticated in this partnership with third-party organizations. The impact would be a faster time to market, possibly launching products months more quickly.
Medical device companies that embrace a proactive approach to quality will ultimately find fewer issues with their products, improve customer satisfaction, and stay competitive for the foreseeable future. Companies that invest in best-of-breed medical device development solutions like Jama Connect will have the upper hand in reducing risk and complying with various standards and regulations.
New cutting-edge technologies in the medical field, like robotics nanotechnology, and wearable health tech devices, bring complexities for medical device companies and risk for patients and consumers. Jama Software will continue to serve as the leading solution and partner to help innovative companies bring medical products to market, in a collaborative, safe, and efficient way.
I believe there will be disruption in the regulatory space in the next five to ten years, so I do not see the trends staying the same.
It will be important to have industry guidance by having industry experts partner with the FDA to help make those improvements. Based on the FDA approach currently, I believe they will welcome industry guidance. In relation to the previous discussion of the FDA 510(k) Third-Party Review Program, if we want to put it into a broader bucket, this is really the FDA utilizing external resources to support the industry. However, the collaboration is not simply due to a lack of resources, it is also because there is a very challenging, difficult infrastructure to navigate. I believe that there is a push to simplify the system and there will be a reliance on industry partners to do so. The industry partners will include those that are doing software product development, providing quality regulatory services, and providing tools to help facilitate medical device development.
The innovations in regulation in the medical device industry that I hope to see is the increasing opportunities for companies to collaborate with the FDA. I also hope to see more companies, larger organizations, or startups, take a more lean, nimble approach and be more receptive to the Agile methodology that software development teams are currently using. Current processes and procedures were generally derived from good engineering practices; however, perspectives of quality and regulatory experts and independent auditors remain the same. I would like to see them be more adaptive towards compliance, as compared to the typical approach of checking the box, and instead, establish a partnership with their medical device development team to help facilitate compliance without sacrificing the quality of the product.
More specifically, I would like to see more efficient uses of tools and technology to support medical device development. There are many tools out there, but they are very disparate. I believe that with more cohesion between those tools it would better facilitate medical device development to comply with the regulations.
In five years, my hope would be that there would be a first pass at simplifying the guidance documents.
In 10 years, I hope to see a streamlining of the processes. I hope for standardization of the submissions. I would hope to see a simplification of the current guidance documents across the board in the form of a standard method for supporting 510(k) and PMA submissions.
© 2022 BeanStock Ventures