As we enter 2023, Jama Software asked selected thought leaders – both internal Jama Software employees and our external partners – across various industries for the trends and events they foresee unfolding over the next year and beyond.

In the fourth part of our five-part series, we asked Shawnnah Monterrey, CEO at BeanStock Ventures – Romer De Los Santos, Senior Consultant at Jama Software – Vincent Balgos, Director of Medical Device Solutions at Jama Software – Michelle Wu, Medical Device Consultant at Wu Consulting – and Ivan Ma, Medical Device Program Leadership – to weigh in on medical device product development trends they’re anticipating in 2023.

Click the following links to visit part 1 – 2023 Predictions for Product & Systems Development Teams – part 2 – 2023 Predictions for Aerospace & Defense Product Development – and part 3 – 2023 Predictions for Industrial and Consumer Electronics Product Development. We will link the final 2023 Industry Predictions when it publishes.

Read more about the authors and their organizations at the end of this blog.

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2023 Predictions for Medical Device Product Development

What are the biggest trends you’re seeing in the medical device and life sciences industry?

Shawnnah Monterrey: Biggest trends we are seeing include a rapid migration to the cloud this includes: IoMT, Digital Health, Digital Therapeutics and Big Data such as Genomics, Biotech, and Pharma.

We are seeing a rapid shift towards newly derived clinical insights using pre-existing data from existing medical devices, such as:

• Companion diagnostics which combine a diagnosis outcome with a therapeutic and monitoring of that treatment
• Digital therapeutics which use software ONLY to treat patients as opposed to a drug or instrument
• Novel clinical insights where two or more measurements are combined to produce a clinical determination
• AI based diagnostics which often consume numerous inputs that could be measured, demographical or even genetic to derive new clinical insights

Romer De Los Santos: Digital health continues to be a major source of growth as personalized medicine, wearable devices, and mobile health gain wider acceptance. Cloud computing, AI, and machine learning are improving patient outcomes by encouraging innovation and making personalized medicine possible. As these constantly evolving technologies continue to grow in complexity the regulatory framework around medical devices that incorporate them are also evolving to keep up.

For many years, medical device manufacturers secured their devices by disabling or designing out interconnectivity. The rise of electronic medical record keeping has forced manufacturers to support limited interconnectivity. They usually depended on security measures taken by their customer’s IT department as the primary risk control measure. That’s no longer acceptable in our interconnected world. The FDA requires manufacturers to consider cyber security threats and to design controls to reduce these risks as much as possible. This has led to developers having to learn more about threat modeling to limit touch points into their software and to creating plans on how to handle data breaches.

The 21st Century Cures Act amended the definition of a medical device to exclude certain software functions. The FDA intends to focus oversight on software functions that affect patient data and therefore pose the greatest threat to patient outcomes. Wise developers architect their software systems based on clearly defined software functions that can be individually evaluated for risk, leading to a reduction in the regulatory burden. Designing and documenting modular software facilitates re-use and therefore faster time to market for novel medical devices.

Michelle Wu: AI and Machine Learning: I continue to see AI and Machine Learning as a trend for 2023. Any pitch competition I attend includes multiple products that are incorporating AI or machine learning. There’s attention now on companies to look for and counteract bias in the data sets and algorithms.

Health equity: A spotlight on health inequities shines brighter since the pandemic and fortunately many companies are looking to do good and do well. Telehealth, remote patient monitoring, digital health apps, are the top areas of innovations that I see to address these disparities.

Vincent Balgos: The pandemic continues to drive the industry, regulators, and the market for COVID-19 related products and services, so I would expect continual development in these areas as new SARS-CoV-2 variants emerge, or other as other diseases arise.

Continual integration of medical life products, and interoperability amongst devices. As software to grows as a critical part of medical device industry, whether standalone SW or integrated with other components, there are many areas for 2023 innovation such as:

• Software as a Medical Device (SaMD), Software in a Medical Device (SiMD)
• Cybersecurity
• Complex data analysis such as bioinformatics, genomic sequencing, imaging processing
• Artificial Intelligence (AI) and Machine Learning (ML)

New or modified regulations (EU IVDR, EU MDR, and potential US VALID Act) continue to change the landscape in how medical device and life science organizations develop, manufacture, and maintain products.

The new FDA Computer Software Assurance (CSA) guidance that revisits validation in context of the current Computer System Validation (CSV) approach. Many medical companies are looking at this new risk-based approach to streamline their activities, documentation and outputs as the current standard practice can be complex and cumbersome.

Biggest Challenges – What are some of the biggest challenges you think medical device and life sciences companies will be working to overcome in 2023?

Monterrey: Two of the biggest challenges I see are: monetization and regulatory clearance.

Medical devices revenue models rely heavily on reimbursement from CMS which require a CPT code. Obtaining a new CPT code requires a significant investment and burden on the medical device manufacturer to provide clinical evidence which not only shows efficacy but also provides A reduced cost of care when compared to existing methods and treatments. We are seeing that digital therapeutics are struggling in this area. One strategy has been for digital therapeutics to partner with an existing reimbursed pharmaceutical via revenue sharing. But on the upside CMS has recently provided a new code which allows prescription digital behavioral therapy to be reimbursed as a medical benefit which is trailblazing the path for other digital therapeutics to follow.

While digital health applications that are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease are medical devices and have been regulated by the FDA for many years, there has been new entrants in the recent years that have gone under the radar. With the recently issued guidance from the FDA on Clinical Decision Support Software, FDA attempts to make it clear which products are regulated medical devices, and which are not. This will slow the reduction in the barrier to entry as many digital health applications begin to play catchup.

Ivan Ma: The supply chain for components and materials continues to remain constrained. With lead times stretching well past 6 months, and sometimes getting close to 12 months. Programs should plan for contingencies and with expectations that milestones that require physical materials will be impacted by the last part in. Be wary of strategies that start early but require more total effort to execute.

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RELATED: Euro Roundup: MDCG Publishes Guidance on MDR, IVDR Authorized Representative Requirements

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In terms of product and systems development, what do you think will remain the same over the next decade? What will change?

De Los Santos: The need to ensure traceability between requirements, testing, risk, and design will continue to be important in the next decade. Changes in what is considered medical device software will lead to revised regulatory strategies by companies agile enough to take advantage of these changes. Documentation must become more modular to match the software they describe.

Balgos: Based on my past 17 years in medical product development, the time pressures to launch safe and effective products quickly to the market has always been a constant theme.

Many attempt the “faster, better, cheaper” approach, but schedule has always been the driver when comes to the project’s managements iron triangle (scope, budget, schedule). While this “faster, better, cheaper” approach may work for other industries, the medical field is especially constrained in that a patient’s safety is non-negotiable.

What will change is how companies adapt to the complexities of the regulation landscape, innovative technologies, and ever growing knowledge of diseases, illnesses, etc. The adaption for advanced tools, processes, and digitization of information will continue to grow industry as scientists/engineers evolve their practices.

What changing regulatory guidelines do you anticipate having an impact on companies in 2023?

Monterrey: In addition to FDA’s guidance on Clinical Decision Support Software there are a few other draft guidance in the works such as Computer System Validation (CSA), Cybersecurity, and AI.

Tools that are used to implement part of all the quality system require validation to ensure that the tool is fit for purpose and mitigates the risk of failures that could pose undetected harm in the medical product. We have seen many of our clients spend significantly more effort on validating tools that do not pose significant risk to their medical device than the medical device itself. FDA’s Computer Software Assurance for Production and Quality System Software draft (CSA) guidance provides great insight on how to take a risk-based approach when validating your tools.

Cybersecurity affects all products in development and on-market, regardless of if they are fully embedded or even connected. For medical devices manufactures that have many legacy devices on-market, this new guidance can pose a significant risk and cost.

Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan provides some additional insights into FDA’s current thinking behind AI. Although there is no current guidance from the FDA, AI devices continue to be cleared under existing guidance increasingly year or over.

Balgos: The US VALID ACT could have major disruption to lab developed tests (LDT’s) and how they are regulated in the US market. The additional restrictions may impact the growth of new tests, but provide additional oversight to help improve safety. This controversial topic has been a continual discussion point in industry, and that the new VALID ACT provides some additional clarification and guidance.

How do you foresee regulations shifting in medical device and life sciences over the next decade?

De Los Santos: There is a growing understanding among regulatory bodies that cloud computing companies are developing technology that will significantly improve patient outcomes.

Tool Innovation – From a medical device and life sciences engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?

Monterrey: From an engineering toolset perspective – finding automated tools that support the regulation and the team’s ability to be agile for the full development cycle will have a significant impact. Typically, we see our clients taking 6 to 18 months back tracking design activities in order to satisfy the FDA when the product is almost completed. If development is done in a more automated and iterative way – time to market can be significantly reduced, more predictable and lead to higher quality products.

Wu: Tools that make regulatory compliance more efficient. The best tools make it easy for companies to enhance, instead of hampering, their product development and business strategy.

Human centered design. While not a new concept, it is not universally practiced and incorporated. Those that do this well have medical devices that resonate with users and have better product adoption.

Ma: Requirements matter more than ever. Avoid building the wrong thing by keeping track of requirements and risks management using a tool like Jama Connect. If you are paper tracing, you’re operating in the 20th century.

Any major disruptions to the medical device and life sciences industry you’re anticipating in 2023?

De Los Santos: AI, machine learning, and cloud computing were instrumental in the response to the pandemic but have far bigger implications for improving patient health. As companies shift focus away from the pandemic, I expect more innovation around personalized medicine and clinical decision support software, both of which take advantage of these emerging technologies.

Balgos: The US VALID ACT could have major disruption to lab developed tests (LDT’s) and how they are regulated in the US market and industry.

What sorts of process adjustments do you think development teams will need to make to be successful in 2023?

De Los Santos: Development teams should take advantage of the guidance on software functions to improve the architecture of their code and their documentation. The sooner development teams create re-useable code and documentation building blocks, the better.

Balgos: Aligning with new regulations, such as the potential VALID ACT, and new FDA draft guidances such as CSA, Human Factors, and others

For the EU market, organizations need to start early. Notified Bodies engagement as the backlog continues to be longer than expected for re-certification for Medical Devices and IVD’s to the new regulations.

In your opinion, what are the biggest differences between a medical device or life sciences company that survives to see 2030, and one that doesn’t?

Monterrey: Companies that strive to maintain agility while being regulated leveraging tool automation as opposed to paper-based and stage gate processes will have a competitive advantage and higher chance of survival by having the ability to:

• Address cybersecurity demands in an ever-changing eco-system
• Derive new clinical insights using real-world data
• Innovate by releasing product and features in more frequent cadences
• Stay ahead of obsolesce issues

De Los Santos: The ability to organize software, hardware, and documentation into re-useable building blocks are key to winning in this kind of environment. You must be fast while maintaining a level of quality that ensures patient safety.

Ma: Products that bring true clinical value will win in the long run. The challenge is finding organizations and sources of capital that are methodical enough to identify true clinical value and have the grit and determination to stick with programs that take more than 5 years to reach human use.

Balgos: Adapting to the environment will be key for a company’s survival. Whether new regulations, innovative technologies, or another global event changes in how industry operates, companies that has the ability, resources, and willingness to pivot will likely survive.

What role will cybersecurity play in medical device development in the coming year and beyond?

De Los Santos: Cybersecurity is here to stay! The FDA requires device manufacturers to document how they handle cyber security threats and breaches. Companies can’t depend solely on risk control measures made by the customer’s IT department.

What advice would you give to new companies entering the medical device and life sciences industry?

Monterrey: Invest in tools, training, and infrastructure upfront and hire industry and technological experts to help you navigate the complexity of the cloud environment and regulated space.

De Los Santos: Take some time to define a simple design and development process. Don’t overdo it! You don’t get extra credit for adding extra process work. Use a risk-based approach to determine how much is too much.

Wu: Understand that the path to commercialization is much longer for a regulated medical device or therapeutic as compared to a consumer good.

Gain an appreciation for the regulations, what claims you want to make for your product, and how those two impact your timeline.

Human-centered design, including addressing diversity and inclusion, will differentiate your product from others.

Ma: A mentor told me that medical devices are a hard but worthwhile sport. Play the sport with the intent to bring positive clinical value to people everywhere. The rest, as they say, will take care of itself.

Balgos: Understand the market, regulations, and intended use of products/services and the associated risks.

Encourage good documentation practices early and consistently, as documentation is the lifeblood of the industry. Because if it wasn’t documented, it never happened.

What topic(s) do you wish companies were paying more attention to?

Monterrey:

• FDA requirements pre-development – implementing a QMS and following a design process.
• Customer needs – developing with the end user in mind.
• Software as a profit center – focused on the revenue opportunity software can bring.
• Tool validation – focus on value-add activities, if you’re spending more time and money validating tools that verifying your medical device you should revisit your QMS for inefficiencies.

De Los Santos: I wish companies would take a little more time cleaning up their processes. Where are you wasting effort? Putting band-aids on your development process costs you more in the long run. What is a working medical product with a poor or non-existent design history file? It’s a brick. It’s a very expensive brick that will require months of remediation work. Design documentation created after the fact is always poor and you’ll also have trouble retaining great engineers if they must spend months remediating documents.

Wu: Women’s Health: While women make up 51% of the population, less than 1% of VC funding is going to FemTech. With an estimated market size of $1.186 Trillion by 2027, the medical device industry is slowly taking notice of the unmet need and market potential of innovation focused on women. Consumer product goods, digital health, and diagnostics are top three product addressing issues unique to women, including menstruation, maternal health, and menopause¹. It’s an under tapped area that continues to be prime for disruption.

¹ Fem Tech Landscape 2021 by FemTech Focus

Balgos:

• Risk Management, with respect to Post Market Surveillance (PMS)
• Change Management
• Systems Engineering best practices

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RELATED: Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management

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What do you think will remain the same in this industry throughout 2023?

Monterrey: I think we will continue to see slow economic recovery as a result of the side-effects of COVID as it relates to supply chain, pivots, and lower year end earnings. The businesses that end up striving will be those who are focused on long term strategy as opposed to short term reactions to the economy. Reinvestment and patience will be essential to staying ahead competitively.

What do you predict for regulation in the medical device and life sciences industry in 2023?

Monterrey: There will be a watchful eye on cybersecurity, additional thinking around AI and significantly longer wait times for approval.

Wu: While not significant changes in regulation, the change to MDR and IVDR in the EU continues its impact to the industry, especially as companies’ previous MDD certifications lapse, but have yet to obtain their MDR certifications. As of a July 2022 MedTech Europe Survey Report, >85% of existing medical devices that had MDD certification have received MDR. And unfortunately, it is the patients and public that live in the EU that will be affected when they no longer have access to the same medical devices and diagnostics that they had previously. With the 13–18-month time-to-certification with MDR-designated Notified Bodies, nearly double the time historically needed, this influences the worldwide go-to-market strategy of companies.

Will those trends still be prevalent 5 years from now? 10 years?

Monterrey: Digital health applications will begin to dominate the market over traditional hardware devices with new and innovative, diagnostics treatments and therapies leveraging cloud, AI and real-world data. FDA trends over the next 5 to 10 years will move towards harmonization to reduce complexity and improve ease of use. The reduce wait times the FDA will continue to extend devices in the break-through designation and rely on the use certification bodies or 3rd party FDA reviewers like BeanStock Ventures.

Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2023 approaches?

De Los Santos: When properly configured and coupled with a simple design control process, Jama Connect significantly reduces the documentation burden for our customers. In the same way that a good source code management system facilitates code reuse, Jama Connect facilitates re-use of requirements, test cases, and risk documentation. There have been some recent improvements to the Jama Connect that I’ve been requesting since I was a Jama Software customer. I hope people take time to take advantage of them.

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Shawnnah Monterrey – CEO, Beanstock Ventures

20+ years’ experience in the medical industry, Shawnnah Monterrey knows a thing or two about guiding innovative products to market.

Prior to founding BeanStock Ventures, she obtained a bachelor’s degree in computer science from the University of California, San Diego and an executive MBA from San Diego State University, then went on to hold product development management positions across numerous global firms, including Illumina, Invetech, Medtronic and Carl Zeiss Meditec. Through this work, she continued to develop a passion for innovation in medical devices, life sciences, and biotechnology.

BeanStock Ventures

BeanStock Ventures is 1 of 9 FDA-accredited Third Party Review Organizations globally which provides software development and regulatory compliance products and services to minimize complexity, and reduce cost and time to market of innovative medical devices.

BeanStock Ventures has over 140 years of combined experience in software development for the healthcare and life science space.

833.688.BEAN (2326)

marketing@beanstockventures.com

Michelle Wu – Principal Consultant at Michelle Wu Consulting

Michelle Wu is a senior leader with 20 years of experience in the medical device and life sciences industries with roles in executive leadership, product and process development, manufacturing, and quality. Michelle has a history of successful medical device product development, strategic planning and execution, building teams, process evolution, and managing organizational change. She values a collaborative and diverse, equitable, and inclusive environment, believing that diverse perspectives lead to the best ideas, more cohesive teams, and better results.

Ivan Ma

Ivan Ma has nearly two decades of experience in the medical device industry holding leadership and design positions spanning a wide range of medical devices; from single use devices and active implantables to complex surgical robotic systems. Ivan specializes in bringing early phase projects through development in preparation for FDA submission and human use by introducing balanced discipline to an inherently chaotic process.

Vincent Balgos 

Vincent Balgos currently leads the Medical Solution at Jama Software. Prior to joining Jama Software, he worked in the medical device / IVD industry for over 17 years with roles in systems engineering, product development and project management. Vincent has successful history in launching new products to the global regulated market, and is experienced in product development, risk management, quality systems, and medical device regulations.

Romer De Los Santos

Romer De Los Santos has been developing software and firmware in the medical device industry since 1999. He is proud to have been involved in the development of a wide variety of medical devices including insulin infusion pumps, continuous glucose sensors, solid state mobile SPECT cameras, sequencers, liquid handling robots, and various IVD assays. He’s served in the roles of software developer, product owner, scrum master, internal auditor, systems engineer, software project lead, core team leader, and technical product manager before joining Jama Software as a senior consultant this past February.