Cybersecurity

2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability

By |

In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises.  

As we enter a new year of further changes, 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 the second part of our five-part series, we ask Steven Meadows, Solutions Lead from Jama Software, and Ryan Moore and Carleda Wade, Solution Consultants from Jama Software – along with Thierry Marchal, Program Director for Healthcare Solutions at Ansys, and Ivan Ma, Medical Device Program Leadership, to weigh in on product and systems development trends they’re anticipating for medical device teams in 2022.  

Read our other 2022 Industry Predictions here: Part One – Engineering Predictions, Part Three – Automotive Predictions, Part Four – Aerospace & Defense Predictions, and Part Five – Insurance Development Market Predictions.

Medical Device Predictions 

Q: What product, systems, and software development trends are you expecting to take shape in 2022?  

Steven Meadows, Jama Software:  

Artificial Intelligence (AI) 

AI, and in particular machine learning (a subset of AI), has been expanding rapidly over the past decade and now has a market of over $6.7 billion across med tech. I see this trend continuing with extra guidance from the FDA helping developers produce safer software with AI elements. AI is particularly exciting as it can enable streamlined MRI and CT scans, instant blood and at-home rapid testing, and a whole host of otherwise manual and often error prone activities.  

 Minimally invasive devices  

Another trend I see in medical continuing in 2022 and beyond is the rapid growth and development of minimally invasive devices. Open heart surgeries are becoming a thing of the past, with cardiothoracic applications becoming the norm. Minimally invasive devices are also becoming heavily utilized throughout most orthopedic surgeries, and increasingly in urology procedures. We have seen a lot of start-ups attempting to bring the next best minimally invasive device to market. 

 Wearables 

Medical wearable devices demand continues to rise, with apps on wearable devices beginning to provide recommendations to users, to improve their health. Heart rate and temperature sensing continue to be the most popular features on wearable tech today but there is increased investment in smart glasses, ‘earables’, and clothing. 

Software development 

Software will continue to be an integral part of many medical devices next year and beyond. We consistently see that our software customers have adopted, or are transitioning to, an Agile methodology when creating their medical system, a shift that has been happening for some time. Gone are the days of slow waterfall-based development practices. 

As I mentioned before, AI based software development will continue to trend and grow next year, and AI software development practices will be geared around a tailored regulatory framework, good machine learning practices, and a patient centered approach. The FDA will continue to refine guidance around AI/Machine Learning (ML.)

Cybersecurity and in particular data security will continue to be a top priority for our software customers, with data breaches and hacks on the rise. The FDA is planning to soon release extra guidance around cyber security in medical devices with a particular emphasis on quality system considerations and content of premarket submissions. 

Ryan Moore, Jama Software:  

I anticipate a trend toward more software-based toolsets and digitization. Also, an increased amount of automation and robotics.  

Carleda Wade, Jama Software:  

I expect greater integration of software tools such as with Requirements Management software with eQMS software. 

requirements-management-hub

Thierry Marchal, Ansys:  

The dramatic COVID pandemic has amplified a trend that appeared a decade ago – progressively calling for the adoption and deployment of in silico medicine. Stormed with the COVID pandemic, the world could not wait for 10 to 15 years to get a new vaccine fully tested and approved using a traditional approach. Furthermore, this COVID disease is impacting people differently, while elderly people are impacted the most, possibly leading to long term disabilities and treatments.  

EDITOR’S NOTE: According to The University of Sheffield’s Insigneo Institute, In silico medicine (also known as ‘computational medicine’) indicates modeling and simulation technologies that directly contribute to the prevention, diagnosis, prognosis, treatment planning & execution, or management of the disease. In silico methods complement traditional in vivo approaches (working with animals and human beings) and in vitro testing (working in a lab.)

Thierry Marchal, Ansys:  

This pandemic highlights what we have been observing for decades: with an aging population, the cost of chronic diseases (especially for old people) is weighing a lot on the healthcare cost. The solution will come from personalized medicine and preventive medicine combining pathologies detection in its early stage to treat diseases before they impact people. The continuous monitoring of patients to detect pathologies early are calling for e-health and mobile health (m-health): wearable and implantable devices continuously and safely watching the patient and soon feeding your own digital twin or Personal Digital Avatar (a computer model of yourself, connected with you, and properly stored in the cloud to guarantee your data privacy) is now an emerging trend. Digital twins will be a crucial innovation for the software necessary to use patient specific data to predict the evolution of the connected patients.

As medical innovation will be essential soon, this evolution cannot be slowed down by an extremely long and costly regulatory approval process: a digitalization of drug and medical device approval, including in silico (clinical) trial is another major trend that we are observing. 

Ivan Ma, Medical Device Program Lead: 

Technologies that enable capabilities via telemedicine with more than just a face and a voice over the screen will make “seeing” the doctor digitally as common place as working from home. 

Protecting patients, physicians, and staff by reducing or eliminating exposure to harmful forms of imaging such as fluoroscopy will always be a valuable endeavor.   

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

 Steven Meadows, Jama Software: 

A lot of the areas I mentioned that will trend in 2022, will more than likely trend over the next decade. 

AI, not only in medical but across most industries, is on the rise and patients will continue to see improved outcomes, quicker diagnoses, and a better quality of life.  

Medical wearable technology will continue to evolve, with improved functionality helping keep us fitter and safer. 

Minimally invasive devices will continue to be expanded across different medical areas, improving recovery times, and surgery outcomes. Increasing emphasis on cybersecurity will resume, to prevent malicious actors from hacking sensitive data and for connected systems to remain operational. 

COVID-19 is not going away any time soon so a reliance on collaborative product development tools, like Jama Software, will continue to be an integral part of any organization placing an importance on quality and overall product and patient outcomes.  

Ryan Moore, Jama Software:  

Medical devices will still be comprised of mainly hardware (HW)/software (SW), while automation and robotics will be a driving force. And users will still need to power devices.  

Carleda Wade, Jama Software:  

Medical device development will mostly stay the same as the regulations are fairly stable. However, I do expect increased usage of software in the process since much of the workforce may now be working in various locations. I also expect to see an increase in AI and Software as a Medical Device (SaMD) as a whole in the industry.  

Q: What are some of the biggest challenges you think engineering firms will be working to overcome in 2022?  

Thierry Marchal, Ansys:  

Contrary to other industries, innovation in healthcare faces the challenge of human variability: as we are all different, it is not acceptable that a treatment would work well for a few people and poorly for most others. Using computer modeling and simulation (CM&S a.k.a. in silico methods) is a cost-effective way to test new treatments efficiently without compromising with patient safety, on large cohorts of virtual patients. 

An accurate prediction of the treatment outcome for a given patient will require combining traditional modeling techniques with biological models, often extracted from big data observations using AI. 

Finally, the community remains skeptical about the reliability of computer model and digital evidence to predict correctly and accurately what is happening in the real life. This credibility challenge will be continuously addressed by more validations and comparisons with in vitro and in vivo data. 

Ivan Ma, Experienced Medical Device Developer:  

The development of medical device hardware will always require teams to gather in front of and handle hardware. As the pandemic continues, and in-person work still not back to what it once was, it is time to think of strategies that maximize time on developing hardware with minimal people in the room. Could digital Operating Room technologies be reconfigured and brought in to support the verification and validation phases of medical device development? The tenets are the same. Minimize the number of people in the room, allow the expert to drive the hardware from afar, make data acquisition, observation and learning access as easy as clicking on a link. 

Q: How do you foresee regulations shifting in medical device product and systems development over the next decade?  

Steven Meadows, Jama Software:  

Although AI has been utilized in medical device and life science products for decades, guidance has been lagging. It’s clear to see that AI has incredible benefits for patients, and so there will continue to be increased regulatory guidance available, to help developers build products which contain AI in a safer and standardized manner. Check out a blog Jama Software authored around machine learning in SaMD and shifting regulations here. 

The medical device regulation (MDR), which was accepted and implemented in the EU in 2017, has been amended over the past few years. The latest change focuses on increasing the responsibility and accountability of medical device companies throughout the entire development of a product. Expect more guidance over the next decade, as gaps are addressed to ensure product safety is at the forefront of any market clearance.   

Ryan Moore, Jama Software:  

I would expect compliance and regulations to be more defined as we move forward. Currently, there is a lot of grey area in how standards/regulations are interpreted. The FDA will need clearer guidance for modern technology that arises 

Carleda Wade, Jama Software:  

With an uptick in AI and SaMD I expect the FDA and foreign regulatory bodies to begin providing more clarity on how these complex systems and software needs to be developed, validated, and maintained.  

RELATED POST: EU MDR What You Need to Know

Q: What changing regulatory guidelines do you anticipate having an impact on companies in 2022? 

Thierry Marchal, Ansys:  

The US authorities developed, without any doubt, the most advanced regulation in terms of adoption of computer model results for the regulatory approval process. However, the number of published cases reporting the actual use of in silico methods by sponsors remains limited. New results will be published in 2022 further encouraging companies to confidently follow this process. 

The European Medical Device Regulation (MDR), in application in Europe since May 2021, is opening the door to digital evidence and in silico approach; unfortunately, the process to validate a model and report simulation results has not been clarified yet. Similarly, as the European authorities are updating their pharmaceutical strategy in 2022, this document is expected to make references to computer modeling and simulation. 

In the rest of the world, we observe a growing interest for in silico methods and the need to regulate this approach. After years of compiling information and experience from other parts of the world, we are expecting that some Asian authorities will start to communicate about this topic in 2022. 

Q: What sorts of process adjustments do you think medical device development teams will need to make to be successful in 2022?  

Steven Meadows, Jama Software:  

One of the biggest process issues we see across our customers is that they view quality as a secondary function and a necessary checkbox activity once a product is developed, or close to being finalized. Because of that, products tend to contain more defects, resulting in more in field CAPAs, negative patient outcomes and even have a greater chance of being recalled. Development teams should ensure quality is prioritized from the get-go.  

Although we have noticed a large shift with software teams adopting an Agile approach when it comes to development, we can’t emphasize enough the importance of adopting a lean and iterative approach.  

Ryan Moore, Jama Software:  

Continue to follow standardized process with focus on aligning with FDA / compliance in parallel with building safe products 

Carleda Wade, Jama Software:  

Teams will need to find the sweet spot of trying to collaborate and innovate while not being physically in the same location at the same time. Due to the pandemic, many teams will now transition to being fully remote permanently or have a hybrid schedule and it may make things more difficult when developing new products with a cross-functional team.    

RELATED POST: Realigning Engineering Teams for Remote Work with Minimal Disruption

Q: From an engineering toolset perspective, what are some of the processes you believe forward-thinking firms will be working to leverage or incorporate into their process and why? 

Theirry Marchal, Ansys:  

As we see the healthcare community adopting in silico method with more enthusiasm both for design and regulatory approval (not mentioning emerging clinical applications), the software community is rushing to deliver the supporting in silico tools. We could mention three major avenues followed by Ansys. 

As in silico clinical trials requires a large number of simulations, specific Simulation Process and Data Management (SPDM) tools structuring the digital evidence following the ASME VVUQ40 standard will greatly facilitate the adoption of this approach. Ansys is customizing its Minerva tool in a Minerva VVUQ 40 template for medical device and pharmaceutical companies. 

It is crucial to model the behavior of a new treatment in its working environment, usually the human body. Human organs such as the heart, the lungs, and the brain are extremely complex to model and validate: this requires a collaboration of various actors. Ansys is closely working with leading academics, global healthcare companies and startups, and clinicians to continuously update and validate virtual hearts, lungs, and brains in collaboration with a large ecosystem. 

Although everybody recognizes the potential of digital twin and Personal Digital Avatar, the necessity of developing quasi-instantaneous modeling capabilities despite the complexity of the model is a real challenge. Ansys is taking advantage of its experience with other industries already using digital twin of equipment to help the pharmaceutical industry to develop digital twin of drug manufacturing equipment and initiate the first steps towards Personal Digital Avatars. 

Ivan Ma, Medical Device Program Lead:  

Engineers need tools that minimize the volatility and error that occurs when bringing hardware and electronics from the drawing board to parts in hand. How do organizations reduce hardware prototype cycles, recognizing that even if the design is right on paper, the production of that design can pass through many hands before it is made into a real part, thus decreasing the probability of a successful build.     

Q: What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not? 

Steven Meadows, Jama Software:  

Along the lines of what I mentioned companies should focus on in 2022 to be successful, medical device companies that embrace a proactive approach to quality (Link here – https://www.jamasoftware.com/blog/three-ways-to-proactively-vs-reactively-incorporate-design-controls-in-medical-device-product-development/ )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, AI, 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. 

RELATED POST: Improving Quality Processes for Medical Device Development

Ryan Moore, Jama Software:  

Defined process, building quality products that meet a specific market need 

Carleda Wade, Jama Software:  

Truly understanding the market needs and being willing to allocate resources so that you become a pioneer in a certain industry will help a lot of companies to succeed; however, having passionate and qualified personnel will be the biggest success factor. Companies that only want to develop “me too” devices will struggle to gain market share, and even if they are able to survive it will be difficult for them to thrive.  

Q: Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2022 approaches? 

Steven Meadows, Jama Software:  

Jama Software provides incredible value for hundreds of medical device companies ranging from start-ups to established corporations. With COVID-19, we’ve seen an uptick in customers looking for an easy-to-use product development tool that offers differentiating collaborative capabilities to keep people connected throughout different design stages. Jama Software continues to invest heavily in the application, and we will see improved core product capabilities as well as integrations, strengthening the tool’s ability to seamlessly work alongside other systems. 

Ryan Moore, Jama Software:  

Jama Connect can be used as the core toolset for requirements, testing, and review/approvals. Jama Software’s ability to branch out into further workstreams (in order of priority: risk management, test automation, modeling/design outputs) will bring exponential value to teams using Jama Connect.  

Carleda Wade, Jama Software:  

I can see Jama Software bringing value to not only the start-up but the established company in the future. As a medical device company, the first goal of the company is to make a good product that meets a market need, this happens even before establishing a quality management system in many cases. Having a tool like Jama Connect will ensure that as products are developed that all the bases are covered. Later, when it is time for regulatory approval having a tool like Jama Connect in place will make the regulatory submission process very simple.  

Thanks for tuning into our 2022 Predictions Series! To see some of the incredible products, software, and systems our customers are building with Jama Connect, visit our CUSTOMER STORIES PAGE. 

 


Decoteau Wilkerson
Latest posts by Decoteau Wilkerson (see all)