Tag Archive for: medical device

Medical Device Security

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from HealthITSecurityMDIC, HSCC Team Up to Establish Medical Device Security Benchmarks  – which was originally published on June 2, 2022, by Jill McKeon.

MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks

Experts from MDIC, HSCC, and BD discuss a new self-assessment tool that aims to establish medical device security benchmarks.

The Medical Device Innovation Consortium (MDIC) and the Public Health Sector Coordinating Council (HSCC), in partnership with Booz Allen Hamilton, created a new survey with the goal of establishing medical device security benchmarks.

Medical device security continues to be a pain point for healthcare organizations, regulators, and manufacturers. The sheer number of devices on an organization’s network at any given time, along with the prevalence of legacy devices and a lack of industry-wide standards, have posed significant security challenges.

Over the years, there has been a lot of finger-pointing and confusion surrounding roles and responsibilities for medical device security.

Dig Deeper:

Related: Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions

“There was no mutual understanding about shared responsibility between device manufacturers, hospital systems, and healthcare providers,” Greg Garcia, executive director for cybersecurity at HSCC, explained in an interview with HealthITSecurity.

“We quickly recognized that as a sector, we needed to be doing something about this rather than just staying in our corners.”

In an effort to address these concerns and promote shared responsibility for medical device security across the industry, the HSCC Joint Cybersecurity Working Group (JCWG) issued the Joint Security Plan (JSP) in 2019. The JSP is essentially a product lifecycle reference guide to developing, deploying, and supporting secure medical devices and health IT products and solutions.

“The JSP is expected to evolve over time and the HSCC intends to establish a governance model to ensure the baseline strategy is updated based on execution of existing plans or new needs identified by members of the stakeholder community,” the 2019 document stated.

The new 44-question survey, based on the JSP, intends to deliver on that statement. The survey serves as a self-assessment tool for medical device manufacturers, helping them identify their own medical device security maturity in areas like risk management, design control, structure, and governance. Use of the JSP is not required for survey participation, and companies using other maturity models can also gain valuable insights from the survey results.

Related: Understanding Integrated Risk Management for Medical Device

Along with measuring the successes and shortcomings of the JSP, the survey will provide much-needed benchmark data on medical device security maturity. MDIC and HSCC are seeking one survey response per company or organization, and all responses are confidential.

“When manufacturers contribute to the survey, they will get a score that will help them to assess their posture in the sector,” Jithesh Veetil, program director at MDIC, explained in an interview with HealthITSecurity.

“And the learning, in turn, will help the industry, and also help us help the Public Health Sector Coordinating Council to update the JSP framework.”

Senior-level product security officers, risk managers, and quality managers were encouraged to complete the survey based on their working knowledge of their organization’s security posture and product portfolio.

“Cybersecurity risk is also a potential patient safety risk. It’s about protecting patient safety. It’s about protecting patient privacy,” Rob Suárez, CISO at BD and chair of the MDIC cybersecurity working group, told HealthITSecurity.

“That is really the reason why we want to give medical device cybersecurity this level of attention.”


in silico

What Is “In Silico” and How Does It Benefit Medical Device Engineering?

The medical device industry is a fast-paced world in which companies cannot afford to make missteps or fall behind. Med device developers who, in the past, have dominated the market are now faced with startups and tech companies entering the field.

Innovations, such as in silico clinical trials, can offer game-changing opportunities for companies to get ahead by reducing regulatory costs, managing risks, and reducing time-to-market.

In this blog post, we’ll provide a definition of the term “in silico,” explain how it fits into medical device engineering and hear predictions from subject matter experts on how it will be involved in the evolution of the healthcare sector.

What is In Silico?

To put it simply, the term ‘in silico’ refers to an experiment that is performed on either a computer or through a computer simulation. The term is related to the more commonly known terms “in vivo” and “in vitro.”

More specifically, 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).

Related: Emerging Technologies That Are Changing the Way Healthcare Is Delivered

How Does It Benefit Medical Device Engineering

Though in silico can complement in vivo and in vitro testing, modeling and simulation can benefit medical device products by offering fast development and safe ways to test the safety and efficacy of a medical device.

Through in silico trials, manufacturers can understand the operating conditions that their devices will work for, thus building creditability, and ensuring that when they are ready to go to a patient, that preparations for safety, accuracy, regulations, and policies are in place.

According to Ansys, “the use of computational modeling (i.e., simulation or in silico trials) is being used more often in the design of medical devices. These simulations accelerate innovation and provide comprehensive evidence of long-term safety. However, in spite of the benefits of simulation, the utilization of computational modeling as evidence in regulatory submissions is lagging. With the introduction of regulatory pathways for in silico testing of medical devices, we can expect to see simulation as an increasing trend in the regulatory side of the healthcare industry.”

The Computer Modeling Evolution

In an example of how in silico can speed up the development, Thierry Marchal, Program Director for Healthcare Solutions at Ansys, writes in this recent post on our blog, “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.”

He continues to share, “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.”

Related Customer Story: Agile Methodology for Medical Devices

Global Standardization of In Silico Trials

There are great efforts from companies working toward making in silico testing the global standard. For example, Ansys is working towards streamlining credibility assessment for healthcare in silico testing through education and awareness.

Measures like standardization play a large part toward standardizing in silico. In this blog, Dr. Marc Horner, Lead Healthcare Specialist at Ansys, shares that The American Society of Mechanical Engineers (ASME) standard on the V&V of medical devices completes the regulatory pathway for computational modeling. “The ASME V&V 40 subcommittee is now working to educate the community about the standard and its best practices. This education is being done through industry days, training sessions, examples, and new work items.”

Additionally, organizations like the In Silico World Project are working to lower the barriers to a universal adoption of in silico trials. Their vision is a future where medical products, thanks to the use of modeling and simulation, are developed much faster and with the highest possible safety standards.

The In Silico World Project, in partnership with the Avicenna Alliance, are actively working toward this goal with efforts such as the Good Simulation Practice (GSP) Task Force, which was created as a community and sounding board for future simulation standardization efforts.

The Evolution of and Future of In Silico Experimentation

As in silico methods evolve and become more rapidly adopted by the medical device engineering and healthcare industries, it can help solve some of the scientific, methodological, ethical, regulatory, and financial issues related to the development of medicinal products to benefit patients.

As predicted by Dr. Liesbet Geris, Research Professor in Biomechanics and Computational Tissue Engineering at the University of Liège and KU Leuven in Belgium. “Very soon, I believe it will be considered unethical to fail to use in silico methods for biomedical research.”

“Given the enormous benefits of the in silico approach, and the increasing accuracy of modeling and simulation tools, there will be a reduced need to incorporate humans or animals into our experiments,” Geris explains. “We will be able to move faster, more confidently, and more cost-effectively toward research discoveries by using advanced simulation tools than we would using traditional in vitro and in vivo approaches.”

According to Geris, one of the primary benefits of in silico experimentation is the ability to create customized models that reflect a specific patient. “Every human body is distinct in its geometry, movements, and behaviors,” notes Geris. “By creating a patient-specific simulation, we can predict how a proposed treatment plan will work not just in a generalized way, but in some cases also for a specific person. This is a revolutionary concept that has the potential to fundamentally change the way we treat patients in a medical setting.”

To learn more about in silico, read this blog post: “Overview of the Regulatory Pathway for In Silico Testing of Medical Devices”


Emerging Technologies in Healthcare

Editor’s Note: In this blog, guest author Rahul Varshneya – President of Arkenea – breaks down emerging technologies that are changing the way healthcare is delivered in 2022.

Emerging Healthcare Technologies

It’s apparent that the pandemic has hastened the healthcare industry’s digitization. Working hand-in-hand with technology is the future of healthcare, and healthcare professionals must incorporate innovative healthcare technologies to stay in the spotlight in the coming years.
The Healthcare Technology Market is expected to be $390.7 billion by 2024. Therefore, many healthcare organizations that would not have been considered tech firms in the past have changed their focus to technology and its potential to transform how their products and services are delivered.

According to the HIMSS Future of Healthcare Report, over the next five years, 80 percent of healthcare providers aim to increase their investment in relevant technological solutions. Today, new technologies are being used in practically every healthcare institution to combat illness, develop new vaccinations, and treat patients to help them live healthier lives.

This article will help explore the four ways in which emerging technology is reshaping healthcare for the future:

1. Integrating Artificial Intelligence And Natural language processing For Seamless Experience

Many technical developments, including AI and NLP, are increasingly being lauded for their ability to alter the healthcare industry.

From enhancing clinical data by mapping data elements in unstructured text to structured fields in Electronic Health Records to converting data from machine-readable or different formats into natural language for reporting and training/education purposes, AI, and NLP have it all covered.

The high-level use case for artificial intelligence in healthcare is aiding in the analysis of enormous amounts of unstructured data.

More recently, Google’s DeepMind created an A.I. for breast cancer analysis. On pre-selected data sets, the algorithm outscored all human radiologists by 11.5 percent on average in detecting breast cancer. Avive Solutions developed Avive AED that utilizes AI to improve survival rates for cardiac arrest.

Given the abundance of patient input, healthcare facilities must begin investing in and deploying NLP-powered patient feedback management solutions to secure and ensure patient loyalty.

A 2018 study evaluated radiology reports for pulmonary embolism and postoperative venous thromboembolism and discovered that unorganized data analysis established 50% more cases than structured information alone.

AI and NLP definitely be the driving force in the future for better clinical decision support and patient health outcomes.

Related: Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

2. The Power of Augmented Reality & Virtual Reality in Healthcare

Patients can find hospitals to be a stressful setting, making it extremely challenging to keep up with anxiety levels and heart rates while undergoing treatment. VR can present itself as an appealing possibility for assisting patients in relaxing and suffering less in such painful scenarios.

A recent Harvard Business Review study showed that VR-trained surgeons exhibited a 230 percent increase in overall performance as compared to their traditionally trained peers. Virtual and augmented reality solutions, which are continually expanding, have had a tremendous impact on healthcare technology

A 2016 report says: “Patients have benefited from VR technology, which has shown to be effective in pain management. Women are being given virtual reality headsets to help them imagine calm places while childbirth.”

Whether it’s using VR to give an exciting experience for patients to virtually visit a health institution or using VR to allow the patient to deal with pain, there is much to be intrigued about.
For the past decade, advancements that were inconceivable are now being realized. In 2022, the number of AR applications in healthcare will also increase.

AccuVein has come up with a real-world problem-solving technique using augmented reality. The use of AR here makes it much easier for clinicians to locate veins when administering injections by sensing the heat signature of the blood flow and outlining it on the patient’s arm. Using the AccuVein vein finder has been found to improve the likelihood of first stick success by 3.5 times and to reduce the need to call for assistance by 45%.

Implementing such emerging technology allows healthcare practitioners unfettered access to activities that are not currently available, as well as allowing individuals to regain their overall health and mental well-being.

3. Role Of IoMT And Wearables In Healthcare

Without a doubt, the Internet of Medical Things (IoMT) is ushering in a new era of change in the healthcare industry by rethinking the interplay between people and devices in the delivery of healthcare solutions.

The global IoMT market was worth $44.5 billion in 2018, and by 2026, it is predicted to be worth $254.2 billion. Investments in IoMT are already on the upswing, and the healthcare technology trend is expected to grow in the future years.

Certain remote areas in the US cannot afford to have full-time hospitals. IoMT devices bring regular consultations into people’s homes, which is especially important for patients with limited mobility. Portable point-of-care devices are being used to run regular tests now and share the results remotely with a doctor.

Devices that are part of the Internet of Medical Things are now solving problems that the healthcare sector had to deal with in 2020.

For example, many patients tend to miss their medications and this needs to be monitored. This issue takes on added urgency since studies demonstrate that only half of the chronic disease medications are used as prescribed.

To address this concern digital blood pressure cuffs (smart pills equipped with edible sensors) are being used to deliver a continuous stream of blood pressure and pulse data to a doctor that will alert their patients if they are taking their medications as prescribed.

In addition, the development of wearable apps in healthcare has made health monitoring easier than in the past. Wearables such as watches, bands, and other accessories have made it easier to track health metrics.

DARPA (Defense Advanced Research Projects Agency) has also been working on various wearable computers that have helped patients with epilepsy and strokes by stimulating or deactivating portions of the brain. This technology helps amputated patients regulate the motions of their prostheses by interfacing with their brain system.

Thus, wide adoption of IoMT devices would be the easiest to predict among the health tech trends soon.

4. Made Easy By Personalized Mobile Apps And Chatbots

Consumers are accustomed to the seamless experience that a mobile app provides. The healthcare sector is not an exception. Numerous patient scenarios can be delivered shortly by a potent native mobile application.

From soliciting physician consultations, uploading a patient’s medical record, and receiving lab tests via a mobile app, health organizations can certainly develop useful digital technology that is ideal for today’s patients.

A customized mobile app with integrated EHR/EMR systems could become the single most essential point of interaction between healthcare practitioners and patients.

One such scenario was when the SharpQuest team created My Care Central, a patient-facing mobile app that allows users to contact clinicians and nurses, view appointments, prescriptions, and much more.

The results concluded improved care processes yielding an average 4.9/5 patient rating, improved clinician satisfaction with easier workflow and positive feedback, and reduced costs from printed materials

Providing a tailored experience is crucial in healthcare, and a chatbot adds another touchpoint that customers value. The way healthcare is probably offered will alter as the number of chatbots grows at such a rapid rate.

With the potential for improvement in patient pathways, there is plenty of scope for improvements in patient routes, medication management, and assistance in emergency circumstances.

Healthily app has implemented this technique to provide information about different diseases’ symptoms, assessments of overall health, and tracks patient progress.

Furthermore, chatbots can be used to provide mental health help by bringing in cognitive behavioral therapy (CBT) to patients suffering from depression or post-traumatic stress disorder (PTSD). Woebot, (launched in 2018) is among those successful chatbots that provide CBT, mindfulness, and Dialectical Behavior Therapy (CBT).

Choices are limitless for chatbots, from care management service to potential diagnosis of mild conditions there’s plenty to be enthused about within the technology.

Related: An Interview with Award-Winning Medical Device Risk Management Educator and Author Bijan Elahi

Final Thoughts

Today’s healthcare industry has profited immensely from technological advancements. Emerging technologies are helping to produce new, better approaches while also lowering expenses. Although some technologies are yet to be completely explored, they have already caused a remarkable shift in the industry.

The arrival of new technologies such as artificial intelligence (AI), natural language processing (NLP), augmented reality (AR), virtual reality (VR), and chatbots are radically transforming the landscape and ushering in a new era in healthcare. In this industry, the purpose of digitization is to improve healthcare quality while reducing the physician burden.

These ‘patient first’ technologies are clearing the way for new sectors of medical science applications, enabling patients to live longer while also contributing to research and innovation.

One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort. 

This post gives a basic introduction to FDA medical device classes and classifications and the implications for your product development schedule and requirements management. 

What are FDA medical device class and classifications? 

The FDA established three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Classification is based on the intended use of the device and indications for use, as well as the risk the device poses to patients and users.   

There are three classes: Class I, Class II, and Class III. Class I devices are those with the lowest risk, Class II devices have a greater risk, and Class III includes devices with the greatest risk.   

The FDA also established classifications for over 1,700 generic types of medical devices and grouped them into 16 panels, or medical specialties. Example panels include Cardiovascular Devices and Radiology Devices. Each of the generic types is assigned as Class I, Class II, or Class III. 

RELATED POST: Complying with FDA Design Control Requirements Using Requirements Management

Impact of the device class and classifications 

The class and classification of the device impacts what FDA premarket submission or application is required for clearance to market. The common premarketing submission or application for each class are:  

Note: These are the common regulatory submission and applications for each class of device. There are exemptions, limitations on those exemptions, special controls that may apply, and exceptions, so be aware whether any of these applies to your device. For example, about a quarter of Class I devices are not exempt, and a 510k premarket submission is required. 

As the process for the 510k submission is 30-90 days, and the process for the more in-depth PMA submission is 180 days to accept or reject, this time should be understood and planned into your product development schedule.   

RELATED POST: Customer Story: Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

Similarly, expect elements from the required design control process and design history file to be included as part of a 510k and PMA. Also keep in mind that when design controls are required for your device classification, the full design history file can be scrutinized as part of an FDA inspection of your organization. Since the FDA evaluates whether a device is effective and ensures the risk to the patients and users is appropriately addressed, good requirements and risk management is key. It’s important to have an organized manner in which to demonstrate and document that risk management and user needs are successfully traced through design inputs, design verification, and design validation. A requirements management tool like Jama Connect™ allows for this traceability in an efficient, collaborative, and regulatory-compliant manner. 

Understanding your device class and classification is a key step to understanding the path for FDA regulatory clearance and subsequent design control requirements for your medical device development. Knowing those expectations up front will make for a smoother medical device development journey.  

Learn more about developing medical devices with Jama Connect!

Risk Management

Medical Device Risk Management

Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a reactive way, is not sufficient to create a safe product. Implementing an effectively proactive process and achieving live traceability throughout development, while adhering to the standard will result in a higher quality and safer product fit for market use.

In this blog, I will share how proactive risk management along with Live Traceability™ are two key areas that every medical device developer should focus on when it comes to risk management.

Reactive vs. Proactive

A lot of medical device developers do not prioritize risk evaluation throughout the different design stages, but instead, consider risk a checkbox activity at the end of development. With important prototype deadlines, limited funding, and resource constraints, it’s very easy to make excuses for not running risk evaluations of initial user needs but waiting until entire subsystems have been designed. This may seem like a minor hiccup, but the lack of ongoing risk assessment from an early stage can be very risky for FDA approval, future patients as well as your business’s bottom line and reputation. The later that risk is addressed, the more expensive changes are to incorporate. Delays become the norm as well as budget overruns.

Jama Connect Enables Live Traceability™ Across Your Development Process: Learn more!

Live Traceability

The number one cause of inspectional observations, product recalls & delays, increased CAPAs, and cost overruns is the lack of live traceability throughout different development stages. With complex medical devices, there can be thousands of user needs, product requirements, risks, mitigating requirements, tests being executed, and defects logged. At Jama Software, we’ve noticed that a lot of medical device developers are using different technologies and applications to store this information including Excel, Jira, Word, and others. The below image depicts that and shows the siloed world a lot of engineering teams are living in:



Unless you have a real-time system that can interface with spreadsheets, tools like Jira and other applications, it’s impossible to get a holistic view of development. This can cause several issues, some of the most critical being:

  • Late identification of defects/coverage gaps due to lack of visibility throughout the development process​
  • Lack of requirement coordination and change management between hardware/software​
  • Lack of ongoing risk assessment and change management​
  • Cumbersome and risky effort to produce trace reports and other DHF artifacts

RELATED POST: Avoid the Most Common Challenges of the Design History File

Without Live Traceability, risk teams can’t be effective in mitigating potential failures or hazards. Outdated and manually updated trace reports and spreadsheets can’t be relied upon. What if there was a way to get a real-time view of traceability throughout development?

At Jama Software, we’ve created the capability for our product development platform to integrate seamlessly with tools like Excel, Jira, and others straight out of the box, and we are proud to be the only vendor on the market that can help engineering teams realize Live Traceability. Risk should be a priority, not a checkbox item!

Get in touch with us to see how we can help you.


In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements management in the medical device industry

Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. However ineffective and inefficient, the industry still relies overwhelmingly on static documents housed in Excel/Word and relies on manual processes that add significant risk to the development process.

Axendia conducted a research study focusing on the medical device industry’s approach to requirements management with a goal to identify and analyze the drivers, barriers, trends, and value of requirements management across the product development lifecycle.

9 out of 10 (87%) Executives surveyed for this report admitted to having a ‘not effective or somewhat effective’ requirements management process.

In a recent webinar, Axendia’s Senior Industry Analyst, Sandra K. Rodriguez and Jama Software’s medical and life science principal solutions lead, Steven Meadows, shared the outcomes of the research including:

  • The impact of having an ineffective requirements management process
  • The critical importance of requirements management to achieve improved patient outcomes, product quality, and time to market
  • The negative impact on budgets, verification and validation activities when relying on manual processes

Watch the full webinar to learn more about The Costly Impact of Ineffective Requirements Management in the Medical Device Industry.


Excerpt from webinar:

Requirements Management in the Medical Device Industry

Sandra Rodriguez: Thank you for that introduction, Marie, and good morning, good afternoon, or good evening, depending on where you’re joining us from today. Really quickly about Axendia, we were founded in 2005. Our headquarters are in Philadelphia, Pennsylvania. I’m physically located in San Juan Puerto, Rico, it’s a balmy 84 degrees today. What’s unique about Axendia is that our analysts all have industry experience. And combined, we average about 25 years of experience. We work with startup companies as well as fortune 500 global clients. And we really focus on the intersection of the business regulatory and technology trends that impact the industry. So really looking forward to sharing the outcomes of our latest market research on the state of requirements management in the medical device industry.

Just really quickly too, for the folks of you on the webinar today, congratulations, you will be the first to receive a copy of the research report. I’m not going to cover the report in its entirety today because we don’t want to take away the thunder of it, but we do hope that you will find today’s information valuable and timely and that you get some great takeaways from the report. Before I go into that, though, just a quick acknowledgment that the content of today has been sourced from our quantitative and qualitative research, as well as our interaction with FDA’s officials and industry executives, and then some firsthand experiences from our clients as well.

All right, so let’s start with the demographics. We surveyed a multitude of companies from around the world, companies that perhaps make more than one type of medical device product, but here you can see that the majority do market and sell single-use disposable consumable devices followed by diagnostic devices that have both hardware and software components and software as a medical device.

So those were the top three. As a result of that, we wanted to look at the data in a little bit more kind of slice it and dice it. So we specifically picked out software as a medical device, and you’ll see in the report, and as well as in the presentation today, how the opinions vary based on the type of medical device company that we surveyed for this report.

In addition, we got a good mix of small companies and large companies. The majority of the companies that did respond to the survey were under 50 million. So they could be startups, they could be a little bit pre-market followed by the $1 billion to $5 billion size companies when it comes to their revenue. So another thing that we did was we went ahead and compared these survey responses based on those two different size companies. We also got a significant number of R&D and product development personnel to take the survey, which is important.

These are what I call the boots on the ground, the companies that really understand requirements management inside and out. They’re the ones who are working on the new products as well as quality assurance personnel. And then we had a 17% representation of executive management. So another thing that you’ll see in the report is that we went back to the data and did do some comparison and filtering based on these three personas. And we were really surprised to see how the attitude shifted.

RELATED READING: 2022 Predictions for Medical Device Development

Sandra Rodriguez: From a geographic standpoint, we had a really good representation. Overall, the majority of survey respondents do work for companies that sell in market products in North America, so Canada, the United States, and Mexico followed by Europe and all the EU member states. And then, of course, Asia, South America, Africa, and Australia. So again, a really great representation of the medical device industry.

So this was our first question. And following the demographics, I think it’s really important to point out that this was the first question that it came when it came to requirements management processes. We wanted to understand from the market standpoint if people felt that their organization’s requirement management process was either effective or I’m sorry, not effective, somewhat effective, very effective or ideal. We were really surprised that when you combine not effective and somewhat effective, straight out the gate, we have a 68% of the market saying that there is a lot of room for improvement here. This is what I call aiming for average. And it’s definitely time for this to change because the complexity of the devices is changing. The regulatory landscape is changing. We have a lot more software as a medical device coming out there into the marketplace. And there’s a lot of hardware and software components that are going into these products, whether you’re doing remote monitoring of the products once they’re out in the field or in the patient.

So because of the complexity alone, you really need to have… You would want to see the very effective and ideal numbers go up because when we combine them, we’re only at 31%. And what’s really shocking is that only 2% of those companies that we surveyed for this research project believe that they have an ideal process. So we wanted to take a look at those numbers from the different personas. The quality personnel were of a little bit more positive. They believe that their requirements management process is very effective or ideal. So they account for about 53% of that. But when you look at the executive management, to have 87%, so almost 9 out of 10 executives indicating that their organization’s requirement process is not effective or only somewhat effective, that’s pretty shocking. Keep in mind that these are the folks that own the budgets.

So if you know that there’s a problem, we really need to do something to incentivize these folks to make the necessary change and get to that very effective or ideal state, even on the R&D and product development side, the same holds true with 68% of those professionals saying that their organization’s process is somewhat effective or not effective.

So we also asked the closed-loop system question. And we define a closed-loop system as one in which the desired output depends on the input signal and the feedback elements that are going to enable end-to-end traceability. So when you’re looking at a typical product development cycle, you have the finished product here in the middle. So you’re going from concept to prototype. Clinical, if you need to have a clinical trial for the type of medical device that you’re looking to bring to the market, going into manufacturing, marketing, commercial, and then obsolescence.

RELATED READING: Axendia Report: The Costly Impact of Ineffective Requirements Management

Sandra Rodriguez: So having that continuous feedback loop, really closing loop around that system, and having the necessary traceability that’s going to be required from a quality and from a regulatory standpoint. So we ask them, how effective is your organization at closing the loop across the product development cycle. Now, mind you, this was question number two. And we see here that 68% of the market, again, admitted that that process is not effective or only somewhat effective.

So again, really need to make the necessary changes there, and probably invest in the solutions so that you can close the gap and get that traceability and close the loop across the product life cycle. It’s interesting as an analyst because we don’t sell or implement software, but we stay really close to the market. And we follow these trends and we see significant investment in the life sciences when it comes to digital transformation or investing in business systems.

But it’s important to point out that without a product you wouldn’t be in business. So the solutions and the systems, the tools that you have in place when it comes to your product should be as important as the systems and tools that you give your salespeople, or your ERP, or however, you’re investing in those systems. You really need to make the necessary investments in order to make sure that your product is of the highest quality and that you can get to market sooner and on time and on budget because we’re going to learn in this presentation that the industry is really struggling with that.

Watch the full webinar to learn more about The Costly Impact of Ineffective Requirements Management in the Medical Device Industry.


In this blog, we discuss key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on digital health technology.

What is Digital Health?

Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise.

Digital health is a broad category that includes:

  • Mobile health (mHealth)
  • Health information technology (IT)
  • Wearable devices
  • Telehealth
  • Telemedicine
  • Personalized medicine

Digital health technologies use:

  • Computing platforms
  • Connectivity
  • Software
  • Sensors

RELATED POST: Ensuring FDA Compliance for Your Digital Health Solution

The Rise of Digital Health 

The past decade has ushered in major disruption in all industries, including the medical device and life science sectors. Market disruptors such as smartphones, social media and more transformed the way that people work, play, and manage their health. Software has transformed how doctors practice medicine, how people manage their health, and the fundamental interactions between patients and providers. During this process, the boundaries between digital health and medical devices began to blur.  

According to the Food and Drug Administration (FDA), “Digital health technologies use computing platforms, connectivity, software, and sensors for healthcare and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device.” These applications are driving a lot of the wearables we see today, like a heart rate monitor running on a smart watch or a mobile application connected to a wearable. Other examples of digital health applications might be something like 23andMe, which uses genetic sequencing data to identify health risk factors.  

The Emergence of Software as a Medical Device (SaMD) 

Traditionally medical devices have been classified as an instrument, sometimes with software running on the actual device itself. 

The lines between digital health technology and medical devices get crossed once the software technology begins to perform a medical function, especially if the technology is not embedded within the medical device. Consider software that determines the right medicine dose for a patient based on his or her personal data, or software that detects and diagnoses a stroke through analyzing MRI images. These are examples of software that could be serving as a medical device. 

As digital health has pushed further and further into the traditional realm of medical devices, an entirely new category was formed and regulated, which is software as a medical device (known as “SaMD”). SaMD is described as “software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case), it’s the software itself that performs the medical function.” 

With the emergence of software as a medical device, there are questions around risks, regulations and safety. Understanding trends and potential risks can help teams mitigate challenges and navigate forward with greater success. 

To learn more about keys to success and best practices in the digital health medical device market, download the full whitepaper

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 productsystems, 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. 


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. 


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. HoweverI 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. 



Design review processes and their impact on product development.

Development organizations typically have a predefined set of formal design reviews that are held throughout the development process. A design review usually includes assessing design input requirements for adequacy, assessing the adequacy of a design to fulfill design input requirements, and verification/validation-related reviews. When done correctly, design reviews are an important part of a robust product development process because they help identify design issues early when they cost less to fix.  When not done correctly, design reviews can be detrimental to the success of a development organization. So what are the top signs that design reviews are hurting your business and not helping you develop better products on time and within budget? 

  1. Not planning design reviews appropriately. 
  2. Performing design reviews that are not effective or efficient. 
  3. Not following up on review action items. 

RELATED POST: Five Key Design Control Practices that Improve Compliance and Help Develop Better Products

Not planning appropriately for design reviews involves not performing design reviews at the correct time and not sending out review material with sufficient time that reviewers can adequately prepare for the review. Often, formal reviews involve reviewing deliverables associated with a milestone or a certain phase of the development process. Because these reviews are required by procedure, they are generally performed but often end up as a status marker of where the project is at, instead of a design review intended to identify issues. Additionally, design reviews can be performed at any time in the development process, when a review of some element of the design is beneficial in identifying potential issues. These technical reviews can be invaluable in identifying design issues early in development and should be performed on an as necessary basis. Development organizations are sometimes hesitant to hold additional reviews, other than the required formal reviews, because of the time required to prepare, perform, and document the review, thus passing up opportunities to improve the design while it is still less expensive to make changes.   

Unfortunately, oftentimes, design reviews are just performed to meet the regulatory requirement, but not with the goal of identifying issues. The check-the-box mentality, prioritizes project schedule over product quality, as it passes upon opportunities to significantly impact and improve on the quality of the design before the design is frozen. In order for design reviews to be efficient and effective: 

  • Reviewers should be provided sufficient time to review the material prior to the review meetings. 
  • An independent reviewer, a person with no responsibility for the design being reviewed, should be invited to the review.  
  • All participants should come prepared for the review, having reviewed the material beforehand. 
  • An experienced facilitator/moderator shall be utilized, the role of the facilitator is to keep the meeting on track, ensure the agenda is followed.  
  • Utilize a scribe to record the meeting minutes, this will free the design owner to fully focus and participate in the review.  It will also allow the meeting to progress more efficiently. 
  • Ideally, utilize a requirements tool, like Jama Software, to automate and centralize the above activities. 

RELATED POST: A Guide to Requirements Elicitation for Product Teams

Gathering metrics on the number of issues found during reviews, the types of issues found, and the amount of time spent in reviews can help determine the effectiveness of your design review process.   

When a review is performed appropriate documentation should be generated. First, a design review agenda should be prepared to detail the date and time of the review, the location of the review, the review objective, the review participants and their roles along with the materials to be reviewed. During the review, the list of attendees should be documented, along with items discussed, decisions agreed to, conclusions reached and any action items generated, along with the person responsible and due date of the action items. Review minutes should be published containing all this information.   

When action items are generated as a result of a design review, a requirements tool, like Jama Software, should be used to track review action items to completion. Ideally, action items should be completed prior to the next project milestone or major review. Not following through on review action items is not only a regulatory liability but can give the impression to reviewers that the time spent in reviews is wasteful, causing them to treat design reviews as a check-the-box activity. 

In summary, design reviews can be a very helpful tool in identifying design issues early, when they are less costly to fix. However, in order for design reviews to be helpful, they need to be planned and held at the appropriate times during the development process, following guidelines for effective design reviews, documenting design reviews appropriately, and following up and tracking design review action items to completion. If you are going to spend the time in design review, let the time be well spent, let reviews serve their purpose, and gain the benefits from the time and resource investment in this activity. 

Requirements Management

Complying with FDA Design Control Requirements Using Requirements Management Principles

Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to each other. Then we’ll discuss how we can build a good requirements management process and how that process can help us improve compliance to design controls.

Okay. So let’s get started. All right. So by the end of this presentation, hopefully you’ll have a good general working knowledge of design controls. You’re going to understand requirements management and how to evaluate and accept requirements, how to perform bi-directional traceability, how to use requirements attributes to help manage the requirements, and how requirements metrics can help you make better decisions. We’re going to learn how to manage and control requirements changes, and then how to use attributes, especially a requirements credit quality attribute to help us on manage and identify essential requirements and requirements that are critical to quality.

FDA Design Controls

Mercedes Massana: So let’s start with design control background. So design controls have been part of the FDA QSR since 1997. So it’s been a long time. The FDA initially implemented design controls to try to help medical device manufacturers identify deficiencies with design input requirements, to identify discrepancies between proposed designs and requirements, and increase the likelihood that the design transferred to production is going to translate into a device that is appropriate for the intended use and satisfies the user needs. And they did this in relation to having a lot of issues in the field with medical devices. So they thought design controls would improve the quality of the medical devices that were being approved.

In the FDA design control guidance, they state that developing a solid foundation of requirements is the single most important design control activities. So that kind of tells you how important FDA thinks design control requirements management is. So design controls is made up of several elements. There is design and development planning, design inputs, design outputs, design review, design verification, design validation, design transfer, design changes, and design history file.

RELATED POST: Ensuring FDA Compliance for Your Digital Health Solution

Mercedes Massana: Now, most of those, even though requirements really falls under design inputs, and that’s what everybody understands by design inputs, most of these items relate to requirements in one way or another. So design outputs, we have to develop design outputs that will conform to design inputs. For design reviews, we’re going to review our design inputs to make sure that they’re appropriate and not conflicting or unambiguous. Design verification will confirm that design outputs meet the design input requirements. And design validation will confirm that the user needs and intended uses are met, which is their another form of design input.

And then design changes, obviously managing requirements changes is important. And obviously all our design inputs or all of our user needs documents or system requirements or product requirements documents will end up in the design history file. And then obviously our deliverables that user needs that we create, or system requirements, product requirements, all become part of our design history file.

Requirements Management

Mercedes Massana: So let’s talk about requirements management. So what is requirements? Why do we need requirements management? Why would we want to do this? Well, if your projects are late because you’re trying to introduce changes at the end, or if sometimes your developers can really figure out what the requirements may mean and they’re making their own interpretation, those are all issues that can be addressed through requirements management. In fact, it is said that approximately for IT projects, which encompass software obviously, that at least 50% of projects are late, or delivered with reduced functionality or over budget.

RELATED POST: The Essential Guide to Requirements Management

Mercedes Massana: If you have a good requirements management process, this will improve those statistics and make projects more successful. So what is a requirement? So for IEEE, a requirement is a property that a product must have to provide value to a stakeholder. That’s the IEEE definition. The FDA definition is a condition or capability needed by a user to solve a problem or achieve an objective. So couple of key items here is, something that is needed by somebody, right? So that tells you that anything that goes into your requirements has to have a purpose. Why is it there? And it’s needed to solve a problem. So it has to solve a problem for the user, right? So if it’s something that a software developer thinks is a cool feature, but nobody needs it, then it really shouldn’t be a requirement.

So requirements management process has four main goals. It tries to ensure that there is an understanding of requirements, but all the stakeholders, that they commit to those requirements or approve or agree that those are the requirements that need to be implemented. That we manage requirements changes. And we’ll talk what managing requirements changes means a little later. And then we identify inconsistencies between project work and requirements. And what that means is that you can’t have a project plan that says you’re going to be done in a year if you have 10,000 requirements to implement, right? So you have to have consistency between the requirements and the other deliverables of the project.

So to obtain an understanding of the requirements, first, we need to know who are we solving the problem for? Right? So we need to determine how we identify the stakeholders. So who are those requirements providers, right? Those are the stakeholders. We need to know how we’re going to evaluate the requirements, how we’re going to know if the requirements are good and complete. And then we need to know who needs to approve the requirements and when do requirements get approved. So that’s how we obtain an understanding of requirements.

Then a commitment to requirements is basically that agreement between the different stakeholders that says, if you develop these set of requirements, we’re going to have satisfied customers, that our agreement is usually made through approval of the requirements.

Managing requirements changes is, obviously the one constant in life is change. So requirements will also change. But it’s very important to manage changes so that the rest of the product reflects the impact of those changes, right? Nothing comes for free, and requirements changes usually are either going to cost more, and we’re going to have to add more resources or we’re going to have to add more scheduled, but something will have to be done in order to manage the impact of that change.

Requirements Traceability

Mercedes Massana: And then maintaining bidirectional traceability. This requires that requirements be traced forward from higher level requirements to lower level requirements and that every lower level requirement be able to be traced backwards to its parent or a higher level requirement. Additionally, other elements like design, tests and risks should also be included in our traceability. And later on, I’ll show you a fully elaborated trace matrix that shows the relationship between pretty much every deliverable that we’ll create as part of our development process.

All right. So what’s the connection between requirements management and design controls? So this table will show us a little bit of that. So these requirements management elements relate to design controls as follows. So design inputs are defined as the physical and performance requirements of the device that are used as the basis for device design. So the FDA tells us that design inputs must be appropriate. That we need to address incomplete, ambiguous or conflicting requirements. And that these requirements related to design inputs are addressed by the requirements management element and obtaining an understanding of requirements.

Design outputs are defined as the results of the design effort at each design phase and at the end of the total design effort. The FDA says that design controls must be able to evaluate the design outputs conformed to design inputs, that we must be able to establish acceptance criteria so that we can verify the design outputs conform to the design inputs. And then we identify the essential requirements or essential to proper function requirements. So again, requirements management can help us meet this part of the regulation.

FDA design controls also state that we must identify document, verify, validate and approve design changes before implementation. Additionally, the design control guidance specifies that the trace matrix is a form of verification. So both of these areas are also covered by requirements management. And here, we can see that there is definitely a relationship between FDA design controls and any requirements management process.


To learn more, watch the full webinar, “Complying with FDA Design Control Requirements Using RM Principles”