Tag Archive for: medical device

Requirements and Risk Management

Congratulations!  Your organization has gained regulatory approval and launched its medical device product.  The ‘History’ in Design History File may elicit impressions that all those design and development requirements are now done and considered part of the past.  However, several components of the DHF continue as a reference and evolve, including requirements and risk management.  Here are 3 ways active management of requirements and risk continues after commercialization:

1: Post-market surveillance

Once your medical device is on the market, post-market surveillance programs, including complaint management processes, must now be exercised.  That includes evaluating feedback, determining if it is a complaint, investigating complaints, and determining whether to initiate corrections or corrective actions.  As part of this process, requirements and risk management are being used in 2 ways, 1) as a resource to evaluate complaints and 2) a living document to be updated with the experience gained.

As a resource, it is important to reference risk management files to determine if the frequency of occurrence and types of failure modes documented during design and development matches the infield data being gathered.  A more frequently occurring failure or new failure mode indicates an investigation is warranted and re-evaluation of the risk.  Depending on the outcome, corrective action may be needed.

For example, during design and development, it was determined that a sensor failure leading to customer annoyance occurred rarely, leading to a low risk rating at the time of market launch.  The first year on the market, reports of this failure occurred rarely, matching the occurrence rates in the risk management file.  Given the low risk and lack of trend, further failure investigation and corrective action were not taken.  However, one year later, a change in supplier coincides with a change in occurrence from rarely to frequent, leading to a medium risk.  This increase in risk prompts an investigation to determine why the sensor failure rate is higher and to determine corrective actions and controls with the new supplier.

As a living document, the risk management files are to be updated with the observed occurrence rates, new cause(s) of the failure mode of the sensor, mitigations and controls put in place, resulting verifications, and revised risk rating.

2: New Products

Another reason requirements and risk management continue once a product is commercialized is to aid in the development of new products, including line extensions, new models, and next generation platforms and portfolios.

The existing product’s requirements and risk management, supplemented with what is learned from post-market surveillance and other feedback from the field, provide the foundation for new products.  A requirements and risk management tool like JAMA Connects® can simplify the management of requirements and risks shared between products to keep teams aligned and prevent requirements or risks being missed during the transfer from one product’s design history file to another.  Likewise, line extensions can be more easily incorporated into an existing design history file if requirements and risk management have been properly updated as needed and are accessible.

3: Change Control Evaluation

Change control evaluations is another way management of requirements and risks continue after commercialization.  Changes to a product and how it is manufactured occur for many reasons, including replacement of a component that has reached its end of life from a supplier, software upgrades to address bugs, duplication of a manufacturing line, and changes that address complaints.

Changes must be evaluated as to their impact on the form, fit and function of the product, and can have varying degrees of potential impact.  Well managed and active requirements and risk management, with traceability to design outputs and verification, become a strong tool for organizations to evaluate the potential impact more quickly.

For example, say a temperature sensor was added as mitigation to prevent overheating of a medical device; overheating that could result in burns to the patient.  The sensor, including the necessary accuracy, is listed as a control for the risk of overheating and burns.  There’s also a corresponding design requirement, and the sensor and its specification are linked as design outputs.  The supplier of the sensor has recently informed the medical device manufacturer that the sensor is reaching its end of life and will no longer be available in 6 months’ time.  A change owner is assigned to identify and evaluate a new sensor.  This person is most likely not the same engineer who originally designed and selected the first sensor.  And that the original engineer may or may not still be with the organization, and may not remember why that sensor was selected.  This is where having accessible and well managed requirements and risk management becomes important.  The change owner can reference and look up the sensor, see the design inputs and risk with which it’s associated, and understand more quickly the criticality of the sensor and ensure the proper selection and testing are performed on a new sensor.

While change post-commercialization is inevitable, difficult change control management is not.

RELATED POST: Product Development Process: How Confident Are You That You Are Not at Risk?

Beyond Commercialization

Management of requirements and risk extends through the entire life cycle of a medical device, including after a device has gained the necessary regulatory approvals and reached the market.  Thus, take care in selecting the tools and developing the processes your organization uses for requirements and risk management.


Requirements and Risk Management

In this post, we will discuss why start-up medical device companies should prioritize requirements and risk management before a quality management system.

As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS).  And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid in building a regulatory compliant design history file, or the electronic-QMS system to establish the FDA required and ISO 13485-compliant QMS?

From my experience over the past 15 years, here are the 3 reasons why I advise start-ups to prioritize requirements and risk management over an eQMS system.

1. Design controls and risk management processes start earlier

For best product, schedule, and compliance success, incorporating design controls should be done proactively instead of reactively.  Companies are typically developing their medical device from day 1.  This is compared to other QMS processes that may not be used until years later when the product is being transferred to manufacturing and being commercially distributed.  A few of these other processes include non‑conforming materials, device master record, product change control, and complaint management.

Thus, purchasing a full eQMS system earlier than necessary results in paying for functionality that may not be used for years.  That is of low value to the start-up closely watching its funds.

In contrast, as the medical device is being developed from the onset of the company, the benefits of requirements and risk management solutions can be realized very quickly and much sooner than a full eQMS system.

2. Requirements and risk management is often unwieldy

Unless your device is ‘simple,’ for example no software, no electro-mechanical parts, low-risk Class 1 devices; thoughtful consideration should be given to the processes and solutions that will manage the various requirements and risk management for your medical device development.  Organizing all the user needs, design inputs, regulatory requirements, requirements from industry standards, system requirements, sub-requirements, and risk management can quickly become unwieldy without proper management.

In my experience, even a Class II electro-mechanical device can easily approach a thousand line items to manage and connect.  Add on embedded software or a digital interface, and that number can easily jump to multiple thousands of line items or more, depending on the complexity of the medical device.  A solution like Jama Connect® has immediate value to ensure all items are linked, traced, verified, and validated for a regulatory complaint design history file and medical device file.

3. In the early years, a company can create and manage a regulatory compliant QMS without an all-electronic system

Does forgoing the eQMS mean settling with a non-compliant QMS?  No.  A company can implement a regulatory compliant QMS without an eQMS system.  SOPs can be implemented in stages, prioritized on the stage of the company.  These SOPs, along with a cloud-based document sharing repository, is often sufficient in those early product development years.  As the company approaches transfer to manufacturing and commercial distribution, then is the time to evaluate whether it’s time to transition to an eQMS system.


In summary, these are the three reasons I advise start-ups to prioritize requirements and risk management first before an eQMS system.  This path allows for the development of a successful product and complaint design history file, as well as establishing the rest of the quality management system, all in a practical manner that maximizes value and meets regulatory expectations.


ON Semiconductor

Editors Note: 2020 is a year we’ll never forget. But amidst a sea of setbacks, companies across the globe continue to rise to the challenge and push forward with innovative product development. Teams who have the right tools and processes in place especially across distributed teams are able to improve collaboration and speed the time it takes to deliver new, innovative products.

In our spotlight series, we highlight companies who are doing extraordinary things in the product development space, and showcase the ways that their innovations are changing the world as we know it. In this post, we applaud the work that ON Semiconductors is doing during the pandemic, and the way they are prioritizing ethics, employees, and community during these uncertain times.

This post originally appeared on Forbes.com on May 18th, 2020.

ON Semiconductor Focusing On Community In Time Of COVID-19

COVID-19 has been tough on everyone. Many companies have had to make many tough decisions during the COVID-19 pandemic and have been challenged to make the correct financial decisions and cost-cutting measures that will allow them to continue operations. More importantly, companies also worry about the safety of those employees who continue to work during the crisis and how to implement certain measures to ensure safety and health. ON Semiconductor is one of those many companies that continue to make the best out of what it has; and what it has and values most is its community of its employees across the globe.

ON Semiconductor’s hard-working community

ON Semiconductor is one of the World’s Most Ethical Companies® by Ethisphere, and this year is the fifth time it has been recognized on this list. They are only one of four companies in the electronics and semiconductors category to receive this recognition. Jean Chong, vice president, ethics, and corporate social responsibility at ON Semiconductor, said, “Our employees’ dedication to maintaining a strong culture of compliance and ethics allows us to differentiate ourselves within the semiconductor industry.” ON Semiconductor’s ethical badge is a driving force for the challenges that come from being in a global crisis. This is especially true for an essential global business that puts thousands of its workers on the frontlines to make life-saving medical devices and other solutions that are deemed critical.

During these pressing times many are looking for examples of leadership, especially as a global organization, ON Semiconductor recognizes that they have a unique responsibility to its employees, in the communities in which it operates and to those it directly impacts with its life saving devices. At the Bucheon, Korea site, Rich Kim, business operations manager has been working with its local authorities to ensure the safety and health of ON Semiconductor employees by taking the correct preventative measures for stopping the spread of the virus. Grace Wan, financial controller in Singapore, works to ensures that her employees have the correct technology and equipment to work from home, as well as doing her best to preserve the communication in work from home environments. Lenka Stralkova, communications manager in Slovakia, works diligently to ensure consistent communication and adherence to corporate guidelines to a workforce that is primarily manufacturing based. These are great local examples of how ON Semiconductor is working to hold strong to its community and ethics, and I think it is a great encouragement for companies who are struggling to find community and ethics during the crisis.

ON Semiconductor working hard for its community

Like many other companies who have offered their services to fight the COVID-19 crisis, ON Semiconductor has been working hard to lend a helping hand. One of the side effects of the COVID-19 virus or coronavirus is the effects it has on the lungs. Across the world, hospitals and medical workers are running out of ventilators for their patients affected by the coronavirus. Many of ON Semiconductor’s devices are used in medical devices, including ventilators. As an essential business, ON Semiconductor continues its operations at its manufacturing facilities, developing technologies that are implemented into life saving devices and helping to save lives across the world, as illustrated through one of their recent video blogs and in a recent release.

As ON Semiconductor continues to manufacture medical supplies, it also is helping its community financially. Keith Jackson, CEO of ON Semiconductor, has said that the organization is matching all employee donations that are made to eligible organizations within the $25-$500 range. Not only is this an encouragement for ON Semiconductor employees to give towards the community, but it is also a great example of Keith’s leadership at the company. Keith also says ON Semiconductor has been donating upwards of 10,000 N95 masks and ActiveAir masks to first responders who are putting their lives on the line across the United States, Europe, and Asia, along with other personal protective equipment that is needed for healthcare workers across the globe.

The ON Semiconductor Research and Development organization has also launched a crowdsourcing initiative to source ideas on how ON Semiconductor present and future devices or business processes can help fight COVID-19 or other outbreaks, and/or improve economies during outbreaks. This challenge is part of the company’s commitment to improve the lives of people in the community where they work.

Wrapping up

Ethics is the driving force behind ON Semiconductor and its encouraging initiative to help and improve on the global community during our global time of crisis. I agree with ON Semiconductor that ethics should not be forgotten during a crisis and the company is making this a priority now more than ever. Ethics is part of what makes us human, and I believe it is a key component to our drive to help those in need. ON Semiconductor has a focus on community and leadership, and it encourages its employees across the world to abide by this principal and ensure its core values are implemented into everything the company does. I believe this makes the company stand out.

Stay tuned as we continue to highlight these innovative companies. In the meantime, see how Jama Connect helps realign remote teams for remote work with minimal disruption.


Innovative Product Development

Editors Note: 2020 is a year we’ll never forget. But amidst a sea of setbacks, companies across the globe continue to rise to the challenge and push forward with innovative product development. Teams who have the right tools and processes in place especially across distributed teams are able to improve collaboration and speed the time it takes to deliver new, innovative products.

Over the coming months, we’ll be highlighting companies who are doing excellent work in the product development space and showcasing the ways that their innovations are changing the world as we know it. And for this one, innovation is imperative to help solve one of our most pressing worldwide challenges… slowing the spread of the COVID 19 virus.

This post was originally published on CNN.com on Thursday, August 27th – you can find the original article here.

This $5 rapid test is a potential game-changer in Covid testing

New York (CNN Business) Abbott Labs got emergency approval from the US Food and Drug Administration for its rapid antigen test, which can detect a Covid-19 infection in 15 minutes. The test is a “game changer,” according to Brett Giroir, the US assistant secretary for health in the Department of Health and Human Services.

Investors sure think so: Abbott’s (ABBOTT) stock was up about 8% Thursday morning. The FDA’s emergency use authorization is for Abbott’s BinaxNOW Covid-19 Ag Card. The size of a credit card, BinaxNOW will cost $5 and will come with a free mobile app that will let people who test negative display a temporary, date-stamped health pass that is renewed each time a new test is taken.

The antigen test, in which involves a nasal swab, uses the same type of technology as a flu test. Abbott says it anticipates producing 50 million BinaxNOW tests a month by October.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, a professor of virology at Baylor College of Medicine, in a statement released by Abbott.

Petrosino’s labs have been leading efforts to provide Covid-19 testing for the college and Harris County, which includes Houston.

“With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus,” he said.

The BinaxNOW Covid-19 Ag Card is the fourth antigen test to receive an emergency use authorization from the FDA.
Antigen tests, which look for pieces of the virus, are not as reliable as traditional Polymerase chain reaction tests, which look for the virus’ genetic material. However they are a quicker, less expensive and less invasive. PCR tests have been beset by supply chain problems as well as back-ups at labs which have delayed results and frustrated patients, doctors and public health experts alike.

Stay tuned as we continue to highlight these innovative companies. In the meantime, see how Jama Connect helps realign remote teams for remote work with minimal disruption.


In the previous blog of this series, we talked about the application of systems engineering principles to the design inputs process. In this post, we explore how the Jama Connect™ for Medical Device Development procedure guide describes connecting design inputs with subsequent processes: Design Outputs and Verifications. By supporting these processes in a single system and ensuring traceability we can build confidence in the conformance to design inputs and the proper definition of verification activities.

The Jama Connect for Medical Device Development solution focuses on two key aspects from the Design Output requirements defined by 21 CFR 820.30 and ISO 13485:2016 section 7.3.4. Design outputs:

  • must  reference acceptance criteria, ensuring they are essential to proper functioning,
  • are evaluated for conformance to design input requirements

Design outputs will vary based on the product, technology, discipline and applicable standards.

The regulation and standards are not specific about the content of the design outputs themselves. The significant activity then from a design control perspective is ensuring a trace to design inputs and visibility into the verification of those design inputs.

When defining design inputs (i.e., system and subsystem requirements), the guide recommends stating acceptance criteria directly in the requirement items. In fact, the system and subsystem requirements are configured capture it out of the box. Below is a sample System Requirement using the out of the box system requirement configuration.

Verification items, traced to design inputs, should be defined based on the acceptance criteria. Similarly, design output items (e.g., architecture diagrams) are traced to design inputs and refer to requirement details and acceptance criteria for design and development.  

For some disciplines, like Software, Jama Connect may contain more detailed levels of abstraction and, therefore, may have items that tie directly into development tools. For other disciplines, Jama Connect may contain very basic information and pointers to other systems managing design outputs details, like parts for manufacturing. 

The Relationship Rule below provided with the Jama Connect for Medical Device Development out of the box configuration shows how design outputs (in orange) and verifications (in green) trace directly to design inputs (in blue). 

Using this approach, the design input serves as the point connecting design outputs and verifications. Design outputs contain or point to evidence of the implementation of the design input, while verifications provide evidence through testing that the intent of the design input is met. Both design outputs and verifications reference the acceptance criteria captured in the design input during their definition and by nature of the trace.


Connecting design inputs with design outputs and verifications.

The trace established by connecting design inputs with design outputs and verifications is visible in Jama Connect’s Trace View. The sample of a Trace View below shows a requirement with two related items downstream, a verification and design output. The verification in this example shows “Passed”, which indicates the intent of the requirement was met via implementation of the related design output. 

By capturing acceptance criteria during the Design Input process, exposing that information to related downstream processes, and using trace as a part of normal product definition activities, manufacturers gain visibility into the conformity of design outputs and build confidence in their verification activities and results. As seen in the Trace View above, relating information in Jama Connect is key to understanding coverage and verification.

In the next blog in this series, we’ll explore making further use of the trace, beyond simply matrix generation.

Haven’t read the earlier blogs in the series? You can catch up here.

Part One: Jama Connect™ for Medical Device Development Explained

Part II: Solution Components of Jama Connect for Medical Device Development

Part III: Design Inputs in Jama Connect for Medical Device Development 


Watch a demo to see Jama Connect Medical Device Development Solution features in action and understand how teams use it to support their development process.





Medical devices have become increasingly complex, connected, and integrated systems. Yet many engineering teams still rely on documents and spreadsheets to manage development, risk assessments, and testing of devices to provide evidence of design control. This approach is no longer viable.

Register to watch Axendia’s President Daniel R. Matlis and Jama Software’s VP of Customer Success, Clay Moore as they discuss how an integrated platform approach to device development improves patient outcomes and reduces risk.


Watch the recording to learn:

• Why documents-based requirements processes are no longer sustainable
• How to align people, process & technology to improve agility and flexibility
• How collaboration streamlines the development process and improves quality
• How to accelerate NPI of complex, connected devices to anticipate market demand
• How to align validation & verification to meet global regulatory requirements
• Case studies from companies using an integrated platform to improve outcomes



Password: 1X@p21D9
Register and you can watch the on-demand recording now.


As medical device manufacturers develop complex products, they require a product development approach capable of managing that complexity.  

At the same time, manufacturers must continue to ensure compliance and alignment with regulations and standards. These define requirements that ensure safety and quality and reduce risk—but ultimately do not prescribe specific tools or techniques. 

This is especially apparent in design control activities. Regulatory requirements define the “what” for compliance but leave the “how” to the manufacturer, as long the procedures describing that “how” remain documented and prove sufficient as part of the quality system. 

This lack of a prescribed approach to managing design controls can lead to uncertainty, but Jama Connect for Medical Device Development envisions that gap as an opportunity. Here, manufacturers have the space to deploy systems engineering techniques within design control activities, supported with a robust requirements, risk, and test solution.

Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part I, and Part II.

Bring systems engineering into the design control process to manage medical device complexity. 

Systems Engineering solves the problem medical device manufacturers face. It takes a complex problem and divides it into manageable units so developers can see the solution both holistically and in its interrelated parts.  

Aligning to 21 CFR 820.30 and ISO 13485:2016 can naturally guide manufacturers towards this approach, requiring trace across user needs, design inputs, design outputs and verifications. The guidance does not account for the abstraction required within these areas, especially design inputs, allowing the manufacturer to determine and implement appropriate techniques and tools.  

The Jama Connect for Medical Device Development solution includes: 

  • A Procedure and Configuration Guide   
  • An out-of-the box configuration of Jama Connect  

Together, these components bring Systems Engineering principles and design control requirements into a single recommended approach. 

Here’s how.

1. Apply systems thinking.

The FDA guidance (FDA, 1997) indicates that product concepts are to be “elaborated, expanded, and transformed into a complete set of design input requirements.” Jama for Medical Device Development’s procedure guide applies systems engineering principles during this design input process. 

  • User needs are fulfilled by functions of the system. 
  • The system allocates them to specific engineering teams or product components for further, discipline-specific definition.  

In some instances, like where software is the system, abstraction of design inputs from system-level to subsystems may not cross disciplines. However, the need for hierarchical product definition remains and is reinforced by software specific standards such as IEC 62304 and IEC 82304.


2. Capture and organize design inputs.

In Jama Connect, these levels of abstractions are managed as Item Types, discrete objects within Jama Connect that allow the solution to enforce rules for how information should trace to one another.  

Concept-level information is captured as Intended Use and User Needs, engineering design responses as System and Subsystem Requirements. The total resulting set of requirements are referred to as the Design Inputs.


3. Establish the trace.

Below is a Relationship Rule provided as part of the out-of-the-box configuration of Jama Connect for Medical Device Development. In blue are the concept-level and design inputs: 

These Item Types are unique data elements within Jama Connect. They allow us to create logical groupings we can use to manage the hierarchical levels of abstraction and to further organize across disciplines.  

Standardizing engineering principles for requirements management using discrete Item Types is a valuable shift. It shows customers shifting focus from pure document generation to support for how they actually work, which can range from top-down, to middle-out, to bottom-up product definition.


The end result: Actionable information and accepted design inputs.

This shift to a focus on discrete items instead of whole documents encourages teams to act on information as it becomes ready. By capturing status within each individual item (e.g., a specific system requirement), items are independently driven from “Draft “to “Accepted.”

“Accepted” indicates a requirement is ready for:

  • Documentation in the Quality Management System (QMS). 
  • Further decomposition or development. 
  • Defining Verification. 

This single state can initiate several activities for other teams and does not require full document completion, which tends to restrict visibility and reduce momentum. 

Although this approach encourages a shift from a document-focused product definition, in reality a document needs to be generated for the Design History File (DHF). To support these potentially conflicting needs, the out-of-the-box configuration:

  • Drives organization of information based on a systems engineering approach. 
  • Uses Jama Connect’s filtering capabilities to pull together information across the project for document generation.  

Using filters for document generation allows you to do more than collect different types of requirements for a single document. You can use data within the items, specifically in the Status of the items, to generate a document of only accepted design inputs. You can also take a baseline as part of the document generation process. The result is a snapshot of accepted design inputs that you can use for comparison reporting to show how design inputs may have changed over time. You can also indicate in each item’s version history which version of a requirement was included in the generated documents. 

Use this Design Inputs approach with the Jama Connect for Medical Device solution to make it easier to generate documentation you need while supporting how you work with systems engineering approaches. 

 In the next post in this series, I’ll show you how to connect design inputs with design outputs and verifications.  

Watch a demo to see key Jama Connect Medical Device Development Solution features in action and understand how teams use it to support their development process.





Editor’s Note:  In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we’re proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by Jama‘s VP of Customer Success, Clay Moore.

Medical device

How Effective Collaboration Can Expedite Medical Device Design

Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.

Weeks after the COVID-19 lockdown, medical device companies continue to face challenges as they manage remote engineering teams working rapidly to keep up with a changing environment. Now that the initial shock has passed, companies are becoming more well-versed in their new workplaces and identifying how to keep remote engineering teams working successfully.

Teams are under pressure to meet quality and compliance standards while staying on pace to hit delivery dates, and optimizing the efficiency of remote engineering teams as they develop complex devices can be difficult. Normally, products can undergo multi-month-long review cycles, which tie up valuable resources. Technology, when properly leveraged, can reduce that review cycle by as much as 75%—a vast improvement.1

Effectively streamlining collaboration is key to expedite design reviews and medical device product launches. The following is how companies can use collaborative technology to maximize output while meeting critical health standards.

Reduce Dependency on Documents

Medical device companies have been forced to come to terms with their current processes to see if they work for remote engineers. Most know that helpful technology exists, but platforms that promise to streamline lengthy processes can be intimidating. Companies that delayed digital adoption are especially disadvantaged.

The document-based requirements management approach often used by medical device companies limits visibility into the design process across teams. This makes it difficult to scale across multiple product lines and versions, especially with teams working remotely, and it increases expenses.

Collaborative requirements management software can help engineers easily communicate and smoothly define, review and validate information digitally to ensure projects are tracking and a clear path to compliance and launch is visible. Effective software reduces manual processes that limit innovation and add time to development.

Medical device companies should seek collaboration tools that help their engineers clearly communicate the path to launch, tasks and ownership, and current status and action items needed. Remote work on complex processes requires seamless communication and understanding where work is being bottlenecked so teams know how to direct their attention.

Stay On Top of Compliance

In the medical device industry, understanding current product regulations is key to shape the product development process. In recent weeks, the FDA has issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.2,3 Companies who have a centralized approach and real-time access to requirements and design can minimize the added overhead of regulatory requirements, streamline development, and minimize risk.

When companies lack resources to efficiently locate regulatory standards and swiftly communicate them to engineers, they’re wasting time and limiting the ability to mitigate risk. Using traditional collaboration tools or Word documents to manage the product development process isn’t effective, leading to teams spending days or weeks to pull together documentation in preparation for an audit. Ensuring compliance requires context and visibility throughout the design process, and innovative tools that structure collaboration and put compliance and regulation at the forefront can provide both.

Good requirements management software uses a lifecycle approach to make sure compliance is integrated into the design process. Team members are held accountable, and workstreams keep track of when signoffs occurred.

Getting compliance right can be a challenge with engineers working remotely—but it is too important and too costly to get wrong. It can cost $600 million to recall a product.4

Remote Collaboration Sets Medical Device Companies Up for Success

Companies forced to embark on their digital transformation journey during this pandemic can save valuable time and money on product launches by embracing requirements management software to help streamline communication, structure collaboration, and ensure compliance.

This level of collaboration is more prevalent than ever, especially considering the state of work may change as we know it. In fact, a Gartner, Inc. survey revealed that 74% of CFOs and finance leaders will move at least five percent of their previously on-site workforce to permanently remote positions post-pandemic.5 Engineering teams need to make remote collaboration an effective part of their normal operating routines, starting now.

By embracing the right technologies, medical device companies are not only investing in supporting their teams at this crucial time but also they are investing in the success of taking products to market, as the world conducts more and more business online.

  1. Case Study: Healthcare Leader Grifols Uses Jama Connect to Cut Costs and Speed Development”. (June 2019). Jama Software.
  2. FDA Relaxes Rules on Ventilators for COVID-19”. (April 2020). The Regulation Review.
  3. EU MDR: Parliament Overwhelmingly Backs One-Year Delay”. Regulatory Affairs Professionals Society.
  4. The Business Case for Medical Device Quality”. (October 2013). McKinsey & Company.
  5. Gartner CFO Survey Reveals 74% Intend to Shift Some Employees to Remote Work Permanently” Gartner, April 2020

Take a look at some of our other resources around collaboration that we’ve compiled for easy review here:


medical device risk management

Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks and others are present through the product development lifecycle, where they must be addressed through specific risk management activities

The ISO 14971 standard, as encapsulated in ISO 14971:2007 and then revised in ISO 14971:2019, is the modern framework for such efforts. An FDA Recognized Consensus Standard, it has a nine-part structure defining the criteria for medical device risk management during production and post-production. ISO 14971 is also required by higher-level regulation under ISO 13485. All medical device companies follow ISO 14971, but their individual approaches to the risk management standard will vary based on not only product type but the actual tools used for handling risk analysis and control measures as well.

Risks as requirements: What’s the best approach to medical device risk management?

Effective medical device risk management is integral to patient health and safety. A study published by The British Medical Journal found that one in 20 patients experiences preventable harm when receiving medical care. Moreover, many medical devices in active use are many years old, meaning that even flaws implemented long ago can continue to pose risks to patients. That means risk must be curbed at every stage of the product lifecycle.

Another way to look at it: Risks are central requirements when it comes to the medical product development process, and safely managing them in accordance with ISO 14971 requires a comprehensive modern solution capable of delivering the necessary coverage, speed and preparation. Risk management is requirements management in the medical device industry. Accordingly, it’s crucial to have the capacity to, for instance, connect eventual verification tests back to requirements, so that teams can be confident of adequate risk mitigation.

However, many existing workflows and tools cannot consistently ensure acceptable compliance, leading to the possibility of recalls, or inadequate workarounds such as alterations to the label or instructions-for-use. Spreadsheets exemplify the limitations of older approaches to requirements management and risk management during the medical device lifecycle.

The problem with document-based processes

Medical device manufacturers may rely on Microsoft Excel to capture risk data and fuel their risk management planning and reporting activities. The potential problems with this approach include:

  • Limited scalability to teams working at multiple locations.
  • Siloed data sources that take time to comb through and reconcile.
  • Human factors such as miskeyed entries or inadvertent deletions.
  • Difficulty proving compliance, due to lack of end-to-end traceability.

Taken together, these issues make it onerous to maintain and execute on a medical device risk management plan that fulfills all provisions of ISO 14971. This standard requires a combination of risk analysis, evaluation and control – all processes that a risk management plan helps simplify by documenting all of the potential risks across the product lifecycle.

How to more reliably put a risk management plan into action

The risk management planning process should produce a plan that contains product-specific data and follows all standard operating procedures in the domain. The plan should also be a living document that can be continually updated as requirements and risks evolve, as it will serve as the blueprint for ongoing risk management activities such as reporting on hazards and risk control measures and also linking back to requirements. Ensuring acceptable levels of detail and accuracy in the risk management plan is much easier with an all-in-one solution than with a collection of discrete documents.

Let’s say a hypothetical medical device company was developing an MRI machine. If it were centering its risk management processes within a massive Excel sheet, lots of valuable time would be lost to stakeholders on the development team having to constantly review the requirements in the shared asset.

Plus, this highly manual, error-prone process can itself create further complications for overall medical device risk management, such as a risk going initially overlooked due to outdated data in a spreadsheet cell. Going back later to write a report about the risks is not a great alternative to building in risk management throughout the development process—but the right tools are needed for the latter strategy.

By switching to a more modern solution, this development team could instead:

  • Take advantage of risk plan templates to ramp up more quickly.
  • See live risk mitigation data, not outdated entries.
  • Avoid the various administrative risks of Excel, like splitting/merging cells.
  • Easily adjust probabilities and severities of the defined risks.
  • Enable real-time collaboration between teams.
  • Visualize and trace risks across the whole product development lifecycle.
  • Prove ISO 14971 and other regulatory compliance more easily.

At the end of the development process, the team making this hypothetical MRI machine would be able to see clearly how its verification tests traced back to the risks and requirements it initially set. More specifically, they would know if the product could move the right amount of air, survive the expected transport and storage conditions and comply with all applicable rules and regulations.

Demonstrating ISO 14971 compliance with Jama Connect

Jama Connect offers a modern alternative to document-oriented processes for medical device risk management. Jama Connect is built to help streamline compliance with ISO 14971.

For example, Clause 7 of ISO 14971 requires attention to residual risks, or those risks that exist even after all risk control measures have been implemented. In Jama Connect, those measures can be efficiently defined and linked to corresponding risks for maximum traceability. That way, teams can spot potentially unacceptable risks early on in development and mitigate them before the associated costs and logistics become impractical.

There are many other features within Jama Connect for complying with all clauses of ISO 14971 and modernizing your general approach to medical device risk management to keep up with changes such as the FDA’s Safety and Performance Based Pathway. To learn more, connect with an expert today.

To learn more on the topic of risk management, we’ve compiled some helpful resources for you.




Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.

Putting the End User in Control

End users, consumers, and patients are finding themselves with more knowledge about — and control over — their health than ever before. And that’s thanks, in part, to recent advancements in medical tech and, wearables, in particular.

In 2018, Apple introduced the first direct-to-consumer EKG wearable “cleared” by the FDA when it rolled out the EKG and irregular heartbeat features on its Series 4 Apple Watch. The watch has been classified as a Class II medical device, and a recent Standford University study revealed it can help detect atrial fibrillation — a type of irregular heart rhythm, which is the leading cause of stroke and hospitalization in the U.S.

Combined with other medical tech advancements like Bluetooth-enabled “smart” inhalers for asthma and COPD sufferers and wearable blood pressure monitors, the medical device industry continues to trend toward giving patients better control and management over their own health. Between 2014 and 2018, consumer use of wearables jumped from 9% to 33%. There are currently almost 200 clinical trials involving medical tech wearables in progress.

The impact of such fast-moving technology is still being measured, and, among other things, it’s making some question if wearables might actually decentralize medical care by making frequent visits to the doctor’s office less necessary.

Read our eBook to learn more about risk management for Class II and Class III medical device development.

In the Field

Medical tech and medical devices continue to improve patient care in clinical settings as well.

Artificial intelligence company care.ai is working with Google to develop a “Self-Aware Room” for hospitals. This technology would monitor patient conditions and send notifications to staff to keep them apprised of patient conditions. The technology could help clinicians better manage patient safety and health by predicting things such as preventable falls, pressure ulcers, and infectious diseases that would compromise patient health.

The partnership is part of an overall trend toward edge computing in hospital settings. Though edge computing doesn’t solve all cybersecurity challenges by any means, the trend does bring computing closer to the data source — in this case, the patient — which can help to mitigate some cybersecurity challenges.

AI and augmented reality technologies are also changing operating rooms. One recent report suggests that as many as 45% of operating rooms will be integrated within the next four years. The intelligent technologies will result in less invasive surgeries and improved patient outcomes.

Microsoft and Phillips have also partnered to develop augmented reality technology for surgery. The technology would transfer live imaging and other sources of information into a 3D holographic environment that the surgeon could control.

Alex Kipman, technical fellow, AI and mixed reality at Microsoft, notes that “[m]ixed reality holds great potential in healthcare, and our collaboration with Philips shows how that potential is already beginning to be realized.”

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Cybersecurity Concerns

Of continuing concern for medical device manufacturers and their partners are cybersecurity threats.

The FDA recently issued a safety communication concerning the URGENT/11 security threats. These vulnerabilities were first identified in July, and they affect several operating systems used in medical tech and industrial devices.

Suzanne Schwartz, M.D., MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, noted that the FDA was not aware of any patient harm resulting from the URGENT/11 vulnerabilities. However, she noted that “the risk of patient harm if such a vulnerability were left unaddressed could be significant.”

The communication highlights the ongoing challenges of not only addressing current vulnerabilities and cybersecurity threats, but also integrating protections into medical devices currently under development. Staying one step ahead of remote attackers is always a challenge for developers in any industry, but in the medical tech realm, patient health is a very present concern. Security vulnerabilities can put patient health and safety at risk.

The FDA also recently introduced a new, voluntary program for medical device and device-led combination products. Called the Safer Technologies Program for Medical Devices, the program is designed to help expedite development, assessment, and review of certain medical devices that are not eligible for the Breakthrough Devices Program. Draft guidance for the Safer Technologies Program is available online; the commenting period ends November 18, 2019.

Learn more about recent pending updates to the FDA’s cybersecurity for premarket submissions in this blog post.

Potential for Collaboration

Though the market entry of such tech giants as Amazon and Apple can pose challenges for legacy medical device manufacturers, the Microsoft/Phillips and care.ai/Google collaborations suggest a development that could benefit all parties.

While tech giants don’t have a long history of navigating the FDA approval process, they have been grappling with cybersecurity issues for some time. Medical device manufacturers and tech giants would be wise to combine their strengths and expertise to continue to combat cybersecurity threats while bringing new medical devices to market and improving patient care.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.