Tag Archive for: medical device requirements

Tag Archive for: medical device requirements

What’s a Design History File, and How Are DHFs Used by Product Teams?

Design history files were first required by the FDA in 1990 for medical devices. Learn how DHFs impact product teams, and get Jama Software’s DHF template.

In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process.

One essential ingredient to medical device documentation is the Design History File, or DHF. While a bad DHF may not result in non-compliance, a good DHF can make the difference between a smooth compliance process and a bumpy one. To create a good DHF that streamlines compliance, design teams should know what to include—and what to avoid—as they go through the entire design and approval process.

What’s a Design History File, and How are They Used by Product Teams Working on Medical Devices?

Before reviewing all of the essential DHF ingredients, it can help to back up and establish what it is and why it’s important.

The Design History File is a collection of documents that describe the design and development activities of a medical device. Its purpose is to demonstrate that the device was developed using the design control process needed to meet FDA requirements.

 

Design Control Process

Figure 1: Design Control Process for Meeting FDA Requirements

 

The DHF requirement was established as part of the Safe Medical Devices Act of 1990. The act describes the DHF in section 21 CFR 820.30, sub-section (j) as follows:

“Each manufacturer shall establish and maintain a DHF for each type of medical device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the regulations of this part.”

There are two key terms in the DHF requirement: “establish” and “maintain.” “Establish” means that the development team must define, document, and implement requirements. Evidence is found in procedures, work instructions, drawings, and other similar documents. “Maintain” means that the team must review, approve, and update requirements. Evidence of maintenance is typically found in document control or change control systems of a company.

While a comprehensive DHF is vital to the FDA approval process, design teams will realize other benefits of maintaining the DHF, including:

What is the difference between DHF and DMR?

The DHF is one of three pillars of design compliance for medical devices:

  1. Design controls: The moving parts of product design and development.
  2. Design History File (DHF): The collection of records from design and development activities.
  3. Device Master Record: The “recipe” for product manufacturing once the design is complete.

As one of the pillars of design compliance, the DHF is important, but it cannot hold up the design process on its own. It’s one leg of a tripod, and removing any one of the legs means that the entire design compliance process may tip over. Equally important to the process are design controls and the Device Master Record, or DMR.

What are design controls, and how does the DHF establish the design control process?

Design controls establish a plan to manage new product development; they are the process pieces that guide development along a predictable path to ensure that requirements are met. The Safe Medical Devices Act requires that manufacturers of Class II and Class III medical devices (and some Class I devices as well) implement design controls over the development process.

Design controls include:

  • Design inputs: The physical and performance requirements for the type of device. May also include types of materials needed, interfaces with other devices, and even packaging required, especially if the device must be sterilized.
  • Design outputs: Usually the final specifications for the device, typically documented in models, drawings, engineering analysis, etc. Outputs should trace directly back to initial requirements. Design outputs are the basis of the Design Medical Record (DMR).
  • Design review: A formal review by the design team and any other relevant parties, such as sales, marketing, manufacturing, etc. Documentation of the review should include the date, participants, version/revision reviewed, and results.
  • Design verification: This process verifies that the design output meets the requirements expressed by the design inputs and that specifications are correct. Documentation of this process must include the date, participants, version/revision reviewed, and the verification method and results.
  • Process validation: Process validation involves producing the device with a normal, low-level production process to confirm that the device will function as designed outside of the prototype process. Documentation of the process is required for the DHF.
  • Design validation: In this process, each manufacturer validates device design under specific conditions on small production lots or batches. The DHF documentation must include identification of the design, methods of production, date, and individuals performing the validation.
  • Design transfer: The process of transferring design into production, distribution, and installation specifications.
  • Design changes: May be referred to as “engineering change” or “enterprise change,” this process identifies and documents any design changes.
  • Design history file: This is the formal document prepared for each medical device that includes either all documents generated in product development process OR an index of documents and locations where they are stored.

As you can see, the DHF is one of many design controls, but it also serves as the repository of records of all other design controls. Think of it as the final stop for the information generated by all other design controls.

What is in a Device Medical Record (DMR)?

The third leg in the tripod supporting your compliance process is the Device Medical Record, or DMR. Think of the DMR as the “recipe” that resulted from the design controls to manufacture the device according to design specifications. It’s more than just a production traveler—it will include device specifications, compositions, drawings, formulations, software specifications, etc., as well as production process specifications, including appropriate equipment, methods, procedures and environments, such as clean rooms, humidity controls, quality assurance procedures, and any specialized equipment needed. The DMR will include everything from beginning to end of the production and shipping process, including any relevant installation instructions.

What are some pitfalls to avoid when compiling the DHF?

Many companies make costly and time-consuming errors when creating their DHFs, leading to longer-than-necessary audits and failed FDA inspections. Avoid these mistakes, and you’ll minimize lost time and unnecessary costs getting to market.

Jama Software hosted a webinar led by Quality Centric Consulting to review:

  • The top DHF errors that are costing you money
  • How to tackle 21 CFR 820.30 requirements
  • How Jama Connect™ streamlines the DHF process

Five of the most common pitfalls of the DHF include:

Not having a DHF: Usually small companies strapped for resources will put all their efforts into designing and getting a product to market, with the intention of doing the DHF later on. This could be due to a lack of understanding of what DHF outputs are required.

Chaotic and unorganized DHF: This is more typical in paper-based companies that keep all information in binders, but leave off dates or include unapproved documents, making it impossible to organize at the time of an audit or inspection. Disorganization — whether paper- or email-based — also makes it difficult to manage changes and revisions due to information silos and lack of sharing information.

Including unnecessary documents: Adding business documents, such as supplier quotes, financial information or unused concepts, can bring a flurry of unwanted questions from inspectors. This can also be a symptom of not having a DHF tool or template, as well as a linear process that involves lengthy review and approval times.

Unmaintained DHF: Often companies use either outdated or improper technology for the job. Paper-based systems, email, shared folders with read-write access and the like, are not always effective document controls. This can lead to lost copies of important records, making a DHF non-compliant.

Not traceable to outputs: Without a DHF, it’s impossible to create your DMR, and very difficult to establish your traceability matrix. If design control results are not well documented, easy to locate or current, your DMR will fail to be compliant.

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

Creating the DHF may feel like a heavy burden, but it is the key to a smooth compliance process. By treating the DHF as part of your design and development process from the beginning, these requirements become seamless and help ease the path to compliance.

Jama Connect can help traceability and requirements management and encourage a systems approach to medical device development, making the creation of a DHF more seamless and streamlined than ever before. To learn more, contact Jama Software.

To learn more about how Jama Software can help Product Teams stay compliant, visit Jama Connect Solutions for Medical Development

 

 


Accelerate medical device development with Jama Connect

Medical device developers innovate to move people forward. They build to help experts help others. But getting there is never an easy road. It can take up to 7 years to get a new medical device to market. And cost up to $1 billion dollars.

Now there’s a solution that can make the road easier: Jama Connect for Medical Device Development.

Empower your  teams with a platform that helps you overcome key challenges and accelerate your product development process. On a single platform, you can lower costs, minimize regulatory disruption, overcome compliance obstacles, and connect teams. Jama Connect activates a digital transformation  and brings your product to the people who need it, faster. 

With Jama Connect for Medical Device Development, here’s what’s possible: Ensure product quality and safety across development teams with increased collaboration. Manage development costs and leave behind document-based and legacy solutions that limit innovation. Stay in control in an evolving  regulatory environment. Stay competitive as connected devices rise in the market and your teams work to support a wider range of complexity. Word docs and spreadsheets won’t make it possible.  Realize value quickly, through an out of the box solution that’s already configured for medical device development. Accelerate development, with built-in support aligned to key regulations and procedure guides created to support design control activities.

RELATED: Your Guide to Selecting a Medical Device Development Platform

With Jama Connect, you can produce Export Templates including trace reports and a Design History File and receive training to ensure team success. Get the features you need to navigate the complexity of successful product development. Free your teams to focus on innovation and rise to meet those who need your product the most, in the workplace and every day.

“Jama Connect frees us up to focus on the design of the product, not the logistics of the work that needs to be done. We are able to spend our time more effectively — helping our customers.” Scott Britt, Systems Engineering Manager, RBC Medical Innovations (now known as Vantage Medtech)

“We all want to spend more time being creative and innovating our products, and Jama Connect gives us more opportunities to do that.” Lars Jensen, Product Quality Assurance Manager, 3Shape

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!

SEE MORE RESOURCES

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.

 

WATCH NOW

 

ISO 14971

Last week, Jama Software launched Jama Connect® for Medical Device Development, which helps teams speed time-to-market without compromising quality or compliance.

In our experience working with more than 200 medical device developers, we’ve realized how important it is to create best practices for risk management under ISO 14971, the FDA’s mandatory standard for risk assessment throughout the product development lifecycle.

In this post, we’ll outline the main clauses of ISO 14971 and explain how Jama Connect can help medical device developers build better, safer products that satisfy ISO 14971.

What is ISO 14971?

ISO 14971 is an international standard that sees risk management as a product lifecycle process encompassing the development, production, and post-production stages. Jama Connect offers a straightforward approach to managing risk according to ISO 14971 in one platform. The standard was updated in 2019, providing more guidance on risk management and adding more detailed requirements.

Managing Risks & Requirements for ISO 14971

Risk management is an inextricable part of the medical device development process. For medical device developers, risks are a core principle of product development and should be tied together in one powerful platform.

Many medical device companies continue to depend on Excel to capture risk data, but Excel simply can’t provide the end-to-end traceability necessary for satisfying ISO 14971. That’s where Jama Connect comes in: It allows teams to easily connect risks, requirements, and testing in one system where requirements and test results stay live in real-time.

Jama Connect and ISO 14971

Jama Connect guides compliance with Clauses 4 through 7 of ISO 14971, which covers how risk should be managed throughout the product development process.

RELATED: Understanding Integrated Risk Management for Medical Device

Risk Management Plan

Clause 4 of ISO 14971 concerns how risk is organized and administered for your product line. It requires the formation of a Risk Management Plan throughout the development lifecycle.

The Risk Management Plan is the record of a planned process for risk management: who does what and when, how risks are scored, etc. It’s a component of the Risk Management File, which contains all the outputs for risk.

Clause 5: Risk Analysis

Clause 5 of ISO 14971 requires that medical device developers identify potential hazards and hazardous situations. Each hazardous situation and its potential consequences must be evaluated. Jama Connect helps teams satisfy Clause 5 by defining device-specific hazards and capturing risk probability and severity.

Jama Connect offers risk management item templates to capture important information about the risk analysis process, including a description of the device, intended use, and the scope of the analysis.

Teams can identify and evaluate potential hazards, sequences of events, hazardous situations, and harms in a single item type.

Clause 6: Risk Evaluation

Clause 6 requires the evaluation of risk for each hazardous situation and the definition of acceptability criteria for determining when risk reduction is required. To satisfy Clause 6, teams take the inputs from Clause 5 and determine the risk level for each hazardous situation.

In Jama Connect, risk acceptability criteria can be customized for a particular product line or medical device classification in the risk management item.

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

Clause 7: Risk Control

Clause 7 requires risk control measures to be developed, implemented, and verified across the product development lifecycle. Risk control measures could include product design, preventative measures in the product, and labeling. Residual risk must be evaluated against acceptability criteria, and risk control measures must be reviewed in case additional risks have been introduced inadvertently.

The risk evaluation item lets users identify risk control options for a specific hazardous situation, such as inherent safety by design, protective measures in the medical device or manufacturing process, and safety information.

Risk control measures, implementation verification, and verification of risk control effectiveness can also be accounted for in the risk evaluation item. Links to system requirements and verifications in Jama Connect can easily be created from the risk item to demonstrate traceability from hazardous situations to risk controls.

Clause 8: Residual Risk

Clause 8 requires an evaluation of the medical device’s overall residual risk. If the overall residual risk is unacceptable, it must be demonstrated that the medical benefit outweighs the residual risk.

When defining risk control measures, teams can capture those measures in Jama Connect and link them directly to risks before updating the rankings to determine the residual risk level.

With traceability through all phases of risk, users can quickly identify potential pitfalls in the product development process and address them before they become bigger barriers to success.

The Bottom Line

ISO 14971 requires a cohesive, well-documented narrative of your product’s lifecycle to assure the FDA that the device is safe, effective, and compliant. Any decisions or actions that aren’t documented could keep your product from reaching the market or result in a recall.

Finding and fixing errors early in the product lifecycle saves money, speeds time to market, and improves product quality. Jama Connect allows medical device developers to review risks and risk controls holistically so that teams can operate with confidence.

From a compliance perspective, the Jama Connect for Medical Device Development illuminates the risk management and product development process, while simultaneously generating the required documentation to support that narrative.

For a deeper dive into ISO 14971 and how Jama Connect for Medical Device Development offers a comprehensive way to manage risk and requirements throughout development, download our white paper, “Application of Risk Analysis Techniques in Jama Connect to Satisfy ISO 14971.”


Medical Device Development

Medical technology companies, especially those developing medical devices with increasing complexity and product variations, are faced with a wide range of methods for managing risk. The toughest part is often deciding which specific methods and data points need to be captured to prove that all angles of risk analysis for product development took place. Against this backdrop of constant innovation, medical device manufacturers face unique challenges to comply with significant regulatory changes in Europe and the United States — some that could support new product development, while others could hinder it.

Changes in compliance standards, such as the new Medical Device Regulation (MDR) in Europe, include sweeping changes regarding how companies and distributors demonstrate the safety and efficiency of products. Companies are required to show clinical evidence for all products as well as provide systems and documents to remain compliant during the device lifecycle. One-way companies are reacting is by adopting modern requirement management solutions for improved agility and flexibility. With the ability to trace all aspects managed in one place, unified cloud requirement management applications can help maintain compliance and facilitate engaged collaboration across geographies. Evolving a regulatory environment means it is no longer feasible to have unrelated content without convenient access.

Whether regulatory authorities are tightening rules around medical devices or responding to market innovation, manufacturers must be prepared to demonstrate their products are safe and effective across the total lifecycle using a more comprehensive array of data sources. Critical factors for medical device makers must transform the way they innovate, design for manufacturability, and differentiate their products in the market. A centralized Agile alternative to disconnected, document-based processes enables pathways to faster product development, improved quality, and compliance to safety regulations.

How can you modernize and where should you start to meet these compliance challenges while streamlining your development processes and creating efficiency? Three improvement strategies can be used to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU Medical Device Regulation (MDR).

RELATED: Getting the Most Out of Your Lab Partnership Ahead of the EU’s MDR

Three Strategies to Streamline Workflow and Strengthen Collaboration when Developing Medical Devices

With the magnitude and complexity of data expanding, medical device firms are working to assemble and analyze data faster. Much of this data is often spread out across information silos. As a result, medical device companies are increasingly looking to modern clinical requirements and safety management systems, including central data capture, that collect and clean this clinical data, all in one manageable platform.

According to a study by the Emergo Group, nearly 60 percent of medical device builders say clinical data management rules are the most challenging component of Europe’s new MDR. An equivalent percentage of companies say they don’t have a strategy for compliance. Having an approach that incorporates a complete view of data can help with the preparation and ongoing compliance. To have a plan of action, three strategies that can help you to focus on a trustful quality and efficient control of developing advanced medical products.

Establish a Single Source of Truth Framework for Reliable Insights

Through medical device development, many disparate documents are gathered into a collected set of information and submitted to regulators. This auditing process can be a time consuming and very manual exercise often done too late in the development cycle. Optimizing workflows to centralize information sets in an item-based approach where processes and documentation move from the document-centric model to a relational database approach can protect your quality of building new products and services. A workflow-driven, traceable methodology, and managing all information sets in real-time brings better handling to safety-controlled development cycles, and maintains a continuous state of acceptance readiness.

Streamline Risk Control with Requirement Definitions

Using a centralized information gathering approach, you can author the risk process directly connected to your development work. Your risk acceptability criteria can be defined and documented as part of the risk assessment related to the required development specifications. Moving to connected risk-requirements workflows, provides a collaborative place where the risk management plans can be viewed holistically by the entire development team in the context of the medical device development environment where requirements, specifications, validations, and risks are analyzed.

Enable Your Expert Community

Building complex products is never a one-person show. Medical device manufacturers when implementing tools, resources, and techniques to develop safe and successful products faster. A substantial factor for success is the team’s understanding and engagement at every aspect and stage of the development lifecycle, creating a robust traceable collaboration community and the ability to initiate a flexible evaluation process. These factors can have a significant impact on achieving a timely and cost-effective control that assures product quality due to a risk embedded impact analysis.

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

Why Risk Management, Why Now?

Medical device developers can optimize the development cycle by bringing risk control and development data together in an information-centric and automated fashion and instead focus on quality, innovation, and efficiency, as well as time to release, allowing medical device builders to recognize new product revenue within shorter release cycles.

Early transitions to renewed regulations, such as the new European MDR/FDA standards, are critical in giving products a competitive advantage. Companies can turn this around into an opportunity by adhering to the following recommended steps:

  • Implement a strategic, information centric approach early on to ensure market compliance and build a trustful reliable data source
  • Handle your risk control elements directly connected to your traced development activities
  • Make use of Jama’s consulting expertise and the available medical assets such as ISO 14971, FMEA, FTA, and 21 CFR Part 820 to rollout your renewed strategy based on industry best practices.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!

Medical Device Security Predictions for 2002

As we enter a new decade of technological advancements, Jama Software asked select thought leaders from various industries for the trends and events they foresee unfolding over the next 10 years.

In the third installment of our 2020s Predictions series, we’re featuring predictions from Chris Gates, Principal Systems Security Architect at Velentium, a professional engineering firm specializing in the design and manufacturing of therapeutic and diagnostic active medical devices.

Jama Software: What are the biggest trends you’re seeing in medical devices right now and how are they impacting product development?

Chris Gates: Regulatory bodies and Health Delivery Organizations (HDOs) are now mandating the creation and lifelong support of secure medical devices. This “Secure Lifecycle” starts with the first step in the development lifecycle and extended to the last day the medical device is marketed. This fundamental shift results in a tremendous amount of new artifacts to be managed and traced throughout the normal document tree, including security plans, requirements, test reports, post-market surveillance reports, approved supplier lists (ASL), etc., not to mention all the activities needed to create those artifacts in the first place!

JS: What are some continuing or new trends in medical device development you expect to see over the next decade?

CG: HDOs contractually mandating Medical Device Manufacturers’ (MDMs) level and nature of ongoing support for the life of the medical device in their organization, including in-field patching of software/firmware; Software Bill of Materials (SBOM); and assuming liability for all damages caused by the use or misuse of the device (such as being hacked and weaponized to attack other systems in the HDO). These are not activities or processes that have been previously supported or funded by MDMs.

JS: What sorts of process adjustments do you think development teams will need to make to accommodate these changes? Do you think they’ll need to make technology investments, process adjustments, or both?

CG: Yes, yes, and yes. This will result in large changes to organizations and how they work, plan, and budget for medical device development. For example, they’ll need “all of the above” to accommodate the ongoing post-market surveillance impacts on the utilization of third-party software packages in future devices. This is all part of the changes to the ASL. No longer can MDMs view medical device development as ‘a separate event’ with a beginning and an end. Securing medical devices is an ongoing collaborative effort with HDOs.

JS: Any regulatory changes you anticipate to medical devices over the next decade? How do you see this impacting development teams?

CG: More enforcement “teeth” being given to the FDA by Congress. Especially in the area of MDMs’ “responsible vulnerability disclosure,” which is currently optional for MDMs. However, the FDA, Congress, and HDOs are all in agreement that this activity needs to be mandatory and thus enforced. Hopefully we will see some worldwide harmonization of security standards and generated artifacts, as currently these regulatory bodies are very fractured in their approach to secure development and the generated artifacts.

JS: What do you think will remain the same in medical device development throughout the 2020s?

CG: Focus on “safety and efficacy” will remain steady, as well as a continued drive to shrink medical devices to the smallest physical package possible to enable more home healthcare scenarios. Similarly, the increased use of “telemedicine” and related connectivity solutions enabled by these home healthcare devices and smartphones.

JS: Anything else you’d like to add?

CG: Even though the transition to secure medical device development and support may be financially uncomfortable, medical device security is the responsibility of all MDMs. Remember, the patient you are protecting might be yourself or a loved one!

Significant growing and shifting regulations are already underway within the medical device industry. Learn how teams can stay ahead of the competition in our eBook, “Conquering Connectivity, Competition & Compliance.”

Medical Device Development

The landscape of medical device development is shifting rapidly. And it’s not just balancing innovative gains with safety that medical device companies must worry about anymore.

In our opinion, there are three main challenges medical device companies will be facing in the coming years (if they aren’t already):

  • The rise of connected, software-driven medical devices
  • Increasingly strict medical device regulation
  • New market entrants making a disruptive splash

Given that the medical device industry is slated to skyrocket to $800 billion by 2030, there’s obviously a lot at stake. Luckily though, there are some antidotes that we explain in our eBook, “Overcoming the Three Biggest Challenges in Medical Device Development,” which is available to download here.

Here’s a closer look at some of those big problems that need to be accounted for in modern medical device development.

Challenge One: The Rise of Connected, Software-Driven Medical Devices

Until fairly recently, software embedded within medical devices had limited functionality. Gradually, like so many products, software came to dominate the core features and functionalities of medical devices.

That combination of quality hardware and sophisticated software has made medical devices a lot more complex, which equates with increased development work for those building the products.

Add to that the element of connectivity which, while extremely powerful and convenient, can introduce a variety of risks — including malware and hackers — and the landscape of medical device development has expanded significantly.

Teams building modern medical devices must not only keep pace with the rapid rate of innovation and demands of the market, but also manage risk that only grows with the complexity of the product design. Managing the development of medical devices through documents and spreadsheets isn’t a path to long-term success, and companies must find new ways to develop their products or get left behind.

Read our eBook, How to Overecome Three of the Biggest Challenges in Medical Device Development

Challenge Two: Increasingly Strict Medical Device Regulation

The increasing complexity of medical devices is forcing regulators to take another look at existing rules and guidance, and for good reason. In the first quarter of 2019, the average size of a medical device recall was 823,126, which was the highest quarter since 2006, according to Stericycle’s Recall Index. And, among all recalls, quality issues were the main cause.

Whether it’s ISO 14971 or ISO 13485, compliance with government and industry regulations remains a constant weight for medical device developers, as regulatory bodies struggle to stay current speed of the market.

This is making medical device compliance increasingly costly and making regulatory standards harder to interpret. For instance, one of the most difficult and time-consuming aspects of proving medical device compliance is sorting through the documentation produced by the design and development teams, including outputs from multiple software tools. Even in a best-case documentation scenario, determining the right documentation to show FDA compliance and systematic management of risks is tricky.

Learn more about how Jama Connect helps teams improve medical device development.

Challenge Three: New Market Entrants Making a Disruptive Splash

When names like Apple and Amazon decide to start competing within your industry, there is ample reason to worry. These sorts of household names benefit from instant brand recognition, quick distribution, and seemingly unlimited resources.

For instance, Apple’s Watch Series 4 received a Class II de novo clearance from the FDA for both its electrocardiogram (EKG) and notification of irregular heart rhythm clearances.

Despite the intimidating nature of goliath companies getting into the medical device space, it’s important to remember most of them are still somewhat new to FDA regulation. This introduces new risks for those tech companies with nontraditional FDA-regulation backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution, which has prompted an overhaul of that system.

For medical device companies, this situation sharpens the focus on an ongoing business problem: Evaluating how your processes are being executed and making sure you’re getting your product right the first time.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!

 

Based in Minnesota, Elucent Medical is a medical device developer focused on creating precise, wireless surgical navigation tools for tumor identification and excision. Founded in 2014, Elucent is helmed by three veterans of venture-backed biotech companies, CEO Laura King, CTO Dan van der Weide, and Dr. Fred Lee; as well as Dr. Lee Gravatt Wilke, Director of the University of Wisconsin Health Breast Center and chair of the research committee of the American Society of Breast Surgeons.

The team at Elucent has been using Jama Connect™ for about a year to manage requirements, tests, and reviews throughout the product development cycle.

Jason Hiltner, Elucent’s VP of Research and Development, had worked with requirements management solutions like CaliberRM before, and he had seen other product teams depend on IBM Rational DOORS and Microsoft Word and Excel. With those experiences in mind, he knew he needed a more intuitive, centralized platform to support innovation at Elucent.

Jama Connect makes Elucent’s product development process more efficient and more collaborative, while facilitating traceability from requirements through testing in compliance with FDA regulations.

And Elucent is creating some amazing things with the help of Jama Connect. Since it’s difficult to locate precise spots in the body, especially in soft tissue, Elucent has developed the SmartClip™ — a tiny implantable product that marks the location of cancerous tissue so surgeons can identify and excise the cancerous tissue more easily. Patients don’t have to endure repeated excisions because surgeons haven’t located or removed all of the cancerous tissue, and the SmartClip™ eliminates the need for painful and costly radiology localization.

The EnVisio™ Navigation System, which is designed to enable real-time 360° navigation in the surgical sightline and provides distance, depth and direction to the SmartClip(s): guiding a surgeon’s tools to make tissue excision and removal even more exact. The team’s hard work was rewarded when the EnVisio™ Navigation System was granted FDA clearance in 2019.

Elucent’s first market will be surgical excision in breast-conserving surgery, and their technology has wide applicability for localization of cancerous lesions throughout the body. Hiltner says the initial response to the clinical product has been “phenomenal for sure.”

Learn how to move beyond the frustrations of document-based requirement systems, streamline your development and set yourself apart from the competition by watching our webinar, “Balancing Compliance & Innovation in the Medical Device Industry.”

We asked Hiltner and Judson Guericke, Senior Director of Quality at Elucent, to tell us more about how they’re leveraging Jama.

Jama Software: What corporate or industry challenge led to your decision to seek out a solution and ultimately purchase Jama Connect? Was there one particular problem that became a huge pain point?

Jason Hiltner: Obviously, in our industry, we have to have well-documented requirements that start with the customer requirements, go to the product requirements, link to the design descriptions and the software requirements, and lead to verification. If you’re going to do that, you need to start with something that allows you to have traceability. We also needed something with a central database, so we weren’t managing a bunch of different revisions of documents and emailing documents again. The big thing I wanted was a platform I could very easily maintain and not have questions about: I would know where things were and be able to easily do reviews. I also knew we needed something stable, robust and cloud-accessible.

How long have you been using Jama Connect, and what was the adoption process like?

Hiltner: We’ve been using Jama Connect for about a year. We’re a startup, so I talked over the idea [of a requirements management solution] with a small group of people. We’re a very lean and focused organization; we’re at only 11 people. We compared a couple of tools and got recommendations from people who had done a more exhaustive search. We went with Jama Connect in spite of the fact that it was more costly than some other tools. The deployment and implementation process was as smooth as I could have hoped for. We had a bunch of sessions with Zeb Geary, a Jama Professional Services consultant, and we were up and running, creating requirements in less than a week. It’s as flexible as I hoped it would be.

“We were up and running, creating requirements in less than a week.” – Jason Hiltner, VP of Research and Development at Elucent Medical

What was the feature/capability/business aspect of Jama Software that won you over?

Guericke: The collaboration and customer support for implementation. The biggest benefit for us is the efficiency in completing and gaining agreement on requirements and testing procedures.

Hiltner: We wanted something that would be very usable, something that would be maintained and around for a while. Our product has customer requirements that flow down to product requirements, which flow down to software requirements and design descriptions. We also maintain our verification suite within Jama.

Guericke: We needed a solution that would facilitate traceability from requirements through testing to comply with FDA expectations for design control. Jama Connect provided a traceability functionality that worked well for our needs. In addition, the collaboration capability of Jama aided us greatly in the definition of our requirements.

How do you measure success for this project? How are you using Jama Software to get there? 

Hiltner: Now that we have that [FDA] clearance on the EnVisio Navigation System, success will mean surgeons utilizing our product to improve patient care.

Guericke: Confidence in assuring complete coverage from customer requirements to product requirements to software requirements to verification and validation. I really like how intuitive Jama Connect is. It was very easy for me to figure out how to navigate and use. There was some learning curve on the system configuration, but the support provided by the Jama Software team made that much easier.

Interested in learning more about using Jama Connect to build medical devices? Download our brochure, “Jama Software for Medical Device Development.”

At Jama Software, we’ve been lucky enough to work directly with some of the world’s most forward-thinking medical device companies. What we’ve learned is that these innovators must balance increasingly complex development processes; the need to release high-quality, regulatory-compliant, market-driven products; intense pressure to nail delivery timelines; and the imperative of patient safety.

With the recent findings by the the International Consortium of Investigative Journalists that more than 1.7 million injuries and nearly 83,000 deaths may be linked to faulty medical devices over a decade-long period, coupled with the FDA’s promise to overhaul its system for approving medical devices, it’s clear there are still plenty of areas for improvement within the industry.

In a recent webinar, we offered project and engineering teams working on medical devices some strategies for gaining a competitive edge by streamlining process, mitigating risk, reducing rework and easing the path to regulatory compliance.

Jama Software’s mission is to modernize, digitize and transform the process of complex product development by transcending the headaches and limitations of document-based requirement systems. To that end, we’re constantly working to ensure our platform and services help teams better manage the growing complexity of developing Class II and Class III medical devices.

Our medical device customers depend on our platform to standardize and optimize their product development processes to mitigate risk, improve quality and trim time to market.

  • Jama Connect helps medical device development teams operationalize their development processes by enabling requirements definition, traceability, testing and collaboration across all stakeholders.
  • Jama Partners allows customers to extend the Jama platform via popular third-party integration hubs or an open REST API to support integration of technologies used throughout the development process.
  • Jama Professional Services assist our customers in speeding time to value for our solutions with a host of offerings including expert assistance in optimizing and implementing the platform, as well as industry-specific consultation and training.

Overcoming Low-Value Work

Over the years, our professional services team has spent many hours working closely with medical device developers, and we’ve learned a lot about their challenges and opportunities.

A key understanding has emerged from our deep dive into the world of medical device manufacturing: Teams are struggling to balance regulatory compliance with how they want to work.

More often than not, our customers are looking to modernize and become more collaborative, but the weight of regulatory requirements can keep them from realizing the benefits of updating their process. Teams can start to see the work and the documentation as being at odds with one another, but that doesn’t have to be the case.

The challenge is balancing the requirements of the quality system with your organization’s approach to product development. You find this equilibrium by ensuring that the quality system needs and documentation in the design history file (DHF), for example, are byproducts of your work rather than defining or constraining factors in themselves.

When this balance is lacking, we’ve seen that a heavy focus on documentation needed for the DHF can introduce time-consuming, low-value work and create friction in team hand-offs.

The Benefits of Greater Efficiency

Among the biggest challenges faced by medical device developers looking to improve their product development process is that teams are spending too much time on work that doesn’t add value – especially when they’re reliant on a document-based approach to defining and managing requirements and testing.

One study of nearly 250 manufacturing organizations, according to Tech-Clarity researchers, found that engineering teams spend a third of their time on non-value adding work, especially manual data management, including manual data collection, content editing and recreating lost data.

In the requirements management space, this time might be spent checking documents in and out and tracking down the latest version for updates or reviews – not to mention time spent in meetings getting everyone aligned and establishing the path forward.

Medical device developers need to bring higher-quality products to market faster, with less risk and at a lower cost. Giving engineering teams a third of their time back would help make this goal a reality.

Stay tuned for more posts about improving medical device development and the integral role Jama is playing for its customers. In the meantime, get a deeper dive into how Jama Connect helps developers balance medical device compliance and innovation by watching our webinar.