Tag Archive for: medical devices


Editor’s Note: This post about getting the most out of your lab partnerships ahead up the upcoming EU MDR was originally published here on Medical Design and Outsourcing on October 5th, 2019, and was written by Joseph Tokos, Technical Director of Chemistry at WuXi Medical Device Testing.

Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the EU MDR, it’s more important than ever to maximize every partnership.

Outsourcing device testing to laboratories or contract research organizations (CROs) offers much needed relief to manufacturers and an opportunity to enhance EU MDR preparation efficiency. Here are a few insider tips to make the most of your relationship with your testing partner: 

Don’t hold back on the details

Your testing partners need to ask a lot of questions about your device to be able to design a concrete test plan and accurate quote. It may seem like they’re asking for too much information before you even sign a contract, but these fine details can make or break a test plan. Failure to thoroughly detail device materials, for example, can lead to flaws in the extraction plan, such as the wrong solvent, equipment, temperature or extraction time. Complete and accurate dimensions are important because the extraction ratio will depend on wall thickness. Surface area information is also important because testing partners need to know whether the device will need to be cut into pieces for testing and whether there would be implications of doing so.

Providing all of the information upfront will save time and help prevent delays, denied submissions due to inadequate results and increased costs when studies aren’t designed properly.

Before requesting a quote, gather detailed information on the following:

  • Purpose, category and patient contact time
  • Size, thickness and surface area
  • Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
  • Procedures used to manufacture and sterilize the device
  • Parts and composition
  • Existing data from previous testing

Read up on regulations

Understanding how new regulations and standards apply to your devices will empower you to educate your internal team and instill a sense of urgency to collaborate with your testing partner. Making an effort to keep abreast of the latest on EU MDR will allow you to have more productive and timely conversations about your test plans.

If you don’t have the bandwidth to dig into testing requirements — after all, that’s part of why manufacturers work with outside resources — you’ll at least want to check in with each person or department involved in device development. Design engineers and material suppliers, for example, will help you understand the intricacies of the device’s design, materials and parts.

It’s also important to note that patient contact time and in vivo testing methods will be under heightened scrutiny. Devices with shorter patient contact time are now going to be held to the same standards as longer patient contact time. This means the current data packages on even Class I devices may be incomplete moving forward. If the duration of patient contact is shorter than 30 days, be sure to ask your testing partner if you have remaining gaps in your submission that will require new testing. Also, take this opportunity to evaluate all of your options with existing in vivo device data or product family grouping data to minimize in vivo testing.

Learn from others’ mistakes

Sometimes, even the best intentions can’t guarantee a smooth testing experience. Beyond looking into what the regulations require and providing thorough product information, there are a few pitfalls that can lead to incorrect testing parameters, delays and added costs.

One common mistake is providing outdated information from a previous design. Start each device information request from scratch instead of copying and pasting from a previous form; then, investigate any gaps. This forces you to consider all the details carefully, which reduces the risk of an improperly designed test plan. Getting it right the first time reduces the risk of needing additional device samples (test article) and repeating tests.

It’s critical to provide truly representative test article of the devices produced by manufacturing. Using a prototype, for example, could yield inaccurate results and put your submission’s approval at risk because prototypes may be made of different materials or employ a different manufacturing process.

Another easily avoidable mistake is failing to describe any device changes in detail. Your testing partner can better address risks of your updated, next-gen device if they have a good understanding of what prompted the updates. Whether you addressed patient safety concerns or made updates to improve user experience, communicating the reasoning behind any device changes allows a lab to tailor the study.

Finally, don’t misunderstand the role of chemical characterization. While biocompatibility testing is important, chemical characterization is what identifies risks you didn’t even know exist.

There’s a lot to consider from a regulatory standpoint right now, and you need to maximize on every partnership to keep pace. Device manufacturers and labs alike are facing capacity constraints. If you provide a forecast to your partner and inform them of what samples they can expect and when, they may be able to reserve testing space and adjust capacity to better meet your needs. For more tips on how to prepare for MDR, read “Countdown to EU MDR: Do you know your options? ,” “Pre-clinical medical device testing under ISO 10993-1 and the MDR” and “What you need to know about reusable devices and Europe’s MDR.”

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


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 disruptionovercome 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

“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!


Solution components in the Jama Connect for Medical Device Development solution help teams reduce time-to-value, provide guidance around customer-specific needs, and drive adoption.

We wanted the solution to offer a collection of training and documentation components that aligns to industry regulations so product development teams could get ramped up quickly.

The result: an out-of-the-box configuration of Jama Connect, an accompanying Procedure Guide, and Jama Professional Services. It’s a solution designed to reduce time-to-value, account for and provide tailored guidance around customer-specific needs, and drive adoption through tailored training and on-going support. Let’s take a look at the components and see how they help achieve those goals.

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

Procedure and Configuration guide: Jama Connect, clearly aligned with regulations.

The Jama Connect for Medical Device Development Procedure and Configuration Guide provides detailed alignment between these regulations and standards and the out of the box configuration and recommended use of Jama Connect:

  •        ISO 13485:2016
  •        ISO 14971:2019
  •        21 CFR 820.30

The scope and processes described in the guide are clearly identified and justified.

An important point to note: we identified the Jama Connect capabilities that align with the most relevant design control requirements needs. Then we targeted those needs, and optimized Jama Connect to meet them exactly.

The regulations and standards establish the design control requirements and provide some guidance, but they are not prescriptive in terms of tools or techniques. The procedure and configuration guide explains in detail how to bring in best practices from systems thinking, supported by use of Jama Connect, while still complying with design control requirements. .

Teams building complex medical devices will benefit from this systems-thinking approach and the way the Procedure and Configuration Guide builds these layers into the configuration. The principles and guidance provided by the Systems Engineering Body of Knowledge (SEBoK) and the recommended use of Jama Connect will bring clarity around product definition and verification activities.

medical device requirements

Out-of-the-box-configuration: Start with standardized guidance and build from there.

The out-of-the-box configuration provides a recommended project template that allows customers to get up and running quickly.  It also serves as a starting point for customer-specific discovery and configuration. Each aspect of the configuration aligns with the applicable regulations and standard through detailed process activities and tasks described in the procedure guide

The configuration also provides Export Templates you can use to generate documentation from Jama Connect for transport into your Quality Management System (QMS), typically used to house all Design History Files for sign-off and audit.


On-site consulting and training services to align your teams quickly.
Jama Software’s Professional Services team works to help customers reach several goals:

  • Build adoption, decrease time-to-value, and maintain ease of use. 
  • Focus on process alignment, people readiness, and best practices for configuration and use.  
  • Take advantage of the recommendations and guidance described in the Procedure and Configuration Guide and built into the out of the box configuration.   
  • Provide end-user training tailored to the customer’s use and configuration of Jama Connect . 

Taken as a whole, the Jama Connect for Medical Device Development solution provides the guidance, justification and a starting framework that not only answers “what” Medical Device manufacturers should do when deploying Jama Connect, but also “how” and “why” they should do it.   

In upcoming blogs in this series, we’ll explore specific aspects of the Procedure and Configuration Guide and the out of the box configuration of Jama Connect. We’ll also look at how the solution components described in this blog are applied in practice.   

Download a Solution Brief for an overview that explains all the ways Jama Connect for Medical Device Development can help your teams manage shifting complexities and maintain product quality and safety.





Today, Jama Software announces a new solution: Jama Connect for Medical Device Development. The launch feels especially relevant right now. Over the next few weeks I’ll share details about it with you here in the blog. I’m going to talk about:

  • The solution background: why it came to be and what it does.
  • Solution Components
  • Design Inputs
  • Connect Design Inputs, Design Outputs and Verification
  • Traceability

We’re pleased we’ll be able to help medical device manufacturers support design control activities in the highly regulated product delivery environment and contribute to their goals of quality and safety.

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

Streamlined and focused configuration for medical device development.

The idea for the Jama Connect for Medical Device Development solution grew from the need to align quickly to medical device regulations and standards within a requirements platform.

The highly configurable Jama Connect platform allows customers to align the system with specific requirements, risk, and test process needs. If there’s a particular type of information to capture or a specific list of values that would support the overarching process, customers can configure Jama Connect to align and support it.

However, a highly configurable system introduces challenges. During deployments, you have to ask, “Yes, we can do anything, but what should we do?” Think of a highly configurable system as a blank canvas. You can find yourself staring, directionless, and not know where to begin.

That matters when there’s an entire team staring at the blank canvas. It wastes resources and impacts the time it takes to gain value from the system. In the end, the result can be a misaligned, frustrating deployment and low user adoption.

An out-of-box configuration that brings immediate benefits.

The challenge described above is precisely why Jama Software created the Jama Connect for Medical Device Development solution. We wanted to help Medical Device manufacturers who deploy Jama Connect in a highly regulated environment:

  • Increase the value of Jama Connect, and decrease the time to realize that value.
  • Access a recommended, out-of-the-box configuration.
  • Maintain alignment with design control regulations and standards that Jama Connect is best suited to address.

With the Jama Connect for Medical Device Development solution, deployments no longer start with a blank canvas. Instead, the picture comes out of the box, justified and properly aligned with medical device regulations and standards. Configuration is still possible and valuable, but streamlined and focused.

Customers can hold an out-of-the-box configuration and recommended guidance against their operating procedures to:

  • Identify and justify unique, customer-specific needs.  
  • Determine the best approach to address those needs.  
  • Incorporate customer-specific nuances for tighter alignment to the company operating procedures.  

In next week’s blog post, we’ll explore solution components in more detail.

Discover more details and watch a demo of the new Jama Connect for Medical Device Development solution here.





jama connect for medical device development

Today, Jama Software, introduced Jama Connect for Medical Device Development, a new solution designed to help engineering teams better manage device requirements, risk and design control all on one powerful platform. The newest release makes regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment with no reduction in quality.

Consistent product quality and safety proves to be the top challenge for innovators throughout the medical device development lifecycle. Constantly evolving regulations and the new complexities presented by connected devices makes management of these shifting complexities difficult. Our teams have been hard at work to bring this solution to fruition and help medical device developers simplify and accelerate the development lifecycle. This single platform can help accelerate innovation, maintain consistency and high product quality, and manage ever-changing complex regulations in medical device development.

“Developers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,” said Josh Turpen, Chief Product Officer at Jama Software. “We’re excited to introduce our new solution designed specifically for medical device companies which will help ease the development process from the start. Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving product teams from the cumbersome and often frustrating process of filing paperwork.”

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

Jama Connect for Medical Device Development can help teams:

• Easily demonstrate traceability
• Manage risk analysis
• Maintain audit trails and export data
• Improve product development with reuse and baseline management
• Streamline compliant reviews and approvals
• Manage design verification and validation

Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven Systems Engineering approach to product development. When you purchase Jama Connect for Medical Device Development, our consultants partner with you to adapt the solution to fit your product delivery process and build adoption of Jama Connect within your organization. Contact us to learn more.

About Jama Software

Jama Software provides the leading platform for requirements, risk and test management. With Jama Connect for Medical Device Development, teams building complex products, systems and software improve cycle times, increase quality, reduce rework and minimize effort proving compliance. Representing the forefront of modern development, Jama’s growing customer base
of more than 600 organizations includes Boston Scientific, Johnson & Johnson, Abbott, and Merck.

Visit jamasoftware.com/solutions/medical-devices to learn more about Jama Software for Medical Device Development.



The Jama Support Community is a forum for Jama Software users to interact and collaborate with other users and with Jama support engineers. It’s full of resources for everyone from novices to masters, including tutorials and webinarshelp guides and FAQsfeature requests and announcements and a robust knowledge base. For today’s post, we spoke with one of our Jama Support Community power users — frequent contributors with great questions and powerful insights into using Jama — about how their organization uses Jama and the value they’ve seen from the Support Community.

Srilatha Kolla works on the DevOps team at at Hill-Rom Cary in the Raleigh, North Carolina area. Hill-Rom’s Clinical Workflow Solutions team develops medical devices that protect patients by anticipating the care they will need and communicating that information to their healthcare providers.

The process of developing these Class II and Class III medical devices is heavily regulated by the FDA, and Kolla’s team needed to achieve full traceability in order to satisfy these requirements. Hill-Rom was using IBM Rational DOORS for their requirements and test case management prior to 2012, but it didn’t meet their traceability needs, among other shortcomings.

Kolla, who started her career as a developer at IBM, was on the Quality Engineering team at Hill-Rom when they began looking for a superior solution. Her QE team evaluated several options before choosing Jama Connect™ in 2012.

Since then, Kolla has moved to the DevOps team, where she’s responsible for deploying and managing processes to help development, requirements and quality engineering teams build, test and release products that are safer and more reliable. Her team is closely involved from the requirements stage to coding, testing and verification of the product, and she’s responsible for managing the solutions, including Jama Connect, that her team depends on.

Kolla’s DevOps team serves as the Jama administrator at Hill-Rom, but the development, requirements and quality engineering teams, she says, also “live in Jama Connect day in and day out.” Among the organization-specific best practices her team has developed is a multi-project structure, which works better for them than a single, more complex project structure.

As an FDA-regulated company, Kolla says, Hill-Rom values Jama Connect for its traceable requirements and test case management: “That’s what we depend on highly.” She’s also a fan of the Review Center in Jama Connect. The Review Center enables teams to collaborate without hunkering down in the same room or emailing a Word document back and forth. Stakeholders can also review and sign off on requirements within the Review Center, which comes in handy when you need to reach consensus between team members quickly.

Kolla began using the Jama Support Community to get her questions answered. She wanted to see how other people were using Jama to address the same product development challenges her team was facing. As Kolla says, “We’re definitely not the only ones using this platform.” ­­

Like many Jama customers, Kolla’s team uses Jama Connect in conjunction with Jira, so she turns to the Support Community to ask relevant questions about Jama’s functionality and interconnectivity with Jira, Microsoft Office and other tool suites. Given her team’s focus on traceability, Kolla has often sought Jama-related input from other users on things like item management, defects, Test Center, Trace View, Coverage Explorer, Reuse and Filters.

Stay tuned for more posts on how Jama users are leveraging the Jama Support Community to get the most out of the platform. In the meantime, connect with Sri and other fellow Jama users on the Jama Support Community

Rendering of the experimental X-59 QueSST, courtesy NASA.

It was a mind-bending year for some of the most innovative companies on the planet. From relentless advances in autonomous driving to Starman orbiting Mars to getting a firmer handle on the future of agriculture, there were some dizzyingly inspirational moments in 2018.

To recap the busy year, we compiled a far-from-comprehensive list of some of the most notable moments from product development teams that are pushing the boundaries of what’s possible and solving problems that will improve the quality of life for millions…sometimes with help from Jama.

Lyft demonstrating its driverless technology, powered by partner Aptiv, at CES 2018.

Tesla, Waymo, Lyft and Panasonic take differing data strategies to advance autonomous driving

Human drivers have plenty of information about how other drivers behave on the road, and driverless cars need that data too. Tesla and Waymo, which started life as Google’s self-driving car project, are at the forefront of this effort to collect and process enough data to develop a reliable autonomous vehicle.

The two companies are taking very different approaches to the challenge, reported The Verge in April: Tesla, leveraging the hundreds of thousands of cars it already has on the road, is collecting real-world data about how vehicles perform with its current semi-autonomous system, Autopilot. Waymo, meanwhile, is using robust computer simulations to drive the development of a small real-world fleet of autonomous cars.

Elsewhere, in a decisive step in the direction of self-driving cars, Jama customer Lyft acquired London-based augmented reality (AR) startup Blue Vision Labs. Blue Vision has developed a way of using street-level imagery to build “collaborative, interactive reality layers” using images captured by smartphone cameras, reports TechCrunch. This technology is crucial to Lyft’s vision for autonomous vehicles, which was on display earlier this year at CES 2018 (pictured above). Both Lyft and arch-competitor Uber are expected to file IPOs in the first half of 2019.

Not to be left out, Panasonic North America announced in August that it was developing a cloud-based data platform called C-V2X (V2X stands for “vehicles to everything”) that pushes traffic information out to users, such as the Colorado Department of Transportation — which we interviewed earlier this year. Cars with C-V2X technology, according to The Denver Post, send out signals 10 times a second to roadside sensors, conveying information about speed and direction from internal sensors such as breaks and airbags. Transportation workers can use Panasonic’s data platform to monitor the road grid and spot problems before they snowball. The system can also deliver customized, time-sensitive messages directly into equipped vehicles.

NVIDIA digs deeper into autonomous driving

During his January keynote at CES 2018, NVIDIA founder and CEO Jensen Huang spoke about the importance of traceability in developing functional safety systems for the autonomous car market. With what Huang calls an “extraordinarily complex” development process, traceability is crucial to achieving safety and functionality. That way, Huang says, “If something were to happen, we could trace it all the way back to its source to improve and mitigate risk in the future.” We may not be used to thinking about traceability as a central concern for semiconductor companies like NVIDIA, but Huang’s keynote reminds us that, as product development grows increasingly complex, traceability is relevant for everyone.

In November, self-driving car startup Optimus Ride announced that it had selected NVIDIA’s Drive AGX Xavier as its development platform of choice for autonomous vehicles. A purpose-built platform for developing autonomous driving systems, Xavier is an open, scalable software/hardware solution designed to streamline development and production for companies working on driverless cars. Optimus Ride founder and CEO Ryan Chin says the company will use Xavier to create Level 4 autonomous vehicles, meaning the cars will operate in specific conditions and locations with limited human oversight and input. (In other words, yes, you can take a nap – as long as the car is on normal, mapped roads.)

Also in November, NVIDIA announced three new deals with Chinese electric car companies to develop technology for autonomous vehicles. These companies – Xpeng Motors, Singulato Motors and SF Motors – join other customers of Nvidia’s Xavier platform, including Uber, Volkswagen, Mercedes and Audi. Xpeng will begin building Level 3 autonomous capabilities into vehicles in 2020. A vehicle with Level 3 autonomy can drive by itself, but the driver must stay alert and ready to take control. Singulato and Volvo – yet another Xavier customer – are also planning to release Level 4 cars in the next two years.

Innovative aerospace company makes history

In June, Lockheed Martin and NASA — a Jama Connect customer — announced they were building an experimental supersonic plane designed to shed the deafening sonic booms normally associated with super-fast airplanes. Peter Coen, project manager for NASA’s Commercial Supersonic Technology Project, described the X-59 QueSST as “a research aircraft flown by a single pilot” in a statement sent to Newsweek. The X-59 QueSST isn’t designed for commercial use, but as a research craft, Coen hopes it will “open the door a to future generation of quiet supersonic travel.” The X-59 QueSST is set to hit the skies in late 2022.

In February, aanother customer of Jama Connect made history by launching the world’s most powerful operational rocket. The successful launch set the stage for faster, cheaper launches of national security satellites and other cargo.

Sowing the future of agriculture around the world with tech

Agricultural technology (agri-tech) is booming in Africa, with investments in agri-tech startups surging by 110% since 2016, according to Forbes. In fact, there were more than 80 agri-tech startups operating in Africa at the beginning of 2018, says Forbes, and over half of those were launched in the last two years.

The reasons for the boom were summed up by Tom Jackson, cofounder of Disrupt Africa: “Everyone knows how important the agricultural sector is across Africa, but until very recently it remained relatively untouched by tech innovators,” he told Forbes. “That is suddenly changing as entrepreneurs and investors realize the scale of the challenges facing farmers, and spot opportunities to reach huge addressable markets.” Kenya, Nigeria and Ghana are the current leaders in the agri-tech market.

And speaking of agriculture: By the year 2050, according to a Duke University researcher, we will need to double our current food production to feed the estimated 9.6 billion people on Earth. Part of the answer lies in “precision agriculture,” which involves integrating technology and farming to maximize production, increase efficiency and minimize waste.

For instance, drones are being developed that are equipped with sophisticated sensors can be flown over thousands of acres to gather data on pest damage, crop stress, yield and other factors. Farmers can use drone-captured images to monitor what’s going on and make adjustments where necessary. Some drones can even plant and water crops, while others help farmers determine how much pesticide or fertilizer is needed.

The Apple Watch Series 4 boasts improved fitness and health capabilities. Image courtesy Apple.

Apple, startups prove wearable medical device market extremely healthy

Wearable health-tracking devices have soared in popularity over the last decade as fitness enthusiasts look to quantify their exercise and health goals. But the technology is also finding a welcome home in the medical community, where patients with chronic conditions can use it to monitor their day-to-day health. As we reported in March, MIT spinoff Empatica’s smart watch, The Embrace, was granted FDA clearance to detect the most severe kinds of seizures for patients with epilepsy, while tracking the frequency and duration of the seizures. In fact, Empatica was able to get the product off the ground thanks to a 2015 Indiegogo campaign that raised $800,000, more than 500% of its funding goal.

On a similar note, the Apple Watch 4 released in September was cleared as a Class II medical device by the FDA. As Forbes reports, the watch offers fall detection and three new heart monitoring capabilities: low heart rate alert, heart rhythm detection and a personal electrocardiogram (ECG) monitor. Apple COO Jeff Williams stressed the watch’s potential as a health “guardian,” and noted that Apple Watch 4 is the first ECG product offered over-the-counter directly to customers.

Other wearable medical devices to hit the market this year, per Internet of Business, include sensors for monitoring recovery in stroke patients. Coordinating care for patients recovering from strokes is complex and daunting, and has traditionally required equipment that comes with a tangle of wires – making it tough for patients to resume daily activity and be at home. Northwestern University has developed stretchable, comfortable sensors that are subtle and noninvasive. These wearables give both doctors and patient precise data about all parts of the body without cumbersome wires.

IIoT leveraged for disaster prevention

Companies pioneering Industrial Internet of Things (IIoT) infrastructure are developing ways to prevent industrial disasters through automation, reports PC Magazine. IIoT platforms offer real-time embedded systems, virtualization and AI designed to save lives – and billions of dollars in disaster damage. With these platforms, plant owners and operators can react more quickly in emergencies, thereby protecting the safety of their employees, the surrounding population and the planet.

Ultimately, says Jim Douglas, president and CEO of Wind River, told PC Magazine that IIoT technology is leading us toward automation: “The next wave is machines that are either fully autonomous or partially autonomous…you can have people be more focused on higher-level tasks and let the robots do the lower-level tasks.”

To learn more about how Jama helps organizations thrive in critical product markets by reducing risk and providing a single source of truth, download Frost & Sullivan’s recent executive brief,“Safeguarding Regulated Products Amidst Growing Complexity.”

In a recent webinar about the common pitfalls of the Design History File (DHF), experts discussed what medical device manufacturers need to know about design compliance. Below are some highlights.

Three Pillars of Design Compliance

There are three pillars of design compliance for medical devices:

  1. Design Controls: The moving parts of product design and development
  2. DHF: Collection of records from design and development activities
  3. Device Master Record (DMR): The “recipe” for product manufacturing once design is complete

In order to achieve FDA compliance and effectively bring your product to market, you must successfully satisfy each of the three pillars.

What is a DHF?

The DHF is a compilation of documents that describe the design and development activities of a medical device. Its purpose is to show that the medical device was developed using the design control process, pictured below, needed to meet FDA requirements.

Design Control Process for Meeting FDA Requirements

The FDA lists specific guidelines for DHF under 21 CFR 820.30 (j):

“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.”

The DHF also provides traceability to requirements, can assist with change control and acts as a tool for knowledge preservation and information sharing within your organization or with your supply chain.

Complications of an Incomplete DHF

As the second pillar of design compliance, the DHF connects the first and the third pillars. As noted, it documents that the correct design control process was followed. The DHF is also the basis of the DMR, which must be created according to design specifications.

An incomplete DHF makes it nearly impossible to prove you used the correct design control process for meeting FDA compliance, or create a compliant DMR.

Furthermore, if there are deficiencies noted within the design control subsystem during an inspection, they are documented by the FDA. If your company’s response is inadequate or not timely – which is likely when your DHF is lacking – a public warning letter could be issued. This could not only hurt your credibility in the market, but it might also give your competition some insights that you’d rather have kept within your company’s walls.

Five Common Pitfalls of the DHF

According to experts, these are some other reasons a DHF might fail:

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.

If it feels like creating a DHF is a heavy burden, you should seriously consider the alternatives as well as the urge to make it an afterthought. If you treat your DHF as part of your design and development process, these requirements become seamless and help ease the path to compliance.

To learn more about preventing these issues in your DHF, watch the webinar, Common Pitfalls of the Design History File and How to Avoid Them.

At Google’s I/O developer’s conference in May, Google CEO, Sundar Pichai blew minds by demonstrating Google Duplex, a feature of Google Home and Assistant, which made a simple phone call to book a hair appointment.

If you missed the demonstration, it was an ordinary call made extraordinary because the conversation between Google’s machine and the salon’s receptionist was indistinguishable from one between two humans.

The demo ended up being an incredible, viral moment that highlighted the power of modern Artificial Intelligence for a wider audience. It also helped showcase how we’re only just beginning to glimpse the potential of AI, and there are still plenty of concerns around its abilities.

Forward-thinking minds like Stephen Hawking and Elon Musk have all warned about the consequences of AI, and it’s worth wondering about its imminent application in an industry as crucial to human survival as health care.

As venture capital firm Rock Health notes, health companies are leveraging AI and machine learning and raising a ton of money in the process — $2.7 billion from 2011 through 2017, to be exact.

A lot of the enthusiasm for the burgeoning technology comes from the belief that it has the power to revolutionize a wide range of areas within the industry, from creating cutting-edge medical devices to reducing misdiagnosis, advancing precision medicine to delivering faster, better care to at-risk patient groups.

That’s not to say everyone is jumping on the AI bandwagon blindly. Many are also weighing issues like patient perception, privacy concerns and potential disruption. Plus, the medical industry has seen its share of new, heavily-touted, messianic tech that hasn’t panned out. To gauge the debate, we put together some current pros and cons of artificial intelligence in healthcare.

Pro: Improving Diagnosis
Studies on diagnostic errors in the U.S. report overall misdiagnosis rates range from 5 percent to 15 percent and, for certain diseases, are as high as 97 percent.

Misdiagnosis is an understandable problem for doctors, as the World Health Organization’s International Statistical Classification of Diseases and Related Health Problems (ICD) lists about 70,000 diseases in total, with fewer than 200 presenting actual symptoms.

Assuming it’s been loaded with all the relevant data, an AI-equipped product has the potential to sift through disease data, clinical studies, medical records, genetic information and even a patient’s health records far quicker and more efficiently than a human physician for a more accurate diagnosis.

Con: AI Training Complications
According to Dr. Robert Mittendorff of Northwest Venture Partners, one significant challenge to AI in health care is the lack of curated data sets, which helps in training the technology to perform as requested through surprised learning.

“Curated data sets that are robust and have both the breadth and depth for training in a particular application are essential, but frequently hard to access due to privacy concerns, record identification concerns, and HIPAA,” Mittendorff as says in a recent Topbots article.

Pro: Better Serving Rural Communities
AI could benefit patients living in rural communities, where access to doctors and specialists can be tough. According to Stanford Medicine data, fewer than 10 percent of physicians practice in these communities.

At the Association of Academic Health Center’s 2017 Global Issues Forum, Dr. Yentram Huyen, General Manager, Genomics & Data Exchange, Health & Life Sciences, at Intel said that one way to address that problem is through collaboration for better data.

“Health centers should collaborate on the data, enabling an idea of federated data analytics,” Huyen says, according to Elsevier.com. “It is critical to break down the information silos. We have to think about how we’re going to collaborate and share the data to form [health care] partnerships.”

Con: Change is Tough
The health care community is still somewhat jaded by the last technology that was going to revolutionize the industry, electronic medical records (EMR).

EMRs were supposed to make everyone’s job easier, from the billings clerk all the way to the physicians. For all its benefits though, many found implementation to be a costly and time-consuming disruption to practices. And, as anyone who has experienced a new technology rollout at a company can attest, if things aren’t handled correctly, widespread adoption can be a major issue.

So for AI to be accepted by the medical community at large, it’s going to require, not just proof that it works, but a project plan that includes input from all stakeholders and evidence it’s worth the investment.

As Google’s demonstration showed the world, AI will be capable of handling complex and unexpected questions as long as it has plenty of good data to begin the process of deep learning.

The people serving in health care and those who supply goods and services to the market would be smart to develop and share a mutual understanding of AI. One thing everyone seems to agree on is it’s just a matter of time before we see it implemented in our health care system.

The future of healthcare is evolving rapidly, and companies building forward-thinking medical devices and related-products must also ensure they’re meeting modern quality and compliance standards. Learn how Jama Software can help by reading this profile of RBC Medical Innovations

Author Traci Browne is a freelance writer focusing on technology and products. 

As companies produce more cutting-edge medical devices — often augmented by the use of software and connectivity — regulators have been lagging far behind.

This problem isn’t unique to medical. Other heavily-regulated industries, such as automotive, are also advancing so fast it has left governing bodies scrambling to figure out how to implement safety standards without stunting innovation.

This is one of the reasons why the Food and Drug Administration, which regulates medical devices in the US, recently announced three new guidances for the industry.

“We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed,” FDA Commissioner Scott Gottlieb, M.D. writes in a recent statement.

Below we’ve offered quick summaries of the guidances — two of which are drafts and one is final — to show how the FDC is progressing its regulations.

Clinical and Patient Decision Support Software
What: This draft guidance revolves around determining which types of clinical and patient decision support software fall within the boundaries of regulation and why.
Reason: Clinical decision support software (CDS) helps providers determine the strongest treatment path for ailments and diseases. If a specific CDS allows providers to independently review the basis for its recommendations, it would no longer need to be regulated. On the other hand, a CDS that analyzes things like medical images or signals from in vitro diagnostic devices, for instance, would remain regulated. Similarly, the FDC recommends low-risk patient decision support software (PDS) would also not need to be regulated if a patient or a caregiver has the power to independently review the offered treatment recommendations.

Changes to Existing Medical Software Policies
The second draft guidance again relates to the FDA’s view of the kinds of software that it no longer considers medical devices. Specifically in this guidance, the FDA is proposing things like mobile apps, that promote healthy lifestyles and pose low risks to patients, likely don’t need to be regulated.
Reason: By updating the categories of products it deems low risk, like mobile apps, this new guidance draft goes further than its predecessors and should help ease concerns of developers.

Software as a Medical Device: Clinical Evaluation
After weighing opinions from around the world, the third guidance, which is final, creates common, globally-recognized principles for regulators to use when evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD).
Reason: The FDA says this guidance gives the agency an initial framework to build from as it assesses and analyzes risk for SaMD, while it also continues to develop its own regulatory approaches and expectations for oversight.

All three of these guidances act as pathways the FDA can follow to draw further definition and clarity around its regulatory reach. By doing this, the FDA is hoping it can focus more of its time on high-risk medical devices, which is an understandable prioritization given the rate at which products are progressing.

See how Jama Software helps medical device companies achieve compliance, improve efficiency and maintain alignment.