Medical device developers innovate to move people forward. Theybuild 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.
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 activatesa 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 teamswith 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.
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!
Infographic: Jama Connect™ for Medical Device Development
We’re excited to share our latest infographic for the Jama Connect for Medical Device Development solution which explains how Jama Connect can help accelerate innovation, maintain product quality, and manage the ever-changing complex regulations in medical device development. This is a single powerful platform for medical device teams to manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.
Bringing a medical device to market requires navigating a sea of complex and ever-changing regulations, not to mention bearing significant costs along the way. A device recall can cost $600 million, while the indirect costs of lost revenue and diminished market cap are even higher at $1-3 billion per company. Those costs are especially significant considering the price tag of product development—$75 million in FDA compliance alone, and an average timeline of three to seven years.
→Jama Connect customers have been able to reduce planning time as much as 80%, thanks to consolidated feedback replacing emails and a document-based approach to project management.
→Better quality products get out the door faster. By understanding the impact of change, capturing decisions and feedback in real-time and reusing existing IP, Jama Connect reduces medical device development time by an average of 130 days per project.
→Jama Software reduces rework, which accounts for approximately 30-50% of a given project and arises from issues such as requirements errors. Improving the ability to track requirements from design through verification and validation ensures teams build the right medical devices with the lowest possible lifecycle costs.
In this infographic,we share how, with the right requirements management solution, you can accelerate the development of cost-effective products that also comply with both safety and quality standards.
You’ll learn:
How to overcome the biggest challenges in medical device development
The ways Jama Connect for Medical Device Development can help
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.
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.
Cities may be opening up, but many engineering teams continue to work remotely on product development as companies slowly reopen.
Has your team found its rhythm? If your organization hadn’t planned for a distributed team, staying aligned without jeopardizing quality, efficiency, or timelines could still feel challenging. Jama Software helps the distributed engineering teams of global companies like Grifols, SITA, and Einride work seamlessly and successfully, and has for years.
Here’s what they say works best to keep the product development process on track.
1. Intuitive technology
Intuitive technology is user-friendly by design. It improves efficiency and momentum on a distributed team. Technology like this helps onboard team members, keep them aligned to projects, and connected to team members and their work.
Healthcare leader Grifols adopted Jama Connect™ to help manage the product development process between teams in different countries. They cite the user-friendly, intuitive platform as a key reason they can bring everybody up the speed on changes so quickly. Right away, teams feel comfortable and encouraged to participate, comment, and engage in robust discussions.
“In the long distance between California and Spain, I feel like I’m connected to the team.”
– Carmen Pazos, Diagnostic Divisions R&D Instruments Senior Manager, Grifols Read the whole story
2. Centralized change management
Scattered engineering teams still face evolving regulations and requirements for increasingly complex products. When teams can manage change like reviews and requirements from a single, central location the risk of rework or miscommunication goes down. Relevant stakeholders that collaborate, iterate, and issue approvals in a visible area never lack context.
Multinational company SITA wanted to align remote teams and facilitate effective collaboration around requirements. They chose Jama Connect to get an efficient, easy way for cross-functional teams to review requirements and a centralized, accessible repository for all the company’s requirements.
“Jama Connect has allowed us to get more people from our other offices involved in the collaboration process … People can come into the system at a time that suits them and review things. And we know their comments will be seen by everybody else.”
The product development process requires teams that work with structured, live data, even when remote. They need to be able to define, review, and validate it at any time. Critical functionality of the product they’re working on could depend on it. Communication among teams and stakeholders needs to go beyond the basics of collaboration. It’s about more than just a conversation or a simple text edit.
Einride’s feature-based development process uses the Jama Connect platform to identify which feature should receive the highest priority for development. The collaborative elements of the Comment Stream feature helps distributed engineering teams communicate critical changes to each other as part of their daily operations. For example: Einride develops features at a fast pace, often enhancing the functionalities of their electric freight vehicles after they’re deployed. Teams need to react fast and change tracks if necessary — and collaborate with each other early in the process.
“This is the biggest challenge — to know what feature has the highest priority to be improved and/or developed…as we don’t have hundreds of developers, it’s crucial for us to know this as soon as possible.”
A must-see webinar about remote collaboration is now available in our Resource Center.Matt Mickle of Jama Software and Sabina Söderstjernafrom our autonomous transport customerEinridedemonstrate how the Jama Connect platform helps remote teams communicate effectively and stay productive.
Learn how Jama Connect supports a feature-based development process for Einride.
Sabina sharesbest practices Einride teams uses as they improve and develop different features throughJama Connect. During her session you’ll learn:
How Jama Connect capabilities help identify which feature should receive the highest priority for development—an extremely helpful benefit if you don’t have a team of hundreds of developers to help you.
How the collaborative elements of Comment Stream and Review Center in Jama Connect impact Einride’s decision-making.
The remote collaboration enabled by Jama Connecthelps Einride’sCore Team fulfill its mission, despite physical distance. Together, they can ensure thatthe product built meets the specifications and requirements outlined.
See the key functions that enable remote collaboration in Jama Connect.
In Matt’s session, he works directly in the platform.You’ll see how Jama Connectworksas a modern replacement for legacy requirements management tools, and how collaboration features set it apart.
The goal is for Jama to be a very easy-to-use tool, for it to be very user-friendly so that a lot of people can jump in and get started right away. – Matt Mickle, Senior Consultant, Jama Professional Services
Matt covers three methods of communication and collaboration:
Collaboration Stream: How to create actionable communication streams to elicit feedback from stakeholders.
Reviews for Feedback and/or Approval: How to bring selected people together to get targeted feedback on a small section or component, or to get sign off on a larger body of work.
Single Source of Truth: How to keep the conversations in one place and connected to ensure nothing gets missed and you don’t have to chase down context.
Learn remote collaboration best practices and see how Jama Connect helps remote teams work more efficiently.
Hear stories about how the shift to remote workimpacts product developmentpriorities and learn what best practiceswork effectively. By the end of the 50–minute webinar, you’ll see a path forward. You cansupport collaboration and innovation throughout your product development process—withoutjeopardizing quality, efficiency, or timelines.
Seehowcollaborative requirements tools in the Jama Connect™ platform help teams work remotely.
Jama Software has 10+ years’ experience helping distributed engineering teams stay aligned throughout the product development process. Clay and Aaron apply that experience as they guide you through your new remote work reality. During the webinar, Aaronlogs in toour requirements management platform Jama Connect anddemonstrate how its capabilities help you:
Conduct entirely remote reviews.
Drive collaboration across distributed teams.
Manage change remotely.
You’ll see howJama Connect can help you on a day-to-day basis. The demonstration also touches on how integrationwith your systems can facilitate change management overall—a helpful benefit even after we all return to a regular work mode.
Traceability is the tracking of requirements across the product development cycle. It documents the status of everything being worked on and shows the history of development along with the impacts of specific changes. Its benefits include easier regulatory compliance, more in-sync teams, and higher-quality releases.
A dedicated software traceability solution may be relied upon to systematically track and trace a requirement’s life. Compared to using discrete documents (e.g., spreadsheets) for the same purpose, this type of centralized platform lets teams make easier, more accurate assessments that support more informed decisions about products. It can dependably identify who made each change, what the change entailed, and why it was made – all in one system of record.
Accordingly, such a platform enables superior software requirements testing and management, in industries as varied as medical device manufacturing and automotive production. Let’s look at five tips for how to improve requirements traceability, along with how traceability software helps with each one.
1. Use Real-Time Communications To Empower Teams
Many requirements traceability processes are highly manual and disconnected:
For example, Team Member A creates a traceability matrix in Microsoft Excel. This matrix is a table containing artifacts like requirements, test cases, test runs, and identified issues. Its purpose is to show that compliance requirements for a project are being met.
However, the artifacts in it get frequently updated during the course of development and testing. So Team Member A goes back in periodically to update the traceability matrix and make sure it is fully up-to-date. This is time-consuming and error-prone work.
Team Member B then has to dig through this matrix to see if the changes are relevant to them. It’s possible that what they see at any given point isn’t accurate, though. Keeping up with changes is its own job, with many back-and-forth email barrages to navigate.
Real-time communications within a traceability solution alleviate these issues. Instead of hopping between static documents scattered across emails, team members can collaborate in one virtual space, in which they can share feedback, participate in livestream discussions, see connections between items and their authors or editors, and expedite reviews and approvals. They also have access to all comments, test cases, and activity streams from the same interface.
Such features ensure that changes are communicated directly to the relevant parties and that software traceability stays on track. Team members do not have to waste time poring over a document that might not be 100% accurate or even applicable to their particular responsibilities. Basically, real-time communications remove the traditional bottlenecks of hunting for the latest updates and wondering about their relevance.
2. Chart the Impact of a Change Before it Happens
As noted above, requirements change all the time during software development. It is essential not only to keep team members in sync about these changes, but also to scope out their full impact across the product development lifecycle.
Altering one requirement will directly affect any related system requirements, along with downstream requirements and numerous verification tests. Teams need insight into what these changes will entail, so that they can see if related items are still correct, make any necessary updates, and ultimately trace the right requirements for quality and compliance purposes.
Live traceability in Jama Connect allows for better impact analysis and more streamlined navigation of upstream and downstream relationships:
For instance, links downstream from modified items are automatically flagged as “suspect” to alert team members to the need for possible action.
Relevant contributors can also be notified right away, and critical decisions prioritized; meanwhile, everyone else can save time by not being pulled into something irrelevant.
System users can see if a requirement has test cases downstream and what percentage of them have passed.
With all risks and requirements being updated in real time, teams can reliably trace them and conduct informed evaluations and analyses.
Through these capabilities, a traceability solution helps everyone be more confident that they are working with the right requirements, while avoiding getting bogged down in rework or in costly late-stage changes caused by not having an accurate picture of what is being worked on at every stage. In other words: Live traceability means that traceability is no longer an afterthought.
3. Create a Detailed Audit Trail With Well-Documented Changes
One of the main reasons for implementing traceability software is to simplify regulatory compliance. Let’s say that a hypothetical medical device manufacturer is planning to bring a new connected device to the U.S. market.
The Food and Drug Administration requires compliance with regulations such as FDA 21 CFR Part 11, regarding electronic records and e-signatures. Creating a detailed audit trail to comply with these rules is more straightforward if a unified system of record with full version histories – i.e., a software traceability solution – is in place. Jama Connect Review Center is compliant with FDA 21 CFR Part 11.
Modern traceability software maps out the relationships and interdependencies in product development, allowing for assiduous tracking of risks and requirements in their full historical context. Real-time collaboration also enables even geographically distributed teams to stay on the same page in tracking and tracing work items. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as medical devices become more complex and software-driven.
In Jama Connect, risk analyses and other data such as product-specific views can also be easily exported to the correct formats to prove compliance. Industry-standard templates are available as well to minimize the setup time for creating a plan that aligns with standards such as ISO 14971:2019, ISO 13485, and FDA 21 CFR 820.30.
4. Connect Everyone and Everything with Trace Relationships
Traceability is about relationships. Because each product in development has its own particular set of customers, stakeholders, and internal team members associated with it, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.
That principle sounds simple enough on paper, but putting it into practice can be more complicated. Consider the question of who responds when a series of changes occurs and checks to see if everything is still right. With complex products, multiple team members will likely have to weigh in on and then sign off on these changes, a process that presents some big challenges:
Decision-makers might not have clear visibility into the impact of changes to requirements, like their ripple effects on downstream or upstream items.
High-quality data on requirements-related changes and why they were done might not be readily available and shareable, either.
Coordinating the decision-making process itself can be cumbersome, with everyone exchanging documents via email and struggling to get in sync.
Fortunately, these obstacles can be overcome with traceability software. By implementing a shared system of record with real-time communications capabilities, organizations can adeptly manage their trace relationships and relieve the various forms of decision pressure outlined above.
5. Make Traceability More Proactive To Ensure Test Coverage
Traceability should not be pursued after the fact. Connecting requirements and other items at a relatively late stage is a recipe for trouble, as it can become difficult to gather all the necessary information and put into proper context. Extensive manual work, and the risks that come with it, are also likely to be required in such a reactive workflow.
In contrast, proactive traceability done throughout the product development lifecycle helps reduce risk and pave the way for higher-quality products that align with all of their requirements. Automation is key to this proactivity. Traceability software like Jama Connect automatically saves user inputs, can apply risk level updates in real time in accordance with a user-defined risk matrix, and ensures a standardized approach to risk evaluation across the organization – eliminating silos and disjointed processes.
A traceability solution also provides clear visual representations of the status of requirements, test cases, and test runs along the way. These data-rich views enable better decision-making, since team members are working with live, easy-to-understand information and can communicate with each other through the same platform. For example, users can easily see test coverage levels and where gaps exist.
Take the Next Steps With Traceability Software
The right traceability software lets organizations efficiently manage all of your requirements in one place and streamline the development process of even the most complex products. It saves the entire team time and money, accelerates development lifecycles, reduces the risk of error, and results in improved product quality and regulatory compliance.
In short, traceability provides essential context and clarity. Look for a modern traceability solution that will keep projects on schedule, on budget, and within scope, thanks to better collaboration and requirements management.
Today, we’re re-running this post from January to help spread the word about our upcoming webinar that dives deep into the Engineering.com report. Register here.
A new research report from Engineering.com reveals how design and engineering professionals are approaching the increasing complexity of both their products and requirements management processes.
For the report, Design Teams: Requirements Management & Product Complexity, Engineering.com surveyed nearly 250 design and engineering professionals about the growing complexity of their company’s products and how requirements are managed amidst this changing landscape.
For a full breakdown of the Engineering.com report with guidance on how to correct some of the issues raised, register for our webinar, “The Great Cost of Poor Requirements Management.”
While Jama Software sponsored the report, the research and its subsequent editorial readout were conducted entirely independently by Engineering.com. And the results are extremely illuminating.
Product Development Increasing in Complexity
One of the biggest takeaways, especially for requirements enthusiasts like ourselves, was that even though more than 90% of respondents reported that their products had increased in complexity over the last five years, a mere 15% relied on a dedicated requirements management platform.
Driving this increase in product complexity are many factors, including how development teams have been:
Integrating more electronic components, embedded software and microprocessors
Increasing the intricacy of mechanical designs
Using different materials
Reducing weight and shrinking size
Building connected products (IoT)
Incorporating AI or machine learning
Given the rapid increase in product complexity, product design teams need a structured information system to handle requirements throughout each stage of product development.
Without a dedicated solution, teams are stuck with ineffective requirements management, resulting in things like product outcome failures (83% of respondents) and reprimands by regulatory agencies (62% of respondents).
The Impact of Investing in Requirements Management
Despite a high percentage of teams encountering regulatory and product outcome failures, most product teams (81% of those interviewed, in fact) believe their requirements management process to be effective.
And yet how can these requirements management processes be considered effective when the majority of teams are experiencing product outcome failures and getting penalized by regulatory agencies?
The reason for this contradiction in perception, according to Engineering.com, might be that “few teams employ a formal requirements management system. Having not purchased a system, they are dismissive and forgiving of failures while offering middling praise for the unsophisticated solutions they rely on.”
In other words, most companies don’t know what they don’t know.
Requirements Management Platforms Can Help Reduce Regulatory Reprimands
It shouldn’t be a surprise that development teams in industries that were highly regulated (66%) were more likely to use a purpose-built requirements management solution.
Perhaps not coincidentally, the analysis also showed that organizations using dedicated requirements management platforms in regulated industries not only received fewer instances of warnings, recalls, fines and production stoppages than those that didn’t, but nearly half reported experiencing none of those problems at all.
Plus, across all industries, requirements management platforms were rated highest in effectiveness overall versus any other method.
As the Engineering.com report concludes: “It is clear from the data that the products most design teams are creating are becoming more complex. Yet, they have not thought of investing in the tools available that would help them manage the requirements this complexity demands.”
Here are some other takeaways from the report:
Product teams must manage multiple types of requirements. On average, product teams cited 4.5 different requirement types critical to their products.
Product feature requirements are critical to 79% of respondents (the other 21% were working on less-complex products with fewer feature requirements).
More than 4 out of 5 teams have experienced product outcome failures, including exceeding cost requirements (46%), lost time to market (38%), product shipped without meeting all requirements (36%), and excessive time spent tracing requirements (36%).
The more sophisticated the requirements management system, the more effective it was found to be.
At a conference I attended recently, I listened to teamsdiscuss the challenges they faced in deploying software in their organizations. The consensus was thatthe software is easy; the people are hard.That is to say, getting up to speed with a newsoftware solution itself is relatively easy compared to getting people to change their behaviorand successfully adopt new software.
ROIRequires that TeamsActually Use the Solution
One of the speakers said something that really stuck with me. This personsaid, “There is no return on investment without adoption, and there is no adoption without user acceptance.” And while that may seem obvious, many times the end user of the software is forgotten. Other priorities — like budget, schedule, and various agendas —put a lot of pressure on the deployment plan. The human aspect, as important as it is, gets lost.
Gaining Acceptance Later in the Implementation Will Cost You
When implementing a new solution, it’s imperativethat you get your team on board from the get-go – and not just for the purpose of keeping them happy. Just as it’s more costly to identify inaccurate requirements late in the product delivery lifecycle, the same principle holds true for user acceptance. Resistance from users identified late is always going to be more costly than adoption issuesidentified and addressed early.
While implementing a new solution may be a top–down decision, it’s important to remember that the users are the ones who will need to adapt to the change. The primary impacted stakeholders (i.e. the end–users) will be more receptive to a major change if they are participating in the process, rather than being told that they must adopt a new tool.
Change is difficult, and without a full understanding of the benefits ofa new solution, teams may feel frustrated or resistant. One way to preemptively combat resistance is by identifying long- and short-term goals for each team member and encouraging users to be involved in the implementation process.
The Key to User Adoption is People
Having worked in professional services for over a decade, I have come to see just how valuable it is to understand the people side of deployments. In my years as a business analyst, I’ve seen from the inside just how difficult it can be to get people on board with new solutions, particularly those that also come with process changes, and how to make those changes stick.
My interest in this topic goes even deeper. A few years ago, I completed a master’s program in psychologywhere I studied human behavior and why people do or do not change. I’ve found that what I learned during my study of psychology has translated quite well to the consulting world.
In this post I won’t be able to outline the perfect adoption plan for your organization; this would be futile as no two companies have the same needs or challenges. But I will discuss the approach we recommend when planning for a solution rollout that maximizes adoption.
If You’re Taking a Trip, Bring the Whole Team Along
I’m going to start with an analogy:
Let’s say you’ve pretty much determined that everyone on your team could benefit from a vacation. You’ve even heard people say so. You’ve had some good conversations about what people want and need, and with that knowledge you pick out a destination that’s going to recharge everyone.
Next, you have to figure out what kind of transportation you’re going to use to get everyone to the identified location. You’ve gone online and talked to some others about what kind of vehicle works best for teams like yours.
So, with the information you have, you go ahead and buy the perfect car for this trip. It has all the things you need.
In case you haven’t figured out how the pieces of my analogy fit into the rollout of a new solution, here it is:
The people are those who would benefit from a new process and solution to meet their business objectives
The “destination” is that ultimate goal, where the benefits are realized
The “car” is the newsoftware solution that gets you to that ultimate goal
But here’s something you have to consider before you embark on this journey: You have to figure out where everyone lives, what kind of baggage they’re bringing with them, and how you’re going to organize picking them all up so you can all be in the car at the same time, happily enjoying the journey to your destination. More on that in a bit.
Key Factors in Planning a Successful Software Deployment
If you’ve ever actually planned an out-of-town experience with coworkers (or family, for that matter), you know it’s impossible to make everyone happy all the time. Introducinga new way of working to your teams can be even more difficult. Why?
Before I answer that, remember that these are the main things to keep top-of-mind when planning a successful deployment:
Bringing new teams into a new solution, with new processes, is not simply a functional or technical issue;it is a people-centric change.
Benefits that require that people adopt the solution inherently require that those people change behavior.
The longer adoption problems go unaddressed the more difficultand expensivethey are to address.
New data for 2019 revealsthe growing gap between product complexity and requirements management. Find out more by downloading our report.
Design Your Approach Based on the Specific Needs of Your Team
Change is hard – especially when people are involved. You can put up your pie chart or line graph with anticipated benefits and have everyone nodding their heads in agreement, and you can find the perfect “car” to get you there.But you cannot assume that pointing at that amazing vacation spot on a map or showing off your awesome new vehiclewill translate to motivation and acceptance for the people whomust be on board in the end.
Of course, some will be on board immediately, so make sure you identify those people and train them to evangelize for the effort. Theseadvocates are a great asset as you complete your rollout to the rest of the organization. Successful organizations often pair these early adopters with new users to help them get up to speed with the new process.
Others may need more attention, and youmust pay careful attention to their fears and objections and speak to them early and often.
Consider the Delta Between Where Your Team is Today and Where You Want to Be
You must considerthe maturity of your organization and teams. Of course, it doesn’t have anything to do with the emotional maturity of the individuals (though that could come into play), but the maturity of theirprocesses and toolset and how they’re accustomed to getting their work done today. In my experience as a consultant, I find that team maturity ranges widely, especially when it comes to requirements management processes and supportingtools.
Knowing where teamsare — or theirlevel of maturity — is important for a number of reasons, not least of which is anticipating resistance. Think about the person who is currently using a Word doc that they keep somewhere on their laptop to manage the requirements for a really complex product. This might be considered a pretty basic level of maturity.
Now, before bringing this person into a new solution, it is important to think about the degree of change being asked of this person. What does a single-source collaborative system feel like to a person coming from Word files on their computer? What resistance can you anticipate and what will be your approach? Again, communication early and often is going to be key to getting this person on board with a new solution.
When change is introduced, the initial reaction from most is to resist. This isn’t necessarily a bad thing, as not all change is good. But if you don’t address resistance, it can lead to rigidity, causing teams to dig their heels in and get stuck.
When you are bringing on a new team into your deployment effort, don’t just set up training on how to usethe tool. You’ll want to engage with your peopleat a personal level so you can uncovertheir anxieties and address them. You’ll need to anticipate their questions and welcome their concerns. When you know their concerns, you can address them; it’s the concerns you don’t know about that can manifest very late and cause problems for the whole deployment.
For example: Consider a person who has yet to log into the software even a month after deployment. What did we not know about this person that let them slip through the cracks? A quick way to find out is to simply ask them.
Remember that unanswered questions today turn into resistance tomorrow. Provide opportunities for people to voice their questions early so you can address them. Consider establishing clear channels for communication with users.
Adopt a Change Management Model to Give Your Project Structure
There are many change management models out there, and I recommend researching these until you find one that make sense for the size of your company, itsculture, and your strategic goals. I personally like the ADKAR model from Prosci.
The five parts of this specific change management model fit well with how we’ve been discussing bringing on teams to improve adoption:
Awareness of the need for change.
Desire to participate and support the change.
Knowledge on how to change.
Ability to implement required skills and behaviors.
Reinforcement to sustain the change.
We’ve also seen great success from teams who have read this book: “Change Management: The People Side of Change,” by Jeffrey M. Hiatt and Timothy J. Creasey.
A good change management model, like ADKAR, will help you consider the approach you want to take as you get started on your deployment plan. You’ll want to think about:
How you will build awareness, not just of new processes and solutions, but also why you’re taking on this initiative and what you hope it will do for your organization.
How you will communicate the benefits of using the solution, particularly the “what’s in it for me” for each individual or each team.
How you will build knowledge about how the solution works, relative to the current tool, and how to get the most of it.
How will you ensure people gain the ability to use the solution with the proper training for their position, in a style that will help them feel empowered and not burdened through the learning curve.
What kind of reinforcements you can use to ensure that the process change sticks and the initiative’s objectives are met.
These are just a few examples of how to use the ADKAR modelbut the key is to engage with this line of thinking early and be open to adjusting as you learn more.
