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Design Transfer

Design Transfer: Best Practices for Translating Your Device Design into Manufacturing Specifications

Manufacturing specifications are successful when they result in your medical device being produced consistently, over and over, and meet requirements and expectations, including those of design intent and quality specifications. In this blog post, I’ll share the best practices I follow when translating a medical device design into manufacturing specifications, specifically the drawings and specifications of parts and assemblies.

1: Start early

When thinking about the typical medical device product development paradigm, design transfer is usually depicted as one of the steps right before commercial production. Sometimes it is shown in parallel to design validation, and always after detailed design and engineering and design verification.

However, in reality, design transfer, especially the translation of your device design into manufacturing specifications, should start earlier.

Creating the right manufacturing specifications starts in the detailed design and engineering phase of product development. Manufacturing specifications are the drawings, part specifications, work instructions for assembly, testing requirements, and other elements of the Device Master Record (DMR), or the ‘recipe’ as I like to call it, to be able to produce your product. Thus, it’s key to be already deciding which technologies will be used to produce your parts and using a Design for Manufacturability (DFM) process to make assembly easier and more efficient and reflect those decisions in your drawings and specifications. And like the product development process itself, translating your device design is iterative in nature. Starting in the detailed design and engineering phase allows you to follow the steps further defined below.

2: Involve your manufacturing partners

This is the time to involve your manufacturing vendors for their input as to how to specify the custom parts and assemblies they will be supplying. They are the most knowledgeable regarding the tolerances and limitations their processes can generally provide while you, as the final device manufacturer, are the expert on the final design intent and criticality of the parts or assemblies they are providing. Working together will result in drawings and specifications that can be manufacturable and meet design intent. This is also another good time to incorporate other Design for Manufacturability (DFM) aspects for the largest positive impact to the design.

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

3: Incorporate risk

Translating your design specifications into manufacturing specifications is not a time to omit incorporating risk. Reference your risk analysis to determine which parts have functional and safety implications and tailor the specifications, including the quality specifications accordingly.

4: Remember the quality specifications

Speaking of quality specifications, having a strong quality control plan, based on risk, is also part of a successful translation of design specifications into manufacturing specifications.

Elements of a quality control plan include quality agreements with vendors; part validation expectations; various inspection requirements, including during receipt of first articles, incoming, in-process, and final acceptance testing; and ongoing process monitoring. Aligning expectations with suppliers of critical components is key. I see these quality specifications as partners to the part and assembly drawings and specifications.

Inspection testing is a good example to see the relationship from a design input specification to a manufacturing specification, specifically in this case, to an in-process testing specification. Say your device has a design input specification for a minimum flow efficiency of 80%. The 80% is based on the clinical need of the device. During design verification, the design is tested with a statistically relevant sample size to have an efficiency of 95% ± 2%. This range is also measured during process validation. Thus, in-process testing can be set at an 89% minimum. Note, this is intentionally tighter than the original design input, so that process issues and drift can be detected earlier.

Another example is related to sterilization. Say the design input is for a sterile product to have a one-year shelf life, i.e., the sterile barrier must maintain its integrity for one year. In this case, a Tyvek heat-sealed pouch is selected as the sterile barrier. During detailed design and development, the specific pouch is selected, the parameters for sealing are determined, and the corresponding peel strength of the seal is measured. Then design verification testing verifies that the pouch, when sealed under the selected parameters, does indeed maintain its sterile barrier after one year (accelerated aging). At this point, the corresponding peel strength of the seal can be used as an in-process specification to monitor the sealing performance. This minimum force specification is based on the performance data measured to date (typically from process validation), with adjustments to accommodate the observed manufacturing variability. Thus, the design input to have a one-year shelf life of the sterile product is translated into a manufacturing, in-process testing specification of a minimum peel test force of the seal.

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

5: Create your traceability matrix

The FDA and other regulatory agencies expect a trace matrix associated with your medical device to show linkages from User Needs through Design Validation.

In the trace matrix, it’s where you can see the direct linkages between part and assembly (design outputs) specifications to corresponding design input specifications. Note that it need not be a 1:1 relationship. Multiple part/assembly specifications can be linked to a design input, and one part/assembly specification could fulfill multiple design inputs.

Here’s a snippet of a trace matrix for a fictional home-use thermometer. Especially for more complex medical technologies, a requirements tool such as Jama Connect® makes it more efficient to create and manage a product’s traceability matrix and ensure there are no gaps. As the Design Output column are manufacturing specifications, this is where you can see the traceability between the design input specifications to manufacturing specifications. It’s in this column where the manufacturing testing requirements in the examples above would be listed.

And a well-specified trace matrix is a good tool to use to understand the impact of future design changes, both for changes that occur after the design has transferred to manufacturing, as well as for any changes that may result from design verification and design validation. At times, if the risk is appropriate, you can choose to perform some design verification activities and design validation activities in parallel. Test units for design validation must be production equivalent, thus being able to trace which revisions of the design and resulting manufacturing specifications used units for design verification activities and design validation activities is important and to be able to justify the impact of any differences.

There are many activities to consider as part of manufacturing transfer. These best practices focus on translating the device design into part and assembly drawings and specifications, including the quality specifications, that are a part of ensuring your device is made the right way every time.


Digital Twin

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from AI Multiple – 15 Digital Twin Applications/ Use Cases by Industry in 2022  – which was originally published on April 25, 2022, by Cem Dilmegani.

15 Digital Twin Applications and Use Cases by Industry in 2022

Digital twin technology is becoming more widespread. According to Deloitte study, the global market for digital twins is expected to grow with 38% CAGR to reach $16 billion by 2023, and the proliferation of IoT technology accelerating this growth.

A digital twin is a virtual/ digital replica of physical entities such as devices, people, processes, or systems that help businesses make model-driven decisions. Digital twins are changing the way work is done in different industries with varying business applications. Knowing those applications can help businesses implement digital twins into their processes. Therefore we examined digital twin applications in manufacturing, healthcare, supply chain and retail. And we created the list of digital twin use cases, applications and examples.

Supply Chain

Digital twins are also widely used in the supply chain/logistics industry. Some applications are:

Predicting the performance of packaging materials

Product packaging can be virtualized and then tested for errors before being packaged. Digital twins help logistics companies determine material feasibility.

Enhancing shipment protection

Logistics companies can analyze how different packaging conditions can affect product delivery with the help of digital twins.

Optimizing warehouse design and operational performance

Digital twins enable logistics companies to test warehouse layouts so companies can choose the most efficient warehouse design to maximize operational performance.

Creating a logistics network

A digital twin of a road network carries information about the traffic situation, road layout, and construction. With that knowledge, logistics companies can design the distribution routes and inventory storage locations.


A digital twin can help construction firms understand how a building is performing in real-time, which allows them to tweak performance to optimize efficiency. Data collected from digital twin can be used for planning and designing future buildings.


Digital twins can help healthcare providers virtualize healthcare experience to optimize patient care, cost, and performance. For healthcare, use cases can be categorized into two groups:

Improving operational efficiency of healthcare operations

Creating a digital twin of a hospital, operational strategies, capacities, staffing, and care models helps healthcare providers examine the operational performance of the organization.

Improving personalized care

Healthcare providers and pharma companies can also use digital twins to model the genome code, physiological characteristics, and lifestyle of patients so that healthcare companies can provide personalized care such as unique drugs for each patient.

Related: 2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability


Applications of digital twins are most widely used in the manufacturing industry. Manufacturing relies on high-cost equipment that generates a high volume of data which facilitates creating digital twins. Digital twin applications in manufacturing are as follows:

Product development

Digital twins can help engineers test the feasibility of upcoming products before launching. According to the test results, engineers start producing or shift their focus to creating a feasible product.

Design customization

With digital twins, businesses can design various permutations of the product so that they can offer personalized products and services to their customers.

Shop floor performance improvement

A digital twin can be used to monitor and analyze end-products and help engineers see which products are defected or has lower performance than intended.

Predictive maintenance

Manufacturers leverage digital twins to predict potential downtimes of machines so that businesses minimize non-value adding maintenance activities and improve the overall efficiency of machines since technicians take action before a failure happens.

However, using digital twins for predictive maintenance tasks is not scalable as it is a machine-specific virtual replica and requires expensive data science talent to build and maintain twins.

For more info on digital twin applications in manufacturing, feel free to check our article about AI applications in manufacturing where we explain each application.

In aerospace and automotive manufacturing, there are further applications of digital twins:


Before digital twins, physical twins were used in aerospace engineering. An example is Apollo 13 program in the 1970s where NASA scientists on earth were able to simulate the condition of the ship and find answers when critical issues arose. Later in 2002, the digital twin concept is introduced by John Vickers from NASA.

Today the importance of digital twins in the aerospace industry is acknowledged by experts that 75% of air force executives have cast the vote of confidence in favor of the digital twin, according to Business Wire’s survey report.

With digital twins, engineers can use predictive analytics to foresee any future problem involving the airframes, engine, or other components to ensure the safety of the people onboard.

Related: Jama Connect® for Aerospace and Defense


Developing new cars mostly takes place in a virtual setting. Digital Twins are used in the automobile industry to create the virtual model of a connected vehicle. Automotive companies use the technology to design the ideal automotive product even before production starts. They simulate and analyze the production phase and the problems that might occur once the vehicle hits the roads.

Self-driving car development

Though digital twin practices can be used in the traditional automotive manufacturing industry, digital twins are handy for autonomous vehicle companies. Self-driving cars contain numerous sensors that collect data regarding the vehicle itself and the environment of the car. Due to the liability questions that surround autonomous vehicles, creating a digital twin of a car and testing every aspect of the vehicles is helping companies ensure unexpected damage and injuries will be minimized. Some applications of digital twins in the automotive industry are road testing and vehicle maintenance.

For more on digital twin applications in manufacturing, feel free to watch the video of Dr. Norbert Gaus who is head of R&D in Automation and Digitalization at Siemens. He is explaining how digital twins help streamline the production process in the real world and providing examples:


Customer modeling & simulations

Retailers can create digital twins of customer personas to improve the customer experience they deliver. For example, retailers can provide ideal fashion clothing products to customers based on their digital twin models.

Finally, you can view our data-driven list of digital twin software to find the best solution that suits your business needs. If you still have questions about digital twin applications, we would like to help:



Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post – P&C Industry’s Future Hinges on People & Technology – we share content sourced from Insurtech Center, which was originally published on May 4, 2022, by Mark Breading.

Property & Casualty (P&C) Insurance Industry Future Hinges On People & Technology

Some people may conclude these developments crowd out humans as automation and AI take over. Nothing could be further from the truth in the P&C industry. The value of insurance professionals will be elevated due to two primary factors: expertise and empathy.

Digital transformation has been an overarching theme in P&C insurance for several years. Carriers recognize the future of distribution, underwriting, policy servicing and claims all are dependent upon digital operations. In fact, every part of the P&C insurance business is affected by the march of technology and the way it is changing customers, risks and operations. The pandemic accelerated tech and digital trends, causing carriers to rethink and reshape their plans. SMA research shows that 100% of carriers in all P&C segments have significant digital transformation plans underway as they increase competitiveness for today and prepare for the future of insurance.

Driving this transformation is the way that digital, connected technologies and artificial intelligence are changing the world around us. We are still far from the science fiction scenarios of robot overlords and androids that are indistinguishable from human beings. But the world we inhabit today is dramatically different from just a decade ago. The average person has many digital interactions every day, from ordering dinner or groceries online to shopping for goods and communicating with family, friends and business colleagues. Real-time video, speech-to-text translation for email or texting, online chat and a vast array of social media platforms are readily available and pervasive in their use.

Every day, individuals and businesses benefit from automated driving and safety features and the ability to remotely monitor and control their homes and businesses via a mobile app. The next 10 years promise to usher in just as much or even more dramatic change than the last decade as we progress toward autonomous vehicles, augmented/virtual reality for daily interactions and the instrumentation of the world — connecting everything insured by the industry to the internet.

The implications for P&C insurance are enormous. While all this tech-driven change may seem overwhelming, it is useful to think about what it means for insurance in three categories: customer expectations, the evolving risk landscape and operational efficiencies.

Related: The Emergence of Technology for Insurance Product Development

Customer expectations

Carriers have been on a path to gaining a deeper understanding of customers (including policyholders and agents). The pandemic has enhanced expectations across the board. By necessity, the world shifted to a virtual, digital mode during the pandemic. Now, instead of asking if you offer remote, digital, omnichannel capabilities, the question is, why don’t you offer these capabilities? Customer journeys have been reshaped and expectations altered for everyone interacting with a carrier, including business partners and employees.

Evolving risk landscape

AI and the digitally connected world have already surfaced new risks, chief among them being cyber risk. As digital data from billions of connected sources flows through the business ecosystem, the cyber exposure increases exponentially. It is a great opportunity for P&C industry leadership. However, there are many new or evolving risks on the horizon. The risk picture is shifting for increasingly autonomous vehicles and homes, businesses, farms, vessels and their cargo, and many more things, as well as people and workers. Will these reduce claims dramatically? Or will they introduce new, unanticipated risks?

New options for insurance operations

Operational efficiencies are already receiving a boost from automation and technologies such as robotic process automation (RPA). Now solutions for data pre-fill, automated decision-making and advanced communication capabilities yield big benefits for insurers. In addition, the potential is high for carriers to gain new insights to improve risk selection, policy servicing and claims.

Related: Simplify and Optimize Processes in Complex Insurance Product Development

The future of humans in P&C

Some may conclude these developments crowd out humans as automation and AI takes over. Nothing could be further from the truth in the P&C industry. The value of insurance professionals will be elevated due to two primary factors: expertise and empathy. Certainly, many simple activities will be automated and taken out of the hands of insurance professionals — to their delight.

However, insurance is a complex business that is foundational to society and designed to meet customers at their greatest times of need. There may be fewer agents, underwriters and adjusters in the future due to demographics, but those roles will be more focused on adding value through their deep expertise and the human touch when advising customers on how to address their risks and guiding them through a claim. The roles will evolve, to be sure, as carriers seek the best tech/human blend, but there will still be a great need for expertise and person-to-person interaction that will not be automated away.

The P&C industry’s future is bright. The world only gets more complex, and the need to aid individuals, businesses and governments in navigating the risk landscape, being proactive in risk management and providing indemnification when bad things occur is likely to increase. This provides a great opportunity for leadership — especially for those willing to take bold action today.

Mark Breading is partner, carrier transformation, at Strategy Meets Action, a ReSource Pro company. He specializes in advanced and transformational technologies.

The opinions expressed here are the author’s own.


Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Medical Device and Diagnostic Industry – Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists  – which was originally published on April 8, 2022, by MDDI Staff.

Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists

The medtech industry’s premier awards program honors significant achievements in medical product design & engineering that improve the quality of healthcare delivery & accessibility.

The Medical Design Excellence Awards (MDEAs), the medtech industry’s premier awards program, organized by Informa Markets – Engineering, publisher of Medical Device + Diagnostic Industry (MD+DI), today announced the winners and finalists for the 2022 MDEA competition. This year, nearly 30 winners and finalists were announced in 10 product categories on www.mddionline.com.

Since its inception in 1998, the MDEA program has honored significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. More than just a beauty contest, the MDEAs convene an independent panel of esteemed jurors—made up of clinicians, engineers, and designers—to select up to six finalists, as well as Bronze, Silver, and Gold winners in each of the 10 product categories, along with overall Best-in-Show winner and Readers’ Choice. The annual competition recognizes products that are moving the $450 billion medical device industry forward through life-saving innovations and remarkable technological advancements.

Entries are scored based on five criteria: design and engineering innovations, user-related innovations, benefits to overall healthcare, benefits to patients, and differentiation in the market.

Related: Requirement Debt™: A Medical Product Program Risk

“This year’s entrants were amazing; each playing a significant role in changing the direction of the industry and bringing viable new innovations that overcome today’s most pressing challenges in the healthcare field,” said Daphne Allen, editor of MD+DI. “Congratulations to our winners and finalists who are shaping much-needed progress in a meaningful and impactful way.”

2022 MDEA Winners are as follows:

Best in Show: HemoScreen (PixCell Medical)
MD+DI Readers’ Choice: CT in a Box (GE Healthcare)

Cardiovascular Devices

Gold: TYRX Absorbable Antibacterial Envelope (Medtronic)
Silver (tie): HydroPICC and HydroMID (Access Vascular, Inc.), TELLTALE Electrosurgical Guidewire System (Transmural Systems)
Bronze: ASSURE Wearable Cardioverter Defibrillator System (Kestra Medical Technologies, Inc.)

Digital Health Products and Mobile Medical Apps

Gold: Minuteful Kidney Test (Healthy.io)
Silver: Oregon Capacity System (GE Healthcare)
Bronze (tie): Bigfoot Unity Diabetes Management Program (Bigfoot Biomedical), FreeStyle Libre 3 (Abbott)

ER and OR Tools, Equipment, and Supplies

Gold: MOLLI (MOLLI Surgical Inc.)
Silver (tie): Baxter EASYGRIP FLO41 (Baxter), Hugo Robotic-assisted Surgery System (Medtronic)
Bronze: TN-Advanced Tibial Nailing System (DePuy Synthes, the Orthopaedics Company of Johnson & Johnson)

Gastrointestinal and Genitourinary Devices

Gold: The iTind Procedure (Olympus Corporation)
Silver: CarePath (I-O Urology)
Bronze: EnteraLoc (Vonco Products, LLC)

Related: Why Your Medical Device Risk Management is NOT Effective

Implant and Tissue-Replacement Products

Gold: ApiFix (OrthoPediatrics)
Silver: Leith Medical Patented Ankle Plating System (Leith Medical)
Bronze: KG2 Surge Interbody Flow-Thru System (Kleiner Device Labs/BAAT Medical)

Nonsurgical Hospital Supplies and Equipment

Gold: Rediroom — Instant Patient Isolation Room (GAMA Healthcare / Care Strategic)
Silver: Flusso TFI (McArthur Medical Sales Inc.)
Bronze: HydroPICC and HydroMID (Access Vascular, Inc.)

Over-the-Counter and Self-Care Devices

Gold: Quick Fold and C-Grip Canes Collection (Michael Graves Design)

Radiological, Imaging, and Electromechanical Devices

Gold: Imagio Breast Imaging System (Seno Medical)
Silver: Smart-C (Turner Imaging Systems)
Bronze (tie): AquaBeam Robotic System (PROCEPT BioRobotics Corporation), CT in a Box (GE Healthcare)

Rehabilitation and Assistive-Technology Products

Gold: INSIGHT System (Adapttech)
Silver: TrueLimb (Unlimited Tomorrow, Inc.)
Bronze: ArmMotus EMU (Fourier Intelligence)

Testing and Diagnostic Products and Systems

Gold: HemoScreen (PixCell Medical)
Silver: KneeKG (Emovi)
Bronze: ASP Device (ASP Health)

A complete list of finalists in the 2022 MDEA competition can be seen on MD+DI’s website.

The MDEA program accepts entries worldwide from companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices. The competition is open to finished medical devices, including instruments, machines, implants, in vitro reagents, mobile medical applications, or other related products that are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions in humans or animals.

To learn more about the MDEA program, visit www.mdeawards.com.



Examining the role legacy requirements management solutions, such as IBM DOORS, play in introducing project risk to the product development process.


Are Legacy Development Tools Putting Your Development Process at Risk?

The past few decades have ushered in a new way of working and now teams are expected to work more efficiently and collaboratively across the organization and supply chain. Companies building highly regulated and complex products often rely on legacy tools such as IBM® DOORS®, yet as product development methodologies evolve, legacy requirements management tools have not kept pace. Misalignment between what teams need vs. what legacy solutions provide can result in increased risk in the product development process, leading to inefficiencies and lack of visibility that result in missed deadlines, defects, compliance gaps, and rework. Companies that have migrated to a modern solution from IBM DOORS have achieved faster development times, greater efficiencies, and reduced expenses. As you plan your next move, we’ll cover everything you need to consider moving forward, including market challenges, how engineering teams are adapting, and why waiting to make a change will continue to expose you to greater unnecessary risks.

Market Drivers Are Pushing Engineering Teams and Technology to Evolve


Today’s products and software have become more complex. This complexity, combined with rapidly evolving customer and market demands, is forcing engineering teams to change the way they work. Now, far more stakeholders need to get involved in the requirements, driving the need for requirements tools to be more collaborative and have functionality that is applicable to diverse users. Organizations that successfully transform to support this new way of working understand that effective and optimized product and system development requires highly collaborative solutions and methodologies. To reduce risk in product development while still accelerating system design and delivery, teams need access to real-time data and alignment across disparate teams as well as across engineering, business, and product management lifecycles.

Leading-edge companies who are successfully supporting transformation of their engineering teams:

Invest in new technologies and agile processes to continually improve product development: Engineering teams prefer to make their own decisions about which best-of-breed solutions support their specific discipline and optimization of their activities – one single tool will not fit all users’ needs. It’s no longer possible for a Prime Contractor or OEM to mandate a single product or vendor across supply chains, and in fact, standards such as ReqIF (Requirement Interchange Format) and OSLC (Open Services for Lifecycle Collaboration) have come about to help products work better together. Modern development solutions prioritize integration across the ALM-PLM ecosystem.

Take a data-driven approach to product development: An organization’s investment in their data is far more than the investment they make in tools, and the primary focus now comes down to availability of data and how that flows across an engineering community (integration) and the value chain (exchange). What is required is a loosely coupled approach that ties together the necessary metadata across disparate tools in a way that connects the desired outcome (user and system requirements) to downstream activities – the digital thread. The digital thread is the best approach to reduce the risk of negative product outcomes while preserving engineering autonomy and productivity.

Support more formal processes to address increased regulation: As product complexity increases, so has the need for more formal processes and compliance with industry standards. Best practices for systems engineering have been prescribed in many industries. This formal process adoption started with the need to comply with aerospace standards such as DO178 or ISO 9001. Now we see engineering regulation or compliance needs increase across automotive, medical, finance, and other industries, which require the same level of rigor in their development process. Investment in tools that support the generation of the necessary proof of-process compliance to standards, most commonly: requirement validation, verification, traceability, risk assessments, and test results, are critical to supporting efficiency while reducing risk.

RELATED POST: Migrating from IBM DOORS – Why and How Rockwell Automation Made the Switch

Why Organizations Originally Invested in a Requirements Management Tool

Requirements management (RM) has long been accepted by the engineering industry as an essential discipline, no matter which process is used, or which type of system is being produced. Organizations originally invested in a requirements tool such as IBM DOORS to establish a standard requirements management practice and process that allowed teams to align on a single source of truth for requirements. They invested in RM with the goal of:

  • Encouraging and motivating teams to follow common requirements practices. 
  • Establishing a single source of truth for requirements to ensure teams were working off the same information. 
  • Creating minimal disruption to the business with an off-the-shelf solution that allowed teams to focus on their core business. 
  • Integrating RM into core workflows and business without impacting how people work. 
  • Tracking the life of a requirement through development, test, and release.

We had this idea that a complete redesign of the requirements process and technology would be a game-changer — reducing the time it took for us to implement solutions for our clients and making it easier for clients to review and collaborate year-round. From the outset, we said that we’re not going to be throwing documents at our clients to mark up with their edits — there was a better way to do this.” Elizabeth Rosenberg – Alight Solutions

The Drawbacks Organizations Have Found with IBM DOORS

You may currently be using a solution which was implemented with all the intentions of producing positive business outcomes. But over time, the market has changed and, as a result, your organization’s needs have changed.

If you feel like you’ve outgrown your requirements management software, you aren’t alone. Complex systems such as IBM DOORS have inherent drawbacks and have also had trouble keeping up with the innovation occurring in highly regulated industries. Continuing to use a solution that your organization has outgrown comes with a variety of challenges, including:

A cumbersome user experience. DOORS has a complex and challenging architecture and an outdated user interface. Existing users are losing the motivation to continue to use DOORS while new users are reluctant or refuse to learn.

A system lacking robust collaboration abilities and a single source of truth for requirements. With stakeholders reluctant to work within DOORS, “librarians” must enter information into the system to keep everything up to date, while the real collaboration happens outside of DOORS in emails or conversations. As a result, organizations lack the ability to perform robust reviews or examine the audit trail for requirements evolution. Additionally, teams using DOORS often must retain dedicated staff, a cost that is unnecessary in today’s competitive market where teams are being tasked with doing more with less.

Risk is introduced due to aging technologies. DOORS 9.6 is already outside of its original support window, which raises questions about how long DOORS will continue. Inevitably, IBM will at some point discontinue support for the DOORS legacy platform, and that leaves customers in a high-risk situation trying to protect their intellectual property. Additionally, a cloud option is not available, which creates challenges with remote working.

A high cost of ownership and reliance on customization. Organizations need to focus on their core business and using a bespoken RM tool interferes with that goal. Companies often struggle to achieve the benefits promised by DOORS without complex customization, and those customizations don’t transfer to IBM DOORS Next.

For example, if a company makes cars, then their core business is to focus on cars. If, instead, they need to spend a lot of time writing customizations for a requirements tool then the focus is on creating a requirements tool and not on cars. The time spent on the creation of customizations is a detriment, moving their focus away from core business. Many customizations are also decades old, and it’s increasingly challenging to recruit or replace staff with DXL skills, once again adding risk to an organization.

Stagnant infrastructure doesn’t support change. At rest, DOORS is working and has a low IT man-power cost of ownership. Changes are constantly happening and ignoring them creates additional risk. Users oftentimes refuse to use DOORs and wind up working in Word/Excel and collaboration is done in meetings and emails leaving decisions and details lost outside of DOORs. As the IT industry faces more demanding regulations, supporting the DOORS architecture is growing increasingly difficult.

Lack of vertical frameworks to support compliance. As industries establish increased regulatory and compliance rules, new and updated industry engineering frameworks have been created (e.g., DO178 A, B & C). Legacy requirements tools made early attempts at providing engineering frameworks, but these have not kept up with industry changes and are now mostly left to users to create for themselves.

Risks and Costs Associated with Staying with IBM DOORS

Tools that are difficult or frustrating to use and require experts to operate will not only slow down development but will also breed resistance and hinder adoption. This creates fragmented processes that introduce unnecessary risks for organizations that must stay current with compliance regulations while developing integrated, complex products that sustain business and maintain market relevance.

The unintended consequences of a fragmented development process are critical functions such as requirements traceability, verification, validation, risk mitigation, product integration, and compliance can be fraught with information gaps, defects, delays, rework, recalls, missed requirements, and significant manual effort. In the complex product, systems, and software delivery lifecycle, organizations can experience negative outcomes such as: 

  • Performance: Product fails to perform specified functions. 
  • Quality: Product defects are discovered by customers post-launch. 
  • Delays: Product release deadlines are missed, or costs are overrun. 
  • Fit to requirements: Product fails to meet the needs of customers. 
  • Compliance gaps: Gaps identified late and require extreme cost to rework and fix. 
  • Regulatory action: Product is not approved for launch or recalled post-launch.

RELATED POST: Is There Life After DOORS? The High Cost of Poor Management Requirements

Considering a switch? If you want to move away from IBM DOORS, you are not constrained by a specific path to migration.

Leaders might already understand the need to switch from IBM DOORS, but they aren’t sure of the next best step. Some lean toward switching to IBM DOORS Next with the assumption that it will be easier to learn and deploy than starting from scratch with a new solution.

However, the only thing that DOORS Next shares with the original DOORS is the name; otherwise, it’s a completely different platform that takes the same level of migration effort that any migration away from DOORS legacy would take. Any expensive DXL customizations — which can sometimes add up to more than a million lines of code — cannot be migrated to DOORS Next.

As you make your decision on whether to migrate away from DOORS or not, consider the risks associated with DOORS and the benefits of choosing a different option. Risks may include: 

  • Loss of control and employee frustration. Employees frustrated with DOORS work outside of DOORS, most often in Microsoft Word or Excel, which means that requirements are no longer maintained in a central system and a rigorous process is not followed. This leads to an inability for management to monitor key metrics for the end-to-end process to identify process risk patterns. 
  • Increased operational costs. Continuing the existing path of using DOORS increases an organization’s risk and expense complying to ever demanding IT security regulations. 
  • Disruption in business. New users are reluctant to pick up the antiquated user interface of DOORS, expecting software to be as intuitive as applications in their social environment. Not having the ability to move fast and scale business to meet innovative market demands will cost your business time and resources. 
  • Missed market opportunities. Errors, defects, and omissions not found until the end of the process cause costly delays and overruns. A company’s long-term success can be hindered by delayed launches and missed market opportunities. 
  • Increased exposure to risk in regulated markets. A requirements management tool helps you stay compliant and increase visibility in regulated markets. Limited customer and cross-functional involvement in the review and approval of requirements and a lack of stakeholder alignment create unnecessary risks. And, the absence of process exception tracking, which determines if requirements have been omitted or modified, creates additional exposure. With more stakeholders refusing to use DOORS, compliance is checked after the fact with the arduous task of tool admins importing data and then running trace analysis. Extended stakeholders who are using DOORS are only able to see any errors long after they have been introduced and eventually imported. 
  • Distraction from the core business. An ineffective requirements management tool encourages organizations to create customizations rather than simply configuring a tool to meet process needs. Developing and maintaining ad-hoc customizations force an organization to focus on how to create requirements management functions rather than focus on core business. A modern requirements management solution enables teams to work faster and more efficiently, leading to faster time to market.

This blog is Part I – Part II is available here – of a series covering this whitepaper:  Why Move Away from IBM Doors Legacy and Why Now 


non-functional requirements
In this post, we look at non-functional requirements are tracked by agile product teams and how they impact the product development cycle.

Imagine that you’re in the market for a new car. As you shop, you have a couple of non-negotiable features or attributes in mind, such as saving destinations within the car’s built-in GPS navigation system or that the car must be black. Although you may consider these to be “must-have” features, they would be considered non-functional requirements tied to the user experience.

What are Non-Function Requirements (NFR)?

Non-functional requirements are global constraints on a software system e.g., development costs, operational costs, performance, reliability, maintainability, portability, robustness etc.

A requirement that does not relate to functionality, but to attributes such as reliability, efficiency, usability, maintainability, and portability.

In systems engineering and requirements engineering, a non-functional requirement is a requirement that specifies criteria that can be used to judge the operation of a system, rather than specific behaviors.

Non-functional requirements may be found in adverbs or modifying clauses, such as “The system prints invoices quickly” or “The system prints invoices *with confidentiality.”

Software has non-functional requirements that are essential to creating a positive experience for the user. And if you miss the mark on these requirements, you may have scheduling delays, budget setbacks and unsatisfied clients.

A project that lacks non-functional requirements may also lack clarity, which can result in vague project scope and a disconnect between the designer and client expectations.

Non-functional requirements bridge the gap between what developers believe customers want and what customers really want.

One study found that 60 to 80 percent of the cost of software development involves rework. And when the non-functional requirements are done well, you may eliminate 50 to 80 percent of product defects.

So, now that we’ve defined non-functional requirements, how do you integrate them effectively into your product development process?

Non-functional requirements focus on the “ilities” of the product

The “ilities” of a product include quality, reliability, manufacturability, usability, serviceability, upgradeability, etc. See SEAri MIT for more information.

Non-functional requirements focus on the user experience. A non-functional requirement is a statement defining a system quality, constraint, or external interface. For example, you might want to build a system that can manage expansion in the future. But saying so isn’t enough. You need to be specific. Instead, you might define that as “building a system that can manage at least 50,000 users over the next 24 months, so customers don’t experience the frustration of system crashes.”

Additionally, a non-functional requirement may:

  • Follow any legal or adherence rules.
  • Define quality attributes of the software.
  • Ensure performance in key areas such as reliability, availability, scalability, and more.
  • Focus on the user experience so the system is easy to operate and the risk for potential rework is minimized.

Just as with car shopping, not everyone needs the same features to make their user experience great. You might want warming seats in a new car, but somebody else might want a third row of seats. So, the non-functional requirements that you define for your project will vary based on client expectations. A list of potential categories, however, can give you a starting point to consider which non-functional requirements need to be on your list.

What are the different types of non-functional requirements?

Think about non-functional requirements as buckets that hold attributes important to the user experience. Remember, it’s not what a product will do (which are its functional requirements), but it’s what a project will be.

If you have selected the right buckets and measured the right things, then you can feel confident that you’re handing over a product that will meet customer expectations – because you’ve clearly defined these expectations up front. Everyone is on the same page, which is even further enhanced when you centralize your requirements management, which we’ll touch on shortly.

For now, let’s look at some of the potential categories for non-functional requirements:

  • Performance and scalability. What are the required response times, benchmark specifications, and other attributes related to performance? How fast does the system provide results, and how will the performance change with higher workloads?
  • Operating constraints. Operating constraints may include any required software requirements, system requirements, and run-time constraints that need to be considered in product development.
  • Platform constraints. Most projects include some sort of platform constraints. Clearly define these upfront.
  • Modifiability. How much effort is required to make changes to the software? Defining this upfront can help the customer better plan for any potential changes.
  • Portability requirements and capability. How difficult will it be to move the software to a different platform? What hardware and operating system does the software run on? Does it conflict with other processes or applications within these environments? Clearly define these elements.
  • Reliability. How often does the software fail? Outline any consequence of software failure and strategies for detecting errors, plans for error correction, and more.
  • Security. Security focuses on the requirements for protecting the system and data. How much time and effort does it take to break into the system, and how can you mitigate these exposures?
  • Usability. Usability is focused on the user experience. How difficult is it to learn and operate the system, and how can you improve any potential uses?
  • Legal. There may be legal issues around data privacy, intellectual property rights and more.

Categories vary by project, yet some common categories include availability, capacity, reliability and security. Using a few of the more common ones to start and then expanding to other areas can help you build a template for new product development projects.

Functional vs. non-functional requirements: What’s the difference?

Attributes of Functions vs Nonfunctional Requirements

Functional requirements are focused on how the software needs to perform or the desired behavior of the system. For example, if a specific condition is met, a system will send a new user a welcome email. A functional requirement is focused on what the system does when a requirement is met. Other functional requirements might involve business rules, reporting requirements, audit tracking, and more.

A non-functional requirement focuses on properties and characteristics of the product that are generally passive. Non-functional requirements are focused on attributes such as privacy, portability, reliability, stability, and more.

What is a non-functional requirements document?

Non-functional requirements are one component of the software requirements specification document (SRS document). This document focuses on what the software is expected to do and how it’s expected to perform. It also addresses what is required in terms of functionality from a user perspective.

The SRS documents include a few sections, such as:

  • Overview of the system. The overview includes high-level details about the system. Any useful terms are defined upfront in a glossary-like format.
  • General description. This section outlines any assumptions about the project and the overarching vision or theme.
  • Specific requirements. This section is where the functional and non-functional requirements are included.

If you haven’t written an SRS document before, or if you want to improve on your existing document, check out examples as a starting point. These also provide inspiration for how non-functional requirements examples flow into the entire document.

What templates exist for tracking and managing a non-functional requirement?

Software and hardware teams collaborate throughout the entire development process as they define functional and non-functional requirements. However, this collaboration becomes problematic when teams use different tools. Centralizing requirements management allows you to save time, align more effectively, and ensure the quality and compliance of product development. Using a single solution enables you to effectively:

  • Experience a single source of truth. A single source of truth offers greater visibility throughout the entire product development cycle.
  • Benefit from real-time iteration. Working within a requirements management platform that has visibility and communication across all development teams enables more informed decisions and improves collaboration abilities.
  • Enjoy stronger visualization. You can more effectively visualize how tests trackback to requirements, resulting in higher quality and compliance.
  • Reuse validation requirements. Reuse validated requirements to quickly replicate features across products.

Centralizing requirements management allows you to build stronger and more effective non-functional requirements, which improves product development. A single source of truth empowers you to connect data, conversations, and decisions – all within a single system.

The result is that you can collaborate and communicate critical pieces of information around product development, resulting in less rework, fewer missed deadlines and happier clients.

See How Jama Connect Streamlines Tracking and Tracing Requirements. 

Risk Management

In this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. 

Teledyne e2v is a global leader in specialized components and subsystems for innovative solutions in medical, science, aerospace, defense, and industrial applications.

  • Over 1600 employees in countries across Europe, America, and Asia.
  • As a result of their track record of innovation and technological breakthroughs, Teledyne e2v continues to be involved in many high-profile ground-breaking programs

Teledyne e2v’s success is built on long-established relationships with industry partners. The combination of their strong, in-house technical capability and links with technical authorities and universities, ensures that they can bring together the right level of expertise for a diverse range of technical challenges.

They offer:

  • RF Power solutions for defense, medical, marine, industrial, and security applications
  • Imaging solutions including CCD and CMOS sensors and cameras, for space and earth observation, life science, machine vision, and medical applications
  • Semiconductor solutions for aerospace and defense hi-rel microprocessors, high speed data converters, and high reliability ICs

A Single Source of Truth Increases Product Development Efficiencies and Improves the Flow of Information for Teledyne e2v

To meet the challenge of producing components and systems with increasing complexity, Teledyne e2v turned to the easy-to-use Jama Connect platform to provide a single source of information and end-to-end traceability for some of their product development teams.


  • Optimize information flow
  • Improve formal review process
  • Find a product development tool that would garner broad adoption

After selecting Jama Connect, Teledyne e2v saw these results

Time-Saving Efficiencies in Meeting and Decision Making

With the single source of truth and real-time structured collaboration that Jama Connect provides, the Teledyne e2v team has streamlined the development process resulting in increased cross-team efficiencies and expedited decision making.

Streamlining and Simplification of Tools

After determining that Jama Connect was a sensible, easy-to-use, and easy to adopt tool that would increase efficiencies, having a customer saying they were going to use Jama simply sealed the deal and is helping Teledyne e2v achieve their goal of streamlining and simplifying their tools and processes.

Jama Connect has enabled a focused model of engineering leadership, with identified owners of top-level vision, and a streamlined, single source of truth. This has shown strong potential to leave developers with greater freedom to manage the detailed development and implementation in-line with the vision that is clearly communicated and controlled within Jama Connect. Leveraging this further across all projects and product developments is a key ambition for the team.

Driving Systems Thinking Across the Organization

Teledyne e2v’s leadership knows that tackling complex engineering problems and projects requires a structured and systematic approach. They needed a tool that would support their engineers and technical specialists to work in a structured way—without the tool getting in the way. Jama Connect enables this and is helping to drive systems engineering discipline further into the team, not only standardizing the way people work, but making it a positive experience.

To see how the team is now leveraging Jama Connect and how their risk management process has already improved, read the full customer story here.

Digital Transformation

Digital transformation helps companies secure a competitive advantage through improved productivity, greater customer loyalty, happier employees and a larger bottom line. It’s the foundation on which companies build more value for their customers. In the past, digital transformation may have been considered an IT project, but the reality is that it ripples throughout every part of the business.

Digital transformation has become more critical during the pandemic as companies are challenged with working remotely and delivering on customer expectations without missing a beat. One study found that over half of IT decision makers (59%) reported plans for accelerating digital transformation efforts when previously, only 15% of companies were prioritizing digital transformation.

As companies move forward, they need tools that support the delivery of what their customers expect, whether it’s faster, more connected experiences or getting the products they need delivered at record speed.

Why is digital transformation important?

Digital transformation helps your company secure a competitive edge that delights your customers and streamlines back-end operations. For example, you may need greater traceability across a product’s life cycle, the ability for employees to collaborate in real time or greater visibility into risk management. It’s the strategy that underpins your decision about what tools are essential. A few benefits include:

Improves the customer experience.

Even if you’re using the tools to develop better products, a digital-first culture has a direct effect on the customer experience. And improving the customer experience is key, since 86% of buyers are willing to pay more for a great customer experience. During 2020, the customer experience overtook product and price as the key brand differentiator.

Builds a stronger employee experience.

Most companies know that employees are their greatest asset, and by providing your people with the tools they need to do a better job, you create a more engaged and efficient workplace, which translates to happier customers.

Optimizes processes.

Digital transformation helps you optimize existing processes and make them more efficient. You can streamline workflows, improve digital processes, automate time-consuming tasks and overall make your workplace more efficient.

Creates greater profitability.

Research shows that 80% of organizations that completed digital transformation reported improving profits, and 85% reported improvements in market share. On average, leaders forecast 23% higher revenue than that of their competitors.

Improves agility and productivity.

During 2020 companies learned that agility wasn’t important; it was essential. Tools that support digital transformation help your company innovate faster, streamline workflows and improve productivity.

RELATED POST: The Importance of Centralizing Your Requirements to One Platform

How can companies embrace digital transformation and achieve better results?

Developing a digital transformation strategy, or revisiting an existing strategy, is a good place to start in creating more agility and success in your plans. What tools will help you meet digitizing requirements or, if you’re developing products, meet complex product requirements? Consider doing the following.

Define what it means to your company.

What is your desired outcome once your digital transformation strategy is deployed? It’s all about the end game, so define your goals well upfront. Consider examining the people, processes, data and technology that you use now, and then align those elements with your goals. Where are the gaps? Are you struggling with efficient collaboration? Is product development inefficient? Identify the areas that matter most.

Foster a digital culture.

Digital adoption comes from the top down. Share your strategy with employees, and get buy-in. How will their jobs improve due to the changes, and how will they be able to serve customers better? Share these details to get everyone on board.

Define value.

A key goal for any digital transformation strategy should be to provide value. How does the strategy serve your overall business vision? Do you need to streamline processes, drive greater revenue or develop larger customer value? You need a baseline and the ability to successfully measure those changes while staying agile.

Support agility.

It’s critical to stay fluid enough to adjust to fast-changing market conditions and respond quickly. Rigid KPIs need to give way to more flexible and agile requirements that have room for iteration. Adaptive design allows you to pursue more frequent changes to transformation strategies and thereby generate the best results.

RELATED POST: Why You Should Swap Documents-Based Requirements Management for Real-Time Collaboration

Avoiding Common Pitfalls

As you define your strategy, it also helps to be aware of a few potential pitfalls so that you can avoid them. For example, more technology isn’t always the answer. Success lies in adopting the right technology. Consider these common pitfalls:

Failure to define a digital transformation strategy.

Digital transformation must start with a vision, and adoption of technologies and tools must directly stem from that vision. How can the technology support the goals and objectives?

Not asking the right questions.

Asking the right questions can help you shape your digital transformation strategy. For example, what do you truly need to better meet customer demands? Do you need to streamline complex product development through improved collaboration? Do you need real-time collaboration to improve workflows? Look at overarching goals and narrow down the tools that make accomplishing those goals easier.

Lack of leadership support.

Digital transformation isn’t a “one and done” project but instead a living, breathing process of iteration. It requires leadership support in continuously revisiting the strategy and making changes as needed to improve the strategy.

Creating strategy in a silo.

The IT department may have largely been responsible for digital transformation in the past, but that is no longer the case. It’s a cross-functional project that affects leaders, as well as employees, from all parts of the business.

Moving Into the Future with Greater Success

Digital transformation is a critical element on the path to the future. Few businesses will stand the test of time without a strong plan to adopt beneficial technologies, such as those needed to digitize requirements management and complex product development. For example, as product development processes become more complex, traditional document-based requirements management has shown its age and limitations. This alone is a powerful opportunity in digital transformation strategy.

However, many organizations haven’t upgraded their requirements and risk management processes to keep pace with innovation, putting them at risk for slow development cycles, costly changes and regulatory recalls. Identifying opportunities such as this will help your company adopt digital transformation with great strength and success into the future.

Check out Part II of this blog series, “How Jama Connect Can Help with Digital Transformation.

Download our eBook to learn how optimize product development with strategic team collaboration.


Product Development Challenges

Do you know the most common product development challenges engineers face? In this post, we have identified them and provided solutions that enable a more modern and efficient product development process.

An ideal product development process requires close collaboration between teams, up-to-date knowledge of applicable regulations, and efficient requirements management platforms for defining, verifying, and validating requirements. However, not every manager is convinced that his or her team needs to do a better job on requirements development and management, or that such an investment will pay off—despite numerous industry studies which indicate that requirements issues are a pervasive cause of project distress.

With the growing complexity of products and software, the more complicated the process required to build it becomes—and the accompanying increased risk of flaws which can lead to expensive, and potentially reputation-harming recalls.

These new complexities have raised the stakes—and made the case—for the need to optimize the product development process from end to end. Engineering and design teams need solutions to the most common product development challenges that provide purposeful, structured collaboration; connect globally distributed team members; and accurately capture and facilitate feedback, decision making, and context for requirements under review.

Doing so requires first overcoming some significant obstacles. To help navigate the journey toward better product development, let’s examine ten of the most prominent product development challenges engineers face and their corresponding solutions.

1. Move on from outdated legacy or document-based solutions

The Product Development Challenge: The traditional approach to managing risks and requirements is highly manual. Teams that operate with a documents-based approach, exchange numerous spreadsheets, and versioned documents via email. This method has real drawbacks:

  • No single source of truth: A spreadsheet with a project’s traceability matrices could have many cells, but no guarantee its data was authoritative or even up to date. Different versions might be floating around, requiring any changes to be painstakingly manually coordinated to achieve team-wide alignment.
  • Limited collaboration: Sending complex requirements documents over email leads to important updates getting lost in people’s inboxes and projects being delayed. As remote teams become more common, such issues are even trickier to manage.
  • Excessive rework: Without effective change management—which is very hard for teams who rely on static, emailed requirements documents—teams often end up developing (or testing) off of older versions of requirements which inevitably leads to misalignment and costly rework.

The Solution: Jama Connect™ provides the single source of truth absent from document-based solutions. Teams from anywhere can collaborate in real-time on a unified platform and capture accurate feedback, review progress, and conduct approvals. That leads to earlier identification and control of risks, which helps reduce rework and keep projects on schedule and under budget.

2. Simplify compliance and meet regulations or standards

The Product Development Challenge: Product development has become much more complicated over time. As a result, so has product risk—and the accompanying regulatory compliance required.

A Jama Software-sponsored survey on Engineering.com found that 62% of respondents reported being reprimanded by regulatory agencies for product development issues. More broadly, recalls have been increasing in certain industries, with medical device recalls more than doubling year-over-year in Q1 2018, due primarily to software-related defects.

The Solution: To address these product development challenges, Jama Connect is engineered to ensure quality with frameworks aligned to key industry standards that streamline design, development, and risk management while maintaining compliance.

Jama Connect helps customers in industries like medical device, aerospace, and automotive solve this product development challenge by streamlining their quality and risk management processes with defined processes for development and production and detailed traceability—from the high-level user needs and systems requirements through to validation and verification. Teams can streamline their product development with templates aligned with industry standards, compliant reviews and approvals, and end-to-end traceability making audit preparation and record-keeping a straightforward process.

3. Establish and implement effective review cycles

The Product Development Challenge: Without the right platform and processes in place, review cycles can be time-consuming and fragmented. For example, under the manual approach to requirements management described earlier, a review cycle can be repeatedly delayed due to versioning issues with documents and lack of visibility throughout the review process. Teams can also spend hours per week in review meetings, just to ensure everyone is on the same page.

Streamlined review cycles require:

  • One source of truth for requirements and tests
  • A straightforward way to send items like requirements, user stories, or test cases for review
  • Best practices for each of the major roles involved (i.e., reviewer, approver, moderator)
  • Real-time collaboration within a shared, dynamic requirements management platform
  • A formal approval process to capture and record sign-off

RELATED: Streamlining Requirements Reviews: Best Practices for Moderators, Reviewers, and Approvers

The Solution: Jama Connect Review Center can solve this product development challenge by serving as the single place for reviewers, approvers, and moderators to collect and manage all requirements and feedback for a project in real-time.

Inviting internal and external collaborators into a review cycle is easy, plus roles can be assigned and all agreed-upon requirements approved much more quickly than with manual processes. Pharmaceutical manufacturer Grifols reduced its planning time by 80% by using Jama Connect to accelerate review cycles.

4. Enable secure, cross-functional collaboration across teams, customers, and complex supply chains

The Product Development Challenge: People working together is at the very core of all product development work. The ability to effectively collaborate is critical for innovation. In this era of rapidly accelerating change, structured and strategic team collaboration is the key to improving the product development process for all team members. And in this era, the “team” includes everyone across the supply chain.

Today’s market demands require companies to build partnerships and seek solutions with more specialized materials. These partnerships mean greater sharing of data across distributed teams, partner organizations, and business units, sending a ripple effect through the supply chain as subsystem suppliers must anticipate features on the finished products and get ahead of release schedules and component costs.

But for engineers who are used to working on internal, siloed teams, these new partnerships present previously unforeseen challenges. What worked before doesn’t work today.

Aligned requirements management is necessary for developing products that meet all customer and market requirements while adhering to industry regulations and standards. More specifically, optimized gathering and authoring of requirements are needed to ensure product quality and meet specific requirements, minimize risks, accurately scope projects, enable collaboration, and align teams.

The Solution: Requirements gathering should follow a systematic process, focused on what eventual end users will do and the requirements that must be met to support those behaviors. This approach ensures that both high- and low-level requirements and their dependencies are covered and that corresponding tests can be set up and run.

As teams seek input and feedback on product and systems requirements, tools like Jama Connect are critical in capturing these insights in real-time. With everyone having access to the most up-to-date information, stakeholders can stay informed and aligned, reviews can be streamlined, and teams have better visibility into the progress of their work. This helps reduce the complexities of communication and saves time by having a single source of information regardless of geographic or institutional location, which enables collaboration across a variety of relationships. Having a single platform where these teams can come together to review and connect will keep programs on track, keep teams collaborating, not let insights slip through cracks, and allow for innovation.

Engineers typically collaborate with outside companies by exchanging requirements. Data Exchange for Jama Connect enables the transfer of requirements and associated metadata between customers and suppliers. The solution allows for the import, export, and update of requirements data to create an ongoing exchange throughout the product development lifecycle, allowing for collaboration to extend to remote engineering teams and companies.

RBC Medical (now known as Vantage Medtech) saved an average of $150,000 per project by upgrading to Jama Connect eliminating the back-and-forth email tag that characterized its previously manual processes.

RELATED: How to Avoid Ambiguity and Save Your Requirements

5. Ensure product quality and improve change management with complete traceability

The Product Development Challenge: Maintaining cross-team visibility and staying on top of disparate documentation and processes along the way is a central challenge of working with manual, document-based workflows. It becomes difficult to accurately assess the impact of a proposed change (i.e., perform impact analysis) and to ultimately ensure requirements are properly tracked across the entire product development lifecycle.

The Solution: To make impact analysis more scalable, teams need end-to-end traceability. In Jama Connect, links that are downstream from modified items get automatically flagged as “suspect,” and relevant contributors can be notified right away to take corrective action. 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.

Important data, such as the percent of downstream test cases that have passed and where coverage may be missing, is also easy to view, while the system’s requirements can be updated in a centralized place as the project progresses.

The right requirements management technology can provide clear traceability that allows teams to maintain a rigorous formal change management process; reveals interdependencies with the process; and enables alignment, making it easier to bring in the right decision-makers at the right time. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as products and systems become more complex and software-driven.

The result is improved confidence that teams are working with the right requirements, have the information they need to conduct useful impact analysis and are generally able to trace forward from, and back to, requirements as needed.

RELATED: Five Tips for Requirements Traceability

6. Manage development complexities across hardware and software teams

The Product Development Challenge: Software is an ingrained part of modern product development and one that can greatly increase risk if not properly managed. Moreover, complex software requirements have to be managed in tandem with those for hardware. The growing connectivity embedded into today’s ever more complex and often safety-critical products, puts pressure on both software and hardware teams to manage their development processes with more efficiency and effectivity. In fact, in a recent study from Engineering.com, over the last five years, 76% of respondents reported dealing with three or more increased measures of complexity and 25% saw their products become more complex in five or more ways.

The Solution: In a platform like Jama Connect, risks and requirements related to software and hardware can be managed proactively, not reactively. Teams can quickly see the full historical context around a requirement when they receive invitations to contribute to a project. Out-of-the-box frameworks that include industry-specific, software development methodology and risk management also minimize setup time, so that important risks in software and hardware can be identified, assessed, and acted upon as early as possible.

Configurable workflows accommodate various process styles, development methods, and tools to ensure adoption, with flexibility to support your Agile, Scaled Agile or Hybrid development process. Requirements data can be integrated with other tools across the development process to ensure everyone stays aligned.

One of the most common scenarios is integration of requirements to Atlassian Jira. With the Jama Connect for Jira integration, product teams can maintain critical information about their product requirements and test cases and directly connect them to development activities in Atlassian Jira, including sprint planning, task management, estimations, and defect and issue tracking.

RELATED: 3 Ways Products Became More Complex in the Last Five Years

7. Increase quality and efficiency by testing earlier in the lifecycle

The Product Development Challenge: It’s well understood that identifying potential defects earlier in the lifecycle prevents costly rework. But how can organizations proactively involve QA at the front end of the process?

The Solution: Early testing prevents defects from surviving until the late stages of the lifecycle, when they become especially costly to fix. In addition, early and frequent testing allows for innovation.

The National Institute of Standards and Technology has estimated that the relative cost of fixing a software bug is 30 times higher in production than in the requirements and architecture stage of development.

Conducting some form of testing, at every stage of the product development lifecycle, is highly recommended. Getting the right feedback at the right time ensures that you can deliver a high-quality product on time.

In the early stages of development, performing customer exploratory testing is the most cost-effective way to make sure your product strategy is on the mark. And, at the end of the development lifecycle, conduct system integration tests to ensure components are working harmoniously.

Jama Connects helps engineering and quality assurance teams define, organize, and execute requirements-based test plans and test cases to ensure quality and compliance. Teams can streamline reviews and approvals, perform manual testing, and integrate with trusted test execution and automation solutions.

RELATED: Characteristics of a Good Test Management System

8. Implement effective requirements versioning, baselining, and change management

The Product Development Challenge: Legacy requirements management systems frequently complicate version control, due to the prevalence of conflicting requirements documents that are manually managed, often owned by varied teams and then distributed cross-functionally. Likewise, they don’t provide the right infrastructure for effective change management, because of the difficulty involved in identifying the latest versions and applying any needed changes amid all of the different documentation in question. Changes might ultimately be made only at a late stage, and at great cost.

The Solution: A requirements management platform like Jama Connect can solve this product development challenge by allowing teams to align their releases to ensure they deliver a cohesive solution/product to their customers. With versioning, baselining, and change management of the requirements in place, teams are able to manage and reuse requirements throughout the development lifecycle. This allows development teams to improve reuse, reduce design inconsistencies, and reduce the discrepancies found during testing, verification, and validation.

Jama Connect offers full control over the requirements you are choosing to reuse. You can not only choose the set of requirements you want to reuse but also the version of those requirements as well. This allows you to take the best and most applicable version of your requirements forward to your next project.

Studies reveal that 60 to 80 percent of requirements, code, and tests are shared between projects. With Jama Connect, you can reuse your data for effective sequential or parallel product development which saves your development teams time and improves time-to-market.

RELATED: Defining and Implementing Requirements Baselines

9. Make it easier to coordinate remote engineering teams

The Product Development Challenge: Remote work is on the rise. Although it has many benefits in team flexibility and cost savings for the organization as a whole, it can complicate collaboration and result in additional operational silos as each remote engineer settles into their own workflow and preferred set of tools.

The Solution: Modern platforms that enable real-time, structured collaboration simulate the efficiency of engineering teams working together in a shared physical workspace. For example, engineers can be easily invited into Jama Connect conversations and reviews, notify each other with custom messages and supporting context, and be assured that they’re always working with the latest information.

Such a setup solves this product development challenge by reducing silos and keeping everyone aligned. Buffer’s State of Remote Work survey for 2020 found that communication and collaboration were among the most cited challenges with telecommuting. Teams that still operate in silos with legacy systems will not be equipped to meet the demands of the market going forward. In this era of rapidly accelerating change, structured and strategic team collaboration is one of the best ways to address the product development challenges and obstacles of the modern product development landscape.

RELATED: Strategies for Remote Engineering Teams

10. Build a more effective and efficient product development process

The Product Development Challenge: Product development is complex and, in most cases, will span multiple teams, solutions, and methodologies. Outdated legacy tools and a documents-based approach aren’t enough for this reality, as they aren’t purpose-built for complicated requirements management.

The often-quoted CHAOS Reports from The Standish Group indicate that three of the biggest contributors to projects that fail or are “challenged” are:

  • Lack of user input
  • Incomplete requirements and specifications
  • Changing requirements and specifications

The Solution: An evolutionary leap forward comes from modernizing requirements definitions as well as engineering and management processes—including minimizing the time your team members spend eliciting, analyzing, documenting, validating, and managing the requirements for their products.

Do you have product development challenges you need to solve?

Jama Connect is a solution for managing complex product requirements from idea through development, launch, and iteration. It brings people and data together in one place, providing visibility and actionable insights into the product development lifecycle. Our platform equips teams to track decisions and ensure the quality of the product they set out to build.

We’d love to speak with you and share how Jama Connect can help your teams find solutions to your unique product development challenges and overcome these 10 common ones. Connect with us today and get started with a better approach to managing requirements in product development.

To learn more about optimizing engineer team collaboration to streamline product development, download our eBook now!



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 (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!