Streamlining Complex Systems Development for Faster Compliance

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End-to-end traceability. Process standardization. Real-time status and visibility. Efficient internal and external collaboration. Maintaining the link between engineering activities and business priorities. These are some of the essential things systems engineers need to develop regulated products, versions and variants.

For companies, the challenge is understanding how the lack of these key ingredients harms the bottom line. This paper outlines common engineering and business problems and points organizations that design and build complex systems toward proven solutions that work.

The number of connected machine-to-machine devices has increased 300% since 2008

According to Machina Research’s annual forecast and analysis of the machine-to-machine/Internet of Things market, the number of connected devices will increase from five to 27 billion by 2024. As software becomes more and more embedded into technology, the rate of innovation accelerates. Connected software has also changed expectations. Customers expect seamless interaction with technology solutions across form factors and devices. They expect their technology will constantly evolve or update post-purchase.

Delivering these products to market requires new teams operating at different cadences and introducing new methodologies and practices.

Many organizations have a hard time keeping up with the rapidly accelerating pace of change, especially when their teams work in silos using outmoded systems. Product development is often plagued by preventable delays, which can make or break your business.

Strategic Supply-Chain Collaboration Is Key

The demand for highly functional device performance requires deeper collaboration among teams developing products. This includes everyone across the supply chain.

Companies actively look to partner and build integrations for specific expertise to meet business demands. They seek solutions using fewer commoditized materials and more specialized materials. This translates to greater sharing of project and product data across distributed teams, partner organizations and business units.

Processors, sensors, memory and power management subsystems are being pushed to get smaller, cheaper and consume less power. These demands have ripple effects throughout the supply chain—subsystem suppliers not only have to anticipate the features on finished products but also get ahead of release time-frame and
component costs.

With increased focus on getting to market faster and customer-driven development, complex manufacturers can gain the edge by aligning business objectives with development. Increased levels of collaboration throughout the supply chain are central to R&D efforts as companies look to share the development costs and drive toward innovative solutions. Additionally, the new focus on software dramatically impacts development throughout regulated industries, which will only intensify in the future. In this new paradigm, focused, cross-functional collaboration is the key enabler of innovation.

Obstacles to Optimized Product Development

In a recent survey conducted by Forrester Consulting on behalf of Jama Software, “unclear or changing requirements” was the most common reason cited for product delays. Communication issues within organizations and teams were also cited as significant obstacles affecting product development. Delayed decision-making, coordination problems and shared resource conflicts are preventable, but common. In many companies, collaboration only occurs when the right people finally find time in their over-scheduled days for a one-hour conference call—and then, half the time is wasted rehashing past decisions.

Forrester Consulting Reports Five Main Factors that Cause Product Delays

  1. Product teams often lack a clear understanding of customer needs. Unclear or changing requirements plague product delivery. Not being able to get timely feedback on possible solutions results in delays and wasted time, effort and money.
  2. Conflicting priorities caused by stakeholder disagreements put product delivery teams in an unfortunate bind. Lack of clarity about objectives, assumptions and possible solutions leads to a lack of focus.
  3. Effective collaboration spans roles, teams and geographies. Modern products are complex, requiring a wide variety of expertise to deliver successfully. The reality of the global marketplace means that co-located development is rare; globally distributed teams are increasingly commonplace.
  4. Unnecessary handoffs and delayed decisions reduce speed and impair quality. Rapid delivery is increasingly a competitive differentiator.
  5. Delivering winning products requires unprecedented collaboration across diverse roles, spanning the organization from executives to operations and from marketing to quality assurance.

Strategies for Modern Requirements Management

Modern systems engineering approaches are fully collaborative, with live data shared and accessible to all teams at all times, crossing geographic boundaries. Companies work together throughout the entire life cycle of a product to deliver business value. The tool teams employ is the key differentiator and facilitator. Kludgey and antiquated documents-based methods delay progress. The evolutionary leap forward comes from modernizing requirements definition, engineering and management.

Decisions must be made and documented in real time. Everyone impacted needs real-time notification. Meetings, emails, and hallway chats don’t work when you need to work fast.

Modern product teams coordinate across departments and teams, they understand customer needs and they work together throughout the entire process. Disruptive technologies are not seen as a threat but as an opportunity. Change is embraced rather than managed. The “old way” of sharing documents via email attachments and having meetings to discuss decisions–that doesn’t work when you need to move fast. Decision-making needs to happen in real time and everyone impacted by that decision or change needs to find out about it immediately–in the tools they are working in. Whether they are mobile, tied to their email or living in.

The good news: Systems engineers working in complex manufacturing industries can take specific actions now to help their teams manage complexity, coordinate effectively and develop, verify and validate faster than before.

Practices for Immediate Impact

Establish a Common Definition of Success

Clarify expectations for define, build and test. In addition to defining the features and functions, define and share the “why.” Approach development with an understanding of what success looks like, based on feedback loops (customer interviews, value testing, design reviews). Build with a view of what outcomes the product should deliver to your customers. Most important, define and clearly communicate the business outcomes your product needs to achieve. Teams need alignment—business with product development, hardware with software, systems with components, buyers with suppliers—on what they are building so they don’t waste time on lower-importance features. Define the “why” and you deliver faster.

Empower Better Decision-Making

With a clear understanding of the “why,” team members can make the right decisions faster, articulate acceptable tradeoffs and navigate technical complexities. Give business leaders full visibility into the progress and tradeoffs under consideration, and give definers and developers visibility into the expectations. Define clear decision-making responsibilities, capture decisions and assign them to owners. Those involved can initiate and resolve follow-up questions and issues.
Good decisions need situational awareness, an understanding of impact and a way to get input from others. By providing context, strong relationships and understanding the “why,” your teams will react to new information more effectively. No more waiting for status check-ins or change control board meetings.

Tighten Up Your Traceability

Regulated industries must demonstrate compliance with governmental, environmental, security or privacy criteria. Traceability analysis proves you have tested your system against regulatory demands and that it meets contractual terms.

In development, traceability generally refers to engineering activities such as change impact analysis (examining dependencies to resolve issues arising from changes), change and risk analysis (supporting general engineering and management reporting procedures) and verification (requirements have test cases, epics have stories, systems have components, components have sub-components).

Coverage analysis helps teams find gaps and understand positive and negative progress; many of these “events” require a follow-up action to either close the gaps or determine contingencies and next steps.

Extend traceability beyond engineering processes, and you can link your development and test activities back to the business rationale. When engineering and business are connected, faster evaluation of all the up/downstream implications of decisions follows.

Collaborate with Purpose

Modern collaboration for systems engineers means connecting data to people—not a feedback free-for all.
The key to purposeful collaboration is keeping communication connected to the work.

Use collaboration to tie conversations, negotiations and resolutions directly to the specific requirement, specification or use case in question. Don’t make decisions outside the process or in documents or emails. Keep conversations connected to the work itself for easy access and understanding.

Reuse Your IP

Don’t limit reuse to code; you can repurpose entire IP blocks—design artifacts, specifications, test cases, content for data sheets and process information—at the outset of new development. With purposeful collaboration integrated into your product development process, you can import every conversation and decision about changes into new projects. The benefit: Teams can be confident they are using only the latest approved and validated information. Companies effectively reusing IP shave development time by as much as 80 percent. With best practices built on reuse, organizations have a repeatable template for success.