Complex development projects can feel like taming an unruly beast with a mind of its own — even when backed by solid research and guided by established business and design control processes. Within the engineering process, missing a single step can lead to unforeseen costs, missed opportunities and project delays. This results in excessive development costs outside of the defined budget, a decreased speed to market – sometimes months to years late, and frustrated management and stakeholders hoping to obtain a high return on investment (ROI) when opportunities are continually being missed.

These 7 development best practices will alleviate the development pressure on your back by providing tips for designing quality systems. With the assistance of these tips, be prepared to expedite your project delivery date, maintain your budget and streamline the regulatory compliance process.

1.    Plan for Integrity in All Phases of Life Cycle
From commissioning all the way through decommissioning, ensure your plan protects the project’s integrity. Plan and design requirements must clearly define the activities necessary to maintain and enhance an asset throughout its life cycle. This can dramatically affect development, manufacturing, and product launches as well as sustain engineering and business behaviors.

Within every phase of a device’s life cycle, there are decisions that are critical to the usability and profitability of that device. If you lack a plan up front, there is little or no formal consideration for managing immediate and long-term engineering, operations, risk, development, enhancements, manufacturing, costs, quality, validation and verification. A concrete blueprint prior to development provides consensual direction that increases the speed to market. Since this is a requirement for nearly any device or system in a high risk environment, planning for integrity offers more profitable opportunities and reduces project costs in the long term when approaching different verticals.

2.    Design and Develop Toward Total Quality
The combination of project and product documentation forms a complete suite, and demonstrates the process and products being developed. Consistent documentation yields better decision-making resulting in a higher quality product. Because it is nearly impossible to test true quality in many devices, quality must be a fully integrated component in every phase of the development process. Quality needs to be considered from different perspectives: functionality requirements, risk assessment, design, development and integration through system test to verification and validation (V&V).

The right documentation defines a device’s behavior, inputs and outputs, and how technical details are implemented and verified correctly. It drives architectural and detailed concepts while ensuring compliance and guides a device through its life cycle. Starting with an eye toward excellence, V&V then becomes a vehicle to confirm quality as opposed to testing for quality.

3.    Analyze Development Risks
Business risk management is an inherent requirement for all device manufacturers. The other risk components are development risks, which are usually overlooked, but are all too real. Vital to delivering a system or component in any device is the identification of what can go wrong during development. Risk mitigation for both business and design can assist in eliminating, minimizing or accepting risks at project conception.

Managing developmental risks is just as critical as managing business risks. With many projects requiring multi-year development cycles and millions of dollars invested, neglecting developmental risks can have long-lasting effects on the bottom line of a company. The consequence is more than just over-run budgets; it impacts customer satisfaction and directly relates to investors’ attitudes, lost sales, missed opportunities and — most importantly — company brand perception.

4.    Design for Test, Verification & Validation (V&V)
With the complexity of today’s regulatory design process for most devices, testing and V&V require a monumental effort and at times still do not capture all aspects of quality and compliance determination. “Designing for Test” during the design input phase will identify processes to illustrate that quality was built into the system by creating traceable methodologies to validate complex systems.

Often, very little thought is given to testing at the outset, even though it may be the costliest phase. By addressing the test process during the design input stage, new approaches, testable requirements creation, designs and a general overall product concept can be enhanced. Significant results can be achieved by addressing these considerations early in the project; this will shorten the test and V&V time while attaining a significantly higher level of compliance and quality.

5.    Audit Your Supplier and Build a Relationship
Outsourced engineering and manufacturing is often the more profitable method of bringing new products to market rapidly. It provides many additional benefits, insights and the resources required to meet the stringent demands of schedules, quality, compliance and technology. Audit your suppliers for standards, past device development examples, quality system, experience and reputation. Ensure that their Standard Operating Procedures (SOPs) complement your standards, because together they form the cornerstone of the development process. Documentation, source code, interfaces, test plans and any other components that should be standardized provide a basis for rapid development.

Not every supplier is the right supplier. The relationship between the device manufacturer and the right supplier can be viewed as a strategic partnership in which the success of each company is intertwined. Each party brings something vital to the table in terms of time, money, knowledge, information and a shared vision to create product success. Consider this outside team an integral component of your team while building trust and dedication for the long term. Ongoing weekly and monthly interaction, with constant feedback and review, can result in a project exceeding expectations in all phases of development and delivery.

6.    Perform Pros/Cons Analysis on Critical Decisions
Sometimes the price of a snap decision is only realized when you’re in a few steps too late. A brief pros and cons analysis with the project’s stakeholders is often all that is needed to fully understand the effects of a decision down the line. List all the possible benefits and drawbacks of each option; this will give the team a clear insight going forward. This analysis can then be “weighted“ to determine how critical each pro and con is overall.

Pros/cons analyses allow a diverse team to objectively look at options without any of their emotional aspects in order to form the most lucrative corporate decision. Many times snap decisions appear tempting and more cost effective or seem to be the clear-cut solution, but they can have far reaching effects on other aspects of the product. Saving a few dollars based on quick decisions during development can result in project misdirection and end up costing millions of dollars in lost revenue in the long-term strategy.

7.    Manage Change
Making changes on any development project is inevitable. However, not all changes are necessary or beneficial. Unmanaged and undocumented changes can kill even the most straightforward project. A major goal in any product design and development is to minimize, isolate or remove as many possible changes downstream in the product’s development. To curtail changes, it is incredibly important to establish a good foundation for the project.

Each change by itself may not be critical in nature, but the combination of multiple changes and a lack of consideration of the full ramifications and the added complexity can substantially increase the duration and cost of a development project. This is especially true in software-intensive projects. These changes can cause a ripple effect across algorithms, controls, user interfaces, reports, design specifications, databases, testing, V&V and manufacturing. Focusing on these changes from a developmental and a corporate perspective will provide management consensus and accordance with the additional costs and slippage in delivery.

Moving Forward
It is easy to make any project look tricky and challenging, especially when it is complex. It takes a lot of experience and insight to simplify complexity. By following “Quality by Design” standard procedures with a consistent and solid methodology, products can be delivered on time to market. Companies can experience instant revenue, new market opportunities, significant ROI, quality that is the envy of competitors, lowered risk, reduced lifecycle costs and the ability to expand products in new directions.

When knowledge of the right processes is implemented by all, and the plan and schedule is followed, the probability of success multiplies. Everyone associated with the project, from senior management to the test engineers, will feel a sense of achievement and ownership of a job well done.