Andrews Cooper Product Development Strategy

Phased Iterative Product Development

Developing a new product is a complex process involving collaboration across multiple disciplines and a large number of trade-off decisions frequently made without complete information.

New product development is a major investment and it is full of risks. It is critically important to business success to know how to do it well. In this article we describe the industry-standard product development model and shows how iterative cycles are used to reduce product risks, project risks, and technical risks.

INTRODUCTION

The critical building blocks of effective product development are phases and iterations:

  • Phased product development is a tried and true approach for inserting checkpoints into the product development lifecycle at major milestones. These checkpoints provide an opportunity for stakeholders to review progress and reaffirm the product development investment decision – or make course corrections that could be as extreme as cancelling the project.
  • Iterative product development is a process of synthesizing creative ideas, building prototypes, and then testing them to characterize their strengths and weaknesses. And then starting all over again, retaining the good parts and refining the aspects that did not turn out so well. The iterative process is used during the earliest product concept formulation, throughout engineering development, and even during production.

These basic notions are combined in the iterative phased product development model which has become a de facto industry standard. It is used for a wide variety of product types – by a wide variety of companies. This article describes the basics of the iterative phased development model with an emphasis on how phases and iterations are used to reduce risks.

There are a lot of trade-offs that can be made to optimize this generic product development model for a specific business situation.  In a companion article, we explain how this basic model can be aligned with the overall business strategy to achieve the best possible product development approach.

Andrews-Cooper specializes in product development for both consumer product and medical device companies. We work closely with our clients to determine how to adapt our product development approaches to meet their business needs and to deliver the best possible value.

Phased Product Development

The Iterative Phased Product Development Model

This section describes the versatile product development model that can be adapted for a wide variety of products. This model has had widespread use across a variety of industries for several decades. It has been employed to in the development of medical devices that meet ISO 13485 and FDA 21 CFR 820.30 compliance standards, and it has also been used to develop consumer products with annual production exceeding millions of units in compliance with ISO 9001. On the more modest scale, it has also been used to rapidly develop very simple, low-volume, low-cost products.

Iterative Phased Product Development Model

The focus of the Iterative Phased Product Development Model is risk management.  During the early Product Definition phases, the team learns about how to best meet customer needs and reduce risks associated with both business ROI and technical feasibility.    During the Product Engineering phases, risks are reduced in the engineering designs, and in the development cost and schedule.   The Product Manufacturing phases focus on reducing risks associated with consistently producing high-quality products at the lowest costs.

The early Product Definition’s Learn-Build-Test cycles lead to the Product Engineering Design-Built-Verify cycles and eventually to Product Manufacturing’s Build-Measure-Improve cycles.”

For fans of agile software development, the process flow shown above looks a lot like the antiquated waterfall model. It is important to remember that we are talking about hardware development, not just software. In some ways this product development flow is extremely agile: within each phase, rapid prototyping and short development iterations are used to reduce technical risks. With the advent of 3D printing and quick-turn PCB fabrication services, hardware designs can be prototyped within 2 to 3 week agile cycles.

But there are also some major differences from the fast agile iterations:

  • Lead times for specialized hardware parts and custom assemblies can be many weeks or even months when custom tooling or fixtures are needed. Therefore, the iterative development cycle can be much longer than the typical 2- or 3-week agile software development cycle.
  • Production parts and processes must be used for product verification and validation activities – therefore manufacturing must build these units. Manufacturing build cycles are typically much longer that engineering prototyping cycles due to the need for custom assembly and test fixtures and formalized production processes and work instructions.
  • Although prototype hardware design and build cycles can be very fast, hardware testing requires software support – and the software needed to test a quick-turn PCA typically cannot be developed in a single 2- or 3-week agile software cycle.
  • Integration of custom software with custom hardware is a lot more complex than pure software integration. Therefore, the system architecture and interface specifications must be defined up front to avoid integration defects and delays. Build synchronization points must be planned in advance to coordinate the electrical, mechanical and software development tasks.
  • The process flow shown above adds phase gates at major milestones to allow management to assess development progress and re-confirm that the product investment makes business sense. These checkpoints are missing from purely agile models, but for investments that can be several hundreds of thousands of dollars or more, a more formal phase gate approach is prudent.

The following phase descriptions further show the emphasis on risk management. Note the overlap of Product Design, Product Engineering and Product Manufacturing across the development phases. Note also how the iterative nature of Learn-Build-Test cycles becomes Design-Build-Verify cycles and then Build-Measure-Improve cycles. The process starts with preliminary product concepts that are built and tested and then matures into detailed designs that are built and verified and then manufactured for sale.

Defining a Winning Product

Product Definition focuses on characterizing the market opportunity and user needs, and the rapid creation and evaluation of product concepts and models. These activities are typically driven by marketing, product strategists, and industrial design specialists. Engineering also plays a key role determining technical feasibility of product concepts, building physical prototypes, and determining product development costs and schedule.

In the end, the product development investment must make sense for the business; the product definition phase provides the preliminary answer to this critical business question.

The inspiration for the product might come from an innovative new technology, new basic science, novel user-driven feature enhancements for a next-generation product, or something more mundane like a replacement product to lower costs or design out obsolete parts. For all of these situations, the main challenge is to conceptualize and define a winning product.

Product Definition Phase
There are three sub-phases within the Product Definition Phase. Note that these phases overlap and can feedback into each other forming larger cycles. Lessons learned from the concept models and engineering feasibility prototypes help refine the overall product concept.

  • Concept Creation: this is where the initial product inspiration becomes tangible. Knowledge gained about the customer and user needs, the market opportunity, and the competitive landscape are blended to create product concept models. These models are constructed and tested with key stakeholders including customers and end-users – beginning with sketches and 3D CAD renderings, and progressing to foam core or 3D-printed physical models.  At this point it is not too early to also consider the Design for Excellence approach.
  • Definition & Planning: as the product concept comes into focus, it needs to be characterized in enough detail to develop it and to estimate reasonably well what it will cost – both COGS and development costs. This phase turns the high-level market and user requirements into verifiable product requirements, a system architecture, analyses of safety risks and other key quality attributes. Detailed development estimates and schedules are also generated.
  • Feasibility Prototyping: the product concept models need a technical foundation – is the case big enough to house the electronics, can the concept models be manufactured within the cost targets, etc. The engineering prototypes determine technical feasibility and set the stage for the product engineering phases. Not all products need feasibility prototyping – the need is proportional the degree of novelty, innovation and complexity of the overall system or critical component elements of the system.

A prototype is like a good design abstraction – it omits irrelevant details to help you focus on what is important at the moment.  It is critical to know in advance what questions the prototype must answer.  Otherwise, you might omit something that is very important or waste effort on something that is not!”

Product Engineering

Product Engineering transforms the product concept into an engineering design that can be manufactured.  As shown below, there are three phases to create, refine and verify the engineering designs and production processes.

Product Engineering

  • Engineering Verification Test: EVT prototypes use rapid prototype parts (e.g. 3D printed plastics, machined metals, quick-turn PCAs) and are assembled by engineering. The main objective is to evaluate the engineering designs and make any necessary refinements before the larger investments are made for tooling and production fixtures. The initial EVT prototypes might start out as evaluations of individual design elements (e.g. PCA testing on the bench). The final prototype is typically fully integrated with good fidelity to the product’s appearance, form and operation.  The EVT phase produces a small quantity of prototypes that can be used for alpha testing with users.
  • Design Verification Test: DVT prototypes use production parts and are fabricated and assembled by manufacturing. The main objective is to verify the engineering designs and give manufacturing an opportunity to generate and evaluate their processes. DVT builds have full functionality and are suitable for verification of all product requirements including testing and certification by independent labs for safety, wireless emissions and any other applicable regulations and standards. Typically, it is prudent to do standards screening on early DVT prototypes. The DVT phase produces production-equivalent prototypes that can be used for beta testing with users.
  • Process Verification Test: PVT phase is focused on verification of production processes and making sure they are ready to be scaled up to production volumes. The final DVT designs are transferred to the manufacturer and manufacturing processes are qualified by testing pilot production units with a subset of design verification tests.

Verification and Validation

What is the difference between V&V?  These terms are frequently confused and applied inconsistently.  Per ISO 9000 definitions:

  • Validation ensures that the product meets customer needs for its intended use.  It uses objective evidence to answer the question: “Are we building the right product?”
  • Verification ensures that the product meets its requirements.  It uses objective evidence to answer the question: “Are we building the product right?”

Generally, validation starts early in the development process understanding the market needs and asking the question: “If we built this product, would it meet your needs”.  The results are a set of “validated” product requirements that form the basis for design verification activities.

Verification is performed throughout the development process starting with document and design reviews and progressing through design verification testing on prototype and production units.   Validation also continues with usability testing under realistic usage conditions of the evolving product prototypes plus specialized activities such as clinical studies for medical devices.

Product Manufacturing

Product Manufacturing: after pilot production units have been verified and the production processes qualified, the manufacturer ramps up to planned production volumes. Sustaining engineering is most intense in the first 6 to 12 months of volume production, which have the highest risk of production of design issues. In the longer term, depending on the production life of the product, parts obsolescence issues may arise requiring re-verification or in some cases also requiring re-design.

Conclusions

This article described the industry-standard iterative phased product development approach with an emphasis on risk reduction.  This model is an effective approach for developing consumer products as well as regulated medical devices.

This generic model can be adapted for better alignment with a specific business situation. The alignment process requires good collaboration between business and engineering leaders to understand each others’ perspective and concerns, and make decisions that optimize the potential for success.

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