Engineering Services & Contract Manufacturing

We are a top-tier engineering and manufacturing services company that designs and produces innovative equipment and products on behalf of its clients. We delivers a full range of design, engineering and manufacturing solutions and is the premier partner for those companies seeking an outsourcing partner to design and/or manufacture their equipment or products.

We partner with you to effectively achieve your goals and contribute to your success. From full-service, turnkey product development and manufacturing to on-site engineering support, our team and processes have a laser-tight focus on meeting your strategic and tactical outsourced development needs.

Product Design, Development and Contract Manufacturing Services

We are a premier equipment and product development partner for those companies seeking to outsource the design and/or manufacturing of their products. Clients from multiple industries (commercial, consumer, government, industrial, and medical) engage us at various points in the product development process and subsequently obtain deliverables ranging from concept designs and analysis to prototypes and continually manufactured products.

Our research and development team is a multidisciplinary, experienced and highly skilled group of mechanical, electrical, software, firmware and controls engineers. Coupled with these capabilities is a world-class operations team and carefully optimized supply chain providing continuous manufacturing services. These combined turnkey product development services provide our clients a one-stop shop for the unsurpassed capability of developing and manufacturing innovative technology products on budget and on schedule.

A Multi-Disciplinary Engineering Approach

Success in any engineering endeavor is more than execution of a good design. It's taking a project from concept to reality with perspective and predictive vision, active participation and accountability. For our Team, success is the culmination of efforts, multi-focuses with one vision; to achieve clients' goals.

Our engineering staff is comprised of seasoned veterans and top recruits from leading engineering programs across the country. We've created a balance of experience, vision and passion to provide our clients' with a breadth and depth of talent and expertise not often found in service providers. Our multi-disciplinary staff has broad experience in the areas of mechanical, software/firmware, electronic and electrical/controls engineering.

Mechanical Design

• Design of complex electro-mechanical systems.
• Strong emphasis on robustness and manufacturability.
• Extensive experience designing injection-molded plastic, sheet metal and machined parts.
• Experienced with extrusions, thermoforming, EDM, castings, pneumatics, fluid handling, servo-hydraulics, and rapid prototyping.
• Motor application development (stepper, servo, AC, DC, linear, fractional - 400 horsepower).

Analysis

• Finite Element Analysis for structural mechanics and thermal systems.
• Analysis, design and verification of digital and continuous domain controls applied to complex linear and non-linear systems.
• Static and dynamic analytical modeling.
• DFX (Design for Manufacturability, Assembly, Serviceability).
• Variable and tolerance analysis.
• Prototype & Testing.
• Functional testing and process development
• In-house model shop and CNC machining

Tools & Processes

• Use of multiple mechanical engineering and CAD packages such as SolidWorks, Solid Designer, Pro/ENGINEER, Matlab, Mathematica, Cosmos, Visual Nastran
• PDM based drawing revision control and integration with Agile PLM system
• Agency certifications supported TUV, UL, CA, CE, FCC.

From full-service turnkey product development to on-site engineering support, our multi-disciplinary approach incorporates systems and processes allowing clients to optimize the outcome of their project. Our exacting standard of excellence, coupled with our energetic, uniquely position capabilities as leaders in the realm of technical service providers.

Engineering Quality

We follow a comprehensive engineering development process to ensure the success and quality of each technical endeavor.We can estimate the cost of a product early in the design phase, We ensure, through extensive design and architectural reviews, that concepts are fundamentally sound and meet the technical and business objectives of the client.

For complete turn-key solution projects, we follow a rigorous new product introduction schedule that addresses each key factor and process involved in the production of all new products. Throughout the development of each new product R&D, Manufacturing Engineering, and Quality Engineering schedule periodic design reviews to validate the design details required for a successful production launch. Detailed plans are then created that describe step-by-step the type of assembly, integration, and testing to be performed. These plans include listing all equipment, fixturing and supplies to be utilized during the testing - including a detailed plan for training the personnel who will be performing the testing.

We also places a strong emphasis on post-release engineering support during early manufacturing in order to accelerate production success. Our design engineering team integrates with our manufacturing engineering and production teams during the ramp-phase to ensure that full design intent is translated into the final product. With this commitment from all parts of the organization, post-release upgrades and design enhancements are quickly implemented in the final product for greater product performance and customer satisfaction. This engineering commitment also transfers to our sustaining engineering function as we look for ways to improve upon the current design and provide technical support to the end user.

We are committed to designing quality into our products throughout the evolution of each project. From small efforts to large endeavors, our clients have peace of mind that we will deliver best-in-class solutions every time.

Respect and Protect - Intellectual Property

We are specifically focused on working with clients to develop and manufacture their products and equipment.We have created a service-based culture that operates at the highest ethical standards. Our foundation is to respect and protect the intellectual property that is both entrusted to us by, and generated for, our clients.

To that end we include rigorous processes and structural controls to maintain the security of the intellectual property and, further, to contain risk associated with its development. These measures include separation of the development teams, key-engineer exclusivity, and secured lab, design and manufacturing spaces. Intellectual property is further secured by our state-of-the-art IT systems, firewalls and security model which ensures that our work is safeguarded and secured.

In business and engineering, new product development (NPD) is the term used to describe the complete process of bringing a new product or service to market. There are two parallel paths involved in the NPD process : one involves the idea generation, product design, and detail engineering ; the other involves market research and marketing analysis. Companies typically see new product development as the first stage in generating and commercializing new products within the overall strategic process of product life cycle management used to maintain or grow their market share.

Types of new product

There are several general categories of new products. Some are new to the market (ex. DVD players into the home movie market), some are new to the company (ex. Game consoles for Sony), some are completely novel and create totally new markets (ex. the airline industry). When viewed against a different criteria, some new product concepts are merely minor modifications of existing products while some are completely innovative to the company.

Types of new products

The process

There are several stages in the new product development process...not always followed in order:

• Idea Generation (The "fuzzy front end" of the NPD process, see below)
• Ideas for new products can be obtained from customers (employing user innovation), the company's R&D department, competitors, focus groups, employees, salespeople, corporate spies, trade shows, or through a policy of Open Innovation. Ethnographic discovery methods (searching for user patterns and habits) may also be used to get an insight into new product lines or product features.
• Formal idea generation techniques can be used, such as attribute listing, forced relationships, brainstorming, morphological analysis and problem analysis.

Idea Screening

The object is to eliminate unsound concepts prior to devoting resources to them.

The screeners must ask at least three questions:

• Will the customer in the target market benefit from the product?
• Is it technically feasible to manufacture the product?
• Will the product be profitable when manufactured and delivered to the customer at the target price?

Concept Development and Testing

Develop the marketing and engineering details.

• Who is the target market and who is the decision maker in the purchasing process?
• What product features must the product incorporate?
• What benefits will the product provide?
• How will consumers react to the product?
• How will the product be produced most cost effectively?
• Prove feasibility through virtual computer aided rendering, and rapid prototyping
• What will it cost to produce it?
• Test the concept by asking a sample of prospective customers what they think of the idea.

Business Analysis

• Estimate likely selling price based upon competition and customer feedback
• Estimate sales volume based upon size of market
• Estimate profitability and breakeven point

Beta Testing and Market Testing

• Produce a physical prototype or mock-up
• Test the product (and its packaging) in typical usage situations.
• Conduct focus group customer interviews or introduce at trade show.
• Make adjustments where necessary.
• Produce an initial run of the product and sell it in a test market area to determine customer acceptance.
• Technical Implementation
• New program initiation
• Resource estimation
• Requirement publication
• Engineering operations planning
• Department scheduling
• Supplier collaboration
• Logistics plan
• Resource plan publication
• Program review and monitoring
• Contingencies - what-if planning
• Commercialization (often considered post-NPD)
• Launch the product
• Produce and place advertisements and other promotions
• Fill the distribution pipeline with product
• Critical path analysis is most useful at this stage

These steps may be iterated as needed. Some steps may be eliminated. To reduce the time that the NPD process takes, many companies are completing several steps at the same time (referred to as concurrent engineering or time to market). Most industry leaders see new product development as a proactive process where resources are allocated to identify market changes and seize upon new product opportunities before they occur (in contrast to a reactive strategy in which nothing is done until problems occur or the competitor introduces an innovation). Many industry leaders see new product development as an ongoing process (referred to as continuous development) in which the entire organization is always looking for opportunities.

For the more innovative products indicated on the diagram above, great amounts of uncertainty and change may exist, which makes it difficult or impossible to plan the complete project before starting it. In this case, a more flexible approach may be advisable.

Because the NPD process typically requires both engineering and marketing expertise, cross-functional teams are a common way of organizing projects. The team is responsible for all aspects of the project, from initial idea generation to final commercialization, and they usually report to senior management (often to a vice president or Program Manager). In those industries where products are technically complex, development research is typically expensive, and product life cycles are relatively short, strategic alliances among several organizations helps to spread the costs, provide access to a wider skill set, and speeds the overall process.

Also, notice that because engineering and marketing expertise are usually both critical to the process, choosing an appropriate blend of the two is important. Observe (for example, by looking at the See also or References sections below) that this article is slanted more toward the marketing side. For more of an engineering slant, see the Ulrich and Eppinger reference below.

People respond to new products in different ways. The adoption of a new technology can be analyzed using a variety of diffusion theories such as the Diffusion of innovations theory.

Protecting new products

When developing a new product many legal questions arise, including:

• How do I protect the innovation from imitators?
• Can the innovation be legally protected?
• For how long?
• How much will this cost?

The answers are complicated by the fact that several legal concepts may apply to any given innovation, product, process, or creative work. These include patents, trademarks, service marks, tradenames, copyrights, and trade secrets. It is necessary to know which are applicable and when each is appropriate. This varies somewhat from jurisdiction to jurisdiction. The advice of a lawyer that specializes in these matters and is knowledgeable with your corporate philosophy regarding IP protection is essential.

Generally, copyrights are fairly easy to obtain but are applicable only in certain instances. Patents on the other hand, tend to involve complex claims and approval processes, tend to be expensive to obtain, and even more expensive to defend and preserve.

Fuzzy Front End

The Fuzzy Front End is the messy "getting started" period of new product development processes. It is in the front end where the organization formulates a concept of the product to be developed and decides whether or not to invest resources in the further development of an idea. It is the phase between first consideration of an opportunity and when it is judged ready to enter the structured development process . It includes all activities from the search for new opportunities through the formation of a germ of an idea to the development of a precise concept. The Fuzzy Front End ends when an organization approves and begins formal development of the concept.

We can distinguish five different front-end elements (not necessarily in a particular order):

• Opportunity Identification
• Opportunity Analysis
• Idea Genesis
• Idea Selection
• Concept and Technology Development

The first element is the opportunity identification. In this element, large or incremental business and technological chances are identified in a more or less structured way. Using the guidelines established here, resources will eventually be allocated to new projects.... which then lead to a structured NPPD (New Product & Process Development) strategy. The second element is the opportunity analysis. It is done to translate the identified opportunities into implications for the business and technology specific context of the company. Here extensive efforts may be made to align ideas to target customer groups and do market studies and/or technical trials and research. The third element is the idea genesis, which is described as evolutionary and iterative process progressing from birth to maturation of the opportunity into a tangible idea. The process of the idea genesis can be made internally or come from outside inputs, e.g. a supplier offering a new material/technology, or from a customer with an unusual request. The fourth element is the idea selection. Its purpose is to choose whether to pursue an idea by analyzing its potential business value. The fifth element is the concept and technology development. During this part of the front-end, the business case is developed based on estimates of the total available market, customer needs, investment requirements, competition analysis and project uncertainty. Some organizations consider this to be the first stage of the NPPD process.

Cost, function, aesthetics, manufacturability and marketing all contribute requirements to a product. The role of Creative Engineering is to generate a design that meets these sometimes conflicting goals while carefully balancing the resulting compromises in order to deliver the best possible product.

Development Process

Brainstorm

Based on your performance goals and design limitations we will develop creative ideas to solve difficult design problems such as: helping to create a revolutionary new product, improving on an existing product or avoiding a patent infringement.

Design

Once a brainstormed solution has been selected we will embody it in a preliminary design. We will focus on keeping the design as simple as possible while ensuring that it fits within the required physical envelope and meets the design requirements.

Breadboard

A proof-of-concept model may be required to demonstrate the validity of a design. This "breadboard" model can also be used as a developmental prototype to try out different components such as springs, gears and motors.

Engineer

Using the parameters established with the breadboard as a guide, complete tooling ready CAD models are created in Pro/ENGINEER or Solidworks. Shaded renderings, perspective drawings and orthogonal views with cross sections communicate the progress.

Prototype

An accurate functional prototype of the product is created using Rapid Prototyping technology, CNC machining, or both. This sample can be used to validate the design, test with consumers, show to customers, photograph for catalogs, etc.

Refine

Customer feedback and functional evaluation of the prototype drive final design changes and improvements that are implemented before freezing the design for manufacturing. Components are carefully checked for manufacturability.

Document

Product documentation capabilities include: Bill of Materials, descriptive text, 2-D detail drawings, 3-D CAD data, core and cavity surface data, perspective views, shaded renderings and computer animations.

Manufacture

Creative Engineering is accustomed to working with manufacturers in the U.S. and in the far east, and can work closely with the factory to ensure a smooth launch.

Debug

Creative Engineering can evaluate your pre-production and pilot production samples to help solve any problems that have been identified in early safety and performance testing and to help "groom the tooling." Digital photos of physically modified parts, updated CAD data, and/or dimensioned drawings communicate updates clearly and quickly.

Product development

Mechanical Engineering

Our mechanical engineering team uses the latest in computer-aided development tools, including SolidWorks, ProEngineer, AutoCAD, and others as required. These tools enable us to compress the concept development and prototyping phases into weeks or even days. We can transform CAD models directly into physical prototypes using either in-house CNC milling or processes such as stereolithography (SLA) or fused deposition (FDM). If multiple prototypes are required and production of hard tooling is either cost-prohibitive or too slow, we can use soft-tooling techniques to generate production-appearance mechanical parts in a couple of weeks, with mechanical properties that rival those of hard-tooled parts. In special cases we will produce prototype parts made with medical-grade resins so they are suitable for use in clinical testing.

Industrial Design

We have a close affiliation with leading industrial design groups, and together we have conceptualized scores of various products including medical devices ranging from knee braces to IV pumps.

Depending on your needs, our industrial design team can do everything from simple concept drawings to convey the design direction to more elaborate drawings and presentation-quality 3D models that can be used for focus groups and trade shows.

Electrical Engineering

Most of the products we develop require both analog and digital electronics. On the analog side, we have a lot of experience . We design stable circuits that thrive in the real-world environments of electrostatic discharge and mission critical applications.

On the digital side, our team uses the latest integrated development tools to give your product reliability, horsepower, and flexibility. Depending on your requirements, we can design an embedded microsystem or build in microprocessor-like functionality without the validation challenges associated with software.

Software Development

We develop everything from firmware for embedded processors to software for PC-based applications. Our expertise includes real-time control systems, graphical user interfaces, image processing, web-based applications, image processing and database development. Languages include C/C+/C++/C#, Visual Basic, Linux, Unix, SQL, XML, OS/2, Windows 95/2000/XP, WinCE, dot Net, TCP/IP, Java and others. For each project, we generate the following documentation: Software Development Plan, Software Requirements Specification, Software Design Description, Software V&V Plan, Software V&V Protocol and Software V&V Report.

Verification and Validation

As part of most development programs, we perform verification testing throughout the development process. This helps to ensure that we stay on course to a successful endpoint. We also typically orchestrate a series of validation tests after the design phase is complete, in order to flush out any shortcomings relative to the original design goals. We encourage the involvement of outside validation engineers during this process, to maximize objectivity.

Compliance Testing

We have an affiliation with two local compliance engineering firms, who can provide UL, CSA, TUV, VDE and CE testing. Because of our relationships, we can usually have a compliance engineer sit in early in the design process to ensure that no compliance issues crop up later.

Regulatory Support

For products that require FDA clearance prior to marketing, we can actively participate in the pre-clinical testing phase. For example, we can assist in providing technical information to support IDE (Investigational Device Exemption) applications, IRB (Institutional Review Board) approvals, 510(k) Pre-Market Notification submissions and PMA (Pre-Market Approval) applications. We can also write your 510(k) for you, or refer you to an associate.

Intellectual Property Assistance

We realize the importance of strong offensive and defensive intellectual property positions in order to compete effectively in today’s medical device industry. Many of our team members are multiple patent-holders, and most have read and analyzed hundreds of patents. As such, we are happy to work with you and your patent counsel to perform extensive searches of prior art, to define non-infringing product opportunities, and to come up with novel, patentable product concepts. We can even author the technical portion of your patent applications, if so desired.