Integrated Design

Bayer opeRA from Bayer Diagnostics (a division of Siemens) is a highly productive chemistry analyzer designed to meet the needs of any size modern laboratory. Bayer opeRA, which can be run in random access mode, has the capability to perform a wide range of tests in a single platform. About 200 user defined methods can easily be implemented. With this device, the reagents can be stored refrigerated on board. The analyzer shows improved performance in terms of reliability and productivity. Features that are unique to Bayer opeRA include unique RA fluid technology, 24-hour access to testing, advanced electrolyte analysis, automatic cuvette washing procedure, immediate STAT interrupt, automatic rerun and dilution capability, automatic ISE calibration and flexible direct tube sampling, and extensive “result review” option.

Although this ambitious project was completed a number of years ago, it continues to serve as a classic integrated design case study. The main objective for this project was to increase sales of a product that had already been on the market for some time by reintroducing it with a new look. Although the task doesn’t seem exceptionally unusual as an industrial design project, there were numerous restrictions which made it very challenging. These included working within significant tooling cost constraints, completing the final production design in less than 4 months and being limited to an existing underlying structure with a preexisting component arrangement. This case study will describe what took place within a 10 month period during which 21 molded parts and over 100 sheet metal parts were designed, tooled, prototyped and ultimately manufactured.

The original RA2000 was essentially a sheet metal enclosure which addressed the functional requirements of the instrument. It can be described as a cabinet with a base storage compartment to house a refrigerator compressor, CPU, and waster storage compartment in addition to three sample handling modules.

Bayer’s upper management and marketing department wanted to regain market share of the RA 2000 blood analyzer without incurring the costs of totally redesigning the entire product. Sales erosion was attributed to poor customer perception related to its general appearance and perceived difficulty in operator interface. Although the analyzer was technologically sophisticated its limited market acceptance was primarily due to its utilitarian and confusing appearance. Subsequently perspective customers were drawn to competitive products which were designed with a more technologically advanced appearance and simpler to operator interface. These aesthetically appealing designs were achieved by applying plastics to more forward looking designs.

The upper deck included a rear wall which included the fluid handling pumps and precision analytical modules which performed he analyses. The top deck also served as the main operator interface to the instrument which include sample loading, reagent replacement and removal of disposables. Market shifts from highly trained technicians to lower skilled labor required a simplified operator interface with the equipment. The current design appeared too complicated for this new group of less skilled technicians resulting in poor customer acceptance. These photos detailing the top deck clearly illustrate the problems associated with the RA2000 design.

In addition to the difficult operator interface the RA2000 also lacked any design elegance or customer appeal. Its appearance was not suited to a commercial clinical laboratory which was accustomed to more attractively designed products.

Numerous aesthetic problems can be highlighted by reviewing the RA2000. For example the louvers on either side looked like they were better suited for an industrial welder than a medical device. They were visually clumsy and lacked any design relationship to the product.

The large boxy base looked dull, bulky and primitive, very much like an old stove top.

When doors were opened they looked raw ad unfinished. Use of standard commercially available hardware for handles, hinges and locks further contributed to the mechanical look of the design. The rounded cylindrical form on the right side of the work surface was a hinged refrigerator cover. This poorly detailed shape was completely unrelated to any other part of the instrument. In addition, the detailing of the cover was overly complicated with many messy crevices making it difficult to keep clean.

We were commissioned to redesign the RA 2000 because of our initially proposed design concepts based on an integrated problem solving methodology and distinctively creative thought process. Unlike conventional industrial design or engineering, we approached this challenging project from a multidisciplinary perspective which enabled us to creatively and analytically solve all the problems concurrently. This approach required a keen understanding of the market needs, manufacturing requirements, and functional engineering specifications for the product.

Early in the program Bayer commissioned two industrial design firms in a runoff competition to propose design alternatives for the new product. The other firm’s limited imagination, lack of technical expertise in materials or processes and preconceptions for the product restricted their proposed design concepts to mundane solutions not much different from the existing product.

These illustrations show two concepts submitted by a competitive industrial design firm whose ideas were rejected because of their lack of marketing appeal. The division’s president related the designs to an old stove.

The division president’s dissatisfaction with their solutions prompted him to compare their designs to an old stovetop. This unfortunate outcome is often encountered by designers who get unwittingly trapped in a perceived dilemma based on legitimate business restrictions. In this case the client’s very practical objective of transforming an existing product into a totally new medical instrument with minimal capital investment was completely realistic. The only problem was the other design firm wasn’t completely aware of their options and they limited their concepts to very superficial cosmetic changes. Conversely our integrated design methodology actually offered our design team many fresh design options that cost effectively satisfied the primary marketing objectives.

After meticulously studying the product, our design team evaluated realistic changes that could be made within the limited scope of the project. This study began with a multifaceted analysis of the medical device based on the following:  

• General product function & operator interface
• Overall component arrangement
• Added functionality
• Manufacturing requirements
• Capital investment restrictions
• Desired marketing image
• Service and maintenance requirements

General Product Function & Operator Interface - Operator interface and human factors considerations were studied during the initial stages of the product review. An operation sequence diagram was prepared to analyze motion studies, location of controls, operator errors and accessibility to frequently accessed areas. These observations were documented in a format report with videos and photographs.

Overall Component Arrangement- 

Component sub-assemblies and placements within the overall chassis were documented with CAD files and photographs. Wiring interconnections between sub-assemblies were noted to assure that the new design would not violate any critical wiring paths. The upper deck was meticulously dismantled and documented with photographs.

After the top wok surface was removed sample handling modules for each operation were revealed. The rear wall was also disassembled to expose all components. The sheet metal upper frame was removed as shown in the photo. These sectional separations helped the design team gain a better understanding of the entire system.

Doors on either side of the lower cabinet were removed, exposing the waste containers shown on the left and the chiller assembly on the right at the rear side of the cabinet.

These photos show the refrigerator sub-assembly removed from the cabinet.

The refrigerator assembly cooled this reagent sample handling chamber located at the far right section of the work surface deck. Temperatures within this chamber had to be maintained with +/- .1 °C. Cooled air was forced through the duct and circulated within the chamber. Insulation and foam were added to the external walls to maintain constant temperatures within.

Added Functionality- The updated product was to include enhanced functionality with the addition of new modules within the same general structure for improved performance. The placement and accessibility of these units were discussed and evaluated with other members of Bayer’s design team to determine their optimal location. Factors that were considered in determining the optimum location included user accessibility, cost, mechanical integration, assembly, appearance and maintenance. These photos of the upper deck wall were taken from the rear and front. They show a newly added module which was introduced to improve overall functionality. This module (shown as a white assembly) created a new aesthetic challenge.

Manufacturing Requirements - Numerous manufacturing related factors were reviewed, discussed and prioritized during this study. Firstly, the main chassis structure which supported all the components was reviewed based on construction, efficiency and overall design. Assembly problems associated with the current product were documented. These problems were primarily derived from tolerance stack-ups and numerous adjustments within the design which prolonged assembly time. In addition, the chassis was reviewed to identify possible minor design changes that could be made which would lead to a completely new appearance.

Concept sketches - Immediately after this study was completed, documented and approved by Bayer, concepts were developed in sketches using a preliminary 3D CAD layout of the existing instrument as an underlay to accurately represent the product.

Preliminary conecpt renderings - After exploring dozens of ideas, four concepts were further developed to presentation level renderings which were unveiled to engineering and marketing directors. A broad range of concepts was presented offering the group a diverse selection of alternatives based on various styles, manufacturing processes and individual advantages.

Refined concept renderings - This group of initial concepts was edited and refined in second iteration of computer generated renderings shown in these pictures. Bayer showed these renderings to their distributors in Europe, Asia and South America. A formal marketing survey was conducted based on the proposed designs as well as specific attributes of each concept. Data obtained from this study overwhelmingly verified Concept 3 as the best choice because of its visual impact and state of the art image as a medical product. Concept 3 offered the optimum balance of form, proportion and function.

Structural foam part sketches- Since tooling investments were so critical to the success of the project, we prepared a detailed preliminary cost study of the selected concept before any engineering development was initiated.  In addition to the cost study other considerations included lead time, risk, part count, and development times were also evaluated based on the following manufacturing processes:  

• Pressure forming
• Twin sheet forming
• Industrial blow molding
• Structural foam molding
• Sheet metal
• Reaction injection molding

This list was further reduced to two processes: structural foam molding and pressure forming. A detailed comparative cost analysis of the accepted design was completed by sketching every major part, estimating the weight, illustrating proposed mounting methods and providing overall sizes based on each manufacturing alternative. Sketches shown  were distributed to 5 reputable pressure formers and structural foam molders to obtain tooling and part cost estimates.

Cost study - Comparative costs were obtained based upon common estimated weights, tolerances, lead times and anticipated production quantities. Vendors were instructed that tools would be cut directly from CAD files provided. No formal production drawings would be used in any stage of the project, except during inspection. When parts were to be manufactured, it was agreed that part drawings would be provided to the molder with dimensions critical only to fit or function. All dimensions related to the part geometry would be within the data file.

After the price quotes were reviewed, it was determined that the external plastic covers would be pressure formed. Pressure forming provided the best combination of low cost tooling, part cost, function and required aesthetic details. Pressure forming also gave Bayer the freedom to make minor design changes at a later date since tooling was more easily modified than other processes.

Foam core model - In addition to the cost study, we also constructed a full scale foam core model of the new analyzer which was constructed around an existing chassis. The full scale foam core model provided marketing with a physical representation of the proposed design well before any time was invested in engineering development. Individuals were able to interact with the product as well as get a true impression of its size and proportions. The foam core model also enabled us to refined human factors and aesthetic details.

Some of its most significant features of the new design are summarized below:

The design visually transformed the RA 2000 into a totally new product without any significant change to the basic structure or component arrangement.

The estimated tooling cost and proposed assembly were well within the taregted budget.

The selected concept integrated the product into a visually cohesive dominant form that could be easily recognized for immediate corporate branding.

The overall form was partitioned into three smaller elements which included a curved darker colored rear planar wall intersected by two lighter colored blocks in the front. This separation of the front and back reduced the visual mass of the product.

Exposing only the frequently accessed sample handling tray and concealing the other less frequently accessed areas behind covers, dramatically reduced operator confusion.

This calculated design decision also improved the overall look of the product without changing any of the existing technology.

Crisp overall forms integrated with an honest representation of the product resulted in a long lasting classic design that is still contemporary by today’s standards.

CAD assembly of upper  sheet metal chassis- Engineering details pertaining to the production design were being developed in a 3D CAD assembly layout as the concept was refined in Phase 1. Translating the design from concept into product was relatively easy since the technical details for the entire structure were clearly understood from the very beginning. The structure was divided into 3 independent sections:  

• Lower console
• Work surface
• Upper chassis

This phase was the most intense and time consuming part of the entire development program. Literally hundreds of parts and thousands of details were completed during this phase. Production design of the sheet metal chassis, exterior plastic covers, hardware and mechanical details for all moving parts were completely detailed throughout this phase. The lower section was defined as the foundation of the instrument to which all major components were attached. Tolerance ranges for the assembled weldment were defined to fall within +/- .040 in. Since all holes within one plane could be held to +/- .005 in., these surfaces were designed to support multiple covers thus minimizing tolerance stackups. Parallel with this effort, cost analyses were updated for parts and tooling to assure Bayer that their budgets would be met.

These pictures illustrate the separate sheet metal parts which formed the underside of the top work surface deck and the back wall assembly. Also shown are the pressure formed work surface and top covers.

CAD assembly of front doors- The pressure formed front doors were designed to swing left and right, exposing all the interior contents within the cabinet. Each door was designed in two parts which were bonded together. This assembly provided a clean looking door on both interior and exterior surfaces. Hinges were also detailed to be concealed as shown in these pictures. The long side panels on either side of the rear wall are also shown in this group of CAD pictures.

CAD assembly of top work surface -The top work surface was designed to provide easy cleaning as well as complying with all aesthetic requirements. Details of the work surface were refined to functionally and aesthetically match up with adjoining panels, covers and doors.

CAD assembly of upper deck covers - Covers on the top deck were also detailed with the same attention to detail as the other panels. The inside and exterior surfaces were designed to look finished in open as well as closed orientations.

CAD details of upper deck covers - This assembly of the chiller cover was a major design improvement when compared to the original design. The new design was cleverly simplified by introducing a foam filled rotationally molded inner cover. Rotational molding tools fell well within the overall tooling budget. The foam filled enclosure optimized the aesthetic, functional and critical thermal insulation requirements for this cover.

CAD overall assembly - The final CAD assembly shown in these pictures represented the complete integration of all plastic and sheet metal parts.

Prototype review - After the CAD design was completed, files were released to a prototyping shop to construct one completely functional prototype. Some files were released for CNC machining while others required preliminary part drawings which were prepared. The first prototype was completed with all plastic and sheet metal parts. Due to scheduling restrictions, patterns were also initiated in parallel with the prototyping effort. Although this introduced added risk, a careful assessment of the design reassured the development team that this risk would be minimal. A total of six sets of cast polyurethane plastic parts were prototyped and delivered within 8 weeks after receipt of the 3D CAD files. Six functional prototypes were distributed to strategic sites worldwide for evaluation and approval before production release. Parts were prototyped directly from the CAD files with CNC machining and other methods. They were eventually painted and assembled to the chassis as shown in these photos.

Prototype rear view and details

These pictures show the rear of the revised chassis without covers. The second photo from the left shows the new power and I/O panel assemblies on the side of the chassis. The other photos depict covers assembled to the chassis at various levels of assembly and development.

After the prototype was completed, the entire product was revaluated based on human factors and operator interface. These photographs show some critical areas of the new design that were significantly improved. A casual view of these photos clearly illustrates how the new design successfully simplified the overall appearance and operator interface. Accessibility to regent modules, door handles and sample handling trays was dramatically improved.

In addition to verifying the overall improvements in operator interface, the design was also critiqued based on ease of assembly, service and manufacturability. Pressure formed part designs were reviewed with the pressureformer and modified if required. In addition, final engineering revisions were concurrently incorporated into the overall design assembly. After less than 4 months from the project start date, designs for all plastic parts were revised, completed and released for production tooling.

During the prototyping and evaluation phase, documentation of plastic and sheet metal part drawings was being completed. These drawings included traditional production drawings for all sheet metal parts and inspection drawings for plastic parts. As drawings were completed, they were immediately transferred to Bayer for review and distribution to appropriate vendors. Production methodology, agency compliance, quality assurance, documentation, and production liaison were all completed during this phase.

Hundreds of part drawings and assembly drawings were created, providing Bayer with a comprehensive documentation package. Part drawings included material specifications, tolerances, paint specifications and hardware callouts. Assembly drawings were prepared in accordance with agreed upon manufacturing methods at various levels or production.

Photographs of first run production parts for sheet metal and plastic components are shown in the following pictures.

Assistance in production trimming and secondary operations -During production liaison, our onsite visits to molding facilities enabled us to assist the molder and Bayer methodize some of the production operations to comply with desired design requirements. Our understanding of pressure forming and rotational molded was very beneficial during this production startup phase.

Our in depth knowledge of the pressure forming process and associated tooling enabled us to design parts with optimized aesthetic, cost and manufacturing details. These photos of different pressure formed molds depict the general configuration of the work surface mold, upper cover and side panel. The wooden form in the middle photo is called a plug assist. This is used in the pressure forming process to push the sheet into the mold for a more uniform walled part.

After parts were formed, they were placed in fixtures as shown in these photos. Excess material was trimmed off by a Thermwood CNC router. During this operation, partially trimmed parts are placed in a cast form, a vacuum is applied to keep the part in place and the computer controlled router removes all excess material according to a program based on the part geometry supplied by Integrated Design Systems.

The trimmed parts are removed from the fixture and detailed with additional fixtures as shown in these photos. Special operations not easily accomplished by the CNC router are completed manually. Mounting blocks, inserts and hardware are applied to the trimmed covers. These photos show blocks beginning cut from strips of raw stock, and adhered in place. Fixtures are again used to accurately position critical mounting holes and inserts.

Quality assurance and inspection -IDS played a critical role in the reproduction startup of this project by assisting during the inspection process. Parts were examined for tolerances, flatness, paint finish and numerous other factors affecting fit, appearance and function. Problems were corrected by improving trimming and assembly procedures suggested by IDS.

These photos of the rotationally molded inner cover for the refrigerated chiller compartment show the one piece design with a groove for the rubber gasket seal. A molded in air duct was also included in the design to provide free air flow to the reagent carrousel.

Painting and masking inspection -This painted cover which concealed the newly added analytical module is comprised of three pressure formed parts adhered into a single inseparable assembly. The masked area was defined in the documentation to visually integrate this assembly into the overall design.

Upper deck -The previous shown cover assembly is shown at the far left side of the unit. One can readily appreciate how the masking and geometry of this cover was cleverly integrated with the overall appearance of the entire product. Attention to detail and creative design skills unified forms and colors with the overall design.

Lower chassis -Sheet metal sub assemblies were fabricated from the part drawings prepared during this phase. Examples of the upper rear wall and base cabinet are shown in these photos.

Easy accessibility to the newly added analytical module was achieved with the elegant vertically sliding door assembly shown in these photos. A concealed push release latch at the top of the stroke retained the door in the open position.

The final assembly of painted pre-production covers is shown in these photos. Counterbalanced covers are partially opened to demonstrate easy access to sample loading stations within the work surface. Details of the top work surface deck are depicted from various views in the other photos.

The new designed refrigerated reagent compartment was a major aesthetic and functional improvement over the original assembly. The one piece rotationally molded polyethylene inner cover provided a visually appealing, easily cleaned and thermally efficient chamber. Specially designed concealed hinges within the front doors also improved overall appearance.

Conclusion

This challenging project was a major success for all program participants. Sales increased more than 400% of initial estimates.  All project participants shared in the rewards and appreciation of Bayer’s upper management as well as new customers.   The objects of introducing a revitalized product with added functionality and minimal engineering redesign were fully accomplished. The new product not only looked much better than the original, it performed better and was much easier to service.

Compliance with capital investment restrictions

Bayer imposed very restrictive limits on capital expenditures. These limitations included caps on design costs as well as tooling because of the relatively low annual sales and relatively short product life expectancy. The targeted budget was matched with appropriate manufacturing processes that would comply with the aesthetic and financial restrictions.

Attaining Desired Marketing Image

Discussions with marketing managers and brainstorming sessions with technical personnel provided our design team with the inspiration to creatively integrate this information into new concepts which were both revolutionary as well as practical. Our objectives were focused on simplifying the perceived complexity if the existing product without imposing more obstacles for the user. We also sought designs that would unify the overall appearance with classic images devoid of clichés.

Satisfying Service and Maintenance Requirements

All proposed designs included considerations for service and maintenance requirements. These design parameters would influence details pertaining to sanitation, ease of cleaning, and accessibility to internal modules for easy replacement by a serviceman. In addition operators would be required to easily access certain areas which would be periodically refilled or emptied during normal use. These would include reagent bottles, waste containers, and certain liquid transport tubes.

The following is an abbreviated list of design objectives that were met in this abitious project  

• A contemporary appearance which would express technological leadership in an international marketplace
• A design which would be distinctive and set a trend in the industry
• A design suitable for a wide range of users, optimizing human factors' considerations
• A design requiring minimal tooling investment, which could be easily amortized during the first year of production.
• Tooling within 10 weeks
• Easily assembled with minimum adjustments and alignment procedures
• A design which would pass shipping tests
• A design which would be easy to service
• A design that insured manufacturing consistency and quality