Development of a Medical Product –
Transition to Production
We keep in mind throughout the development of a medical product process that the rule of design for any medical product, like the physician’s creed, is to “first, do no harm”. At critical design and development review points along the way we perform detailed analysis of the sequence of usability for the prduct, and identification of any opportunities for misuse or failure, for example, with handheld surgical product a set of safety interlocks and inspection procedures can be developed and specified that are required to assure the device is always safe in the user’s hands, and safe for the patient.
We employ a convergent medical product development process. And as we move the product toward production Bresslergroup’s engineers and designers bring a broad and deep experience base in design for an extremely wide range of manufacturing techniques, including rapid prototyping, casting, NC machining, injection molding, blow and rotomolding, pressure forming, metal injection molding, powder metal, stamping and sheet metal forming.
Bresslergroup development personnel stay involved to assure success at every step of the way in bringing the development of a medical product to market, including first article inspection and vendor management, both domestic and overseas. Bresslergroup team members remain active through final documentation and through production. This interaction ensures that product development intent is maintained even as tradeoffs are made when selecting final components, tweaking the final part design for maximum production efficiency during the development of your medical product.
A great example of effective development, medical product design and engineering for effective production is the BD BACTEC™ FX. The Bactec product a Microbial Detection System for the growth and detection of microorganisms in clinical specimens. The medical product is ergonomically optimized to offer the most efficient workflow and high capacity output in the smallest footprint available.
The BD BACTEC™ FX Blood Culture System is used by medical technologists in clinical laboratories to detect development of bloodstream infections in patients. This new system improves clinical decision-making, patient safety and laboratory workflow by enhancing culturing practices with real-time user feedback and remote monitoring.
Compact and stackable, development of this medical product included an embedded, centralized computer and is available as either a 200-vial bench-top model or a full 400-vial stacked unit. Taking into consideration when lab space is limited, the BD BACTEC™ FX system spans only 25” wide, making it ideal for all laboratory environments.
Significant medical product development challenges were presented in the development of the BD BACTEC™ FX. The product needed to overcome conflicting requirements to increase vial capacity, maintain a 25” linear wall space and integrate optimal ergonomic standards to maximize product workflow.
The solution consists of a modular stacked unit with sliding drawers on the left and right sides, separated by a central computer processing area. Each sliding drawer contains 100 sample vials. The “stacked” aspect of the configuration enables the unit to feature the smallest footprint offered in the market place relative to capacity.
Through a process of examining anthropometric standards and Human Scale factors of user demographics during the front end of development of this medical product and creating several vial-accessing configuration scenarios, the team was able to determine the stacked, drawer configuration as superior in accommodating 400 vials while maintaining a desirable ergonomic work envelope.
A significant design and development challenge was to implement a unique system of 3 colored status indicator lights on each drawer (red, yellow and green), using an indirect lighting scheme. Rather than using a more pedestrian approach of discrete indicator lights that might be hard to see from a distance, 3 large bands of colored light were created on each door that illuminate the large recessed ellipse around the medical product drawer handles. The result created a very clear set of indicators that can be seen from anywhere in the room, while highlighting the BACTEC™ FX iconic design.
The key development and product engineering challenge was to specify and configure the LED’s to create 3 large, bright, discrete washes of color, without creating a muddy effect between the color bands. This is critical since a red light or positive detection signal can mean that medical patient risk is very high. The resulting color and location of the color bands needed to be controlled in order to provide an unambiguous read as to the status of the BD BACTEC™ FX, and whether samples in each drawer yielded positive or negative results. Engineering development consideration of the number, placement, cone angle, wavelength and brightness of the LED’s was critical to the success of the implementation, as well as the color, material, shape and texture of the elliptical reflective surfaces.
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