Answer for the medically fragile

When designing new products for established markets, it is imperative to consider unmet patient and clinician needs. Whether or not products address unmet needs can determine their success in the marketplace. One new product – designed around the needs of the patients, clinicians, and the laboratorians it serves – is the BD Microtainer MAP Microtube for Automated Processing.  While considered a routine procedure in laboratory medicine, obtaining a blood sample from a medically fragile patient or a patient with difficult venous access (DVA) can pose unique challenges.

Medically fragile and DVA patients include those who are very tiny preemies and neonates, or those with chronic conditions such as cardiac disease, cancer patients, genetic diseases, and those patients who need to save their veins for future treatment of chronic kidney disease (CKD). Additionally, it may be considered best practice to collect lower volumes of blood from these patients, as well as other patients at risk of iatrogenic anemia such as patients in an ICU.^1,2,3

To address the needs of patients requiring very small volumes of blood, the MAP tube requires only 500µL of capillary blood while still accommodating a full-size patient identification label for safety. The MAP tube can run in automated mode onmost hematology analyzers to improve turnaround time for results, eliminating manual steps in the laboratory. The process of getting from unmet customer needs to a product that meets those needs can be complicated.


Know the process
When thinking about new products, understanding the current processes and workarounds will help drive focus towards viable solutions. The first step to understanding unmet needs was to study the techniques used by experienced nurses, phlebotomists, and clinicians to address the medically fragile and DVA patients.

One common solution was to use a micro-collection tube filled with capillary blood accessed by a lancet designed for finger or heel stick, thereby avoiding the vein altogether. A micro-collection tube also requires a smaller volume of blood for testing than a full-size blood collection tube. However, micro-collection tubes can be harder to handle and label due to their small size, and have been associated with manual laboratory processing, which requires additional steps, delaying the time to results. Understanding these concerns around micro-collection sampling led BD Diagnostics to undertake the challenge of working with customers and instrument companies to resolve some of these issues. The journey to develop the BD Microtainer MAP Microtube for Automated Process (MAP tube) involved the following process:

Product design must balance the needs of customers and products with the requirements of instrument and reagent compatibility.A cross-functional team, including representatives from all related functions, worked together on the new product development team. The design process for the MAP tube began with a thorough review of the customer sensing effort that surfaced the need for low-volume blood collection products that fit into existing work practices. The next step was collection of extensive market research and voice of the customer (VOC) by watching and learning from clinicians as well as laboratorians who processed the samples.

It became apparent that due to low volumes of blood collected via capillary collection, the users had unmet needs concerning faster turnaround time, reducing patient identification errors, and improving overall workflow/efficiency. Resolving these issues became the goal of the product development team.


Finding focus
The team used Design for Six Sigma tools in order to distill hundreds of VOC images. This resulted in a concise list of user needs for the team to focus on while developing design solutions. Then, creation of various design architecture models helped obtain end user feedback from multiple countries. The simulated use customer feedback allowed evaluation of various interfaces that are important to the end user during the collection and handling part of the process. Additionally, communication with instrument companies took place to ensure the success of product functionality with both current and future analyzers.

As the MAP tube transitioned from concept to design, numerous elements needed to be determined, and in many cases, making the proper trade-off decisions throughout this phase is what ultimately determines success or failure of the product.

Determination of everything from product features, to materials selection, and what manufacturing technology to use was the next step. Product features help determine fit, form, and function of the product. Material selection is a driver for numerous processes, cost, supply chain, and sustainability outcomes of the project. Deciding what manufacturing technologies to utilize quite often drives the make vs. buy decisions, as well as strongly influencing where any given product can be manufactured based upon access to technology, and the required human skills to operate and maintain that technology. All of these were essentially determined in this phase of the project. If these diverse decisions are not properly aligned and complementary to each other, the likelihood of success for the product diminishes.

Throughout the process of product development, the marketing and medical affairs team members constantly interfaced with clinicians and laboratorians to ensure that any design trade-offs do not impact the acceptability of the product in the market or diminish its value.


Manufacturing
In terms of manufacturing, numerous elements factor into the decision on where to produce a product. Some of these elements include proximity to the markets served, experience/expertise with the selected technologies that will be utilized, and long-term outlook for the product in terms of growth and volume. Once settled on the manufacturing approach and site by the new product team, it was crucial to engage cross-functional associates from the manufacturing site with the ongoing product development team. This created the expertise within the team to discuss, debate, and ultimately decide about ongoing trade-off choices between product features and manufacturability.

This constructive tension, while at times challenging, is an essential element of a robust outcome for any product development initiative. In a very simple form, viewing the issues as a triangle is best, with the three tips being product design, process design, and materials selection. If the project makes decisions, which pull too much towards any one of the outer points, there is high likelihood that the other elements are under-represented in that solution.


Quality counts
The concept followed in developing the MAP tube and all products at BD, is to regularly meet or exceed customer expectations in respect to quality. The way we do this is to start in design (both product and process) and then instill quality in every stage of the project going forward. This must first begin with robust and detailed knowledge of what quality means in the eyes of the customer around the product. This leads to clear definitions of the critical-to-quality characteristics.

In turn, these characteristics are embedded, and are robustly challenged throughout each remaining phase of the project. These characteristics have profound influence over what materials are deemed acceptable; the final shape and dimensions of components; which technologies are/are not employed in the process; what, if any, special skills will be required of the technicians on the line; and what training is required for any associate working on the product.

As stated previously, cross-functional teams are a key enabler to success. That is never more evident than when it comes time to actually start the manufacturing operations. If key plant associates have been involved in various phases of the process development and have been part of the team that conducts factory acceptance runs, then they have also been learning by doing throughout the project.

There is no magic recipe to addressing the challenges of controlling expenses when production associates are involved prior to the start of manufacturing. A realistic assessment of the complexity of the operation, the skills that are required for the various line positions, and the likely length of the learning curve for those roles is required. In addition, most adults learn by doing, and it is an excellent training opportunity to involve associates in evaluation runs while the equipment is in development.

At the end of the day, early involvement of production associates in the project will almost always more than pay for the costs of such involvement in terms of faster ramp-up of the manufacturing output; fewer mistakes, resulting in less waste; and, ultimately, the ability to realize more sales earlier in the process than would otherwise have been possible.


Efficacy
Once the manufacturing team began producing final product for the MAP tube, the medical affairs team conducted clinical studies to validate the efficacy of the product and create data that for submission for regulatory approval and customer acceptance.

Clinical studies were performed by applying good clinical practices (GCP) and good laboratory practices (GLP) at external clinical facilities.

Extensive testing of the MAP tube was performed and compared with the existing microcollection products available in the marketplace. Subjects that were tested ranged from healthy adults, to patients suffering from a variety of hematological disorders. The data generated from these studies was used to generate marketing collateral.

The end goal is to ensure the end product meets the needs of the clinicians and laboratorians it is intended to serve, with the expected quality and cost.
 

¹    Current Management o Anemia in Critically Ill Patients: Analysis of a Database of 139 Hospitals, Dasta et al., 2008
²    Evaluation of a Blood Conservation Strategy in the Intensive Care Unit: A Prospective, Randomised Study, Mahdy et al., 2009
³    Effects of Blood Sample Volume on Hematocrit in Critically Ill Children and Neonates, Lister et al., 2008


BD Diagnostics
Franklin Lakes, NJ
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