Friday, June 12, 2009

Team Medical sticks it out to win product design competition - SDM Pulse, Summer 2009

By Rajesh Mishra, SDM ’08

Team Medical shows off its winning design for a needle-
stick injury solution: Stikaway. Team members are, from left,
Andrei Akaikine, Tieyu Li, Rajesh Mishra, Arun
Balasubramaniam, and Shailendra Yadav.
(Eumir Reyes is not pictured.)
The first week of the spring term had ended and the deadline for submitting team rosters for our class in Product Design and Development (PDD) was closing in. Yet 15 of us out of 98 in the class were still trying to assemble into teams for the semester-long project—to conceive, design, evaluate, and prototype a physical product.

Although none of us was sure what we wanted to create, six of us finally coalesced around our interest in health care, forming Team Medical: Andrei Akaikine, SDM ’09, and SDM ’08s Arun Balasubramaniam, Tieyu Li, Rajesh Mishra, Eumir Reyes, and Shailendra Yadav.

Our first task was to determine the most compelling unmet needs within this broad field. Each of us investigated a range of venues—including emergency rooms, pharmacies, and blood drive centers—interviewing everyone from nurses to phlebotomists. We zeroed in on three target populations: 1) drug consumers who need to organize their pills; 2) health-care workers using needles; and 3) potential blood donors.

After presenting our initial findings to the class, we eliminated the third option. Our remaining dilemma—should we develop a device that would make it easier to organize pills or one that would prevent injury and infection from a needle-stick— was resolved when another team chose to work on a pill organizer. Initially we asked a series of questions: Who is at risk of needle-stick injury? What are the consequences of such an event? Who cares about needle-stick? How does needle-stick occur? Are there any regulations that govern needle use? What other safety solutions exist?

A preliminary investigation revealed that a host of needle-stick prevention solutions already exist, so Team Medical set out to find a solution that was novel, more effective, and easier to adopt. A variety of techniques taught in class helped us to generate product concepts. These included individual and group brainstorming—uncritically exploring various structures, materials, functions, and uses; morphological feature analysis—generating concepts by examining different operands for each solution and underlying process; and mind-map construction—organizing the concepts generated from brainstorming and morphological feature analysis methodically.

We came up with 18 different concepts, then used the Pugh concept selection method to compare them. We initially selected the three that scored highest, but to our dismay, subsequent patent and product searches revealed that all three had been either described or implemented previously. Had we chosen our target user group and needs correctly before performing the Pugh analysis? Since the results showed otherwise, the team decided to return to the proverbial drawing board and redo the analysis. This was a valuable lesson: Pugh selection is sometimes an iterative process, not just a one-time evaluation.

We took a fresh approach, posing the question: Who needs this problem solved and has not yet found an adequate solution? This line of investigation led us to examine the prevalence of needle-stick injuries in dental environments, where the syringes used are different from those designed for other medical uses—they are capable of storing vials, or carpules, of anesthetic to allow the needle and syringe to be used multiple times during a patient visit. We learned that few solutions exist to prevent needle-stick injury in dental clinics, as dentists were comfortable using existing technology and were less apt to adopt newer needle-syringe systems. Also, the Needle-stick Prevention Act of 2000 set the guidelines for dental practitioners to use a one-handed technique as a manual means of preventing injury.

We conducted a survey to assess how significant a problem needle-stick is for those in or aspiring toward a dental profession and how effective current methods are at prevention. Of the 110 respondents, 83 percent cited safety as of paramount importance and 65 percent agreed that current methods, of which the most common is the technique of inserting the needle into the cap and pulling it closed with one hand, were not adequate to prevent needle-stick.

Although this data seemed compelling, we decided to seek the advice of an expert to ensure we were on track to meet a need. We were fortunate to obtain the assistance of Dr. Kanchan Ganda, director of medicine at Tufts Dental School, whose experience investigating needle-stick injury in dental settings dates back to 1991. Ganda informed us that needle-stick occurs as frequently as 65 times a year at Tufts and the likelihood of contracting a viral disease such as HIV, Hepatitis B, and Hepatitis C is high in such settings.
Figure 1: Proof-of-Concept

Reassured that needle-stick is an important cause for dental institutions and clinics, Team Medical developed an initial proof-of-concept for the needle-stick prevention device. Our “needle clamp” [see Figure 1] was designed to allow the user to recap the needle after use with a single hand. Implemented with paper clips and an existing needle cap, this first concept led us to consider a guide on which the syringe could rest so that the needle could slide easily into the cap.

Figure 2: Pre-alpha
Our second prototype was created out of foam core [see Figure 2] and shown to practicing dentists and dental students, including Maulik Kotdawala at Tufts. One concern these potential users cited was how to prevent the needle from being retracted once it was capped for disposal. The “aha!” moment that occurred while brainstorming was to push the base of the needle, or needle hub, through a “trapping device” so it could not be pulled back—an O-ring seemed promising for this purpose. We also improvised our design to include a “parking area” for the syringe between uses. Based on the initial user feedback and our own improvisations, we planned the construction of a third prototype using computer numerical-controlled (CNC) fabrication. We sent our CAD drawings to a local machine shop and anxiously awaited the manufacture of our first “real” prototype. When the prototype [see Figure 3] arrived soon thereafter, Team Medical was thrilled to demonstrate it to potential “customers”!
Figure 3: Alpha Gen 1

Our excitement was short-lived, as users cited three critical issues with our latest design: 1) The needle capture hole was not well aligned with the syringe guide, so the needle could miss the cap; 2) the gap between the parking area and the syringe guide could allow a hand to get caught, which might cause the device to topple, exposing the needle; and 3) the presence of both the “parking area” and the syringe guide might confound the user as to where to rest the syringe after use. Changes to accommodate this input had to be made quickly, just days before the final product presentation.

Figure 4: Alpha Gen 2
By stroke of luck, another PDD team came to our rescue, advising us on the services of a local shop that used a rapid-prototyping method called fused deposition modeling (FDM). As a result, our final prototype was born [see Figure 4].

With our freshly minted prototype in hand, Team Medical rushed to revisit its lead users for their assessment. Aside from a few minor requests, both Ganda and Kotdawala from Tufts accepted our prototype in concept and agreed to demonstrate it on film to our class. Our team was gratified at the outcome of our toils and felt confident showing Stikaway for the final PDD presentation.

With so many interesting products on display during the finals, including an automatic door opener and a calendar for the blind, all of us on Team Medical were extremely proud to win first place in the competition.

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