What is it with story a.k.a. word problems?! It is one thing to stare at some equation and try to work through it, now you’re asking me to come up with the equation and then work through it! Ugh! Can’t we just study math without having to extract it?! Hmm, how many times in life have equations or formula just been presented to you in real life situations? Sorry – they just aren’t floating around waiting to be solved.
A lot of the study of mathematics gives you equations to work on your mathematics skills & techniques (i.e., multiple equations and multiple unknowns). The real world doesn’t give you clear equations or formulas to solve. The real world gives you problems. Some of these problems can lend themselves to math to solve. Many other vague problems require logic, engineering, psychology, sociology, history, knowledge of laws, regulations, and state of the art science to solve.
When you were young and first presented with word problems, they were a challenge. You had to know how to identify the variables and their relationships and then create an expression which could then be solved.
There are 96 fourth graders at Blue Lakes Elementary School. 43 of them are girls. On Friday 5 fourth grade girls and 4 fourth grade boys were absent. How many fourth-grade boys were at Blue Lakes Elementary School on Friday?
Gleaning out the keen elements of the story problem was not so easy at first. What is pertinent, what is superfluous or irrelevant? Some of us developed our discernment skills and readily communicated the problem in clear expressions. Some of us decided we preferred other areas of study and moved on.
Either way though, we all end up solving word problems every day: Shopping, planning a trip, cooking a new dish, home repairs, etc. These are the problems of everyday life. Depending on your life training and experience you become adept at solving specific types of story problems. Presented with story problems that are outside our normal repertoire and we can flounder a bit, like those early days when we were first presented with story problems.
Floundering can really hurt project timelines! Long periods with no net progress or trial & error “never enough time to do it right, always enough time to do it over”.
Engineering and Science disciplines involve extensive story problems solving. Product development involves taking the fruits of the research and applying the pragmatics which includes meeting appropriate standards and regulations. Clinical studies and Quality & Regulatory disciplines become experienced with solving clinical validations, quality control and regulatory strategies as their repertoire of story problems. These disciplines become more and more adept as they practice solving the word problems in their areas especially when they have been confronted with many varied scenarios. The more the skill is practiced in differing circumstances, the better the skill becomes at dealing with difficult and/or complex word problems such that what may take a junior resource a long time with trial and error could be addressed very efficiently with some prudent use of expertise.
The question becomes when does my organization’s story problem solvers need of some help?
This help could be in the form of just getting the team started with the specifications or a protocol. Or it could be developing strategies and tactics out of a gray nebulous challenge ahead.
This help can be to “teach a man to fish” or if necessary, in a crunch “give a man a fish” or even set up processes to develop organizational “fishing lessons”.
Let’s look at product realization using the V-Diagram. The V-Diagram can have many flavors but ultimately, we are starting with a user need defined in user terms. There is a bit of an art to generating user needs. They shouldn’t be so prescriptive as to overly constrain the design, yet they need to inform the design enough to create a meaningful set of requirements. They also must lend themselves to product validation. This is a story problem. This is taking a real world need and describing it sufficiently for a solution to be developed and validated.
Next, we want to decompose this user need into more quantifiable requirements. Houston, does it sound like our word problems above? This is indeed a story problem pulling out user language and turning it into defined quantifiable requirements that can be tested at the system level with clear pass/fail criteria. Risk analysis is also a story problem requiring careful consideration of scenarios and assigning risk priority numbers. Even taking the product requirements, distributing roles/responsibilities among system components, and translating these into hard specifications at the lower level is a story problem. Coming up with ways to test these specifications can also tax the inexperienced and lead to gaps and deficiencies.
At Qserve we have a team of story problem solvers. This team is well versed in dealing with the gray world of applying regulations and general & particular standards to specific domains and technologies within Medical Device and IVD. They “thrive in the gray” by everyday practice across a large variety of story problems.
Qserve’s clinical research organization can help with Medical Device and IVD user needs, validation protocols, literature searches supporting validation, data analysis and reports. Our System/Software Engineers can assist with setting up verifiable requirements/specifications, standards interpretation, outside agency testing guidance. Our quality/regulatory team can help with setting up compliant processes, performing audits, creating and compiling submissions to address the constantly changing/updating global market regulations.
The Qserve story problem solvers have been solving a depth and breadth of IVD and Medical Device challenges for years. They don’t gold plate nor provide anemic solutions – hence our motto – the practical approach! Qserve understands the regulations, regulators and the ins and outs. They stay abreast of changes in regulations, standards and guidance and they are continually advancing their story problem solving through a broad range of product lines, applications and geographies. They can tailor their story problem solving assistance per client needs to help as appropriate and help avoid the churn, setbacks and to setup for successful product lifecycle in an ever-changing regulated environment.
The next time you sense story problem floundering in your Medical Device or In Vitro Diagnostic project consider if a dose of Qserve’s expertise can help move you forward!