Developing a Diagnostic for Home Use? Assemble the Right Team and Consider These Issues
diagnostics is becoming the “darling of the medical industry because of potential growth,” says josh blackmore, global healthcare manager at thermoplastics resin supplier m. holland co. “patients have been using simple but accurate devices at home for years—think of the pregnancy test. we are used to seeing high-quality testing devices in laboratory settings, but it wasn’t until the fitbit proved to the world that patients would spend a significant amount of non-deductible money to monitor vital health markers.”
start-ups are now looking to take sophisticated tests from the laboratory and bring them into the home, blackmore told md+di. “an entire industry is popping up for lab-quality, reliable testing that can be miniaturized in a point-of-care (poc) reader,” he says. “these tests utilize the same test methods as lab-scale equipment —they have to be reliable. if they are wrong, people’s lives may depend upon the results. doctor visits, prescriptions, and treatment are often based on these test results.”
to bring such products to market, it is important that product developers assemble cross-functional teams. “they do a good job by involving the molder for dfm, for instance, but, they don’t always get representatives from regulatory departments involved—and those experts know what regulatory hurdles have to be passed,” he said.
material suppliers should also be involved because “not all engineers know the full breadth of medical-grade plastics,” he said. “the mechanical engineers know the mechanical side of things, but don’t consider marketing or regulatory concerns during material selection. selecting the wrong plastic can also increase supply chain risk. so, it makes sense to have meetings upfront that include design, manufacturing, regulatory, and marketing so they don’t go down the road to a dead end.
“i’ve participated in so many new product development teams that don’t set up the right team,” he continued. “you need to get input. if you get these groups together upfront, you could avoid selecting materials for pathways that later prove to be wrong and materials must be changed.”
miniaturizing test devices makes it even more critical to have a wide team, he added. “issues driving the expansion of the team include supply chain risk, country intended to manufacture, regulatory, manufacturability, ergonomics, and finished part cost,” he said.
blackmore advised that in addition to fit, form, and function, which consider chemical and temperature environment along side physical properties, look at higher functionality, which sometimes includes:
hydrophobic versus hydrophilic materials. “surface tension is highly important for fluidics,” he said.
light permissiveness versus blocking select wavelengths. “some think a clear product is a good solution, but ambient light could interfere with a test performed by spectrophotometer,” he explained.
biocompatibility testing. “more and newer materials are being tested for certain biocompability tests,” he said. “some pass all of them and some only pass a subset. knowing which resins have the ability to pass these regulatory-driven tests open the door to use new or lower cost materials.”
electromechanical features for the device. “plastics can be made to conduct electricity the same way copper does, and this can be done inside the plastic plane of a housing to reduce the overall footprint,” he said. “some can provide emi shielding. plastics allow combining of this type of functionality.”
stability in materials supply. “not all materials are available in all parts of the world. not all materials are equally popular in the market. not all materials have multiple manufacturing sites. these three factors can increase the supply chain risk of a material not being available or increasing the final part cost unless managed with a material supplier like m. holland,” he said.
in addition, when sophisticated tests crossover from the institution to the home, they pick up “consumer-driven” expectations; developers should consider more than aesthetics. “it is not just about making the product attractive, but rather making it worthwhile,” he said. “is the data actionable—not just a fun fact? if blood sugar is low, for instance, what action can be taken?”
and ease of use is critical, especially in taking a sample, inputting it accurately, and running the test, he said. “once there is a clear rating, will the results be understood?” he asked. “so much education has to take place for the consumer. and the consumers are highly motivated to learn about tests that can monitor their disease state.”
finally, there is a new social aspect emerging with such at-home devices, which become integral to lifestyles. “mothers of children who play sports collect blood sugar information from their diabetic child, for instance, and then want to openly share their experiences with other mothers to optimize solutions that that particular social group is commonly facing,” he said. “social networks based on disease state form easily and offer support and solutions.”
ultimately, at-home diagnostics must offer distinct advantages. “if after surgery i was looking at markers to determine whether i was on the right path to recovery, i’d pay,” he said. “i’d run that test as often as i could and have the data uploaded to my doctor to drive individual discussions on recovery or when it was time to go to the doctor’s office.”