How does the growth of home diagnostics affect manufacturing?
The home diagnostics market has seen significant growth over the past few years, reinforced by the COVID-19 pandemic where many were encouraged to test at home for symptoms. However, home diagnostic tests are not limited to just COVID-19 testing. Rachel Chapman, product manager, Owen Mumford discusses what this means for medical device manufacturing.
The increasing prevalence of diseases such as diabetes, obesity and sexually transmitted infections, combined with an audience wanting to be better informed about their personal health, has increased demand and resulted in a market value of over US$ 5.4Bn (in 2020) with expectations to reach US $8.5Bn by 2030.
Patients are turning to at-home testing and sampling kits for their convenience outside of clinical environments, allowing them to detect health conditions early from the privacy and comfort of their home. Although not as thorough or reliable as seeing a healthcare professional, home testing and sampling provides a solution for busy patients and over-resourced doctors – or those who feel embarrassed or nervous about specific health issues such as sexual health. These tests allow patients to take the first step towards diagnosis and treatment at their own pace.
The most searched-for at-home testing and sampling kits
A search using a keyword tool by medical device experts Owen Mumford has revealed the most searched-for at-home medical testing and sampling kits.
The research found that food intolerances were the most searched-for at-home test with 46,430 average total Google searches. This was followed by blood tests with 40,420 average searches, then chlamydia with 33,750 searches.
Selecting the right safety lancet
A crucial element of the home testing kit is the safety lancet provided to draw a blood sample. A finger prick blood sample is taken using the lancet and stored in a collection tube which is then sent to a laboratory for analysis.
There are several considerations when selecting a safety lancet for home test kits. The first is the user-centricity of the device and instructional material. Without a healthcare professional present to supervise or demonstrate, devices must be simple to use, safe in order to avoid unnecessary injury, and reduce the risk of preanalytical errors when collecting the blood sample. A contaminated sample means results are either impossible or inaccurate, rendering the test useless.
The mode of activation, such as contact-activated or side-fire, should also be considered to support ease of use. Beyond that, designs that help to reduce the pain sensation when taking a sample can make the experience more pleasant for users.
With many brands offering devices in different specifications, selecting the right configuration for individual tests is essential. Needle gauge and depth can be adapted to draw small amounts of blood for tests including blood glucose monitoring, through to amounts in excess of 200μl for multi biomarker tests.
Although some home test kits are available to buy physically in stores, many are delivered by mail. Ideally, the packaging should fit through a standard letter box to ensure safe delivery, so each component of the kit must be optimised to ensure it can fit inside without compromising on usability and success rate.
Typically, a testing or sampling kit will come with three to five safety lancets to ensure users can obtain the right blood sample volume to conduct analysis. Compact safety lancet designs not only fit easily into smaller packaging but can also be provided in larger quantities without compromising on space.
Chapman said: "At-home test kits have become increasingly popular over the last few years and are a great way for people to screen from the comfort of their own home for any underlying medical conditions.
"Owen Mumford has been leading the development of point-of-care testing devices for many years with our Unistik capillary blood sampling devices. Our range of high-quality, cost-effective single-use lancets and lancing devices can be used for capillary blood sampling across a large range of tests, including blood glucose, blood coagulation, cardiac markers, cholesterol tests, infectious diseases and many more."
The popularity of at home testing represents an opportunity for both patients and healthcare professionals to alleviate pressure and make the route to diagnosis more straightforward than ever before. For medical device manufacturers, this boom reinforces the need for safe, simple lancet devices that make home testing accessible and accurate, ultimately supporting the migration of diagnostic testing from clinical environment to the home.