Consumer health products are simple and affordable home-use medical devices. And they often involve a service of some sort. Take the Ellume COVID-19 Home Test for example. On December 15, 2020, the FDA issued emergency use authorization for this over-the-counter test that consists of a disposable device that plugs into your phone and uses an app to make a diagnosis. It then automatically sends the results to a physician or public safety database.

Until recently, in vitro diagnostic testing like this was only done in a laboratory on very expensive equipment by a highly trained clinical laboratory scientist. But products like the Ellume home test are transforming healthcare by migrating functional care from the hospital and the doctor’s office into the patient’s home.

Right now, whole new technology-driven product categories are being born. Vessel Health’s in-home wellness tracker is a stellar example. After peeing on a simple test card and scanning it with the smartphone app it instantly and accurately uncovers nutritional information. Its website states “It’s like a team of nutritionists and doctors in your pocket, to help you feel better.”

What can your company do to profit from this trend? Learn where to look for the next new business opportunity and the hallmarks that define a winning consumer health product.

What Does the FDA Consider a Home Use Device?

According to the FDA, a home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.

• A user is a patient (care recipient), caregiver, or family member who directly uses the device or provides assistance in using the device.
• A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so they can aid or train care recipients and caregivers to use and maintain the device.

Home use medical devices fall into one of two categories: those that require a prescription and those that do not. Sleep apnea devices, oxygen concentrators, and blood glucose monitors are examples of products that need to be prescribed by a doctor. The FDA designates products or drugs that don’t need a prescription as OTC. Blood pressure monitors for example, and all the other products you see on the shelves at a drug store fall into this category.

Developing solutions begins with a study of personal needs regardless of whether a prescription is needed or not.

You’re entering a new paradigm shift when designing for a consumer as opposed to a healthcare professional. Professionals follow defined standards of care and established workflows. Consumers on the other hand are unpredictable and may simply be looking looking to improve their quality of life.

6 Ways the Best Consumer Health Products Improve Quality of Life

Offer Peace of Mind

No one likes to be sick. No one wants to watch a loved one suffer. Fear of the unknown is quite frightening.

Thus, putting people at ease quickly should be one of your top goals. Help them answer the most pressing questions: “What’s wrong with me, and how serious is it?” These answers are usually addressed in one of three ways:

1. Waiting and hoping the pain resolves itself.
2. Calling a physician for advice who then can’t or won’t diagnose over the phone.
3. Heading to the local emergency room.

In general, people hate hospitals. Just the thought of going to the emergency room can make them feel physically sick. The anxiety and nervousness is often amplified when it’s a loved one’s pain. For example, as a parent with a child writhing in pain at 3 a.m.

Throughout the development cycle of your consumer health product, continually ask yourself, “Are the strategic and tactical decisions we are making now going to offer peace of mind and put our end customer at ease?”

You need to answer yes in order to succeed.

Give Around the Clock Care

Getting sick often happens at the worse time or place. It’s never convenient. The middle of the night, per se, or while you’re on vacation in a distant, foreign land.

There are already hundreds if not thousands of products and/or apps that enable easy access to physicians — usually on a pay-per-use or subscription basis. One such app, Doctor On Demand, boasts 24/7/365 live access to a doctor, including video calls from a smartphone.

Simplifying access, eliminating obstacles, and tailoring a solution that offers unobstructed healthcare access will increase the usefulness and subsequent sales of your medical device or app. In fact, this has largely already become the price of admission in a rapidly evolving new healthcare world.

Continually ask yourself during development, “Are we doing everything we can to reduce obstacles and simplify access to healthcare?”

Provide Added Convenience

Today’s busy people expect technology to simplify their lives and give them more time for the things they love to do. It’s human nature to choose the path of least resistance — or the simplest way from point A to point B.

Why should a diagnosis involve three, if any, trips? The first to a doctor, the second to a lab for a test, and a third for a return visit to the doctor to interpret results seems excessive. Which is why it’s often all avoided.

Is there a way that your new consumer health product, or a product bundled with service(s), can be offered in a one-stop shopping format? This goal is tied into the simple imperative of developing a better quality product.

Your medical device should do all it can to save people time. After all, that’s truly their most valuable asset.

Promote Stronger, More Consistent Patient Engagement

“Out of sight out of mind” describes the way most people view their health. If you don’t feel sick, you aren’t sick, right? We all know that’s not quite true, but it’s a fundamental way of thinking for many of us. Getting people to consistently take medication, engage in therapy, or continue with treatment is at least a $100 billion dollar problem in the U.S. alone.

However, patients increasingly want to be in the driver’s seat. It gives them a sense they control their lives. Therefore, your development team should find ways to engage the patient in their treatment plan. There are many ways to involve patients, but allowing the patient to choose how and when are the most critical components.

Your development team should focus on designing an experience with your product that leaves customers saying, “I just don’t know how I ever lived without this!”

Creating an emotional connection determines your consumer health product’s ultimate success.

Ensure Continuity of Care

There is a good chance your grandparents went to the same doctor most of their lives. One who had a hanging file folder with their name on it that contained all of their medical records. Scanning a person’s medical history as part of a diagnosis was simple.

The healthcare system today is super complex and much more fragmented. The industry, reeling from a technology hangover, is trying to play patient record catch-up.

It is not unusual for someone with a chronic disease to see different specialists from multiple institutions in many different locations. It’s crucial for their healthcare records to be accurate, updated, and accessible.

A medical device company’s responsibility now extends beyond developing a safe and effective product. Enabling storage and access to patient data on HIPAA-compliant servers is equally important.

When a physician or patient opens a virtual medical record, will the results from your device or service be waiting for them? And, even more importantly, will the user interface display the information in a way that is meaningful, easy to understand, and actionable?

Allow Remote Monitoring

Technology that connects patients and physicians remotely will likely not force doctors’ offices and hospitals to close. The probability is high that even some of the most common illnesses will continue to require an initial in-person diagnosis by a doctor.

What some new technology does best is enable physicians to remotely monitor, compare, and check a person’s progress. This may range from simple blood pressure monitoring to manipulating an ultrasound imaging device under a doctor’s real-time remote instructions.

Monitoring the progression of certain conditions or symptoms on a regular basis after diagnosis is important. For example, SkinVision is a mobile app that allows you to “understand your risk factors for melanoma skin cancer and keep track of your moles … and monitor them over time.”

The key is to use technology to establish a baseline and make comparisons with regular frequency.

It’s entirely possible that simply adding connectivity and monitoring capabilities to your existing product could be a breakthrough. Ideas like this can come about as a result of stepping back, freeing your mind of constraints, and using conceptual product design techniques to explore all the “what if” questions.

Are you thinking yet of any innovative ways to leverage technology? Are there ways to allow people and their physicians to easily keep tabs on their progress?

Go Beyond Bells & Whistles

There you have it — six different ways to build greater value into your consumer health product. And improve your chances of success.

Ultimately, bells and whistles are not enough. For your product to resonate with consumers, it’s important that you focus your development efforts on easily recognizable quality-of-life enhancements.