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Medical Devices 101

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Medical devices now go beyond the doctor's surgery, encompassing personal, wearable health technology. With consumers struggling to access medical services, these products allow anyone to assess their own health at home. Here are our tips for succeeding in this new and increasingly competitive market.

Vital signs looking healthy

The overall medical technology sector is, unsurprisingly, in a healthy state. Growth increased 4% to US$379bn in 2017/18, and it's a big export business. India, for example, imports 75% of its medical devices from overseas.

But as an e-commerce business, most of your market is probably in a smaller subsection of the market: the growing consumer medical devices sector.

More than just Apple Watch

The wearable medical devices market expanded at a rate of nearly 14% between 2014 and 2017. And that growth rate is only expected to rise in the next few years. It is estimated that 1 in 5 US consumers will own an activity tracker by 2021, with the Apple Watch currently taking around a third of unit sales.

The Apple Watch Series 4 became the first mainstream wearable to gain FDA approval in 2018 for taking an ECG. It also has fall detection technology, becoming attractive to an older demographic. Look out for smaller producers creating similar medical devices, perhaps with fewer features. Could specific features attract new customers looking for wearable health tech?

Most consumers cannot afford to continually purchase the latest smartwatch models and the new medical capabilities they bring. Accessories such as AliveCor's KardiaBand can replace an original Apple Watch strap, equipping older models with ECG technology. There is also a market for creating interchangeable fashion straps, with Michael Kors and Coach already on board.

TIP: Every product has its target market – think about how you can make them yours.

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Getting certified

Mobvoi's TicWatch Pro and various Fitbit products also offer heart-rate monitoring. While they cannot then be marketed as medical devices (as this requires FDA approval in the US), inclusion of heart-rate readings means consumers expect scientific accuracy.

The FDA therefore launched a precertification pilot program in 2017 for companies wishing to expedite the medical device certification process, with Fitbit and Samsung among those selected to take part. Smaller startups can still achieve medical device status by conducting clinical trials and presenting their product to the FDA for user risk analysis, but a lengthy pre-market approval period should be expected.
TIP: It won't be quick – or easy – so make sure it's worth it.

Portable healthcare

Wearables are increasingly popular for personal health and fitness tracking, with increasing numbers and types of devices capable of monitoring a wide range of vital signs on the go. These include pacemakers and insulin pumps, and by connecting them to the internet, doctors are instantly aware of potential issues.

Item 1

Always add to human knowledge

Verily's Study Watch allows users to become involved in medical research, with 10,000 people forming a five-year study for Parkinson's disease. The device, which has been certified as reliable enough for clinical usage, will track their heart rate and inertial movements on the go.

TIP: The danger of wearables is lack of scientific credibility. Verily's device, among others, helps combat this problem.

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Beating Diabetes

Continuous glucose monitors (CGMs) that sync up to smartphones are increasingly popular among diabetics, allowing users to monitor their glucose levels day and night. Taking real-time readings from a small sensor inserted under the patient's skin, users can then make informed food choices based on current glucose levels as well as being alerted of any sudden changes.

TIP: Glucose monitoring will become a key area for wearable tech.

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Constant monitoring

Ada functions as a personal healthcare companion app, drawing on users' symptoms, previous medical history and years of real-world cases to provide the most accurate diagnosis. By acting as a pre-screening method, it helps to relieve overcrowded hospitals by covering thousands of conditions, while also flagging situations where the user should seek professional medical advice.

TIP: The 'wearables as a safety net' message is compelling.

However, concerns have been raised about the vulnerability of such devices to hacking. While no incidents have yet occurred, it is still a possibility. A study of the FDA's policies found that they did not sufficiently cover how to respond to cybersecurity risks post-market, so updates will now involve incorporating cybersecurity as a core component in their manufacturing. It's unlikely you stock pacemakers, but are you reassuring your customers and educating them about the security risks of connected health devices?

TIP: Safety is paramount – ignore it at your peril.

However, concerns have been raised about the vulnerability of such devices to hacking. While no incidents have yet occurred, it is still a possibility. A study of the FDA's policies found that they did not sufficiently cover how to respond to cybersecurity risks post-market, so updates will now involve incorporating cybersecurity as a core component in their manufacturing. It's unlikely you stock pacemakers, but are you reassuring your customers and educating them about the security risks of connected health devices?

TIP: Safety is paramount – ignore it at your peril.

Home-testing kits

Another new area causing difficulties for device regulators is in home-testing kits. These typically fall into one of three categories: blood tests that examine your health, DNA tests that decipher your genes, and microbiome analysis that assesses your gut.

However, a recent study in Nature found that up to 40% of the kits they examined for testing genetic disorders were inaccurate, and the UK's drug safety watchdog seized around 10,000 STI test kits in 2018 that were actually counterfeit.

In the US, the FDA is actively working to set standards for the readily available kits. While they can be reliable for conditions such as hepatitis C, home genetic tests are far more problematic.

TIP: Don't always believe the hype – do your research properly.

DHL MEDICAL EXPRESS

We spoke with DHL Medical Express Programme Manager, Marta Duda, about how they can help when shipping home-testing kits.

Marta: "DHL Medical Express is a premium service that combines our logistics expertise with a dedicated and unique range of features to create a flexible solution for the Life Sciences & Healthcare industry."

If you're an e-commerce retailer looking to reach health-conscious consumers both domestically and overseas, consider partnering with DHL for guaranteed delivery windows, online tracking, expert advice and secure shipping in over 220 countries and territories worldwide.

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