How to Build Better Wearable Medical Devices

The healthcare industry is an incredibly large global market that is very challenging to penetrate. Worldwide, the healthcare industry is projected to reach a market volume of $94.19 billion dollars by 2027 (Source: Statista). A significant part of the growth of the healthcare industry is the introduction of wearable medical devices.

How much of an impact will medical device wearables have? According to a Market Research Future (MRFR) report, the wearable medical device market “is anticipated to reach USD 174.48 Billion by 2030 at 27.1% CAGR”. In other words, the size of the wearable device market for medical applications might exceed the general healthcare industry itself (due to the inclusion of multipurpose wearable devices such as smartwatches in addition to dedicated devices used in a healthcare setting).

The market for wearable healthcare devices is large; numerous companies—both established device manufacturers and new startups—aggressively compete for market share. To stand out in a competitive and crowded industry, device manufacturers will need the ability to meet stringent quality standards while maintaining a rapid (and stable) supply chain for their clients.

Design Considerations for Wearable Medical Devices

When designing wearable medical devices, many things must be considered to ensure costs are controlled, device performance is optimal, and all relevant regulatory standards are met.

Some considerations for medical device design and manufacturing that ATL Technology’s engineers frequently help other engineering teams with include:

Defining Use Cases

How and where will the device be used? Will it remotely monitor a patient in a hospital setting, or “at home”? What kind of monitoring technology should the device use to collect the information necessary for the device’s specific use case?

It is crucial to nail down details about how the device will be used in order to optimize every aspect of its design. For ATL, projects typically start with an in-depth examination of the device’s use case before moving on to device design.

Optimizing Device Durability

Wearable medical devices are subjected to atypical forces often; especially ones meant for “at-home” use in the general market.

For example, wearable medical devices are often exposed to: impacts and abrasions against walls as wearers walk, partial or total immersion in water, exposure to extreme temperatures, etc. These stresses often cause damage to internal and external components—which can lead to premature device failure and product warranty claims/recalls.

Designing wearable devices for optimal durability to meet expected stresses, without overengineering them in a way that wastes money and material, is crucial for ensuring the success of the product line.

Deciding on Device Reusability

Will the wearable medical device be reused for a prolonged period, or is it a disposable item that has a limited life? This decision often depends on the specific application of the device.

For example, a blood glucometer device that injects a sensor probe into the wearer’s body will, by necessity, be a disposable device. Otherwise, leaving even a single probe in the body for too long would lead to probe degradation and possible infection at the injection site.

Conversely, a heart rate monitor that is worn on the wrist will likely be a reusable device since it would not require an invasive probe.

Ensuring Biocompatibility

Wearable medical devices are often tested extensively to ensure they will not adversely affect the wearer. Biocompatibility issues have led to recalls for a variety of medical devices—both implanted and wearable.

Manufacturing Parts Tolerances

When manufacturing complex devices at scale, part tolerances can be an enormous issue. A variance of a single millimeter in a group of device components can lead to numerous quality control problems and part rejections for medical devices assembled from those components.

Therefore, it is important to partner with an organization that has the right manufacturing capabilities, to consistently meet the extremely tight part tolerances required for every medical device component they produce.

Deciding on Remote Connectivity/Communication Methodologies

How will the wearable medical device communicate with healthcare systems? Different communication solutions such as RFID, Bluetooth, and Wi-Fi have their own unique benefits and drawbacks when it comes to issues like power consumption, communication range, and how much information can be transmitted from the device to the healthcare system.

ATL helps manufacturing engineers choose the best communication and connectivity solutions to match the specific use case of each wearable medical device, and help to meet the needs of their downstream customers and users.

Ensuring Strong Supply Chains for Wearable Devices

Time-to-market is a crucial issue for any product. Delays in the medical device supply chain can lead to lost business opportunities, complaints from current customers, and delayed revenue.

ATL Technology helps medical devices achieve a rapid time-to-market by offering manufacturing capacity from facilities located in the USA, Costa Rica, China, and the UK. With geographically diverse manufacturing capabilities, we help our clients get their products to the global market quickly so they do not miss out on time-sensitive sales opportunities.

Also, by distributing our manufacturing capabilities across three different regions, ATL Technology helps ensure that disruptions in one region do not bring the supply of devices to a halt. Production can simply be pushed to another facility to help meet demand in the interim.

Work with a Proven Medical Manufacturing and Design Partner

Are you looking to penetrate the wearable medical device market, or need extra manufacturing capacity to meet high demand? ATL Technology is here to help!

Our proven engineer-to-engineer approach has helped numerous manufacturers get their medical device products launched. With our post-launch manufacturing optimization support, we can assist you in achieving greater resource efficiency while improving time-to-market and ensuring compliance with strict FDA standards.

Connect with our engineers to get started.