The wearable medical device market is estimated to grow from $27.91 billion, in 2019 to $74.03 billion by 2025 at a CAGR of 17.65%, according to a report by Mordor Intelligence. The need for faster health monitoring, diagnosis, and identification of the line of treatment has led to the rise of Wearable devices. There has been a shift in people’s perception towards health tracking. They are becoming Proactive in devising ways to reduce the chances of severe illness and keep their metabolism balanced. Keeping a regular track of health is one of the major priorities for health conscious and technologically armed generation of 2021. Wearables like smart health tracking watches, pods and biosensors are offering a convenient way to keep a careful watch on health.

Johari, as a Global wearable medical device manufacturer understands user’s need, comfort and intended impact. Experts in our team work on making the wearables compact, cost efficient, stylish and contemporary. The AI-enabled algorithms and big data enable fast paced and remote connectivity along with enhanced functionality and seamless user experience.

Let us understand the 7 key points, we as a wearable healthcare device manufacturer keep in mind:

1. Material Selection:

A wearable is something meant to stay in close contact with the human body. Material selection is utterly important as incompatible material can result in health issues like rashes, allergy and eventually lead to product failure.

2. Evaluating the power sources:

Often, designers miss out on evaluating the power sources at the preliminary stages. This involves deciding whether to make a device battery-operated or rechargeable. It’s important to evaluate the power source at the design stage to avoid unnecessary delays in Go-To-Market.

3. Easily comprehensible application process:

The device must be easy to operate and understand. The complicated interface can easily ruin the purpose of the device. It’s important to keep the primary motive in focus while designing the interface

4. Proper disposal and safety concerns:

While designing Medical Device it’s important to trace the entire lifecycle of the product. Once the device has been manufactured its disposal automatically comes into the picture. The material, functions and intended use all affect the disposal options.

5. Undesirable Interference:

Wearable devices are easy to get interrupted by signals. It’s necessary to keep the interference factor in mind while designing to protect the device from significant interruptions.

6. Sterilization Methods:

Wearable devices are sterilized with ethylene dioxide, gamma radiation, and e-beam. For the devices that are to be sterilized entire design must be made with the sterilization process in focus.

7. Adhesive selection:

Ignoring adhesive selection in the primary stage of the Medical Device can result in manufacturing defects, device malfunctions, and harm to the end-user. Being careful about minor details avoids any mishaps and faults at the mass manufacturing stage or in the market post launch.

 

Johari Digital Wearable Medical Device Manufacturing

1. PCB Designing –  At Johari, we help our clients in designing customized PCB according to wearable. These include flexible PCB and Rigid PCB in multilayered formats to make the device compact and easy to mold into various shapes and sizes.

2. Design & Development – Wearables require intricate designing skills, unlike conventional big clinical Medical Devices these are usually small and hence require special user focused designing in all aspects. The mechanical, electrical and software design must fit the user’s requirement and intent.

3. Prototyping – At the prototype stage, we give a proper frame to our design. Multiple iterations are created and best is chosen amongst them to transfer for mass manufacturing.

4. Regulatory Support – We ensure maintaining every document from day 1 to ensure that every change, flaw and processes are recorded. Every step of our process is in compliance with US FDA guidelines and ISO 13485. With recorded documents and quality compliant manufacturing we confirm fast paced Go-To-Market.

Why are Wearable Medical Devices so much in trend?

• Convenience: The wearable devices can be used anywhere and anytime without any trouble in handling. Most of these are classified as OTC devices so these don’t require a prescription for application. This also makes it easier for end-users to buy them directly from online and offline sources.
• Cost: Wearables are one-time Healthcare investment. These help you keep a check on your daily health variables so that you don’t make huge investments in healthcare.
• Privacy: Although cybersecurity concerns are rising, in general privacy is a big factor that has fueled the popularity of Wearable Medical Devices. These are easy and well equipped with incorporated credential safety. Thus, offering privacy and care at the same time.
• Aesthetic Appeal and portability: The Aesthetic appeal of new-age Wearable Medical Devices is a very strong factor for attracting youth. In addition, the handy designs make them easy to use while on work or at home.

Types of Wearable Devices

Wearable devices are generally classified into three broad classes including:

• Fitness Tracking (Surveillance devices) : Surveillance devices are involved in the general tracking of health conditions including heart rates, blood pressure, oxygen concentration, and so on.
• Wearable Diagnostic Devices : Diagnostic wearables on the other hand are involved in the diagnosis of the health condition that requires specific consultation or treatment.
• Wearable Therapeutic devices : Wearable Therapeutic Devices are used for giving the final treatment or as a tool to keep a check on existing critical parameters like sugar level in case of diabetes or cholesterol in case of heart diseases.

Some common Wearable Healthcare Devices examples ruling this segment are:

• Wearable Fitness Trackers
• Smart Health Watches
• Wearable Blood Pressure Monitors
• Wearable Heart Rate Monitors
• Biosensors

iNishCalm –  A smart wearable sleep inducing device

iNishCalm is a next-generation CES based sleep-inducing device for anxiety, insomnia and relaxation. The stylish design, minimal handling, and advanced aesthetics make this a premium product. It is smart wearable with integrated electrodes and a chargeable battery enabling comfortable use in homes, gyms, parks, office spaces, spas, and so on.

Key Features

• Smart phone app controlled device wearable
• Comfortable Stimulation
• Inbuilt Rechargeable Battery

Conclusion

Conclusively, a wearable Medical Device must be designed keeping the user’s ease and convenience on priority. The manufacturers must evaluate the functionality, interface, and data security & storage. From the prototype stage itself the manufacturers must keep end user’s needs and market dynamics in mind so that any loopholes are identified at the initial level and there are no major losses. A wearable device must be easy to use for all users irrespective of their gender, weight, height, or level of technical expertise.