This article is written by Muhammad Aslah, pursuing a Diploma in Business Laws for In House Counsels from lawsikho.com.

Introduction

Medical wearable companies are those that produce medical wearable devices. They are new in the field of healthcare. The introduction of medical wearables is the result of new technological inventions and innovations. Medical wearables allow the patients to receive quick data of their health risks from their comfort zones. This article talks about medical wearable startups and the pros and cons of these devices. 

Medical wearable devices

Medical Wearable Devices are those devices that help the consumers to check their health and wellbeing. Examples of medical wearable devices are smart fitness trackers, biosensors, smart health watches, wearable ECG monitors, etc. With medical wearable devices, a consumer can check his or her health at their fingertips. These devices help the consumers to detect any problem in the human body at a faster pace without the consultation of a doctor for minor health conditions thereby helping mitigate potential risks of a severe nature. For this, the medical wearable devices use a certain kind of technology that allows the device to collect the data of the user’s wellbeing and body status. Moreover, the global medical device market is expected to reach $432.6 billion by the year 2025 with the US as the largest exporter of medical devices across the world. However, there are still some health risks that a person cannot cure without the advice or consultation from a doctor. 

Let us now look at the advantages and drawbacks of medical wearable devices.

Advantages of  medical wearable device designed by the startups

The use of medical wearable devices designed by the medical startup companies provides some advantages to its consumers. They are:

1. 1. Quick results: By the use of medical wearable devices a patient can have quick results at their hands without the consultation of a Doctor. It reduces the long queue in front of Doctors and enables the consumers to check minor sickness from the comfort of their home.
   2. Cheaper rate: Medical wearable devices are sold at a cheaper rate by startups. A patient can easily get their own devices through online shopping. The rate of a medical wearable product is much less compared to the consultation fees of doctors and hospitals. Furthermore, it is an added advantage to the middle class and low-income earners to save their money.
   3. Continuous Communication: A medical wearable device continuously communicates to its user with the usage of technology and artificial intelligence. It is very helpful for a person who would otherwise need to have travelled long distances to visit the doctor. A patient can always communicate with these devices at any time compared to frequent visits to hospitals.
   4. Easy to use: Medical wearable devices are easy to use compared to large devices used in hospitals. Every patient can hold medical wearable devices at their hands without the feeling of pain. 
   5. Easy help to Doctors: A medical wearable device is not meant for only patients and consumers. It is beneficial to doctors also. There are some medical wearable devices such as those of smart glasses manufactured by medical wearable company Augmedix which saves time of the physician as elaborated in detail later in the article. A doctor can use a medical wearable device to detect the problem of his or her patient and provide a quick remedy by analyzing the patient’s checked data with the usage of technology such as wearable glass, artificial intelligence, etc.

Drawbacks of medical wearable device designed by the startups

A medical wearable device has its own cons. They are:

1. Expensive at the first launch of a product: For every product designed by a company, there is a huge cost that the consumers need to bear on. It is due to the limited availability of funds by the startups. Hence, a medical wearable device is also subject to huge costs at the initial launch of the product by the startup company.
2. Regular charging: A medical wearable device uses a charging facility to have them functioning properly towards the consumers and patients. Battery or reduce functionality at the time of usage leads to the requirement of charging. It is a disadvantage to such devices. However, not all medical wearable devices are chargeable and it is only applicable to those kinds of smart health watches, wrist bands, etc. 
3. Lack of training to the Doctors: Doctors are the healers of patients. With the advancement and usage of medical wearable devices, a doctor can easily detect the sickness of his or her patient. Unfortunately, most of the doctors are not highly trained to use medical wearable devices properly. Moreover, the startup companies sometimes fail to provide adequate training to the users of their products especially doctors in the hospitals.
4. Failure to train the blind: Medical wearable devices are not only meant for those people who have no disabilities, but also help the differently-abled. Some such devices are- Irisvision, NuEyes, eSight, etc. These are the devices designed by various medical wearable companies. Sometimes people often fail to train them on how to use the device effectively.

Examples of medical wearable startups

Medical wearable startups are the new face of technology and innovation. There are some already well established medical wearable devices designed and sold by the world’s emerging startup companies. They are:

1. Augmedix: Augmedix is a medical wearable startup company that allows the doctors to connect with their patients virtually. The platform is easy to use for documentation and administrative tasks. The company also provides smart glasses to the doctors that allows them to communicate with their patients in the format of live streaming with human transcribers. The smart glass also has the facility of taking and recording notes along with the latest record of a patient’s data before the patient enters a physician’s room instead of scrolling down on a computer screen which contains huge data. It further saves time for both the patients and doctors as it allows them to have a quick bio on patients health. 
2. GOQii: GOQii is a startup company which developed the world’s first-ever built wrist band with sensors. The company is a partner in Fit India. The company provides the facility of an application to maintain the health of its consumers. The app provides the latest health-related notifications. One of the most known products of GOQii is GOQii vital ECG smart health, a wristband that allows its users to screen their Electrocardiography (ECG) reports, monitor blood pressure, check up on calories burned, etc. These reports can often be used to share with the user’s physician. One additional facility that this device provides is that the users can even call and send messages towards their physicians.
3. Proteus digital health: Proteus digital health is a company that built the world’s first digital medicine. The company makes smart pills which are made up of ingestible sensors. These sensors can be used by the users by wearing small wearable sensor patches probably in the ribcage of the body. The ingestible sensors upon seeing a symptom of disease send a message to the wearable patches that the digital pill has reached inside of a patient’s body. Furthermore, with this technique, the doctors can monitor a patient whether he or she has taken proper meditations remotely via the Proteus cloud.
4. Bagmo: Bagmo is a startup company that provides information related to the blood bank to hospitals and clinics. The company takes blood from the people and stores it in each separate bag after removing the components. Each bag is attached with a Radio Frequency Identification Card (RFID) along with a Unique Identification Number (UID) in a refrigerator. The hospitals and clinics can enter the details of their requirement in the company’s cloud platform and the platform allows the users to quickly understand which bag is fit for use and in which refrigerator it is stored. Furthermore, this technology reduces the leakage and wastage of blood which is a serious concern at blood bank centres. 
5. ten3T Healthcare: ten3T Healthcare is a leading startup which produces health monitoring devices. The company was awarded IoT Next’s top health tech startup in 2018. The company was also selected by Google as one of the Medical Startups and is a part of Google’s Accelerator Program. One of the most renowned devices of the company is Cicer which helps in monitoring the patient’s chest by inserting the device into each patient’s chest. The device also provides results concerning ECG, pulse, blood pressure, O2 saturation at a much faster pace by analysing the body of its users.
6. Neurotech: Neurotech is an innovator of Electroencephalogram (EEG) setups. The company is considered as one of the leaders in the EEG industry. The company makes remote EEG devices which can monitor and record the patients and provide quick results about the patient towards the doctor. The doctor can also store their patients’ data in a much simpler way by using the company’s technology. Moreover, the EEG device can be used at the home of the patient also. 
7. ActoFit wearables: ActoFit Wearables is a startup company that manufactures smart fitness trackers and wristwatches. The device is exclusively meant for professionals and sports enthusiasts. Each of its products has a science-backed fitness and sports analytics system. The main product of the company is Actofit smart scale which is used to monitor Body Mass Index (BMI), body fat and skeletal muscles along with the help of Health chatbot and Actofit impulse workout tracker in which the users can track their all-day activity, heart rate, number of calories burned, etc. 
8. Helfis: Helfis is a pioneer in customized healthcare solutions. The company’s main customers are individuals and organizations. The company manufactures various products such as Helfis Cyclist for monitoring the heart rate, gesture, etc. of cyclists and Helfis Assessme in which the users can track their BMI, body weight, fat, visceral fat, etc.

Legal compliances for starting a medical wearable company in India

A person or group of people cannot unilaterally begin a medical wearable company. There are certain legal measures to be taken off while starting such a company. They are:

1. Protection of data: Medical wearable devices are run upon the usage of technology. These devices store a huge sum of patient’s data. It is the utmost duty of the parent company of such products to ensure that there is no leakage of data and privacy which is a serious threat that may have legal consequences. The legal consequences may be in the form of violation of the right to privacy, breach of data privacy, breach of share and sell off a patient’s confidential data, etc.
2. Fundraising: The biggest challenge that a startup faces is lack of funding. Funds are a crucial part of any business. Without much money, no person or group of people can start a company. Hence, having a proper structure on how the fund is generated and upon what basis it can be increased need to be discussed by such a company.
3. Patent and Trademark registration: A startup company may have new products to be launched in this world. There is a high chance of copying the ideas and creation of such companies. Thus, a medical wearable startup company must register for patent and trademark before the concerned authority.
4. Compliance with Medical Devices Rules, 2017: In 2017, the Government of India brought in a new rule book for medical devices. Any startup company intending to manufacture and produce must comply with the rules specified in the Medical Device Rules, 2017. Nevertheless, all medical devices in India are regulated as drugs as per the latest amendment in Medical Devices Rules, 2020.
5. Registration with the Drugs Controller General of India: The Government of India in their latest amendment to the rule book of Medical Devices stated that all such devices are considered as drugs and those who qualify the criteria mentioned in the rule need to get registered under the Drugs Controller General of India.
6. Registration of the business under a structure: To start a company, the founders need to think of under which business structure it needs to be registered. In India, a company can be registered as a company, partnership firm, Limited Liability Partnership (LLP), sole proprietorship, etc.
7. ISO Compliance: For a startup company, getting an ISO certification is an added advantage to its product or device. By having such a certification, a company can exaggerate their market value and growth.
8. Compliance with legal documents and licenses: For any company to start its business, it needs to have necessary legal documentation certified by a lawyer. These documents may be a Co-founders agreement, documents for LLP, company, partnership, etc. Without these legal documents, a startup company may face serious legal consequences. Likewise, a company also needs to get the necessary licenses to run its business or sell the devices manufactured by them through the concerned authorities. 
9. Know about the different types of taxes in India: A company is not exempt from tax liability. It needs to pay taxes to the government on an annual or quarterly basis. Knowing about tax rates and kinds of taxes helps the founders of a medical wearable startup company to prioritise the decisions. However, a startup company is exempted from the tax for capital gains and investments above fair market value for three consecutive years if it is registered under the Startup India initiative.  
10. Set Up a winding procedure for the company: A person or a group of people may start a company upon finding its product and devices. The product or device may easily catch up in the market. But there are circumstances that a startup may fail to catch up on the market. In such a case, the founders of the company may need to dissolve the entire business of the company. Having a proper winding structure helps the company to easily get dissolved. The Startup India Initiative provides fast track winding-up procedure within 90 days under section 55, 56, 57 and 58 of the Insolvency and Bankruptcy Code (IBC), 2016.

Recognition under the startup India initiative for the medical wearable company

A medical wearable startup company can be recognized as a startup with governmental benefits if it gets recognition under the Department for Promotion of Industry and Internal Trade (DPIIT). A company that wishes to get such a recognition, need to meet up the following criteria:

1. The decision on the age of company: To get recognition under the DPIIT, a company must not be more than ten years old from the date of its recognition. If the company is more than ten years old, then such a company shall not qualify for the DPIIT recognition.
2. The decision on the company’s business structure: To get recognition under the DPIIT for a startup company, the company needs to decide under which business structure it needs to get registered.
3. Limit on annual turnover: To get the recognition as a startup under the DPIIT, a company in any financial year after its incorporation should not exceed its turnover above a hundred crore rupees. If it is above the prescribed limit, then the company is not eligible for getting the recognition under DPIIT.
4. No recognition for restructured or split businesses: A company to be recognized as a startup needs to be fresh. It should not be made or incorporated due to a split or restructure in an existing company.
5. A company must have innovations at its hand: Startups are companies that produce and manufacture new devices using the latest technologies. To be considered as a startup, a company must be innovative at all the time and need to work towards the development of its product.

Conclusion

Medical wearable startups are companies that sell new devices in the market at fair market value. These devices help in quick recovery for the patients and instant results to doctors. Such a device reduces the hours of both the patients and doctors in analyzing the data and results. A company is not simply started. It has certain legal prerequisites to be followed at all times. However, with the increase in technology and newer inventions in the field of healthcare, new medical wearable devices may emerge as a result along with the new legal rules and procedures.

References

1. https://www.digiswitch.org/what-is-wearable-technology
2. https://techengage.com/sensors-wearable-technology-healthcare/
3. https://www.businessinsider.in/here-are-the-top-health-tech-companies-and-startups-developing-wearable-medical-devices/articleshow/71193457.cms
4. https://lowvisionmd.org/3-medical-devices-that-are-helping-the-legally-blind-to-see/#:~:text=The%20same%20technology%20that%20is,the%20legally%20blind%20to%20see.&text=It’s%20called%20%E2%80%9Cwearable%20technology%E2%80%9D%20because,glasses%20or%20worn%20over%20glasses 
5. https://actofit.com/about-2
6. https://www.startus-insights.com/innovators-guide/5-top-wearable-devices-startups-out-of-598-in-healthcare
7. https://www.sdglobaltech.com/blog/10-brilliant-examples-of-wearables-in-healthcare
8. https://augmedix.com
9. https://goqii.com/in-en
10. https://www.bagmo.in 
11. https://ten3thealth.com/recognition
12. https://helfis.com
13. www.varonis.com/blog/5-privacy-concerns-about-wearable-technology
14. https://arogyalegal.com/2020/article/all-medical-devices-in-india-to-be-regulated-as-drugs-medical-devices-amendment-rules-2020
15. https://www.startupindia.gov.in 
16. https://taxguru.in/corporate-law/fast-track-insolvency-process-corporate-person-chapter-iv-part-ii-code.html 

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