With more than 75% of healthcare costs linked to chronic conditions, it’s easy to apprehend the upside potential of the medtech market. Wearables have typically been associated with consumer-focused fitness-promoting technologies (such as Fitbit or Jawbone), but there is substantial promise in the development and use of FDA-cleared, medical-grade wearables for use in clinical settings. These types of medical wearables allow for the better treatment of a patient and promote greater insights for the attending physician; moving away from consumer wearables to embrace clinical FDA wearables is a particularly profitable (and less capricious) shift in the medtech approach. Analysts forecast that the medical technology market will balloon to more than $50 billion over the next 3-5 years. This is largely due to the demand for technology that allows for continuous monitoring, preventative health insights and personalized treatment based on the individual’s physiology, medical history and lifestyle. For medtech companies capitalizing on the trends in medical technology, innovation is the key to success and marketplace viability. Developing a meaningful medtech wearable solution will not only allow patients to enjoy a better quality of life, but also ensure the competitiveness of your business.
Leadership and innovation
Everyone loves “innovation,” but its backbone is constructed entirely from that inglorious and time-consuming substance known as R&D. Success with medical wearables is closely linked with experimentation and knowledge aggregation; the fact of the matter is that no company can afford to skimp on R&D. With heavyweights like Samsung sinking more than $10.4 billion into R&D (2013), it is unthinkable for companies that want to stay viable in the marketplace to avoid significant investments in R&D, new technologies, and employees. Moreover, expect agile wearables startups founded by MDs and former medtech executives to nip away market share from traditional medtech companies. Innovation is no longer optional.
Market leadership hinges on tech investment: now is not the time for corporate solipsism. Competition in medtech will not be limited to your own vertical, either. Your company may not only be contending with startups, but also with large, established companies one or two verticals away from your usual competition that will encroach into your space with their medical wearables. For example, you may need to compete with Google, which is developing a wearable device that allows for better medical assessments. Enterprises on the cutting edge of technology are in the best position to lead. For example, Elfi-Tech develops advanced biosensors and sophisticated algorithms for non-invasive monitoring. The sensor module monitors an array of metrics, from the skin blood flow, blood velocity and coagulation to a general fitness assessment of the user. The obvious implication of a multi-metric device is that it can be utilized in a broad range of settings (for example, hospitals, walk-in clinics and research facilities) to cut costs and better target patient care. A strong commitment to experimentation and learning also pays dividends. For example, a medtech startup is taking advantage of advanced research to monitor nitric oxide levels in asthma sufferers; the company’s device would allow for improved treatment and the avoidance of possible complications from the disease, such as increased rates of pneumonia.
For wearables companies, devices need to have meaningful and trustworthy healthcare benefits that are reliable and cost- and time-efficient. Inaccurate fitness data is no longer acceptable. In addition to moving towards FDA grade accuracy, soon the single-function device will be a thing of the past as healthcare providers move to embrace technology that fulfills a variety of purposes (think of Dr. McCoy’s tricorder). Medtech wearable devices need to be able to monitor multiple functions and support physician analysis in promoting the individual’s health and treatment options.
Other than the IRS or NSA, few three-letter agencies cause a visceral response like the FDA. FDA regulations may seem insurmountable, but applying for clearance is being eased by companies like ClearRoadmap, which helps guide wearable developers and medical professionals through the search and FDA clearance process. Most medtech devices fall into the second category of devices; Class I devices have no potential risk to the user (band-aids), Class II devices may expose the user to minimal risk (powered wheelchairs) and Class III devices may expose the patient to significant risk (implants). A number of companies are already capitalizing on their clearance. For example, HealthInterlink (now owned by Welch Allyn) received FDA 510(k) Class II clearance for its Beacon 2.0, a mobile software system for home health devices. Nexus6 obtained FDA clearance for its smartphone-connected inhaler, SmartTouch, as a Class II medical device.
Lead, innovate, invest
In order to enjoy success and growth in healthcare, medtech companies need to focus on leadership and innovation. Acting as a trailblazer in this medtech wearable arena will not only allow your company to compete, but it will open up new market opportunities to drive growth. Innovation is the key to developing the best products that target illnesses or health problems, but this will require a serious commitment to R&D, with emphasis in wearable medical devices that will provide unrivaled continuous patient monitoring and invaluable, trustworthy data. The future belongs to those medtech companies who can offer innovative, cost-efficient and holistic healthcare approaches to preventative and diagnostic medical care. Medtech firms must consider medical wearables.
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