Molly Maloof, a medical doctor specializing in using cutting-edge technologies, was invited to speak about the utilization of wearables in the area of health care and preventive medical applications. She partners with growing companies that operate at the intersection of technology and medicine.
1. What are your thoughts about how wearables and IoT are assisting in preventive medicine?
Maloof: New technologies are going to enable so much more information to be transmitted from our bodies to our phones and then eventually to our physicians allowing, us to catch things before they become a full-blown disease.
2. Tell us how you think wearable data is going to change the health field and give your assessment of the devices out there.
Maloof: Physicians are hesitant to adopt these tools because they feel they are untested. They feel that the amount of data being produced by them is just far more than they are capable of having time to analyze. Right now, we are in this data collection phase. The next phase is going to be the data analytics phase.
3. I have to speak to medical device manufacturers that are providing larger devices to hospitals and doctors. Many of them are not paying much attention to wearables.
Maloof: I think that wearables and sensors are only going to become more ubiquitous: they are going to become more invisible and they are going to be embedded into all sorts of things in our daily lives. For medical devices manufacturers, there is this opportunity for them to really create a new market for what they currently have as in-hospital devices. I think that wearable technology isn’t going anywhere. We’re in the early stages of this really exciting industry. Ignoring this would be really short-sighted.
4. Tell me more about FDA process.
Maloof: There are weird rules about how you can take a product to market and how you can show data to consumers. If you take a continuous glucose monitor to market, per se, and just go direct to consumer, you actually aren’t allowed to show the numbers, you’re not allowed to show the measurements. You’re allowed to show general trends. But if you want this to become a clinical device, and you want this to be used in clinical practice, you absolutely have to go through the FDA. A few years ago, everybody was afraid to go through the FDA. But that’s really shifted. It’s a competitive advantage if you have this “Stamp of Approval” from the FDA.
5. It is not uncommon for a startup to have feedback or go through the FDA cycle five times. The cost of having to submit every time is fairly expensive. Currently, there are medical professionals who just specialize in being able to help companies go through this FDA process. Tell us about how this could help accelerate the innovation with health and wearable tech.
Maloof: There are two things to think about here. You need to know how to get FDA approval, but a lot of these companies also need to learn how to do clinical research in or on their tools. It’s one thing to get approved, but it’s another to demonstrate that you have actual valid outcomes.
6. From a doctor’s perspective, what would you like to see?
Maloof: I want to see a shift away from the concept that “We must go direct to the consumer.” The big problem with most wearable technology and mobile tech is that they are so direct to consumer that they’re ignoring the real problem cases in medicine: the real people who are truly sick. Seeing solutions with a large impact and that have a large scalability for large problems—I think that’s the big ticket. The people who are going to really succeed at making a big difference in people’s lives are people who are looking at really big problems in medicine and the chronic diseases that are affecting thousands or millions of people.
7. What about startups that are concerned about taking that B2B or B2B2C approach because they will have to deal with the large entrenched oligopoly within the health tech space that has intentionally created a proprietary system?
Maloof: The great thing about small start-ups is that they are extremely agile and fast-moving. You can do so much with a small start-up that you couldn’t do with a large company because the large company will move so much slower. For a small start-up to be competitive with these large groups is that they need to know what the costs are for the large companies, how can they beat those costs, and how can they use their competitive advantage to find some traction in the market in order to demonstrate their value early on. The early small start-ups will become competitive by being faster and having better prices ideally early on— which doesn’t necessarily have to last, but in order to compete with these large companies, you have to be able to price yourselves appropriately.
8. Who are the likely advocates or early adopters [in the health ecosystem]?
Maloof: Insurance companies … the government—there are a lot of grants and a lot of money from the government for the VA specifically—because they are trying to improve the health of their populations. Big pharma is completely aware that drugs may not be the future of medicine. You shouldn’t present yourself as an acquisition target, but as someone who can potentially partner with these companies. Look for problems that exist, look for companies that have problems you want to solve, and don’t think of just going direct to the consumer. If you want to be an entrepreneur, you need to have an iron will. We need new companies to create products and solve the problems that are plaguing society. There’s so much room for innovation in this industry.
About Scott Amyx
Scott Amyx is the founder & CEO of Amyx+McKinsey, a wearables strategy agency specializing in smart wearables strategy and development. As a thought leader in smart wearables computing and Internet of Things, Scott explores the intersection of enterprise implications and consumer decisions of adopting wearables and IoT technologies. He writes for Wired, InformationWeek, IEEE Consumer Electronics Magazine, IEEE Technology and Society Magazine, and speaks at global conferences on wearables & Internet of Things strategy and innovation.