Apple has been hot for nearly two months. In addition to the unprecedented market capitalization of Amazon's one-month break of the trillion-dollar mark, the pre-heating of the new product launch on the 13th has long been in the major media. As a professional research media in the medical field, the arterial network reporter watched the conference and found that in addition to the larger iPhone screen, Apple, which has always been tepid in the medical field, actually brought the first FDA approved Apple. Watch Series 4 is also equipped with the ability to monitor falls and instantly alert. Compared with the previous slow action, this seems to be a "big move" through FDA regulation. But after carefully studying the recent views of Silicon Valley medical innovation companies and analyzing Apple’s previous actions in the medical field, we found that – 1. Whether Apple can change the superficial presence characterized by "hardware + APP" in the medical field is still a question mark; 2. To achieve its ambitious goals of multiple claims, there are also many obstacles that are difficult to overcome. FDA approved ECG ECG In the medical field, the issue of regulation of consumer-grade wearable devices has been discussed by the public. It is not easy for a product to satisfy both the user and the doctor. Take the next-generation Apple Watch released by Apple yesterday, there are three health-related features that are eye-catching: The first is to identify the user to fall and call for help; the second is to remind the heart rate abnormally, urged to seek medical treatment in time; the third is the most bright feature of the product, ECG ECG shows that this is the world's first consumer to directly measure the ECG. And all ECG records are stored in the Health app for later sharing with healthcare professionals. Many fitness trackers and smart watches have heart monitors in their class, but their accuracy varies. Simple heart rate doesn't always convey a lot of useful medical information . This time Apple’s move does seem to be a “great leapâ€. Although there is an FDA-approved blessing, due to Apple's past "consumer electronics" label, the certification of this product has caused many media and medical circles to question on Twitter. Christina Farr, a journalist in CNBC's Health and Technology section, said that tech journalists should be cautious about FDA's "Approved" and "Cleared." The meaning of the two is not the same, although there is "approval" meaning, but Apple is getting a lower level of "Approved", as the quality of medical products , it still needs to be questioned. Here we intercepted the instructions on twitter for readers' reference. Source: twitter In the paradox of the Internet, most people question the question: "What data does Apple submit to the FDA to obtain permission?" "What kind of usability monitoring did they do?" "What kind of post-cleanup monitoring they intend to do, FDA is What are the requirements in this regard?" However, the ultimate question is, how does Apple pass the FDA certification quietly? Obviously, Apple used the data set to provide FDA certification, which caused widespread suspicion. Some people even think that if you only test on young people, its accuracy should be questioned. Compared with the Jobs era, Apple in the Cook era seems to lack a subversive move. In the face of complex medical environment and policy supervision, can Apple enter the medical battlefield through a smart watch to "play"? In fact, the “effectiveness†of the technology giant’s innovation strategy in medical technology has long been discussed in foreign media. The gap between consumer electronics and medical products: "fast fail" is not good in the health field Recently, CNBC published an article written by former employee Robin Goldstein (who was a senior manager of Apple's special health program) who worked for Apple for 22 years and publicly questioned Silicon Valley's medical technology innovation companies. “The mentality that Silicon Valley brings to technology innovation companies in it is that bad products or bad user experiences have no effect other than a specific product or experience, and they can always erase everything and start over.†This strategy, called "fast fail", seems to her to be a good fit in the digital health arena. It must be said that in the field of medical health, the storms that have been set off by former employees in the past three months can be described as a wave of unrest, and Apple’s former employee’s strategy of “quick trial and error†for Silicon Valley is a product. The strategy of improving immediately after being badly evaluated, the application in the field of health technology innovation has a "singing bad" attitude. There are three reasons: 1. Unlike other consumer products, digital health products and users are “a matter of life and death†Although we refer to them as “healthy†products, their current role is mainly in the diagnosis, screening and management of diseases and diseases. Digital health products are vital to life and death, which makes them fundamentally different from other products. 2. Digital health products require the support of users and their healthcare providers It is not enough to just use health-related devices or applications, and the user must form a closed-loop relationship with the clinician before making any meaningful action. Therefore, if a patient uses a digital health product, but their health care provider does not accept and incorporate the results into their treatment, it is a failure; if the primary care physician recommends using a device, but the consumer does not, it is also a Kind of failure. 3. In health care, the first impression is crucial As the saying goes: "You don't have a second chance to make a first impression." This is especially true in health care. This is because when adopting new technologies, the market implements a model that assesses perceived benefits, perceived risks, costs, maturity, and history. For health, a bad outcome can be truly catastrophic. With these three factors in mind, Goldstein points out that companies engaged in health technology are at higher risk than ever before. In a nutshell, healthy products require slow and thoughtful thoughts, and they are confirming the old saying that they will not do medical treatment: they lose money and are jailed. These dilemmas faced by a large number of Silicon Valley medical startups may be the reason why Apple is hard to triumph in the medical field. Apple's layout in the health care field Admittedly, the market opportunity in the healthcare sector is huge, and Apple places healthcare and health at the heart of its applications, services and wearable strategies. Now Apple's goal is to become a user's personal health record platform, into academic research, medical equipment and so on. As Tim Cook said, the medical market makes the smartphone market look small. In fact, annual medical expenditures exceed $7 trillion, which is close to 10% of global GDP. Compared with other companies, Apple has a huge market opportunity. In the United States alone, Apple has more than 80 million iPhone users, which makes the number of users of any health insurance company dwarf. Since Apple released its health app and HealthKit in 2014, medical care has almost become the core of every press conference, and there are also some medical-related actions every year. In March 2015, ResearchKit and Apple Watch were released. Since then, Apple has made a series of innovations around Apple Watch, the world's largest selling smart hardware. In 2016, Apple began a partnership in healthcare, starting mergers and acquisitions (acquisition of digital health companies Gliimpse, Beddit) and hiring medical executives. In 2017, from health-related Apple Watch applications, feature updates to clinical research, to a number of healthcare talent programs and acquisitions, Apple continues to demonstrate that it is moving toward a provider of healthcare services. In 2018, Apple is gradually building a clinical research ecosystem around the iPhone and Apple Watch, and has built a health care clinic for its employees to provide better primary care services for employees. Combing the content of the above timeline, Apple's actions in the medical field can be mainly classified into the following three sections: 1. Create an interoperable data platform Whether it is personal health data or electronic medical records, Apple uses three Kit modules to connect patients with medical institutions and researchers. All "Kit" are data and application module tools for developers: First, HealthKit released with iOS 8 in 2014 represents Apple's popularization of the concept of public health data interoperability. Its built-in health-related modules such as body data and nutrient intake are the basis of common health applications. Second, ResearchKit, which appeared in the spring 2015 conference, is based on HealthKit's data interoperability, allowing researchers to obtain a large amount of first-hand data for scientific research; Third, CareKit, which appeared in the spring 2016 conference, is a one-to-one patient service framework that is built on the former two platforms and is patient-centered and shared health data between doctors and patients. In addition to the three kits, in terms of data sharing, according to CNBC's June 2017 report, Apple is developing a secret plan to turn the iPhone into a personal center to provide all medical information. Such a grand project, even if Apple is a super-great company, cannot be done on its own, and its medical team has been working with a small startup called Health Gorilla. According to sources, Health Gorilla has partnered with Apple to add diagnostic data (such as blood information) to the iPhone through integration with laboratory testing companies and imaging centers such as hospitals, Quest and LabCorp (the two largest third-party inspection service providers in the US). ) and so on. Through this move, Apple is seeking to solve the big problems that have plagued the medical industry for decades. It is often difficult for hospitals to obtain important data about patients at the point of care, which is disseminated in third-party laboratories, primary care groups, and experts. Many studies have found that these knowledge gaps often lead to missed diagnoses or unnecessary medical errors. Apple is trying to solve this "interoperability" problem by making patients the center of care. The goal is to provide iPhone users with the tools to query, store and share their own medical information, including lab results, allergy lists, and more. This is a task that is slightly different from Apple's previous focused health work. Prior to this, Apple's health work focused on summarizing the basic health information of the human body, such as the number of steps, sleep time and other basic data. 2. Monitor monitoring with Apple Watch as the core Although there are three kits to support, more often, devices that rely on IPhone or other terminals are still relying on third-party development of Health category applications. In Apple's free Health section, it covers the data analysis of the four major sections of Gymfit, Psychology, Nutrition, and Sleep, and works with the corresponding APP. Apple's leaders have been talking about participating in diabetes and heart disease management, which is one of the biggest cost drivers in the US healthcare industry. Apple is working with Stanford University to conduct a study to see if Watch's sensors can detect heart abnormalities; previously, there have been reports that Apple is interested in non-invasive blood glucose monitoring, but this plan has not been too much. Confirmed. In addition to monitoring personal health data, Apple Watch is more of a platform for third-party software to provide real-time monitoring for certain diseases, such as Smart Monitor's recently launched SmartWatch InspyreTM program for Apple Watch to be compatible with IOS systems. The seizure episode is detected and an alert is sent to family members and caregivers as soon as the solitary person is ill. 3. Acquisition of medical startups Although services such as HealthKit, CareKit, and ResearchKit are entering the field internally, Apple's investment in medical startups is scarce. Apple's two acquisitions were: in August 2016, the acquisition of the patient data platform Gliimpse; in May 2017, the acquisition of sleep hardware company Beddit, Beddit developed a sleep monitor that can track heart rate, breathing, oxygen saturation And sleep quality. With only one hardware for medical treatment, can Apple cut into the heart of medical health? In many ways, Apple is still a company built in the image of Steve Jobs: focusing on anti-traditional and demanding products. But today, Apple is walking at the crossroads. Under the leadership of CEO Tim Cook, Apple's ability to capture emerging technologies has sparked many new problems. In the previous series of actions, we observed the following characteristics: 1. "AI is Apple's Achilles heel" This sentence is not the judgment of the arterial network. CBinsight's research indicates that although Apple has made 12 AI-related acquisitions in the past five years, there are indications that these companies are not directly related to medical care. Among them, only Lattice Data is linked to medical care in the business structure. Strictly speaking, Lattice is a dark data analytics company that is using artificial intelligence to transform unstructured, unavailable "dark data" into structured, usable data. In the medical field, artificial intelligence has become the “land of the military†of the major players. The most prominent Google, in July 2017, established a new fund, GradientVentures, which specializes in investing in AI. Domestic BAT Needless to say, Baidu has invested in two companies involved in AI drug research and development abroad. Alibaba's Alibaba Cloud has become a strong brain in the medical field. Tencent has laid out “Tencent Shadow†in the core diagnostic field. 100 medical institutions. On the battlefield of technology giants, medical artificial intelligence has already begun, but Apple seems to be falling behind. 2. The gap between regulation, consumption and medical care, can Apple solve it? In December 2017, the US Food and Drug Administration (FDA) approved Apple Watch's first FDA-approved Apple Watch accessory, KardiaBand. KardiaBand is compatible with Apple Watch's 1, 2, and 3 series. The Apple Watch on the KardiaBand strap is available as a medical device. The reason why Apple uses third-party accessories is still related to the time-consuming filing of the FDA (US Food and Drug Administration). For example, AliveCor, which provides Apple Watch with EKG detection function, has taken two FDA certifications. Year time. In terms of Apple's behavior in wearable devices, the FDA's approval process has been a hurdle in its transition from consumer electronics to medical-grade electronics. According to CNBC's report, Cook's previous attitude has been "Don't want Apple Watch to go through the FDA process... because it will hinder our innovation." But this time it seems to be the opposite, releasing an FDA-approved device. Coordination between consumer and medical grade products has been a common problem. Consumer wearables companies know how to make devices that people want to wear everyday, but they lack the infrastructure, processes, and experience required for the accuracy, clinical validation, and regulatory approval of medical grade devices; although medical device companies have medical devices that are suitable for medical devices. Infrastructure, processes and experience, but they lack an understanding of how to produce everyday wearables that consumers actually want. The convergence of the two, in the technology giant Apple, whether it is just right, further verification, in response to the response of many doctors on Apple's medical-grade devices on social media such as Twitter, want to change the doctor's behavioral preferences and get their Trust is not an easy task. And at the core of medical care, such as medical devices and drug sales, Apple has little relevant experience and does not touch these areas because of their lack of knowledge in this area. But it's not that Apple is not interested in these areas. Among the participants in the new pre-certification program announced by the FDA in September 2017, Apple is one of nine companies. Based on the above, how to innovate and iterate in future products, and at the same time to deal with the regulation of data accuracy, FDA approval is bound to be a hurdle that Apple has to cross. 3. A lot of data, how to deal with Apple? Apple's expectations or the dream of Apple's mobile phone users is that medical records can be managed by a digital center like iTunes centrally manages music. According to CNBC, in January 2018, the Apple manufacturer announced a new app for health records, and said it is working with Cedars-Sinai, Johns Hopkins Medicine and Penn Medicine hospitals, as well as Epic Systems, Cerner and Athenahealth. Cooperation. Apple is trying to break the barriers to decentralized storage of medical data and has developed a set of standards that have been adopted by many large companies to share data across different systems. Although in the eyes of some industry insiders, developers open up software and services to develop apps for consumers while allowing consumers to push data for developers is Apple's most successful initiative, but it seems difficult in the medical field. Adopted. The difficulty of data sharing is that the medical clinic records vary from state to state. Patients can send purchase requests in a variety of ways, including but not limited to personally going to the hospital, mail, mail, fax, telephone or even use special Online website. Every step here guarantees absolute privacy and security. An online journal published in 2016 entitled “Forwarding Health Data Management†argues that many medical institutions still use the old system, although 78% of doctors use it, one third of the doctors surveyed Two-thirds of people are very dissatisfied with this technology, but it does not affect the doctor's use of the old system. How new products/technologies can be promoted without changing the doctor's medical habits is the most headache for all medical innovation companies. In the March news, Apple highlighted the protection of patient privacy data and some of the work that needs to be done to achieve this. A doctor asked Apple about the question: Now people give all the data to you. Of course, the more data, the better, but how do you summarize the data? He thinks this is an extremely tedious job. "This is not music, not a book, or an app." Source: "2017-2018 China Hospital Informationization Survey" According to the research report of the "2017-2018 China Hospital Informationization Survey" just released, from the data, the first notebook and tablet brand that is most used in domestic informationization is "Lenovo ThinkPad". Secondly, "Lenovo Lenovo", Apple ranked only fifth, of the 484 samples surveyed, only 28 hospitals, with a share of 5.79%. We suspect that in China's huge market, Apple's low share has both cost issues, as well as compatibility issues with IOS operating systems and data security issues for cross-border electronic products in the medical field. Never underestimate the complexity of the medical field According to CBinsights, Apple's health-related patent portfolio is not dominant compared to other technology giants, and innovation in the medical field is not so rapid. Apple, Microsoft, Amazon, Facebook, Google patents in the health field (Source: CBinsights) Even in personal health data, electronic medical records, and even academic research, Apple has made efforts, but for the core of medical care - the diagnosis and treatment, everything seems to be too marginal. Erik Gordon, a professor at the University of Michigan's Ross School of Business, once said that the problems in the health care field are large and complex, involving all parties' interests, which cannot be solved by industry companies alone. The key task of large technology companies is to cultivate a complex medical problem. Deep insights. Many companies with strong technical strength and technological competitiveness fail because they underestimate the complexity of the medical industry. Technology companies like Apple have always been known for creating good product experiences, so it's easy to apply product strategies to the medical industry to create better medical experiences for patients, and Apple is already working hard to design new health products. And find new applications for their existing products. The products of these companies tend to be weak and have insufficient stamina. One of the key issues is in line with one of the key factors pointed out by Apple's former employee Goldstein in the previous section – it is not enough to just create a product that patients like, and these products need to be used by doctors, nurses and administrators. . If a product that can share a patient's electronic medical record is introduced to the market, patients can easily use it, but doctors and medical institutions refuse to access, so the best interactive experience can only be ineffective. If Steve Jobs is still alive, he will remember the Sunday with John Sculley. Jobs, who had just made Apple a successful IPO, said to Sculley, who was the CEO of PepsiCo: "Do you want to continue selling sugar for the rest of your life, or do you want to change the world with me?" According to CBinsights' article, Jobs's daughter revealed that in the last days of Steve Jobs' death, he still outlined an iPad-based hospital unit plan on the hospital bed, including fluid monitors, X-ray equipment, and better ward design. blueprint. Of course, in an interview with Fortune magazine in the fall of 2016, Cook also mysteriously told reporters at the time: "Apple has a lot of movements in the health field, but I can't reveal too much, we are working hard, obviously there are some Business, including business that is not commercial, we are all exploring." For the entire market of medical health, Apple's new product release should be exciting, especially for the market and application of wearable devices, more companies should be involved in innovation in this field. Undoubtedly, the world's largest consumer electronics company, any action in medical care, like a butterfly flapping its wings on the other side of the ocean, its "butterfly effect" has a trending guide for global health. Stay hungry, Stay foolish. Although we haven't seen Apple's “thinking about thirst†in the medical field, at least after releasing an FDA-backed medical-grade device, we still believe that “changing the world†is Apple's dream, and I look forward to one day like iphone. Subversive innovations in the consumer electronics arena can drive technological innovation faster in healthcare. Otherwise, the major technology/medical media that have been staring at Apple can only sigh after every new action: "Apple is not in a hurry, we are all in a hurry." Potassium Salt,Potassium Oxalate,Oxalic Acid Anhydrous,Oxalic Acid Monohydrate Wuxi Yangshan Biochemical Co.,Ltd. , https://www.yangshanchem.com
