Leonardo da Vinci designed the first pedometer in 1472 to calculate the distance a Roman soldier walked. In many ways, healthcare technology has progressed significantly since the Renaissance. But the most popular connected health device on the market today is still used for counting steps. Healthcare lags noticeably behind other connected industries, and the meandering product development cycle contributes to this problem significantly.
There is a myriad of opportunities in the connected health industry, from in-body devices to environment monitoring to patient compliance tracking. According to Jabil’s 2018 Connected Health Technology Trends survey of more than 200 business decision makers, all participants plan to develop and bring a connected health device to market. Most importantly, the medical industry is trying to improve patient outcomes through smart devices. Download the full Connected Health Technology Trends Report.
Almost three out of four healthcare executives predict that healthcare devices that are part of the Internet of Things (IoT) will be disruptive within three years. Connected health technology will enable remote patient monitoring, making healthcare more available, increasing value- over volume-based care, empowering patients to take more control of their lives and improving quality of life. Overall, healthcare will shift from being reactive to proactive and preventative.
While there is incredible potential and a high level of buy-in from key decision makers, there are several barriers to the production of connected healthcare solutions. Many of these relate to a lengthy and strenuous healthcare product development cycle.
Almost half of the Jabil survey participants reported that the connected healthcare product development cycle takes from 18 to 36 months. Large companies especially struggle to complete a cycle in a year or less; 15 percent of companies with 1,000-5,000 employees reported that 12 months was an adequate amount of time, as opposed to only 2 percent of companies with more than 5,000 employees. With consumers expecting the greatest release of a new product yearly thanks to the quick product development cycles of consumer electronics, it is difficult for healthcare to keep up.
What are some of the most significant factors in slowing down the product development cycle and what measures can healthcare manufacturers take to overcome them?
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The slow-moving, risk-averse nature of the healthcare industry makes it difficult to progress through the production cycle, an undertaking that requires both speed and a degree of risk. Unlike connected home or building solutions, which can be experimented with and adjusted to some degree, connected healthcare is much more precise and calculated. Solutions cannot be glitchy or inept; they must be decidedly functional and effective. After all, an inaccurate diagnosis or poor treatment method could be the difference between life and death.
There is always a significant risk that a product will not reach the market. In my experience, because of the intense focus on technology and feasibility studies as well as issues like human factors, companies abandon healthcare projects more frequently than consumer electronics. One in five companies that produced a healthcare solution that solved technology, production and compliance issues had to retract it, according to Jabil’s survey.
Although only 17 percent of survey participants stated that manufacturing problems were the most daunting challenge in developing their connected health solutions, 95 percent did admit to facing manufacturing challenges. The top reasons were a lack of sufficiently sophisticated enabling technologies, high manufacturing costs and the ongoing electronic component shortages. In fact, we don’t believe relief is on its way anytime soon; the shortage is expected to last another two or three years.
Like every other connected industry, the ongoing component shortage is taking its toll on connected healthcare, with one in four citing it as a handicap. There is a lead time of 500 days to obtain components like resistors and capacitators. This creates problems for devices already in production as well as new designs utilizing legacy components. Component shortages may delay launching a new product to the market, discouraging companies from further investments in new product launches. More importantly, the product development cycle may become exponentially more expensive as manufacturers wait for a 10 cent part that's holding up production.
These factors either drag out the production and launch cycles or deter healthcare manufacturers from attempting to launch in the first place. According to Jabil’s connected health survey, when it comes to connected devices, only 3 percent of companies have reached the certification stage of the product development cycle, and only 13 percent have reached testing. Overall, only 16 percent have successfully launched a complete product; 60 percent either have not delivered a product or are still testing a prototype. However, there are several measures they can initiate to make the process easier and more efficient.
More than 60 percent of survey participants said they produce healthcare solutions that require FDA approval. There are several advantages to working with the FDA or other regulatory bodies native to each government. Early engagement with the FDA could help shorten the healthcare product lifecycle. Rewinding 30 or 40 years, even though the personal computer was a boon to the healthcare industry, people hesitated to utilize them because of the uncertainty factor. Today, however, it is a standard tool in any hospital. Connected devices could become integrated in the same way. By working with government agencies to pinpoint concerns and risks and address them earlier, companies might be able to accelerate the regulatory approval process.
In an initiative to ease the obstacle of regulatory oversight, the U.S. Food and Drug Administration is working to implement the Digital Health Software Precertification Program. This pre-certification program, which will launch its pilot program in 2019, aims to provide a more streamlined and efficient regulatory oversight of software-based healthcare solutions.
Nine companies, including Apple, Samsung and Johnson & Johnson, have been selected to participate in the development of the pilot program. Companies that achieve “pre-certified” status will be able to market lower risk software-as-a-medical-device (SaMD) without the hassle of undergoing a premarket review of individual products. They will also be eligible to participate in a streamlined pre-market review and access real-world post-market data.
The FDA plans to help companies cut down on the time spent trying to get regulatory approval by assessing the companies participating in the program. With insight into organizational excellence and product performance across the lifecycle, the FDA will utilize a streamlined premarket review and verify the continued safety, effectiveness and performance of the software medical device.
Companies are also working toward changing the classification of their medical devices. Currently, the FDA places medical devices into one of three categories. The most low-risk devices, like patient monitors, are sorted into Class I. Class III contains the riskiest devices, like implants and pacemakers. By altering their Class III device to meet the criteria of a Class II or I, companies are hoping to get through the regulation process more quickly. For example, if a Class III device contains an external communicator that retrieves data from the device that it sends to the cloud, the communicator is also considered Class III simply because it is a part of the device. However, if manufacturers only allow the communicator to perform low-risk operations (data collection, for instance, as opposed to data processing or decision-making), this will mitigate its risk to the system. Therefore, they may be able to get the communicator classified as a Class I, thus making it easier for the device to push through regulation.
Companies should also consider partnerships. Establishing a partnership can be one of the easiest and most effective ways to gain a new area of expertise and push your connected health solutions forward.
According to Jabil’s survey, the partners perceived to offer the most potential benefit are manufacturing companies with expertise in connected devices. This makes sense, given the struggles I discussed earlier. At 63 percent, technology partners with knowledge in cloud and data privacy ranked second, and nearly half of survey respondents saw partners with expertise in government processes who can assist in cutting through confusing, lengthy regulatory processes.
The biggest opportunity in connected health to cut down cycle times, from my perspective, is to use connected devices in clinical trials. Customers say they need around six or eight months to slice through the Gordian knot of regulations. If they have connected devices that help them gather information during trials – for example, a wristband that gathers blood pressure and heart rate – then they are positioning themselves to gather much more data in a shorter time frame (more patients and automated data gathering). From there, they can analyze the data, make conclusions and prove outcomes much faster than they do currently.
In some ways, the lag in healthcare is understandable; people’s lives may depend on this technology. However, it can allow doctors to monitor their patients remotely, detect symptoms of illness or medical conditions before they become serious (through predictive analytics) and give patients more control over their own health. Maybe it’s time to flip the question from “can we afford the risk of pushing innovative healthcare solutions?” to “can we afford the risk of not offering innovative connected health solutions?” We can start improving millions of lives by speeding up the healthcare product development cycle.