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    Online Exclusives

    Prototypes Enable a Wearable Hypothesis Investigation

    Securing data from a prototype device can present challenges for medical device manufacturers.

    Prototypes Enable a Wearable Hypothesis Investigation
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    Walt Maclay, President and Founder, Voler Systems10.26.18
    The human body gives off billions of data points everyday. Imagine if we could collect that data and make sense of it. We could provide health recommendations to patients based upon it. That’s exactly what medical researchers and clinical care professionals are clamoring for. Medical researchers and clinical care professionals want to gather physiological data related to a condition or complication to refine diagnosis or therapy, or they want to detect new conditions earlier.
     
    To gain a competitive advantage, some equipment manufacturers want to develop a wearable device to complement their main product by collecting additional sensor data. Others see untapped opportunities based on new data.
     
    A Prototype Review
    Prototypes are an important part of the hardware development process. At the simplest level, a prototype is an initial or preliminary model of the product. A prototype is fabricated to test key assumptions about the product. Further, they can be used to test feasibility risks and desirability. A prototype can be handed to a customer for them to manipulate to answer questions regarding how well the product satisfies the market’s requirements.
     
    Rapid Prototypes Save Time and Money
    Prototyping tools provide a useful method for quickly developing a functioning prototype. Developers can rapidly develop fully functional working prototypes, saving 75 percent of prototype development time. Furthermore, being able to develop prototypes more quickly and less costly allows a development team to place the product into the user's hands earlier, test assumptions, and gather data. Through the feedback the prototype receives, the developers can better understand the user and product purpose or use case. The marketing and engineering teams can use prototypes to secure necessary feedback, test the use cases, and ultimately, build a better product.
     
    Not All Prototypes Are the Same
    The type of prototype needed will be identified by the current stage of development and the type of data required. In early stages, spreadsheets, illustrations, storyboards, wireframes, paper prototypes, and other low fidelity prototypes may be sufficient to generate the feedback necessary for initial buy-in. Later product decisions may require a functional prototype or proof of concept. For example, alternative ways to solve a problem may be explored by prototyping a few solutions and putting them in the hands of the user to observe the interaction. A prototype could be used to test and measure how the design affects power consumption or Wi-Fi range. Alternatively, the prototype may be employed to test the behavior of a sensor in a wearable device where the contact to the skin or motion of the person creates a challenge in capturing the required measurement.
     
    The more information and data that can be captured from the prototype prior to manufacturing, the more likely a product is developed that satisfies the use case. Also, the less likely the development team makes product decisions that would be too costly to reverse.
     
    There are many challenges involved in new product development. The first and foremost is ensuring accurate data is being utilized. Arguably, the greatest challenge with sensors used directly on the body is the collection of clean, valid data. If not captured correctly, there can be false or missing data, making diagnosis difficult. Additionally, for wearable devices, the need to manage power consumption and wireless data transmission can introduce additional complexity. The result may be inconsistent collection or unreliable data, which makes assessing the impact of a clinical intervention virtually impossible.
     
    In some cases, the data may only be needed for the trial and it will be gathered by an adjunct unit. In other cases, it may be integrated directly into the device or incorporated into a treatment protocol. There is a temptation for researchers to press graduate students into a product development role—to hack something together quickly to support the primary research but this often leads to other problems.
     
    A Quick, Cloud-Based Solution
    Voler’s Universal Health-Sensor Platform is a pre-engineered solution for wearable medical devices. It provides a rapid pathway to capturing and transmitting accurate patient data. The pre-engineering prototype platform is small enough to be worn, and provides wireless data transmission so developers can access the data in the cloud. The company can quickly add the right type of sensor for an specific application and ensure it is collecting quality data.
     

    Walt Maclay is the president and founder of Voler Systems, an electronic design firm in Silicon Valley. His company is committed to delivering quality electronic products that are easy to manufacture. Voler Systems specializes in designing wearable and IoT devices by implementing its expertise with sensors, wireless technology, and power management.
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