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7 Key Steps in Developing a Wearable Medical Device

So you want to develop a wearable medical device? The good news is that the industry is booming – with sales of medical wearables to reach $19.7 billion by 2024 (IDTechEx). However, that also means you're entering a competitive, saturated market.

In our extensive experience in the medical device industry, it’s not just about what you’re making – it’s how you make it – that determines your success. While there are many nuanced steps to developing a medical wearable, here are a few of the most important aspects for you to consider.

1. Understand the marketplace and user needs.

Innovation is great – but alone it won’t guarantee a successful wearable product launch. Your technology or design must also provide a solution to a current problem for users or medical professionals. Researching the needs and pain points of your audience is crucial to the development process. Compared to the competition, how will your wearable be smaller, more comfortable, more durable, more convenient, more accurate, more cost-effective, or provide another in-demand benefit?

2. Achieve regulatory compliance.

The medical device industry is highly regulated with many complex, ever-changing compliance considerations. All your hard work will be for nothing if you are unable to get your product approved for regulatory issues. In the United States, that means following FDA guidelines. For starters, you must determine if your product meets the FDA's definition of a medical device. And if so, which category (or medical specialty panel) it falls into. The FDA’s medical device website provides a wide range of resources and guidance.

3. Risk assessment and management.

While a wearable medical device is intended to improve the health or well-being of its users, it can also pose risks. Identifying and mitigating risk should be an ongoing effort at all stages of development – from design all the way to production. By understanding the potential and severity of risk from product malfunction, misuse, or environmental factors, you can adjust the design and manufacturing to prevent these issues from harming your users and business.

4. Address the challenges of sticking to skin.

Human skin is designed to protect our bodies from injury and disease – and it does a very good job. Due to the unique and constantly changing attributes of skin, foreign objects (such as a wearable) have a hard time sticking to it. Fortunately, technology in skin-friendly adhesives has improved greatly over the years. There are now many reliable skin-friendly tapes and patches that can be incorporated in wearable medical devices. However, it’s important to find the right solution based on the target audience of your medical wearable, how long the product will be used, environmental conditions, and other factors.

5. Verification and validation.

You never know how a concept or design will work in reality – until you test it. Verification and validation are critical to making sure you’re putting out a high-quality, reliable, and durable product. And small changes can make a big difference. With a full range of printing and converting capabilities, Tapecon can provide materials testing and rapid prototyping to help you fine-tune your wearable device before moving to trials or manufacturing.

6. Improve speed to market.

Every day that your product is delayed getting to market is lost revenue. It also gives your competitors an opportunity to catch or surpass you. At Tapecon, we can help you get a quality product to market quicker in many different ways. As part of our new product introduction support, we consider the manufacturability of the design. This ensures a quick and cost-efficient transition from development to full production.

7. Choose the right manufacturing partner.

Once the wearable design is finalized, the next choice is whether to manufacture the product in-house or outsource it to a contract manufacturing partner. As you already know, the medical device industry is complex and has unique challenges, so not every vendor will have what it takes.

At Tapecon, we have more than 30 years of experience manufacturing medical devices and components. We've invested in our facility, technology, and professional expertise to deliver exceptional quality and ensure regulatory compliance.

  • We use a sophisticated, proven quality management system
  • We are ISO 13485:2016 registered for creating medical devices
  • We are FDA registered

Get started with medical wearable development.

At Tapecon, we have over 100 years of experience helping customers solve their complex product challenges. Learn more about our new product introduction support services and wearable skin tapes and patches applications.

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