In the fast-changing world of medical wearables, the right product development and design partnerships can save time and resources, and accelerate ideas to market.

Deepak Prakash

From primary care to clinical trials, healthcare providers, researchers, device developers, insurers and others are exploring how digital health solutions can transform care delivery, improve outcomes and enhance the patient experience. Medical and wellness wearables, such as body-worn devices that collect and transmit biometric data, are right at the heart of many evolving strategies and emerging care practices.

Amid this sea change, wearable medical device development is burgeoning with innovation and activity. It seems a new mobile health application, device, or venture is announced almost every day. Companies large and small are racing to turn wearable medical ideas into commercially viable solutions.

The pace of wearables product development is quickening, driven by strong investment, growing competition, and the promise of profitable returns for those who capture market share. Against this backdrop, device OEMs who can reduce cost and time to market will have a competitive advantage.

Collaborating Across Disciplines

The most efficient medical wearables developers excel at multidisciplinary collaboration. Their product development pipeline is designed to leverage expertise from diverse supply chain partners. These partners might include businesses and individuals specializing in advanced materials science, cloud computing, data analytics, sensors, mobile apps, electronics, clinical research, physiology, and other medical fields.

Wearables remain a relatively new product area, which makes it more important than ever to identify trusted partners with some experience in the space. When suppliers can share their experiences about what works and what does not, it can help device OEMs shave weeks if not months off product development cycles. For example, a materials supplier may be able to alert a wearables developer about potential allergic reactions to certain substrates. Without this insight, it's possible a wearable device could reach the consumer testing phase before an allergy issue comes to light. Then the OEM would face not only significant delays but also costs associated with new material specification and sourcing.

In a strong product development and design partnership, suppliers and the OEM can explore many ideas for the wearable before the first prototype is ever made. Through an iterative process, cross-functional teams can collaboratively discuss the desired end user experience, aesthetic requirements and core functionality. With experienced partners at the table, they can effectively vet important decisions such as:

When these questions and many others are addressed very early in the product development process, device OEMs can avoid considerable amounts of wasted time and resources.

Managing Quality, Safety and Risk

Another way to reduce cost and time to market for wearables is to prioritize regulatory compliance and quality standards from the very beginning of product development. From materials selection to prototype manufacturing, it's advantageous to collaborate with suppliers who are ISO 13485 certified. This means their facilities' quality management system meets rigorous standards for design and manufacture of medical devices.

There are other quality and safety-related qualities to seek in the wearables supply chain. For example, does a supplier have clean room processing capability at both pilot-line and high-speed production levels? Are sterilization services available? While such questions may seem low on the priority list when compared with issues around data compatibility and wearable signal accuracy, they may need to be addressed later on to document patient safety.

In addition, when suppliers' operations are registered with the appropriate regulatory agencies in the United States and globally, this will help streamline the path to regulatory approvals for the wearable down the road in the product launch process. When any major consideration affecting product quality and safety can be addressed sooner rather than later, the OEM stands to streamline wearable development.

Scaling Up Smoothly

Finally, if and when a wearable medical concept proves viable and begins its journey toward commercialization, it's crucial that the device OEM and its supplier partners are ready to ramp up production. To ensure a smooth transition from prototyping into full-fledged production, there are key questions the OEM and suppliers should resolve as early as feasible in product development, such as:

Suppliers should be willing to engage in frank discussions with OEM partners about their ability to scale from prototyping to producing large volumes.

In conclusion, wearable medical device development is a dynamic and quickly evolving area. As such, there will always be the need for course corrections and fresh takes on device design. What OEMs want to avoid are sharp right turns in their wearables development, or worst case, concept abandonment. When OEMs partner with seasoned suppliers across multiple disciplines, they are much better equipped to move at the speed of digital health, staying a step ahead of the innovation curve.

Deepak Prakash is global director of marketing at Vancive Medical Technologies, an Avery Dennison business. He can be reached at 312/629-4604 or [email protected].     

[Photo courtesy of VANCIVE MEDICAL TECHNOLOGIES]