What startups need to succeed when selecting medical device materials

Whether a startup targets an emerging category such as wearables or a more mature device market, a well-planned approach to medical device materials selection can make a significant difference in the product launch cycle, economic model and other variables.

Deepak Prakash, Vancive Medical Technologies

Materials selection can be a make-or-break issue for medical device startups. Even minor problems cause major headaches: Consider the migraine that Fitbit dealt with in 2014, when it voluntarily recalled more than 1 million Fitbit Force wristband activity trackers in response to customer skin rashes. Although the issue ultimately only affected 1.7% of users who had an allergic reaction to small levels of methacrylates in an adhesive used to make the wristbands, it caused negative publicity and put a dent in customer trust.

Without the benefit of shared expertise from strategic supply partners, new businesses can face troubles such as delayed market launches, flawed pricing assumptions, quality issues and production capacity constraints. Despite all that, startups can steer clear of many issues by engaging with advanced materials experts early on.

Cutting through competing priorities

Medical device startup companies, especially in the high-growth wearables category, are dealing with many competing priorities. For example, a digital health startup often must juggle software development, mobile app interfaces, sensor selection, battery life issues and cloud computing concerns. That’s not to mention pressure from investors for return on investment.

Amid this whirlwind of activity, entrepreneurs understandably turn to the low-hanging fruit. What product development tasks can they readily tackle and check off the list? In this situation, software and mobile app development can become an early central focal point for mHealth (mobile device) startups. After all, functionality around the digital user experience, data collection and analysis is the innovative heart of a wearable.

It’s easy to see how something such as material selection – finding an adhesive to attach a device to the body, for example – could fall off the radar for a while. Yet a medical wearable is a device system. If any one part of the system falls short of expectations or behind schedule, it could cause bottlenecks and have other profound effects on other parts of the solution.

That’s why it’s important to maintain a holistic view of product development. Smart startups keep multiple aspects of device development, including material selection, moving simultaneously. If this isn’t the case, big problems can crop up. There could be incorrect assumptions about material compatibility, costs and regulatory review timetables. Or the new business may base its economic model and pricing projections on one set of wear-time expectations, such as a 2-week product lifespan.

But given the end-use requirements, existing materials on the market may only support a wear time of one week. When this type of discrepancy between the business plan and procurement realities is uncovered late in the game, it can have major consequences, such as impacting the product’s launch timing and overall value proposition.

Shop around for expertise

One of the best ways to head off such surprises is to look for materials information, product samples and potential partners as early as possible in a product-development process. This can be accomplished by attending trade shows, reaching out to medical materials suppliers and meeting with converters. It also is worthwhile to network with academic research institutions with advanced material programs.

Many mHealth startups are led by entrepreneurs from outside the medical device industry. This makes it especially relevant to turn to suppliers and other strategic partners with knowledge of regulatory laws, insurance reimbursement trends and different industry standards. For example, environmental sustainability standards can be complex. Some regulatory bodies update their lists of restricted substances annually (California’s Proposition 65) or bi-annually (the European Union’s REACH). To comply with REACH standards, it is necessary to provide extensive technical documentation regarding all chemicals and materials used in a device.

Device manufacturers may also have to disclose detailed information directly to consumers if they receive inquiries. Advanced materials partners should have the resources to stay abreast of all restricted substances and global regulations. They can help a startup ensure its materials comply with specific rules by trading bloc, country or individual state. In turn, they also should be able to provide documented proof that their upstream suppliers do not use any restricted substances. Maintaining this level of supply chain transparency is challenging but can be crucial to a successful product launch.

In addition, working with a seasoned medical materials supplier can deliver peace of mind when it comes to biocompatibility, a major factor in patient safety and comfort. No device maker wants to repeat the nightmare Fitbit dealt with in its adhesive selection.

Sometimes it takes a deep knowledge of material science, including teams led by doctoral-level chemists and researchers, to recognize potentially incompatible adhesive chemistries and biocompatibility risks. Likewise, these same experts can work with startups to help them identify innovative ways to incorporate the latest chemistries and materials into their products. In many cases, there is no need for startups to reinvent the wheel and develop brand new materials. The development of custom materials adds significant time to the product development cycle and can drive up costs. By comparison, when startups adapt materials already on the market to their particular end uses, they benefit from more economical pricing from suppliers, who can efficiently run large volumes of the material.

In conclusion, medical device startups, especially in the mHealth space, are inevitably charting new terrain, learning and innovating as they go. But when it comes to materials selection, there is a great opportunity to lean on experienced suppliers to avoid pitfalls that have plagued other pioneers. Early engagement is the key to prosperous partnership and new product success.

Deepak Prakash is global director of marketing at Vancive Medical Technologies, an Avery Dennison business. He has 20 years of healthcare experience spanning marketing and product development.