Many device OEMs and contractors likely have been asked in recent years to tackle something they’ve never done before. Consequently, companies are increasingly looking outside their four walls for solutions. They might seek answers beyond their usual stable of suppliers or maybe even explore vendors in other industries—anything for a competitive edge. The advent of mobile health (mHealth) has prompted medtech firms to forge unconventional partnerships in an attempt to secure new technical capabilities.
One way to overcome new challenges is by leveraging custom materials. Materials, in most cases, are usually the building blocks of any medical device. Adhesive materials are an example—they may hold a device together, adhere it to the patient, or both. By collaborating with an advanced materials supplier, an OEM or contractor can potentially meet new market needs with novel adhesive formulations and products. These new creations could range from a new wearable application with extended-wear functionality to a wound dressing with unique release properties, or securely-bonded substrates that have never before been connected. The custom adhesive must meet the end goal in a biocompatible, U.S. Food and Drug Administration (FDA)-compliant way, delivering a solution that is both comfortable for patients and cost-effective for providers and insurers.
By working together, device makers and materials suppliers can accentuate their strengths and propel innovation forward efficiently. Device OEMs, for instance, usually have the best understanding of the product’s end use, the way in which it should perform, the price the market will bear, and how providers and patients will engage with it. However, they need a responsive supply chain to help them achieve these objectives. In the case of custom materials development, it is most cost effective to turn to a specialist with the staff and equipment ready to tackle the challenge.
Laying the Groundwork
The nature of the new material will affect many facets of the custom development project. Is it a new product for a novel end use or is it a tweak to an existing material for a new application? The amount of novelty and the number of performance claims will affect project complexity, time, and resources. Each new claim must be proven. To use an analogy from another industry, imagine the difference between developing a flip phone enhancement and introducing the first smartphone. For the first smartphone, an enormous battery of tests and reviews were required to prove every safety aspect and promised functionality. Likewise, new materials need more time for custom development. To enhance or change certain properties or performance characteristics of a known material, it is essential to have the benefit of building on already-set groundwork. Either way, it’s necessary for all partners to understand the end product need, including specific performance requirements, manufacturing processes, and cost targets.
In selecting a supplier to develop a custom-formulated adhesive or other material, think holistically about the entire solution needed. Consider, for example, the level of service required beyond the material itself, and whether the supplier can ship short runs within quick lead times. The material provider’s commitment to environmental sustainability is important, too, as are the types of sustainable practices it uses at its factory and its track record of eco-friendly medical materials development.
Plan multiple site visits to meet potential partners and tour their facilities. As Medical Product Outsourcing reported in its October 2016 issue, the ISO standard 13485:2016 for medical device quality management systems calls for greater evaluation, monitoring, and documentation of supplier processes. Companies should ensure that their partners’ Occupational Safety and Health Administration and FDA documentation is in order. Firms should also look for any visible safety issues.
The most successful custom materials projects draw on a combination of deep scientific expertise, a diverse product portfolio, specialized equipment/facilities, and a strong compliance record. Other factors that could affect outcome include the number of doctoral-level scientists and medical doctors on the supplier’s staff, cleanroom conditions, and the findings of the last FDA site visit. Equally impactful is the materials supplier’s corporate makeup—is it part of a larger corporation, and can it effectively cross-pollinate ideas between divisions?
Beyond the core capabilities—namely, having the necessary pilot-scale prototyping equipment to produce custom material runs—there are other considerations as well. The supplier’s suite of value-added services is particularly significant. Such amenities, for example, can help a partner determine whether the supplier can die cut material so it flows directly into an OEM or contractor’s sheet-fed operation for the next step of prototyping. Also, the breadth of offered services is important for strategizing the product development process. For instance, does the supplier offer some basic level of assembly, or would that have to go to another vendor or be done in-house by the OEM?
Finally, another crucial part of initiating a custom material partnership is to determine intellectual property (IP) rights and ownership. Will one partner have full IP rights, or will the OEM or contractor claim exclusive IP for certain applications and the material supplier reserve rights for other markets and end uses? IP can be a sensitive issue, but it is important to resolve all details before development work begins, leaving no ambiguity about ownership rights and future marketing potential for the product.
Managing the Development Process
Communication is essential once the custom material project is underway. Set expectations at the outset and provide frequent status updates along the way, sharing both good news and bad. In particular, be as transparent as possible about scheduling. Ensure that everyone clearly understands when equipment and staff must be in position and capacity reserved in order to manufacture the new product.
In addition, get to know each other’s people and processes, with proper disclosures to protect the privacy of proprietary processes. The more the materials supplier knows about how the OEM or contractor ultimately will test and produce the end product, the better.
For medical materials development, teams from both sides should agree on rigorous adherence to solid scientific methods and statistical process controls. Repeatable, reliable processes, proper regulatory pathways, and strict quality systems are all necessary ingredients of successful custom materials development. While each step takes time and resources, eliminating any one step or best practice could end up adding time and cost to the project. Consider the creation of an existing material in a new color. It might be tempting to skip a consumer perception study and get the new material to market sooner, but it’s possible that the new color additive could be a skin irritant for some patients. Partners must weigh the importance of such potential discoveries.
It’s also critical to be mindful of any mid-stream changes to the original product parameters. OEMs and their partners must determine whether a potential change will make a meaningful difference with customers. They also must figure out whether they can effectively articulate the added feature to the market and win a premium for it. Even if a change to the material specifications does not seem significant, it might add six to 18 months to the project timeline, especially if new regulatory filings are required. It also could take time to schedule additional runs of the new formulation on the supplier’s pilot line. In cases where project timelines are impacted, the partners must deduce whether the market opportunity will still be there once the product is ready for commercialization.
In conclusion, plan for the unexpected in every custom material project. Build in time for a certain number of iterations, speed bumps, and course corrections. With any creative endeavor, there is always compromise. Teams will have to balance the need for speed with requirements of a safe, sound, science-based development plan. With common sense, best scientific practices, and a sincere spirit of business partnership, there generally will be good results.
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. He holds a master’s degree in chemical engineering from the University of Akron and a master’s degree in business administration from Northwestern’s Kellogg School of Management. He can be reached at phone 312-629-4604, email: email@example.com, www.vancive.averydennison.com.