You know the old adage, “the whole is greater than the sum of its parts”? Well, it certainly doesn’t apply to the creation of a medical device.
While true in some regards, a device’s success comes down to each individual component and whether it is the right fit for the application. If one component is off in some way, it can disrupt the device’s overall ability to fulfill its intended function. Therefore, material selections, for instance, often strongly influence device success. If they are not compatible with each other (in a device with multiple layers) or other parts of the assembly process, they can cause the device to fail. Adhesives in particular play a significant role. If they are unable to adhere components together or keep the device fixed to the user’s skin for the intended wear time, a device can fall apart or detach from the skin prematurely. When a device is supposed to help the user monitor a chronic condition or help them make critical health decisions, there is no room for error.
One of the most effective ways to help prevent these issues from happening is having a strong, collaborative partnership with your materials supplier. Like with any relationship, it can take dedicated attention to find your groove working together. But, ultimately, the investment can be worth it if you are able to produce a successful device. To help you foster such a relationship, here are four tips we recommend considering.
Work with a Supplier Well Versed in Science, Technology and Other Areas of Expertise
When looking for a material supplier, the quality of materials they offer should be a primary filter. It should not be the only filter, however. Understanding whether prospective suppliers have supported similar projects before, worked with similar production processes or are well versed in other relevant areas of expertise can be an asset throughout development. For example, they would be able to reference previous experience, both mistakes and successes, which could help guide the project.
If you are creating a wearable device, finding a material supplier knowledgeable in the science of skin and the challenges of sticking to it would be advantageous. Skin is a unique substrate—one that is a living, breathing organ that grows hair, sweats, stretches and produces oil. It changes with diet, environment and age. Not every material is compatible with sticking to it for the desired time period along with avoiding injury upon removal.
Before beginning the vetting process, start by thoroughly understanding your target end-user and then cross-referencing the demographic information with your device’s intended function. Your end-user’s age, where they live, how active they are and a sense for their overall health can help identify other characteristics or functions your device must possess to be considered a success. This knowledge can also help you determine the areas of expertise your materials supplier needs to have to help ensure the best materials are chosen.
Pull Them into the Process as Early as Possible
One of the best ways to help set your project up for success is to involve your materials supplier as early into the development process as possible. Because the choice of materials can help dictate whether a device will be able to fulfill its intended function, it is critical to choose the right ones for each project. They also affect your device’s overall design, how it can be manufactured and sterilized, and other subsequent development processes.
When materials suppliers are brought in too late, the device runs the risk of needing a redesign. That might not be determined until it is impossible to make cost-effective changes, potentially pushing the project over budget and past its timeline.
The good news is that redesigns can be prevented. If you followed the first tip, your supplier is an expert. And if they are able to be part of designing the device, they should be able to counsel and guide development teams on what materials would be best, given your product specifications, and what ones are not well-suited for the job.
Establish Open Lines of Communication
The success of a partnership often comes down to communication. Both parties can be well established in their fields, but if they are unable to effectively communicate, their collective expertise can only take the project so far.
Changes during development can happen fast, and they can happen frequently. It can be hard to know who is working with the latest information. When you start a new project with a materials supplier, establish a pre-determined cadence between your team and the supplier. That way when changes inevitably come up, both teams will know what is expected and how to communicate.
Adjustments to materials are an expected part of the material development process, as well. They help evolve the material and its capabilities, and it can happen at any phase, from development to maintenance. It can be inconvenient, though, if changes happen unexpectedly during a project. Sometimes, the changes may not be noticeable in your device, or there is a similar material that could replace it. Other times, the changes could require subsequent alterations to the device. In either scenario, a robust change management plan helps both teams navigate and know what is expected for documentation, as well as any verification and validation needs.
Consider a previous project in which you were involved but not fully integrated into. The project’s main team consulted you for your expertise but may not have shared the project’s entire vision. Was it challenging to know what advice to give? And whether it was valuable? Did you push them to share more with you? In some circumstances, a limited view is workable. But often when the insights needed will affect the rest of development, it is better to share more rather than less with the right precautions in place.
Keep this in mind when working with your materials supplier. In our experience, the more development teams let their supplier in, the better the supplier will be able to consult. As part of your communication agreement, set up any needed parameters, like non-disclosure agreements, so that information gets shared symbiotically.
These considerations can provide a starting point for more productive partnerships. All partnerships are unique, though, and may require additional ones to be successful. Consider opening the dialogue with prospective suppliers to understand what other parameters they require, as well as communicate the ones your team has in return. Working together from the start to outline what your partnership will look like helps establish a common vision for success and set expectations to achieve that vision.