All failures are a lesson learned. But cultivating relationships across disciplines, especially when projects “fail,” improves the odds of success.
Bret Ludwig, Ph.D. Senior Product Development Specialist, 3M Medical Materials & Technologies
A sentiment from John C. Maxwell that device development teams could hear more often is, “Fail early, fail often, but always fail forward.” Not every project will be prosperous or marketable, but pushing the boundaries of innovation is often essential to create a novel product or feature. Still, developing and executing a novel device can feel much easier said than done.
A key to success I have learned in my 25 years as a product developer that I keep going back to is that cultivating relationships across disciplines, especially when projects “fail,” can make all the difference. Design engineers should approach the development process with the attitude that all failures are a lesson learned. They might just need a little help figuring out what the lesson is.
Achieving innovation as a lone engineer can be nearly impossible in today’s world. But with the right team and mentality, unearthing a new approach or feature to design a successful medical device can become a reality. To help encourage pushing the boundaries across all team members, break down what each function or role you work with might require throughout device development.
When working with designers
Creating space for creativity can be pivotal. It can help those responsible for designing the device to question traditional thinking or approaches, thus identifying a new path or opportunity. Specifically, ask for team members’ points of view on the challenge. Ask if they have suggestions or know additional contacts to include. In any development stage, if one contact is good, three is better. A simple quantity of connections can provide the one spark a project needs to stand out.
When working with customers to create initial concepts and design, go beyond the what of the product and get to the why. Investigating customer needs and complaints reveals pain points and key insights, which can lead to more relevant designs or material changes connected to specific customer needs and desires. For example, if the team aims to design a glucose monitoring device, the “why” might be creating a tool that helps people with diabetes live life to the fullest without their device getting in the way. The design team should go beyond thinking about how the device can best capture data and information by also considering how it will withstand sweat, sun and water contact. Casting a wide net and keeping options open is how a development team can produce innovative designs. Of course, such inventions might take multiple attempts, but this approach helps drive your design down the right path.
When working with suppliers
When it comes to suppliers, communication is paramount. Being as open as possible about progress and needs, with the appropriate confidentiality agreements (CDAs) in place, can improve a product’s performance and costs. Determine a regular communication cadence that works for all parties to help ensure everyone receives timely updates throughout the project.
Consider this, regular communication with your materials supplier can help prompt discussions on topics such as material formulation changes. Even if the changes aren’t noticeable or the material can be easily replaced with another, clearly setting expectations can support a more seamless development process. Then when situations arise where design teams need to go back to the material selection drawing board, identifying the root cause of the need is easier given documentation, verification and validation.
If managing multiple partners proves difficult, consider minimizing the number of vendors involved. Streamlining the points of contact can reduce the effort spent on projects management and allow for partnerships to be strengthened.
When working with manufacturers
Even engineers who have developed products for decades cannot foresee everything that will happen during scale-up. If a team is pushing the boundaries of innovation, there will be unknown variables scattered across the scale-up process, meaning surprises are difficult to avoid. The sooner a team identifies the root cause of any obstacles, the sooner they can get it fixed or find a way to work around it.
Manufacturers may be able to help forecast more finite details, such as environmental conditions that could prompt concerns such as humidity. With their expertise, teams can pinpoint where a breakdown might occur and why, because transitioning from lab equipment to full-scale production can require adjusting process controls and protocols. Minimizing variability on the manufacturing line is important to executing a design effectively. Predicting every difference between lab prototypes and full-scale manufacturing is challenging, so pulling from a diverse set of experiences is key.
Often the best way to avoid or overcome challenges is to involve your manufacturing colleagues as early in the process as possible. They can help deal with the known variables to control production process effects, such as the impact of heat on device materials or the transition from gallon- to drum-quantities at the speeds used in production settings.
When working with clinicians
Clinicians often have experience executing a clinical trial program correctly to gather accurate, reliable data. Their expertise in moving an innovation through this phase is critical to overcoming new impediments – especially as many clinical trials continue with reduced in-person contact – and conserving relationships with participants.
To support and engage a clinical testing team, ensure that all protocols and controls are clear. There are many factors at play in clinical trials; outlining protocols should cover everything from how the product is stored to how it is applied. When contact with participants is limited, being as thorough as possible in directions can reduce knowledge gaps and the risk of inconsistent results. You may want to consider creating a video of the correct procedures or other visual guides.
Monitoring trial progress also helps strengthen relationships with clinical testing teams. Take the time to understand their perspective on the process and proactively ask for their suggestions. If results are not living up to expectations, that may mean it is time to end the study. Calling off studies when results are trending poorly helps maintain a relationship with the clinical group because it demonstrates respect for their time.
With your team, learn to accept “failure”
A great invention not sold is nothing but a curiosity. While this statement is oversimplified, knowing when to call off an idea is a necessary evil. Projects can end for many reasons, such as financial barriers or a technical hurdle. To keep your team invested and engaged with the current project and beyond, it can be helpful to conduct regular check-ins. Ask team members, “if this were your investment, would you wager this bet?” When the answer is no, dedicate time to discern what will help your project fail forward and bring those learnings with you to the next project.
The trials and frustrations of medical device development can help lead to the next big innovation. As cliché as it may sound, failures are part of the process and provide an opportunity to learn. Development teams who can work together, even in the face of adversity, can make new discoveries and push projects to a whole new level.
Don’t fear failure because when innovation finally comes to fruition, the sense of accomplishment balances out the frustrations encountered along the way. No engineer creates the next great invention without the support of others along the way, so cultivating those relationships and maximizing each partner’s potential along the way can help teams push past adversity and make the most of every project.
3M Medical Materials & Technologies