Copy to clipboard 
Numerous opportunities will present throughout the year to reflect on adopting commercialization best practices. A typical time for rumination is when a project starts or ends. Another could be when you gain or lose a teammate. Of course, you might set resolutions at the beginning of a new year.
StarFish Medical, a device design service provider, polled their quality, regulatory, project management, manufacturing and engineering experts on their 2023 commercialization resolutions. De-risking early, communicating often, testing and managing pivots were among the top themes. Highlights of their intentions and insights might spur ideas for ways to improve your orthopedic device commercialization efforts this year.
Pay attention to early de-risking. Explore technical uncertainty in medical device development. Focus on prototypes and experimentation that tackle the significant risks first. Try not to add fluff to designs that may eventually be required, but will likely delay resolving the big risks early in the process.
You are more successful when a smaller team works on solving complex problems before more people are brought in to make a product. Every project is slightly different, but they all have a lot of commonalities. Take what you’ve de-risked and then turn it into a product.
Establish a clear go-to-market strategy. Regulatory landscape monitoring is crucial to understanding which markets will be easy or difficult to enter and what regulations are changing.
The EU Commission announced significant changes to the implementation dates of the MDR, proposing to push the transition period deadline to December 2027 or December 2028, depending on the risk class of the device. We are all waiting to see how those changes play out.
Prepare to pivot. Always plan multiple iterations of your product design to account for successes and failures. Add iterations into the schedule to leave time to re-spin ideas that don’t work as expected.
As you learn more about the clinical need and your planned technology, you may nix your lofty original goals and identify a new way to make an idea successful. A device could be designed for surgeons, but its intended use might change after iteration and development. Someone assisting the surgeon in the procedure might become the intended primary user. If this happens, the business case is modified and needs product management validation to guarantee its success.
Predict product performance. Modeling and simulation provides design analysis, answers design-related questions, tests failure modes and leads to substantial savings in time and resources. Physical testing requires a longer timeline to build and break things. Simulation expedites changes that harden designs before informal and formal testing.
Learn from the past. Leverage previous work to make your product testing process more efficient. Create a repository of completed projects and be proactive in thinking beyond the immediate goal that you’re working toward. Information gleaned from past projects becomes more powerful when it’s applied forward.
Make informed decisions. Run data through core technology development to confirm that it’s doing what you expect and want it to do. Come up with an easy way to test your device early in the design process, and keep applying that test as the device evolves.
Notable findings aren’t usually identified until you try things at scale or amass large amounts of data. Make your core technology more viable with verification and validation. Have a standardized way of retesting devices through all stages of development, monitoring and manufacturing.
Focus on the end-user. When faced with a problem, many product designers engineer functionality that can be unattractive or too complex. A device should be simple to use so surgeons can operate it efficiently and easily in the field.
Understand the actual need. Don’t jump to a conclusion based on building toward a final device. Investor criteria, milestones or timelines could become priorities, but truly understand the product’s needs and adapt the project’s development accordingly.
Communicate and collaborate. Make sure that every stakeholder involved in a project is engaged in its success. Regularly scheduled check-ins with team members, leveraging collaboration tools and using active listening skills allow for quick adjustments to be made on the fly.
Confirm that the parts are in place. You may not be able to execute a design that you love because needed parts aren’t available. To avoid this issue, involve manufacturing and supply chain project managers early in the design process. Remember to think about manufacturing and supply chain concerns earlier than you did before COVID-related disruptions impacted the market.
Inform manufacturing and supply chain project managers of design changes that might impact the bill of materials (BOM). Taking on stock and then making a BOM change could result in getting stuck with unneeded inventory or having to send back unused supplies. As prototypes get nearer to products than proof of concepts, consider the capabilities that your contract manufacturers will need to possess.
Build a collaborative approach. Emphasize system testing for prebuilds as much as you do for pro builds. The automotive world taught us about the importance of a paper build. Manufacturing and engineering teams produce the initial product and walk through every stage of the lifecycle asking, “Do we have everything we need?” Many issues can be flushed out during this process. It’s comparable to a trial run.
Champion cultural growth. Create safe, experiential spaces — both communal and personal — in which employees can do their best work.
These aren’t trivial resolutions. We often overlook the impact of incremental improvements on everyday processes. Product development goals are achieved through clear objectives, technical know-how and collaboration. That’s not as simple as it sounds. Keeping commercialization best practices at the forefront is an essential first step to a project’s success.
