New medical device projects are full of ups and downs with lots of surprises and twists along the way. We asked our employee experts to identify actions and advice that help ensure new medical device projects start on the right foot. This blog shares four areas that can make or break a new medical device project from the start.
Maximize The Initial Team Meeting
At the beginning of the project, gather all stakeholders (including key external stakeholders) involved in the product. Talk about the priorities of the project. Line up the project in terms of the most important things. These are usually budget, time and quality but may vary for unique projects. Identify and agree on the order of importance for the various priorities in the project charter.
Sometimes the design team and the project client (internal or external) are not aligned on the priorities. Having all the information out really helps align everyone and get to the right solution in the right time.
Understanding the stakeholders’ business and regulatory goals are important too and can greatly influence the priorities. For example, if the goal is to enter a market that is about to undergo a regulatory shift towards a more challenging submission (e.g. the EU’s MDD to MDR or FDA’s adoption of cybersecurity requirements) then time is of the essence to take advantage of any transition period.
During the group meeting, get to know each other, and understand the lines of communication. Who is responsible on the client side and on the design team. Agreeing on clear methods of communication is important because sometimes in bigger projects, who’s doing what can become a problem. This is like RACI (Responsible, Accountable, Consulted, and Informed) and is part of the project charter. Each letter in the RACI acronym represents the level of ownership for each person in a project. Essentially it identifies who is responsible for what and who is driving what. Getting the team together and understanding roles and responsibilities is a pretty important first step.
Starting projects with a team kick-off gives everyone a common understanding of project vision, objectives, reasons for the project and expectations for next steps. Aligning the team with a chance to discuss the important details of the project (or voice concerns) up front is a great way to set everyone up for success. It helps break down barriers between people who have not worked together before.
If team members haven’t worked with you before, a team kick-off allows them to get to know you, how you lead, and understand how you will engage them in next steps. This may sound obvious and simplistic, but its importance is often overlooked. Without a team kick-off, members may be disconnected to the project mission and their role in the team. The result is often a lack of buy-in and poor engagement.
Once everyone is set up on the project and team members know what they’re doing. They need to know where the project is going. A lot of the time, the initial priority is for short term objectives. Long-term priorities are often set by client needs and wants from project sprints or the overall program. Communicate that information to program managers, project managers and the team, so all eyes are on the same horizon.
Know Your Regulatory Strategy
Understand the regulatory strategy and who is driving it. What markets are they looking at? Who is handling the submission? The amount of time and commitment is going to vary depending upon what they are looking at. It’s smart to get that understood upfront.
Regulatory drives early requirements gathering and overall development strategy. Not taking the time to really consider what is needed to get the device into a particular market may leave the project vulnerable to costly and inefficient changes mid-development.
De-Risk Technology Early
De-risk any technical uncertainties as early as possible in the process. Many projects are well into developing a medical device without proving the core technology first. This can be an expensive and time-consuming path, without ever having shown the technology can get to the desired destination.
Make sure the core technology is sound. Many times, stakeholders think the technology is ready to go, but there are issues with the core technology and the stability or repeatability of the device. Think about how the technology links back to the user requirements. Are you set up to seamlessly pass verification and validation or has an important detail been missed that will cause unwanted troubleshooting and development deep into the testing phase. Also check the documentation in detail. You may think everything is ready to go. A deeper dive into the documentation can uncover missing or below standard documents in late stage NPI projects that need design transfer or begin manufacturing.
Have Tools and Facilities in Place
Make sure to have exactly what you need in place. At the start of a project, things you need or want at the facility might be missing and slow progress. For example, everything needs to be calibrated and in the proper condition to begin work. But the lead time to get equipment calibrated and available for a project on time is difficult.
Make sure that you have even things you might tentatively need in the right condition, or rent or buy them, before anything starts. That also goes for third-party testing. Do not underestimate how long something like 60601-1 or biocompatibility testing could potentially take. Engage third-party testing early to understand their timelines and availability.
Now that you’ve read our employee actions and advice to start new medical device projects on the right foot, we enjoy hearing reader tips, advice, and experiences. Please contact us if you are starting a new medical device and need assistance.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.
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- Source: https://starfishmedical.com/blog/starting-medical-device-projects-on-the-right-foot/