Company insight
Who to bring on the medical device quest
3M is a science-based technology company that is committed to improving lives and doing business in the right way. It loves applying its science to creating products that, in big ways and small, make things better in some way: helping people to be safe, making them more productive, protecting their health and safeguarding the environment.
ike any notable journey, the quest of successfully bringing a device to market promises challenging twists and turns. It may feel like traversing across rough terrain, preparing for battle at dawn, searching for mystical treasure and wishing for the everyday comforts one had before leaving on an adventure. But just like any notable journey, it
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doesn’t need to be taken solo. A party of people with diverse powers is needed to help navigate and ward off product foes. At 3M, it has been on a few adventures itself. It knows the terrain, has gone to battle at dawn, found mystical treasure and made it back home, only to rest up and start out again. Because of the trials and tribulations 3M has experienced, it knows a thing or two about who to summon to successfully bring a medical device to market.
against them – they’ll persevere to find a combination that works.
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Manufacturing expert: These experts will help ensure the design can go from a singular prototype to mass-produced devices. Look for ones who have expertise in scale-up and designing a device and manufacturing process that work together. Manufacturing can greatly impact design, so make haste to get them involved.
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Materials specialist: They understand the nuances, characteristics and complexities of materials – how they’ll act under different circumstances, how they’ll interact with other materials, components and environmental forces, and how to select the right ones from the beginning. Keep them close during all stages of development.
“Because of the trials and tribulations 3M has experienced, it knows a thing or two about who to summon to successfully bring a medical device to market.”
Who to summon to navigate bringing a device to market Every journey is different, so let the device and what needs to be accomplished lead the way in identifying who needs to join the party. It may be all of the roles 3M suggests, it may be others; either way, its intent is to aid the selection to help get the journey started down the right path: ■
Product development specialist: They love a challenge. Working against all odds – even when designs, processes and materials seem to be
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Clinician: Clinicians are particularly important as one designs, plans and executes clinical trials, helping ensure the trial’s design fulfils clinical requirements while keeping in mind whether credentialing and education in clinical research and biomedical ethics are expected or required. Clinicians can also be the interface between the development team and trial participants.
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Biostatistician: Another key role during clinical trials, biostatisticians help ensure trial results will be
Medical Device Developments /
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statistically relevant. They can also help identify sub-population requirements for the trial, as well as help with producing product descriptors to design a process for a specific claim or instructions for use.
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Regulatory affairs: These experts understand the rules of play in the medical device space. They act as a guide in navigating the mission critical parameters and considerations of the journey.
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Legal counsel: A legal counsel is the trusted advisor on protecting intellectual property and risk management matters, to help to protect the party on their journey and to complete their mission.
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Business leader: They are the leader who understands the landscape and the dynamics to put the team towards the path to success. They can be an advisor and can help influence other leaders when needed. Again, they likely do not need to be involved in every step along the way, but they are a powerful force to keep on your side.
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The mentor: A wise and trusted guide throughout the whole process. Go to them with questions and when advice is needed. One with expertise in the device, having been there and back again, can be particularly insightful.
Guiding the journey
When one is able to harness each party member’s powers and work together as a team, they will be better able to navigate bringing the device to life. If more guidance is needed, read 3M’s ‘A design engineer’s guide to manufacturing’ or ‘A design engineer’s guide to clinical trials’. ●
www.3M.com/MedTech 99
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