If you’ve read through our previous blogs, you’ll have had a comprehensive guide on what to look for when onboarding a CMO: the skills, services, applications, and capabilities you now know to ask for. This checklist is here as a guide to make sure you use this new information to your full advantage. Here’s how to take your project from just an idea to a tangible reality:
RESEARCH
Think about your concept for a product and what you want from a CMO. Will it be better to go local or do you want a global manufacturer? Do you want a CMO that specialises in a niche or do you want a provider with all-around capabilities? Once you’ve answered the basics, look up multiple potential vendors who will fit best with your project.
RELATIONSHIP
Think about your concept for a product and what you want from a CMO. Will it be better to go local or do you want a global manufacturer? Do you want a CMO that specialises in a niche or do you want a provider with all-around capabilities? Once you’ve answered the basics, look up multiple potential vendors who will fit best with your project.
ASSESSMENT
Have your potential vendors explain their services, applications, and capabilities and assess which of them is best equipped to take on your project. Asking for this information to help you in your assessment is also important in seeing whether they can communicate effectively with you or not.
PROJECT DEEP-DIVE
Give your potential vendors an overview of your project and ask what you can expect from them. How long do they estimate this will take? Do they lack the capabilities for any of the facets of the project? Do they expect any high or low-risk steps along the way?
FACILITIES TOUR
This step can’t be skipped. Whether virtual or in-person, it is essential to get a good look at the actual location where your device will be manufactured. What do the production lines look like? How effective is the workflow? This also opens the door to ask questions about their facilities.
PRICING
Probably the part of onboarding that everyone looks forward to least: how much is this going to cost you? Remember that this isn’t just the cost of production, but also further possible costs if it is likely to be a long-term relationship like annual increases or inflation rates.
SUPPLIER COLLABORATION
Find out your potential CMO’s relationship with suppliers. Do they have established networks or are they reliant upon you to find the suppliers? Are they adamant about using their own suppliers or are they open to using a suggestion?
SAMPLING
Every CMO worth their salt will have products that they have already made or are currently manufacturing. Ask for samples to see how these potential CMOs treat their products. Are they of high quality? Do they have obvious issues? Have they produced something along the same lines as your project before?
CONTRACT AWARD
This is the step where all your question-asking will come to fruition: making the actual choice. The above steps should help you choose the best CMO for your project. Once you have awarded the contract, you can begin the process of making your project a reality.
PRODUCT VALIDATION
Because it is important for medical devices to be certified by the proper regulating authorities, it is important that this is an early step after you have awarded your contract.
PRODUCT MANUFACTURE
Now you can fully open the floodgates and manufacture your medical device. Make sure that you are still communicating often with your CMO to make sure you understand what is happening, when you can expect deliveries, and any updates along the way.
We hope you found this miniblog useful and hope this CMO Onboarding Checklist helps.
For the previous blog in this mini-series, which looks into medical manufacturing timelines, please CLICK HERE.