This blog post was written by Deniz Temelli, Business Analyst at TechAlliance.
Commercializing a medical device is not easy and unfortunately, there are no great ways to learn how to go about it other than experiencing it first-hand. The commercialization path is rarely the same for different devices as there are so many nuances that are based on the classification of the device, country of origin, manufacturing process etc., which can make the process difficult to navigate. That being said, there are basic steps that each device has to go through, it’s just how you accomplish each step that varies.
I am by no means an expert, but based on my previous work experience, I’ve put together this extremely high level flow chart for commercialization. All of the steps may not be application, or there may be steps missing, but it’s a good place to start to wrap your head around what it takes to commercialize a medical device. This is mostly applicable for regulated devices as many of these steps stem from the requirements for Good Manufacturing Practices and regulatory certification. This is also applicable for medical software.
- Quality Management System (QMS) – This includes the overarching processes, policies, organizational structure etc. needed to implement quality management which dictates all of the company activities. Some specific examples of this include revision/document control, multiple sign offs for documentation and quality inspections during manufacturing. If you are outsourcing any key activities, like manufacturing, you will have to audit your suppliers to make sure they have an adequate QMS. This is a requirement for any regulatory approval.
- Design Inputs – Be sure to talk to the end customer to figure out: what problem you are trying to solve and what features/functions does the solution have to have?
- Prototying – Have fun and be creative to design the device that meets the design inputs.
- Design Review/Design Freeze – When you have a final prototype, you must have it approved and that design becomes Version 1. From that point on, any design changes must be approved and documented.
- Manufacturing – Involves determining all the manufacturing protocols including quality inspections. IQ/OQ/PQ are verification tests needed for any piece of manufacturing equipment to ensure it is appropriate for the job and is doing it’s job properly.
- Risk Management – This is a key piece for regulatory where you consider every possible way the device can fail, evaluate each failure mode using the Risk Assessment Matrix, then mitigate against unacceptable risks.
- Validation and Verification – Are you making the right product? And are you making the product right? This involves multiple tests as suggested in ISO standards and can include clinical/animal/human trials if necessary.
- Packaging, Labeling and IFU – You must ensure the packaging protects the mechanical integrity and sterility of the product while the labeling and Instructions for Use must follow appropriate standards and be translated into all relevant languages.
- Regulatory Submission – All of the documentation from the above steps are then put together into a regulatory package for submission. Each regulatory body (like FDA, Health Canada) has their own forms and guildlines so a separate package is required for each.
For anyone at the beginning of this process, or trying to figure out where to start, I hope this gives you a little bit of perspective on where you’re going and how to get there. And please feel free to reach out to the Startup Services team (email@example.com) if you have any questions or need any guidance!