The difference between wellness devices and medical devices lies deeply in the intended use outlined in product definition. That factor often determines how much further product development needs to take place to fully realize the devices’ new purpose and regulatory compliance. A project manager from Innokas Design Studio was interviewed about the product development viewpoint of wellness device to medical device transformation.  

Product definition guides the product development process 

Sami Melkoniemi is a project manager from Innokas Design Studio that is available for product development projects. He initiates and secures resources and oversees project mechanisms, weekly meetings with customers, and internal stakeholders. Additionally, he leads customer steering groups that monitor project alignment with original plans and identify potential scope changes affecting costs, schedule, or resourcing.   

When asked about his experience with wellness device to medical device pipeline, he underlines that development team’s involvement is most crucial when the products new definition and intended user base requires fundamental changes to the devices design and functionality. “The most important part of the project is the start. Customer must provide a comprehensive product definition that encompasses usage details, user profiles, restricted usage scenarios, and operational mechanics. QA&RA specialists work together with product developers to make standard check and establish where the device or service fits in the existing categorization. Based on that they will begin forming a plan on how to actualize the product within parameters of the regulations and what tests need to be passed. Most of the production will depend on how well this phase is done, so seamless collaboration with developers and QA&RA specialists is pivotal, as well as customers involvement.”  

Marketing claims must adhere to regulations and product definition 

The marketing of the new product will need to adhere to the product definition as well. Sami notes that particularly startups sometimes inadvertently make plans to market their wellness device as a medical device. “As all marketing claims must be proven to align with the defined product and user requirements, it should be noted that wellness device promotion cannot make commitments reserved for medical devices,” Sami says; wellness device’s marketing cannot legally promise the reliability and veracity of its data to the extent that it can be used as clinical decision support.

“This is also why medical device certification is attractive to companies. There is motivation to grant added value to the device with certification. However, certification comes with a much lengthier iterative process, extensive testing and documentation that also inevitably raises costs, so it needs to be considered carefully whether it’s a suitable path for the product,” Sami adds. Collaboration with QA&RA specialists ensures that the product can be properly classified at the start of the development project.  

Development and regulatory specialists ensure successful redevelopment

In the end, the choice to have wellness device redeveloped into medical device lies heavily with the plans company has for their device. Some startups might prefer to intentionally make their first device demos wellness devices while the medical certification is underway, while others might first have the idea of turning their wellness device into medical device only to later realize that medical device certification is not inherently necessary for the devices intended use. It’s always beneficial to seek the guidance of an experienced partner when thinking about the possibility of turning a wellness device into a medical device.  

“There have been many instances where we were able to give particularly important input on customers' ideas at an early stage and guide their development in the right, more uniform direction from the start. At best, well executed initial phase saves customer time and money while the product can be made into the best version of itself, be it wellness device or medical device,” Sami concludes.    

Innokas has an experienced product development team that is able to work in close collaboration with QA&RA specialists under the same roof. If you have any questions or need an experienced product development team to support your process, please do not hesitate to contact us via the form through this link.   

If you are interested in more regulative nuances of the wellness device to medical device redevelopment, our Senior QA&RA specialist Linda Kellberg has provided an interview on the same topic that you can read through this link.