Blog

Wellness device to medical device redevelopment

Project timeline:
months
Service areas:
Product development
Written by
Teija Tulinen
Innokas content creator
Innokas employee on a laptop with accompanied by "Innokas sustainability report 2024" title

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.  

Lead Magnet: The 101 of medical technology innovation
Download

Ask more about this project

Innokas highlights

Here you can find more of our latest news and insights in this category.

Innokas sustainability report 2024 published

Read more

Innokas sustainability report launch

Read more

Introducing Valter Ritso, the new Director of Operations and Leadership team member at Innokas

Read more

Innokas Medical Rebrands as Innokas – Paving the Way for Growth and Innovation

Read more

Innokas highlights

Here you can find more of our latest news, tips and insights.

Did you know distinctions – High-tech device versus smart device

Read more

Getting the best return from prototyping

Read more

Efficient production transfer between factories

Read more

Why contract manufacturing?

Read more

Innokas highlights

Here you can find more of our latest news and insights.

Case Terveystalo – Innokas software team helps develop medical software expertise

Read more

Case Nexstim – Familiarity with the sector and flexible operation gives a competitive edge

Read more

Case UKK Terveyspalvelut – Problem-solving skills and customer-oriented operation

Read more

Case MEGIN – Functional brain mapping by solutions based on magnetoencephalography technology

Read more

Innokas highlights

Here you can find more of our insights, news and tips.

No one builds alone – Contract manufacturing took the spotlight at Alihankinta subcontracting fair

Read more

Innokas challenges design thinkers to integrate circular design in healthcare

Read more

Arab Health 2024 – Our take and review

Read more

Innokas highlights

Here you can find more of our insights, news and tips.

Importance of hobbies in work-life balance – Insights from a Software Engineer

Read more

Europe's best – Innokas Medicals senior software engineer heading to Euroskills competition

Read more

Hire an International Student Campaign – Meet Ondra

Read more

Tomi Hugg is the new Director of Design Services at Innokas

Read more
Siberian husky sled running in a snowy environment. Innokas brand green glass theme. Background.

Let's get started!

Contact us and find out what we can do for you.

Contact us