Wellness tech, mental health tech, self-care, biofeedback, self-hacking, BCIs, aesthetic implants, virtual personal assistants and avatars, sensory augmentation. These applications are hard to encapsulate into a strict definition. I use the word selftech or self-tech to englobe them all. They are the enablers of what some call the Quantified Self.
If you are working in this space, you may not fall under the scope of medical device regulations (at least in some jurisdictions). That can sound like a good thing, as it avoid significant expenses, risks and delays.
But it is easier? Without regulations, how to ensure products and services are safe and effective for their users (patients and HCPs), the environment, and society as a whole? Professional ethics lead to aiming at “best practice standards” but what are the relevant standards in the absence of regulatory guidance?
Are you planning to release a wellness product first, to avoid the cost of regulatory oversight and build up your value proposition further with some early revenue and - as important if not more - with access to users to iterate and validate your progresses?
If you are innovating in Self-tech, and are puzzled by these questions, give us a call. We can help you:
- understand whether there are regulatory requirements applicable to your innovation,
- identify and comply with technical standards and other resources to build a safe an effective solution,
- design a global strategy that maximize the potential investment value for your company whilst minimizing the regulatory risk.