Meeting Objective:

We want to bring together a small group of pharmaceutical and med device executives along with innovators in the wearable device space to talk about what is needed to move from the potential that consumer wearable devices offer to healthcare provision to actual benefits in a clinical setting. 

In order for consumer health technologies to become recognized medical devices there are significant technical and clinical validations required.

These validations are key for both regulators and pharma companies to commit the resources required to incorporate these devices into clinical development and treatment pathways at scale.

There is a potential for mismatched expectations as to what validation actually means between consumer wearable companies and these other stakeholders with real impacts for timelines and funding for wearables businesses.

We want to discuss the journey from consumer wearable to medical device, the collaborations between wearable and pharma companies that are working to bridge the validation gap and make the promise of these technologies a regulated reality.

Talking Points:

• Is this "validation gap" recognised by consumer wearable device companies?

• Moving from a consumer health wearable to a clinical setting.

• How can pharmaceutical companies, health systems and device developers work together to bridge the validation gap to achieve wide scale clinical adoption?

In order to help frame the discussion we would ask each person attending to reply to the following brief questions so as to ensure we have a relevant mix of experience around the table to make it a fruitful meeting for all.

• Have you experience with wearable devices or digital biomarkers in a drug development/clinical setting? Please use the comments to elaborate as this is a broad question.

• Can you discuss examples of regulatory approval pathways for what was originally a consumer wearable device to use in a clinical setting?

• Do you have experience using consumer health devices in regulated clinical studies or to aid patient care?

• Have you observed any partnerships between drug developers and wearable device companies that are doing a great job in terms of providing technical and clinical validation in a clinical setting?