Not Just About Temple: India’s Wearable Impasse

SUMMARY

• From developing new health metrics to navigating clinical trials and regulatory approvals, Temple’s journey offers a glimpse into the challenges and opportunities facing India’s next wave of wearable startups

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“There is no established playbook for making wearables in India. If you have the capital, you can set up a team, hire a bunch of researchers and scientists and come up with a product and even start selling it,” a California-based Indian founder of a wearable startup told us this week. 

The heated and contentious battle on X over Temple has brought out a lot into the open. A lot has been said and written about Temple this month, and who’s right and who’s wrong. What has gone unanswered in the cacophony is what it takes to actually launch a health or fitness tracking wearable that’s made in India. 

Where do founders turn when they need their hypothesis tested? Which agencies are the most approachable and how much red tape can one expect? These questions are not just about Temple. It’s about any new device that’s being launched in India, whether it is looking to track blood flow to the brain or it is just a heart rate or fitness monitor. 

The distinction matters in a market where wearable manufacturers can build and sell products that track physiological parameters without necessarily undergoing the clinical validation expected of medical devices. 

For India’s wearable industry, the debate has exposed gaps in how companies develop, validate and market products that make health-related claims or even basic activity tracking. But first, let’s see where Temple stands before diving deeper into the ecosystem of health wearables. 

Temple’s Bet On Something New 

Deepinder Goyal launched Temple with a core proposition of tracking blood flow to the brain and entropy. The company set out to create two new metrics that give users something their smartwatches could never.

Firstly, BrainFlow is said to track relative changes in the blood flow to the brain during everyday activity. On the other hand, Goyal has described Entropy as a measure of how hard the body works to shed heat. 

The company’s website says the metric captures the body’s load across thermal, immune, digestive, cognitive, emotional, pharmacological, postural, reproductive and recovery systems. However, research papers uploaded on its website clearly state that Temple cannot directly measure cerebral blood flow. 

In response to Inc42’s questions about how these are measured, Temple said the Brain Flow Index is a relative index derived from optical signals collected at the temple. The company said the index rose and fell alongside blood-flow velocity in the middle cerebral artery, a major artery in the brain, as measured through transcranial Doppler ultrasound.

Temple said the metric currently has two applications in its fitness app. It helps users compare the intensity of their cardio sessions and sends prompts to move when their Brain Flow Index drops during long periods of sitting.

Unlike heart rate or sleep tracking, which have been part of consumer wearables for years, Entropy is being positioned as a new physiological metric. Its scientific validity will depend on whether the underlying signals can reliably measure what the company claims. 

The fact that Temple is broaching new territory with these metrics is what has set alarm bells ringing. Founders we spoke to say most wearables already have algorithms available for the heart rate and sleep tracking that have been improved and enhanced over the years since the first such devices came about. 

“The real work comes when you develop a new tracker or establish a new biomarker or a new benchmark for measuring something new,” the founder quoted at the beginning said, adding that specialised algorithms need research papers and validation. 

This is why there’s so much scepticism around Temple in the medical fraternity, with many doctors accusing the company of pushing a product without adequate backing. 

Temple’s research page lists multiple studies examining its BrainFlow technology, including a study involving 23 healthy adults that compared its reading with transcranial Doppler (TCD), a clinical technique used to measure blood-flow velocity in major brain arteries. 

Another study compared Temple’s BrainFlow readings with near infrared spectroscopy (NIRS), a technique that can distinguish blood volume changes in the brain from those in the scalp.

The company says it has partnered with academic institutions across the world to study additional and more diverse groups of people, with further validation studies underway.

Both studies are listed as being under peer review. A Temple spokesperson told Inc42 that validation work on Entropy is in its final stages and that it plans to publish the findings soon. 

Of Preprints And Peer Reviews

After much criticism, on November 8, Goyal acknowledged the gap between the peer reviews, the studies and the launch of the devices, adding that the research on Entropy would be published soon. He also said BrainFlow was not the primary proposition behind Temple, but the starting point for its research. 

In an earlier November 5 post, Goyal said preprints would precede peer-reviewed publication and that further validation would continue as the product reached users.