# Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company

- Show: [The Hardware Story](https://hardwarepodcasts.com/podcast/the-hardware-story)
- Published: 2024-06-26
- Length: 1h 22m
- Page: https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa
- Listen: https://podcasters.spotify.com/pod/show/thehardwarestory/episodes/Episode-1---The-Hardware-Story-of-Inito-w-Aayush-Rai--Building-a-B2C-medical-hardware-company-e2l850k

## Summary

Aayush Rai, Co-Founder and CEO of Inito, discusses building a B2C medical hardware company from Bangalore, India, targeting the US market with a home fertility monitoring device. He details the journey from prototyping with Arduino to navigating FDA regulations, securing $15M in funding through a unique angel-first strategy, and the critical pivot to focus exclusively on the iOS ecosystem to achieve product-market fit.

## Chapters

- [0:14](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=14) Introduction and Company Overview
- [6:27](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=387) Market Strategy: Why the US Over India
- [26:31](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=1591) Prototyping and Engineering Challenges
- [39:34](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=2374) Regulatory Strategy and FDA Compliance
- [45:28](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=2728) Manufacturing and EMS Partner Selection
- [1:04:43](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa#t=3883) Fundraising Journey and Product-Market Fit

## Topics

- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Prototyping & iteration](https://hardwarepodcasts.com/topic/prototyping)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

companies scaling up

## Mentioned

- Inito (company)
- Siemens (company)
- YC (company)
- Fireside Ventures (company)
- IKP (company)
- Arduino (tool)
- Raspberry Pi (tool)
- FDA (other)
- CDSCO (other)

## Related episodes from other shows

- [Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-sara-naab-on-going-from-idea-to-funding-to-one-of-the-bay-areas-most-innovative) (Global Medical Device Podcast)
- [065: Hardware Funding from Seed Financing to Millions](https://hardwarepodcasts.com/podcast/product-startup/2021-03-02-065-hardware-funding-from-seed-financing-to-millions) (Product Startup)
- [#012 - Feel the beat - creating the world’s first wearable device for musicians, with Florian Simmendinger of Soundbrenner, Germany - Hong Kong](https://hardwarepodcasts.com/podcast/the-hardware-entrepreneur/2017-02-08-012-feel-the-beat-creating-the-worlds-first-wearable-device-for-musicians-with-f) (The Hardware Entrepreneur)
- [#015 - How to benefit for your hardware project from the first major crowdfunding platform, with Sandy Diao of Indiegogo, USA](https://hardwarepodcasts.com/podcast/the-hardware-entrepreneur/2017-03-01-015-how-to-benefit-for-your-hardware-project-from-the-first-major-crowdfunding-p) (The Hardware Entrepreneur)
- [Succeeding in Hardware with Joshua Hsu of Introhm](https://hardwarepodcasts.com/podcast/predictable-designs-podcast/2020-03-24-succeeding-in-hardware-with-joshua-hsu-of-introhm) (Predictable Designs Podcast)

## Citing this page

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