# Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-02-17
- Length: 34m
- Episode: 246
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium
- Listen: https://podcast.greenlight.guru/episode/overcoming-barriers-to-receiving-510k-clearance-one-companys-go-to-market-triumph

## Summary

Scott Anderson, Chief Clinical Officer at SyncThink, explains how the company uses its EYE-SYNC platform to objectively measure eye movements for neurological assessment, covering conditions like concussions, ADHD, and neurodegeneration. Anderson details the company's journey from Department of Defense-funded research to obtaining 510(k) clearance, highlighting the logistical challenges of tracking 10,000 subjects across multiple locations using retrofitted mobile testing units. He discusses the strategic decision to focus on specific indications like concussion and ADHD rather than 'boiling the ocean,' and predicts a future convergence between consumer wearables and regulated medical devices for proactive brain health monitoring.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=0) Introduction: Scott Anderson and SyncThink's Background
- [3:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=190) EYE-SYNC Technology: Eye Tracking and Neurological Assessment
- [7:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=472) Clinical Applications: Concussion, ADHD, and Neurodegeneration
- [11:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=690) From Military Research to FDA 510(k) Clearance
- [14:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=865) Specific Indications: Concussion and National ADHD Study
- [16:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=986) Medication Titration and Pharmaceutical Partnerships
- [20:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=1211) Logistical Challenges: Mobile Testing and 10,000 Subjects
- [23:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=1394) Strategic Focus: Avoiding 'Boiling the Ocean'
- [25:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=1533) NFL Concussion Protocol and Game Day Operations
- [29:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-17-overcoming-barriers-to-receiving-510-k-clearance-one-companys-go-to-market-trium#t=1756) Convergence of Consumer Devices and Medical Regulation

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies

## Mentioned

- SyncThink (company)
- EYE-SYNC (product)
- Greenlight Guru (company)
- Shire (company)
- Takeda (company)
- Q collar (product)
- Priority Designs (company)
- Apple Watch (product)

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- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)
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## Citing this page

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