Mail

Are devices dying? Re: "Biotech's hidden stepsister,"1 about the current hurdles facing the device industry, I was the founder and CTO of Avocet Medical, a medical device start-up producing a hand held meter to prevent strokes by monitoring proper level of oral anticoagulants. We raised $38 million in venture capital financing between 1991 and 2001. Although we obtained FDA approval, th


Register for free to listen to this article
Listen with Speechify
0:00
4:00
Share

Re: "Biotech's hidden stepsister,"1 about the current hurdles facing the device industry, I was the founder and CTO of Avocet Medical, a medical device start-up producing a hand held meter to prevent strokes by monitoring proper level of oral anticoagulants. We raised $38 million in venture capital financing between 1991 and 2001.

Although we obtained FDA approval, the FDA changed the rules on us by insisting at the last minute, after all clinical trials were done, that users do additional (and redundant) safety checks each time they used our product. These redundant checks pushed the cost per use from $6 to $21, and made the product uneconomic.

We had to exit the field. Although this hurt our investors and employees, the much bigger damage was probably to the thousands of patients per year that we might have been able to save. Failure of a medical device is conspicuous, while preventable ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to digital editions of The Scientist, as well as TS Digest, feature stories, more than 35 years of archives, and much more!
Already a member? Login Here
May digest 2025 cover
May 2025, Issue 1

Study Confirms Safety of Genetically Modified T Cells

A long-term study of nearly 800 patients demonstrated a strong safety profile for T cells engineered with viral vectors.

View this Issue
iStock

TaqMan Probe & Assays: Unveil What's Possible Together

Thermo Fisher Logo
Meet Aunty and Tackle Protein Stability Questions in Research and Development

Meet Aunty and Tackle Protein Stability Questions in Research and Development

Unchained Labs
Detecting Residual Cell Line-Derived DNA with Droplet Digital PCR

Detecting Residual Cell Line-Derived DNA with Droplet Digital PCR

Bio-Rad
How technology makes PCR instruments easier to use.

Making Real-Time PCR More Straightforward

Thermo Fisher Logo

Products

fujirebio-square-logo

Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test

The Scientist Placeholder Image

Biotium Launches New Phalloidin Conjugates with Extended F-actin Staining Stability for Greater Imaging Flexibility

Leica Microsystems Logo

Latest AI software simplifies image analysis and speeds up insights for scientists

BioSkryb Genomics Logo

BioSkryb Genomics and Tecan introduce a single-cell multiomics workflow for sequencing-ready libraries in under ten hours