10 ms·

The FDA does a fair bit of this already, both through their open API https://open.fda.gov/device/enforcement/ https://open.fda.gov/device/enforcement/ and throu

by graeham 11y ago

The FDA does a fair bit of this already, both through their open API https://open.fda.gov/device/enforcement/ https://open.fda.gov/device/enforcement/ and through MAUDE https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/s... Maybe I'm missing what you're doing on top of this? What data leads to purchasing decisions - I don't know I follow the data you're looking to collect mapping to the initial application? For implants I've worked with, surgeon preference often plays a big role and cost. Surgeons keep up to date with journal articles, reports on failures, and compare notes with colleagues.

lordumoh 11y ago
You're right, the fda's open API is a great new tool that they're building as well as the Maude database. But it's very limited in collection and accessibility of clinical data. For example, 510ks are redacted and require manual requests for full information each time. The problem with Med journals is their exclusivity in publishing research and often times doctors only read certain journals, leaving out smaller, lesser known research. I've experienced this as a pharma rep with first to market clinical data that was ignored because we weren't in a certain journal. To overcome the trouble with late and in-frequent submission of data like adverse events from manufacturers, we want to position an access point for our data capture software at the point of surgery/device usage where we combine device id with patient id for tracking. At this point, adverse events or device failure is detected at the point of hospital intervention. Looking at the data that triggers purchase, there's actually a huge shift occurring. More hospitals are moving to committee based decisions rather than submitting to physician preferences. As prices for devices skyrocket in conjoncution with the known relationship of physician and vendors, hospitals are looking to base purchasing decisions across clinical evidence, financial data, and comparative analysis. So we think these trends are favor our thinking and strategies initially.

by graeham 11y ago

lordumoh 11y ago

You're right, the fda's open API is a great new tool that they're building as well as the Maude database. But it's very limited in collection and accessibility of clinical data. For example, 510ks are redacted and require manual requests for full information each time. The problem with Med journals is their exclusivity in publishing research and often times doctors only read certain journals, leaving out smaller, lesser known research. I've experienced this as a pharma rep with first to market clinical data that was ignored because we weren't in a certain journal. To overcome the trouble with late and in-frequent submission of data like adverse events from manufacturers, we want to position an access point for our data capture software at the point of surgery/device usage where we combine device id with patient id for tracking. At this point, adverse events or device failure is detected at the point of hospital intervention. Looking at the data that triggers purchase, there's actually a huge shift occurring. More hospitals are moving to committee based decisions rather than submitting to physician preferences. As prices for devices skyrocket in conjoncution with the known relationship of physician and vendors, hospitals are looking to base purchasing decisions across clinical evidence, financial data, and comparative analysis. So we think these trends are favor our thinking and strategies initially.