What do we Do? Healthcare Vigilance as a Service.
NIHPO provides Medical Device and Pharmacological “Healthcare Vigilance as a Service.” Using Open Data from EU and US agencies, we help our clients to save both time and effort. While lowering their liability profile.
There are hundreds of Open Data sources from federal agencies (CMS, FDA, NLM) in the US and EU (EMA, EudraCT) that can be useful across the clinical, RA/QA, regulatory, and sales and marketing spaces for medical devices and pharma products.
The challenge NIHPO solves is that we integrate all those data sources into a single, simple-to-use system. Our users can quickly obtain actionable information to make better business decisions. From bench (chemical compounds) to bedside (adverse events and provider reimbursement), NIHPO offers a concierge Open Data analytics service.
We alleviate all the friction that comes from going into multiple websites to find all the published information about a drug or medical device. For example scrapping information off the websites of FDA, European Medicines Agency, ClinicalTrials.gov, and EudraCT, among others. Plus copying and pasting from PDFs, CSV, Word and Excel files. It’s very expensive to pay a Ph.D. to download and parse CSV files.
NIHPO’s software platform provides a 360 degree view of a drug or medical device, in one place, for users to be more effective and efficient in delivering value to our user’s customers. Let us show you how we do this.
NIHPO’s repository of Medical Device Open Data includes:
* Over 66,000 510(k) documents in PDF format (searchable in plain text)
* Over 38,000 PMA documents
* The entire MAUDE database (including the recently-released Alternative Summary Report Data database)
* Device establishment database
NIHPO’s repository of Pharmaceutical Open Data includes:
* The entire AERS database from 1968 to today
* All ClinicalTrials.gov data
* All EU clinical trials (EudraCT)
* European Medicine Agency’s public files
* FDA’s filings
* Drugs@FDA database
* FDA’s Orange Book
In addition to specific Medical Device and Pharma information (above) we also hold and have available for full text search:
* NLM’s PubMed and ChemID databases
* EPA’s facility listing
* Medicare’s provider list (NPI)
* HHS’ Open Payments database (payments from medical device and pharma manufacturers to healthcare providers)
* USASpending’s entire database
These are graphical representations of how we integrate all the Open Data available for both medical devices and pharmaceutical products. We’d love to work with your organization to fine-tune our data models to better serve your specific needs. Contact us.
Who do we Serve? Healthcare Industry.
R&D teams can analyze current device’s regulatory filing and adverse events history. Leading to better NPD decisions.
RA / QA teams can more easily fulfill manufacturer’s regulatory requirements.
While keeping track of adverse event filings.
Regulators can compare the manufacturers’ submissions with Open Data in both the EU and the US. We call this Regulatory Informatics™
Hospitals and insurance companies can make better purchasing, treatment, and reimbursement decisions. And lower liability risk.
Benefits of NIHPO’s System. Better Answers, Faster.
Many organizations are looking for an easy way to integrate Open Data into their internal business processes. Unfortunately, non-technical users find it both challenging and very time-consuming to use huge amounts of raw data to meet their organizational needs. In data analytics, 80% of the time is spent just getting the raw data into a usable format. That leaves users with 20% of their time to perform real work.
We perform the tedious and complicated task of downloading, processing, parsing, and combining raw Open Data into very simple-to-use formats. We call that Enriched Open Data™
NIHPO’s clients use our Enriched Open Data to easily and conveniently run their business analysis processes. We save clients’ time, helping them make better decisions faster, driven by accurate and up-to-date Open Data.
No IT Involvement
Our system is completely cloud-based, Software as a Service (“SaaS”).
There is no need for IT involvement, as NIHPO directly provides technical support and training to each user.
Lack of IT support can affect the agility of your business to quickly respond to users’ needs.
We have the skills, specialized tools, and endless patience required to tackle data-processing challenges that your organization’s IT staff may not have either the time or expertise to address.
Think of NIHPO’s team as a staff augmentation option that fits within your corporate credit card’s purchasing limits.
We work on a fixed price, fixed schedule basis, with a predictable impact on your organization’s budget. Contact us.
The raw data provided by government agencies tends to have many variations on the names of manufacturer, devices, and drugs.
We harmonize all those variations into the correct names, to provide users with a comprehensive search experience.
A few variations of the name “DePuy”:
NIHPO’s system can run locally, in your organization’s facility or data center.
This “Local Instance” is a fully-functioning copy of NIHPO’s own cloud-based system, but under your organization’s total control.
This local instance ensures your organization complete privacy and confidentiality of your user’s searches.
We can generate customized datasets that integrate Open Data with internal data you may already have in-house.
We can also integrate Open Data from additional US or international sources / agencies to then allow your users to conduct searches and analysis against multiple datasets simultaneously.
NIHPO’s system currently includes data from European Union and US agencies.
Our goal is to provide users with a truly global perspective on both medical devices as well as pharma products.
Some products cleared in one market may not be allowed in another. Analyzing these market differences may lead users to powerful new insights.
Free Samples. Download Risk Profiles.
Medical Device Risk Profile
Below please find a spreadsheet with a comprehensive analysis of Edwards Lifesciences (a large US-based medical device company) and their “Certara” product line.
The spreadsheet is an example of how NIHPO’s system integrates Open Data related to medical devices. Across agencies (EPA, FDA, Medicare), and across continents (EU and US).
In this single spreadsheet you can see individual sheets for:
* all adverse events (MAUDE) filed against this manufacturer
* clinical trials this company has participated in (both EU and US)
* payments to US healthcare providers, including for research purposes
* PMAs and 510(k) filed by manufacturer with the FDA
* listed facilities (as per both EPA and FDA)
* thousands of PubMed articles directly related to the manufacturer, its device, and the condition(s) that the “Certara” device treats
This spreadsheet provides user with a 360 degrees view, from bench to bedside, of the medical device’s life-cycle journey.
Notice: the file is 53 MB in size, please be patient.
Pharmaceutical Risk Profile
Below please find a pair of spreadsheets with a comprehensive Risk Profile analysis of 02 oncology drugs:
Using Open Data, NIHPO is able to trace a drug’s entire lifecycle:
* starting with chemical compounds (NLM’s PubChem)
* through clinical trials (ClinicalTrials.gov)
* documentation on regulatory pathway (IND, NDA, etc.)
* reported adverse events (FDA’s FAERS)
* manufacturer payments to providers (HHS’ OpenPayments)
* Medicare reimbursement data (CMS’ Provider Utilization and Payment Data)
These spreadsheets are just a sample of the type of integrated analysis our users can conduct in our system. We’ll create customized reports based on your specific needs. Contact us.
About Us. Passionate Open Data Geeks.
We are a small team, and our passion is to “Transform Public Data Into Actionable Knowledge.” Founded in 2007, NIHPO, Inc. is a minority-owned software development and data analytics small business based in Miami, Florida (USA). We focus on acquiring, organizing, cleaning up, and transforming raw Open Data from state, federal, and international agencies in the healthcare field into Actionable Knowledge. We save your team significant wasted time and effort by avoiding the data cleaning and management steps.
Our previous work includes a semantic search engine for health data; integrating data from ClinicalTrials.gov, PubMed, NIH grants, FDA AERS and MAUDE; and other federal and state datasets; and using the LexEVS taxonomy at the core.
José C. Lacal, CTO / Founder
A self-taught Data Geek, his passion is to improve people’s health through technology. José spent 15 years at multinational high-tech companies (Siemens, Motorola, Stryker), and built 05 startups, starting at age 22.
Vincent Caldevilla, COO
Vincent is an Engineer with an MS in Management Information Systems. He has extensive publishing (The Miami Herald) and process-improvement experience. Responsible for process control, strategy, and financial planning.
José A. Bozzone, Software Manager
José guides software development for NIHPO’s customized analytics platform.
He led the team that developed NIHPO’s earlier Geographic Information System (“GIS”) for fraud prediction. Built using Python, PostgreSQL, and PostGIS.
Contact Us. Let Us Help You.
15625 NW 15th Avenue
Miami, FL 33169
José C. Lacal, CTO
+1 (561) 777-2577
NIHPO is a Minority-owned (Hispanic) Florida Certified Business Enterprise (CBE).