Our Mission
RAW PhD, LLC is an innovative research and analysis company specializing in the medical device arena that uses FDA data to find and make big cases for law firms and guide purchasing decisions by hospitals, healthcare providers, and medical device companies.
Dr. Rachel Weintraub
- PhD in Organic Chemistry, University of Colorado Boulder
- Former FDA Center for Devices and Radiological Health (CDRH) Reviewer and Analyst
- Expert in Pre-market Submission Review & Post-market Surveillance
- Specialist in Adverse Event Analysis, Safety Signal Discovery & Investigation
- Subject Matter Expert in Biocompatibility, Chemistry & Toxicology
- Patient Advocate & Health Policy Professional
- Published Author & Investigative Journalist
Dr. Weintraub is an Organic Chemist by training, with a PhD from the University of Colorado Boulder. Following graduation, Dr. Weintraub went to work for the FDA's Center for Devices and Radiological Health (CDRH), where she discovered a new passion for public health.
At the FDA, she did a mix of pre-market submission review, post-market surveillance (i.e., adverse event/MDR review, safety signal discovery), post-market review (recalls, inspection reports (EIRs), allegations), safety signal investigation, and subject matter expert (SME) work in biocompatibility, chemistry, and toxicology.
The pattern recognition skills and love of puzzle solving and investigating that drew her to organic chemistry, coupled with her passion and skill for information science, navigating databases, and locating information online, made Dr. Weintraub uniquely adept at discovering and investigating serious issues that were hiding in plain sight.
The Discovery That Changed Everything
While working at the FDA, Dr. Weintraub noticed that there were so many potentially huge cases waiting to be discovered. However, it seemed that nobody outside the FDA learned about them unless there was significant and widespread news and media coverage. This appeared to be true even when there was a recall, including for some of the Class I recalls.
This concerned Dr. Weintraub, as it meant that patients often didn't know that their devices were harming them, attorneys didn't know to recruit those patients, and doctors didn't know to discourage use of those devices.
Turning Insight Into Action
After leaving the FDA, her newly discovered passion for public health led Dr. Weintraub into patient advocacy and health policy, where she remains active. Dr. Weintraub discovered that while difficult to access, most of the FDA's data is publicly available. This led her to realize that she could make a career out of doing the post-market surveillance and safety signal investigation work that she loves, even though she no longer works at the FDA.
She realized that by working with attorneys, hospitals, healthcare providers, and device companies, she could help bring serious issues to light, ensure that injured patients get the compensation that they deserve from the companies responsible for the harm, and help protect patients from future harm.
Powered by Device Events™
Dr. Weintraub learned that Madris Kinard, Founder and CEO of Device Events, had created a user-friendly software application that could simultaneously search multiple FDA data sources at once and get around some of the limitations. She reached out to Ms. Kinard, who had previously contacted Dr. Weintraub regarding her MDUFA VI public comments.
The two decided to collaborate, with Ms. Kinard quickly becoming Dr. Weintraub's professional mentor. Ms. Kinard shared that some companies really wanted someone to do the work of utilizing Device Events and other databases for them and translating the information obtained into answers.
Dr. Weintraub decided to team up with others to cater to this market. Consequently, RAW PhD, LLC offers a one-stop, service-oriented solution that does the heavy lifting of finding the information and translating it into answers.
Beyond RAW PhD™
Dr. Weintraub is also an avid writer, patient advocate, and budding freelance investigative journalist. She has authored numerous public comments to various public health agencies and has been quoted in multiple news articles. She also submits articles and editorials to various news outlets with the aim of calling national attention to serious issues.