#openqrs

On deck: an open source version of the QRS method. Get in touch if you want to help us with its design or with usability testing. [Look for that to be released this fall.]

One of the core tenets of OpenQRS is to build a decentralized system of QRS accountability that provides data analysis and product performance metrics from local data scientists. We want to build a QRS system that strengthens the data analytic capacities of a global workforce and supports the local economies where these products are being deployed. So, for example, if a medtech product is made in the UK, when it is deployed in Kenya, the data is analyzed by Kenyan data scientists.  

We recently discovered an unlikely OpenQRS model- a cosmetics company in the USA. Yes, we know, that’s not our target market. We are focused on QRS for medtech in low and middle income countries. But this company’s approach reflects what we envision when we champion OpenQRS.

Our goal is to create open source tools and methods for assuring quality and safety of medtech deployed in low and middle income markets where no regulatory systems exist. We aim to empower entrepreneurs and makers:

to determine the QRS risks of their products

to set standards for how to address these QRS risks, as appropriate to their product and market, in a transparent way

to monitor performance meeting these standards (in a big data platform with auditing services for those who opt-out of an open data model)

to open source the tools and methods developed to monitor QRS in order to reduce the costs and improve the quality of these resources

Let’s take a look at Beautycounter, a US-based company, that sells cosmetics and personal care items- everything from sunscreens, shampoo, and soap to mascara. Despite its name, the Food, Drug and Cosmetics Act does not regulate cosmetics, except for color additives though notably not ones used in hair dye. (1) Well known words, such as “organic” and “natural”, do not have any standards for when they can be used. With over 10,000 possible ingredients, the FDA’s (industry funded) ingredient review panel has restricted only 11 ingredients from use. (2) Meanwhile, the EU has restricted use of over 1300 ingredients from cosmetics. (3) This discrepancy demonstrates how unregulated the cosmetics and personal care industry is in the US.

Drawing upon those ingredients banned in the EU, Beautycounter developed a list of 1500 ingredients that are suspected to be linked to cancer, hormone disruption or other health problems. The company has made a public commitment to “never use” these 1500 suspect ingredients. Confirming this pledge, the independent, non-profit Environmental Working Group (EWG) rates the majority of Beautycounter products as “EWG approved” or with a green “safe” label. (4)**

Faced with the challenge of an unregulated market, Beautycounter:

Chose to create their own standards when none were required

Raised the bar by adopting standards beyond existing EU standards

Made their self-established standards transparent (“never use” list)

Met their commitment with accountability (externally verified by EWG)

Beautycounter exemplifies that this challenge navigating unregulated markets is not limited to low and middle income markets. With a President who has pledge that every new regulation will include the removal of two regulations, it is a critical time for American consumers to become informed advocates and for companies to raise the bar on their own practices.

If you have a medical technology designed for deployment in low and middle income markets where no no regulations apply, we want to hear from you about what you are doing to address the Quality, Reliability & Safety of your product.

**Disclaimer: This post is in NO WAY meant as an endorsement of Beautycounter’s products nor its business model. To advance its mission to educate people about the safety of personal care products, the company employs a direct sales model, aka network marketing or multi-level marketing model. MLMs are a controversial business model with critics. (5) 

Disclosures: Per its business model, Beautycounter came to our attention through a friend who is an independent consultant. We received no financial or in kind incentives for writing this post. However, after reviewing the company’s approach and products, Kate entertained the possibility of joining the company as an independent consultant with the aim to redirect any profits from that endeavor to support her philanthropic activities, which include OpenQRS. In the event that decision is made, this post will be updated accordingly.

1. How FDA Evaluates Regulated Products: Cosmetics https://www.fda.gov/aboutfda/transparency/basics/ucm262353.htm

2. Why This Matters: Cosmetics and Your Health, EWG, April 12, 2011 http://www.ewg.org/skindeep/2011/04/12/why-this-matters/

3. Cosmetic Ingredient Review, Intertek http://www.intertek.com/cosmetics/ingredient/