MasksOn.org - Protecting Clinicians. Saving Lives.
The acquisition of Personal Protective Equipment (PPE), particularly masks, posed a formidable challenge for clinicians during the COVID-19 pandemic due to a confluence of factors. The unprecedented surge in demand for PPE strained global supply chains, leading to shortages exacerbated by manufacturing limitations and distribution bottlenecks. Additionally, the escalating worldwide demand created intense competition for these essential supplies, often resulting in bulk purchases by governments and healthcare institutions, leaving smaller facilities and individual clinicians struggling to secure an adequate supply. The dynamic nature of the pandemic, coupled with uncertainties in predicting the scale and duration of the crisis, further complicated procurement efforts. As a result, clinicians found themselves grappling with the critical need for protective gear, facing challenges in sourcing reliable and sufficient PPE to safeguard both themselves and their patients.
MasksOn.org was an amazing grass roots, non-profit effort created to mass-produce reusable, sanitizable emergency masks and distribute it to those clinicians who did not have access to FDA-approved PPE at the start of the pandemic. Over 36,000 safe, reusable, sanitizable EUA face shields were shipped to clinicians in dire need… all without any cost to them.
In episode 114 of the Global Medical Device Podcast, host Jon Speer talks to Sanjay Vakil and Devon Campbell to discuss the impactful efforts being made at that time through the MasksOn.org initiative to providing personal protective equipment and relief at no cost during the coronavirus pandemic. All three were deeply involved in the effort and recorded this podcast with hopes that medical device startups may find valuable lessons within the story.
Key points:
Devon and Sanjay discuss the critical lessons they've learned regarding the balance between swift progress and navigating regulatory intricacies in medical device product development.
Emphasizing a user-centric approach, their perspective advocated for prioritizing physicians and users throughout the design and development stages to create effective solutions that addressed real-world problems… quickly.
The conversation touches on the regulatory landscape with a focus on the FDA's PPE guidance, which provides clear directives on labeling and emergency use authorization (EUA), particularly for masks intended for medical providers.
How seemingly small details can have a profound impact on people's lives.
How unique environment at MasksOn, where progress takes precedence over ego, allowed the team to move at unforeseen speeds. As a non-profit organization led by physicians and run by volunteers, the focus remained unwaveringly on advancing towards a safer future for clinicians without hindrance.
