👩⚕️ Unsafe medical devices and changing regulation
New regulation requirements will benefit vendors, providers and patients.
Hello and welcome to Careviser by Marie Loubiere, the weekly newsletter that cuts through the healthcare noise with a single focus: productization of the latest research and tech breakthroughs.
A quick ask for my French 🇫🇷 readers: do you know a GP or ob-gyn physician that is Paris-based and interested in new ways to deliver primary gynecology care?
I would love to chat with them!
When Netflix launched the documentary The Bleeding Edge in 2018, it generated a lot of reactions. Viewers were shocked to learn that there is a long history of medical devices causing harm to patients. Vendors are responsible for post-market surveillance. Sometimes, it isn’t enough. That’s why both the FDA and the EU have passed new legislation to better track medical devices.
✂️ Medical Device Tracking—How It Is and How It Should Be by Madris Kinard and Lisa McGiffert is a viewpoint article about the tracking of medical devices in the US 🇺🇸.
Since 2013, the FDA mandates that all medical devices have a unique device identification number (UDI) on the label of all implantable and life-supporting/life-sustaining medical devices. By Q3 2022 this requirement will be extended to non implantable devices. The UDIs are stored in a database maintained by the FDA. Access to such data can greatly improve medical device safety as it allows to check quickly if a device has been recalled, has expired or contains allergen materials.
However its implementation is far from perfect:
🔍 Tracking of the UDI in EHR claims payment forms hasn’t been implemented yet, meaning that most of the time knowing which device has been implanted in a specific patient isn’t easy.
🤯 Some allergen materials such as nickel are not disclosed as the vendors claim that such information is a “trade secret”.
🧨 The UDI isn’t required in adverse event reports or recalls (!)
📖 The database doesn’t include additional information about a device (e.g., instructions for use, safety instructions…) that could be used by physicians.
🦠 Reusable devices (e.g., ventilators) are not tracked even though they could spread infections especially in covid-19 times.
More transparency and a better tracking of UDIs and associated outcomes would benefit all stakeholders:
📈 For medical device vendors, it could enable them to track outcomes batch by batch and show that their devices produce superior outcomes. It can also enable them to track performance in real-world settings (which is always super challenging) and get insights for the R&D of new devices accordingly.
🩺 For physicians, it could enable them to better understand which devices lead to superior outcomes for which types of patients and stratify care accordingly.
💰 For health systems administrators, it could allow them to calculate the true cost of a device: not only its purchase price but indirect costs associated with poor outcomes and recalls.
🇪🇺 The European Union regulation follows the same trend as a UDI database is about to be created. Medical device manufacturers will have to apply an UDI on the device label between 2021 and 2027 (depending on the type of devices).
The new UDI regulations in both the US and the EU open the door for new business opportunities in multiple areas:
🌍 Supply chain end-to-end solutions to track devices from the factory to the patient
🤑 Software applications to calculate the true cost of a device based on recalls and outcomes
🤖 Automation solutions at the point of care to scan when a device is used / disinfected and reduce errors linked to manual inputs and save time
Get in touch if you’re building a venture in that field, I’d love to chat!
The most exciting startup I identified that is already active in the UDI management segment is Rimsys. Founded in 2017 in Pittsburgh, Rimsys has developed a Regulatory Information Management software for medtech companies.
🗝️ The pitch: Regulatory affairs is a complex changing field. Lack of compliance can be extremely costly, and yet it is seen as less “core business” than R&D or Sales.
💻 The product: Rimsys has developed several modules that enables regulatory affairs team to:
Register devices UDI and manage changes during the product lifecycle
Manage registrations with local authorities
Manage global standards and link them to specific devices
Manage essential principles
Keep up with changing laws and regulations
Their product is integrated with Quality Management Systems software and linked to EPR/PLM software leading to time savings as the info flows between all these software.
🚀 Traction: Rimsys targets medium to large size corporations that are present in a lot of markets, already have a full tech stack in place (advanced EPR and QMS) and need to make sure they keep up with changes in all markets. Traction seems really good which is impressive as we know how hard & lengthy it is to sell to medium to large medtechs. Rimsys claims to have secured major corporations as clients: J&J, Transferix, Siemens Healthineers. As someone who has worked at several medtechs and seen first-hand how hard regulatory affairs can be (even for Class I devices), I can understand the appeal of the Rimsys product. It is extremely hard to find compliance software that is user-friendly and well integrated with the company tech stack. The founder is a former regulatory affairs director so he knows his audience, and can build a product that matches their needs.
💸 Funding: Rimsys raised $1.5mn last year from Allos Ventures, a midwest VC.
That’s a wrap for today! Don’t hesitate to reply to this email with comments, I read and answer all emails :)
I wonder if a blockchain could be leveraged in order to secure UDIs and build an infrastructure that could be trusted globally.