In the booming medical device world, everyone's chasing the next hot technology. But too often, "new" can mean "untested" – and patients unknowingly pay the price. Netflix’s documentary The Bleeding Edge sheds light on how the medical device industry and the healthcare companies that are quick to go-to-market without proper testing or regulatory compliance put patient safety in jeopardy.
Although the tech and thought behind medical devices are noble, you cannot skip steps when it comes to quality, testing and compliance, especially when the FDA (Food and Drug Administration) or CDRH (Center for Devices and Radiological Health) is involved.
In no particular order the following are five ways medical device companies can fail in the product lifecycle.
1. Improper Labelling or Instructions
Too often companies provide marketing information that does not provide the evidence needed that the device is safe and effective. Companies must understand who their users are. Cautions and warnings on labels are insufficient without consideration of the data that only testing and eventual validation can provide.
2. Rushing to Market
When you rush the product development process and skip testing and other vital steps you risk a product recall post-market but you also potentially risk injuring or causing deadly harm to your customers.
3. Human Error
Medical device manufacturers are only human, but when shipping a new product, risk assessment and risk management don't often catch every issue. The root cause of an adverse event is too often due to human error compounded with legacy systems, and can result in serious injury and damage patient outcomes.
4. Lack of Training Records
The regulated medical device industry requires that you know who has been trained and certified on a product, process, or standard operating procedures (SOPs). It’s vital that you keep good training records on all types of processes and documents used to manufacture and deliver products to your customers.
5. No Quality Management Software
How can you be sure your device is compliant and testing was thoroughly conducted from product development to clinical trials? You need to employ a quality management system to ensure each piece of the product development is compliant and accurate.
Medical Devices and QMS in Propel
Propel provides the only QMS solution that is seamlessly connected with CRM and PLM, so you can have a true closed loop that can quickly resolve your product issues and customer complaints. Propel eliminates manual data entry, siloed departmental processes and rigid software configurations that can hamper even the best companies.
With Propel, you can drive higher product quality, customer satisfaction and regulatory compliance.
Propel's Quality Management Benefits for Medical Devices
Integrate Quality Processes to Improve Responsiveness and Compliance
Propel integrates with Salesforce to capture product issues from customers, partners or IoT feeds. Make it easy for everyone to collaborate on quality management processes, CAPAs, NCMRs, SCARs and ECOs.
Ensure Employee Certification and Compliance with Comprehensive Training Records
Use Propel to track every employee’s training requirements, identify who is non-compliant, and notify employees of upcoming training. Propel ensures employee training records get updated based on the latest product updates.
Track Product Specifications to Ensure Compliance to Industry Standards
Use Propel’s quality management software to track compliance of items to regulatory and environmental specifications like RoHS, WEEE, REACH, China RoHS, JEDEC, Japanese Green Initiative, and Conflict Minerals standards. Manage medical device recalls