Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges.
Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential liabilities and avoid adverse valuations that can affect a start-up’s bottom line and ultimate success.
Some of the challenges facing medical device start-ups today include:
- Increased overhead due to more stringent clinical and regulatory standards
- Changing regulations landscape both domestically and internationally
- Growing R&D expenses from increasingly complex and sophisticated devices
- Reduced reimbursement and increased pressure from Group Purchasing Organizations (GPO)
- More demanding and diverse customer bases
- Increased competition
It’s safe to say that virtually every medical device manufacturer, sooner or later, will likely face some kind of regulatory challenge arising from FDA, HIPAA, GDPR, ISO MDR, issues. More than ever, it’s crucial that medical device start-ups do their homework and minimize risk by working closely with an experienced regulatory consulting firm.
Here at MEDIcept, we specialize in medical device start-ups. We provide start-up support through our Entrepreneurial Start-Up Assistance program. It’s designed to help pre-revenue start-up companies develop effective quality assurance and regulatory compliance strategies to obtain FDA clearances and ISO approvals. Our team of highly experienced regulatory compliance specialists and quality system engineers can help you avoid unnecessary expense and costly delays by developing a quality system aligned with the complexity and growth stage of your company.
While some start-ups may be tempted to purchase one of the relatively inexpensive quality systems available online, these often prove to cost substantially more in the long run because of costly and time-consuming quality requirements and limited customization. In reality, we may be able to develop a less expensive, less rigorous quality system that will meet your specific needs, reducing complexity and bureaucracy to you both money and time.
To learn more about our start-up assistance services, contact us today – we’re here to help companies just like yours.