Steute
Complying with U.S. FDA regulations, the MDR in Europe, or both can be, as we all know, a slippery slope. Certifying the medical devices you make is necessary. Still, it can significantly tax your staff with time distractions and ultimately take a real dent out of your R&D budget and your cost to market.
But the reality of what this can mean to your organization and manufacturing costs can be far worse than you even imagined. According to a Feb. 27, 2024 blog by Meridian Medical, a UK-based manufacturer of sterile and non-sterile disposable medical devices, the costs can be substantial, ongoing and must be factored into annual budgets. “Meeting stringent regulatory standards is non-negotiable, but the work required to gain regulatory compliance adds to your overall medical device manufacturing costs. Budget auditing costs at approximately $2,800/day (per audit) for your ISO registrations and certifications. Device technical audits can range from $3,300/day to over $10,000/day.”
And, whether the process is FDA-related or MDR-related, the news is very sobering. In an Oct. 10, 2024 article by Easy Medical Device, it stated, “some companies are investing more than five hours per week in managing the MDR; that could be anything from communicating with stakeholders and their notified bodies, managing their data, and hiring and training staff to help them comply with the regulation. The process could cost 5% or above of the company’s annual revenues, while some 40% of companies have said that they believe it will be between 6% and 10%.”
The news as it relates to the FDA is equally daunting. A June 18, 2024 blog by Fulfyld reported, “Obtaining FDA approval for a medical device involves various expenses:
Preclinical and Clinical Trial Costs
- Preclinical testing - $10,000-$500,000
- Clinical trials - $1M to $10M
Application and Review Fees
- 510 (k) application fee – Approx. $12,432
Premarket Approval Application (PMA)
- Approximately $365,657
The complexity of the medical device can also influence the cost of FDA approval. Devices with intricate design or advanced technologies may require even more extensive testing and evaluation.”
That said, proven techniques can help minimize the pain. John Kapitan, founder and CEO of Kapstone Medical, said in an August 12, 2020 article, “Here are just a few examples of potential time and cost savings associated with early integration of regulatory requirements:
- Early identification of predictive device-pragmatic design and material selection to ensure adherence to regulatory standards and potentially streamline approval.
- Early identification of required tests. Structuring those tests into the development plan and identifying testers with the right expertise, instead of retrofitting the team or doubling back at the submission stage.
But we’ll do you one better. There is a better solution out there for you that might involve a trusted and qualified associate who can help take the burden of time and costs off your shoulders, thus freeing up your engineers, your R&D and your regulatory people to do what they do best. Truly service-oriented suppliers are increasingly pledging their expertise to better prepare customers for successful regulatory compliance and, beyond that, smoother new product launches.
OEMs are accomplishing this by offering specialized knowledge, streamlining processes, and ensuring adherence to stringent standards ultimately facilitating quicker market access and reduced costs by offering: specialized expertise and knowledge of the regulatory landscape; maintaining robust QMS; assisting with product design, development and testing (ensuring that devices are designed for compliance from the outset); help with optimizing manufacturing processes for efficiency and compliance; and helping with BOM control.
They can also help streamline processes and reduce precertification costs by; leveraging their expertise so manufacturers can expedite product development and launch, reduce in-house development, manufacturing and regulatory compliance costs; and accessing turnkey solutions.
And OEMs can help ensure compliance and quality via their familiarity with standards like ISO 13485; their extensive knowledge about FDA regulations and requirements so that medical devices will meet safety and effectiveness standards; robust quality assurance standards; providing customers with training and support to help them better understand and comply with regulatory requirements; and even helping manufacturers with the design of products that meet regulatory requirements.
SteuteOne of the best examples of this supplier/medical device manufacturer compliance partnership is Steute, the recognized world leader in medical-grade foot switch technology. Steute offers its customers unmatched resources for free to take the burden of time and costs off their shoulders and to address:
- ISO 9001
- ISO 13485
- IEC 60601 and applicable subclauses
- cCSAus and CB certificates
- Documentation for wireless products like coexistence and cybersecurity tests and reports
- Certificates – FCC (USA), IC (Canada) and MIC (Japan)
Sometimes your greatest resource for overcoming the pitfalls of precertification and regulatory compliance can be as simple as selecting the right component supplier early in the development phase.
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