A number of decisions about bringing a medical device to market are dictated by regulatory requirements. Chief among those requirements are the specific design controls in US FDA 21 CFR 820.30 and ISO 13485 that speak to quality and risk management for medical devices.
How these controls are applied is dependent on the class of medical device, but no device is completely exempt from the process. Manufacturers must demonstrate medical device quality assurance and risk mitigation strategies that meet intended use and, moreover, produce safe, effective solutions for end users.
Risk management in the medical device industry can leave some manufacturers at loose ends as to where to start and how to guide the process for their devices. Add in medical device quality assurance and the complexities of compliance could exceed the time and resources manufacturers have to devote to it.
That’s where partnering with a single-source medical device consultant such as Kapstone Medical proves valuable. In addition to expert regulatory compliance consulting, the collaboration serves to expand a manufacturer’s focus in all areas of a medical device project — from big picture ideation to nuanced risk management strategies.
In many ways, a medical device consultant bridges the gap between regulations and reality.
In many ways, a medical device consultant bridges the gap between regulations and reality. Working together to understand and comply with design controls is an ideal demonstration of how a consultant functions as both an independent expert and as part of a manufacturer’s team.
Starting point: design & development planning
A design plan is foundational to medical device development. The US FDA views it as the point at which a manufacturer establishes the device concept, using design control to maintain and document related activities.
In the simplest terms, a design plan obligates a manufacturer to manage risk and ensure quality by:
- Describing design and development activities
- Identifying any functions impacting the device design
- Documenting and approving or updating activities as changes evolve
It’s a tall order without guidance from a medical device consultant experienced in design control milestones including inputs, outputs, reviews, verification, validation, and compiling an accurate design history file.
Let’s break down how a medical device consultant partner helps drive medical device quality assurance and risk mitigation within device control compliance.
Design inputs: Device physical & performance characteristics
Design inputs define all characteristics included in the initial medical device design. Inputs run the gamut from functionality, safety/reliability, and regulatory requirements to labeling and packaging, sterilization, and compatibility with other devices.
A critical design input is “human factors,” which delineates the interactions (or, interfaces) between humans and devices. A clear understanding of human factors naturally plays an important role in risk management for medical devices. Patient safety is paramount.
A medical device consultant will be diligent in asking and helping answer questions that ensure the accuracy and logic of design inputs, such as:
- Do the inputs address user needs and intended use?
- Is there objective, measurable data to support meeting the user needs and intended use requirements?
- Are there any requirements that are incomplete or ambiguous?
- What part(s) of the design plan need to be addressed to resolve any conflicts in requirements?
- What process is in place to document and review any design inputs?
- What does design input approval entail?
- Is the process to document, review, and approve design inputs compliant with FDA standards?
Design outputs: Proper device function & technical acceptance criteria
The path from medical device concept to completion is rarely linear. Medical device quality assurance and risk management can — and usually do — call for device planning and development to undergo rounds of modifications.
Design outputs contain CAD drawings, formulations, specifications, code, electrical schematics, etc., that measures the results of each device design phase, and the end of the overall process.
Manufacturers that partner with a medical device consultant can leverage the benefit of critical review and practical experience.
As with design inputs, manufacturers that partner with a medical device consultant can leverage the benefit of critical review and practical experience. A consultant will both guide and challenge how design outputs are established and maintained by questioning related procedures, including:
- Are design outputs defined and designed in ways that can assess device conformance to design inputs?
- Have acceptance criteria been established?
- Is the acceptance criteria measurable?
- Have design outputs essential to the functionality of the device been defined and documented?
- Who is responsible for signing off on design output documentation prior to its release?
- What plans (i.e. quality, inspection) are in place to make sure the device is being made properly?
The pivotal role of a medical device consultant in compiling a Design History File (DHF)
Risk management in the medical device industry is nothing new. Neither are the risk mitigation strategies that device manufacturers put in place.
Aligning risk management with medical device review, verification, and validation practices is a dynamic process — and one that is essential for medical device consultants to oversee in conjunction with device manufacturers.
However, aligning risk management with medical device review, verification, and validation practices is a dynamic process — and one that is essential for medical device consultants to oversee in conjunction with device manufacturers:
- Design review is a documented, systematic way to determine if the device design requirements are adequate and can be accomplished, and to identify any issues
- Design verification uses objective evidence — tests, reports, independent data, etc. — to confirm that design outputs meet design inputs. It is proof that the device was made correctly
- Design validation uses objective evidence — tests, reports, independent data, etc. — to confirm that specified requirements meet user needs and intended use under defined operating conditions, initial production batches, and/or under actual or simulated conditions. Unlike design verification, design validation proves that the correct device was made
A Design History File (DHF) contains all information upon which design review, verification, and validation are based. The US FDA requires that manufacturers compile and maintain a DHF on each medical device they bring to market. This can be a daunting task for those uninitiated with the lengthy, detailed, and meticulous process of capturing the base information, design changes, and other relevant data.
On the other hand, a medical device consultant is well versed in understanding what needs to be included in a DHF to comply with regulatory requirements. They can also dedicate specific time and resources to its accurate assembly on behalf of a manufacturer.
A medical device consultant is well versed in understanding what needs to be included in a DHF to comply with regulatory requirements. They can also dedicate time and resources to its accurate assembly on behalf of a manufacturer.
Further, a DHF is often instrumental in a device purchase and transfer. An acquiring company considers a DHF an asset because it minimizes remediation efforts and costs necessary to legally sell the device on their own. Again, with the expert handling of a medical device consultant, a DHF pays dividends in risk mitigation and device quality management.
The benefits of partnering with a medical device consultant are many, especially when you choose a single-source solution like Kapstone. We know the ins and outs of all facets of the medical industry and how to successfully introduce devices into it.
Our guide US FDA 510(k): From Concept to Clearance demonstrates how a device consultant combines expertise and innovation to help you succeed. Download your copy now.