By aligning the many interlocking parts of the design process, manufacturers can greatly increase the likelihood of regulatory approval.
The invention of a medical device is only the first step in the process of determining its clinical and commercial viability. From the moment a manufacturer selects a device to develop, the design and engineering of that device should proceed in parallel with assessments of the device’s operation, safety, and other design specifications.
To help guide manufacturers through this assessment process, the U.S. Food and Drug Administration (FDA) has provided a clear framework for incremental quality control in medical device design. Manufacturers who follow this framework are far more likely to design devices that will pass FDA scrutiny, obtain regulatory approval, and proceed to the clinical trial stage.
This article provides an overview of the key steps involved in preparing a medical device to obtain regulatory compliance, along with common challenges related to each aspect of the process.
The design process of the medical device must be traceable in order to obtain regulatory approval.
Every well-organized medical device development process begins with a set of design inputs: operational parameters, performance metrics, user requirements, and so on. These inputs feed into the design process itself; and at each stage of that process, the device is tested, generating outputs which serve as design inputs for the next stage of the engineering process.
By matching design outputs from one stage to inputs for the next, a manufacturer creates a traceable design process, ensuring that the device meets the needs of its intended users, and functions within desirable parameters. A traceable design process also reduces the risk that a product will have to be rolled back to a much earlier stage of design, since its viability has already been validated at each stage so far.
Most importantly for a product’s clinical and commercial viability, traceable design significantly increases the device’s likelihood of obtaining FDA approval, since the FDA requires a traceability analysis as part of the regulatory approval submission. To aid in this aspect of the submission process, a the manufacturer should keep a design history file, in which every set of design inputs can be mapped back to a set of corresponding outputs.
The device must be fully sterilized and safely packaged in order to pass regulatory scrutiny.
As soon as a device’s physical parameters have been established, the design team should begin work on sterilization measures and packaging. Certain materials used in the device may respond poorly to certain types of sterilization, while other materials may be sensitive to light or heat, requiring more robust packaging. The sooner in the design process these considerations can be determined, the more time the design team will have to iterate through possible changes in materials, sterilization methods, and/or packaging.
For example, if the device is to be kept sterile between uses, the manufacturer will need to select a sterilization method that is both effective, and realistic for the end user. Sterilization by steam or dry heat may be sufficient for home-use devices, but in some cases those methods will need to be supplemented by ethylene oxide or even radiation, requiring more advanced clinical equipment and personnel. In any case, the sterilization method must be validated n terms of practicality as well as efficacy.
In terms of packaging, the design team must consider the balance between safety and preservation on the one hand, and ease of use on the other. Devices containing parts sensitive to temperature fluctuations may need to packaged in an insulated pouch, while parts prone to breakage may be protected with shock-absorbent packaging, and parts sensitive to moisture may be wrapped in an absorptive material.
Regulatory agencies will examine packaging and sterilization measures just as carefully as they examine the device itself, which means manufacturers would do well to consider these as core elements of the design process, rather than as afterthoughts.
The regulatory submission itself should be prepared by experts, to streamline the approval process.
As challenging as the design of the device and its packaging may be, the assembly of an effective regulatory submission constitutes a challenge all its own. The manufacturer must consider the ideal time and place to submit the device for approval, and the submission packet itself must be prepared in a way that streamlines the consideration process. Delays at any stage of this process can involve considerable time and expense.
For all these reasons, it is ideal to work with experts who have experience in medical device regulatory approval, in order to maximize the device’s chances of approval. Such an expert can assist with the compilation and verification of a written assessment in accordance with ISO 10993-1 and 14971 biological safety standards, for example; and can ensure that all preclinical reports demonstrate adherence to good laboratory practice (GLP) and sterilization validation, while demonstrating traceability.
In addition, a regulatory approval expert can advise as to whether it is ideal to begin by submitting the device to regulatory agencies in the US, or in other lucrative markets such as the EU, or in Asia. The expert can also prepare a timeline of submission priority, enabling the manufacturer to rapidly obtain approval for clinical in markets with brief review processes, while continuing to work with regulatory agencies that perform more rigorous and lengthy assessments.
A manufacturer that aligns the many interlocking parts of the design process, from design inputs and outputs, to packaging and sterilization, will greatly simplify many common difficulties of obtaining regulatory approval. And by hiring an expert in the preparation of the regulatory submission itself, a manufacturer stands a far greater chance of obtaining approval in the most efficient manner possible, and proceeding to the clinical trial stage on an ideal timetable.
