So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market.  For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be steep.

It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions.

Pre-market requirements include those for obtaining marketing authorization, including 510(k) clearance (21 C.F.R. Part 807, Subpart E), De Novo authorization (21 C.F.R. Part 860 Subpart D), or PMA approval (21 C.F.R. Part 814), and for conducting clinical trials (21 C.F.R. Part 812).

Post-market requirements cover activities such as registration and listing (21 C.F.R. Part 807), establishing a quality management system (QMS) (21 C.F.R. Part 820), labeling (21 C.F.R. Part 801), unique device identification (21 C.F.R. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R. Part 821), medical device reporting (21 C.F.R. Part 803), and reporting corrections and removals (21 C.F.R. Part 806).

It is not surprising that many start-ups focus on the pre-market requirements first, as not achieving marketing authorization makes the need for compliance with other requirements moot.  A question that often comes up is: when is the best time to start preparing for post-market requirements?  For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission.  For 510(k) devices, sponsors could wait to establish a quality system that covers all post-market requirements until device development is further along.  Waiting too long, however, could lead to delays in being ready to sell and distribute devices if the marketing authorization is received before all necessary procedures are established, so it is important to have a plan that ensures timely development of a full QMS.

There is one section of the QMS, however, that is worth starting early in the product development lifecycle:  Design Controls.  Design controls (21 C.F.R. § 820.30) are described in FDA’s guidance, Design Control Guidance for Medical Device Manufacturers, as “an interrelated set of practices and procedures that are incorporated into the design and development process” (p. 1).  Design controls are applicable to Class III, Class II, and select Class I devices, including those that incorporate software.  Id. § 820.30(a).

In practice, a standard operating procedure for design controls is developed to describe how medical device design will be performed and documented.  Design controls include requirements for:  design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes.  There are many resources that provide information and guidance for each of these required elements.

Why should a device start-up company, with limited resources and plenty of work to produce initial prototypes, be thinking about design controls early in development?  There are a number of reasons why it is worthwhile.

First, a design history file includes many documents that must be submitted as part of a 510(k), De Novo, or premarket approval (PMA) application.  For example, FDA generally conducts fairly extensive reviews of software documentation.  It will generally be easier to generate these documents contemporaneously with device development as part of a structured procedure, rather than doing so afterwards.   Or, to put it another way:  We have not yet met an engineer who enjoys remediating the documents for development work that was done in the past.

Second, if clinical data will be needed to support the marketing application, compliance with design controls is required.  The Investigational Device Exemption regulation exempts a device from the requirements for good manufacturing practices except for the requirements for design controls.  21 C.F.R. § 812.1.

Third, establishing and following a process for design controls early in device development may improve the safety, effectiveness, and quality of the device, and the quality of the application for marketing authorization.

Specifically, when following a structured design control process, device requirements and risk mitigations may be more formally discussed cross-functionally, leading to a robust design and decreasing the risk that design changes are needed when design controls are eventually applied, or as part of FDA review.  By following a structured process for identifying requirements and risks, it may be easier to identify issues that could benefit for pre-submission discussions with FDA.

In short, following design controls imposes a certain amount of burden, but the benefits just described usually make it worth the time and expense, even early in development when they may not be strictly required.