As the design for a medical device progresses through the development stage, it’s important to have an eye on the requirements of the first clinical studies. But how far should you go in perfecting the design or manufacturing processes to get ready for those trials? In this article, we examine how to judge what’s “good enough” for the clinical trial stage.

When you’re in the middle of development for a medical device, and the first clinical studies are on the horizon, compliance might seem a rather daunting prospect. But the reality is that although the final compliance needs are not under your control, the degree and type of effort to optimize your design for clinical trials is a judgment call that you have some say in.

Rigorous Evaluation, Lower Risks?

The first thing to be aware of is that the regulatory demands that apply to a device during the initial clinical feasibility studies are subtly different from the ones it will face at commercial launch. For example, devices in early feasibility trials may:

• Serve a narrower purpose
• Be tested in fewer patients with more interest in adherence
• Be tested under closer supervision
• Be evaluated against gold-standard comparators.

All of this means that, in something of a paradox, the risks associated with using the device in a clinical trial may actually be lower than for the finished market product. This can make the task of compliance for the clinical trial a little easier, because it reduces worries over safety that would only arise in certain ‘edge cases’ that are outside of the tightly controlled clinical protocol.

The narrower “intended use” acts as a key input into an ISO 14971 analysis process, which considers the potential hazards that users of the device may encounter during a clinical study, and determines whether controls are necessary to ensure patient safety. Teams should also consider the existing “state of the art” and predicate devices and review the relevant standards. From these, developers can infer risks that have been identified by other device manufacturers and regulators, and make sure these are considered in their own risk assessment.  

When hazards are considered up front, the result is a focused device design that protects study participants, without overburdening teams with the development and verification “nice-to-have” features that can wait until the technology is more mature. Through careful documentation of risks, developers and regulators can be confident that the control measures they have implemented are appropriate for the stage of clinical study.

In short, an ISO 14971-led development process gives design clarity and allows developers to demonstrate their technology and obtain valuable clinical data faster.

Manufacturing for Flexibility

Another daunting factor is the question of how you’re making the devices that will be used in the clinical feasibility studies.

When manufacturing processes may be susceptible to change, you don’t want to be putting into place fully automated, validated systems at great expense. Instead, it’s often sufficient to demonstrate a high level of control and rigor during the manufacturing process—it doesn’t need to be as streamlined and cost-effective as you ultimately want it to be.

So, what we would suggest is to avoid “over-developing” the process for the sake of the clinical trials. Instead, you need to put in place rigorous traceability, in-process checks, and testing protocols that guarantee patient safety during the trials, while maintaining enough design flexibility to keep the door open to further iteration and improvement. The decision on which process controls are, or are not, necessary is ultimately guided by a risk-management process and in discussions between technical and clinical experts. Ethics boards, notified bodies, or regulators will review evidence of this before a device is accepted for a clinical study.

Adapting Design Maturity to The Clinical Trial

The upshot of the previous two points is that for clinical trials, you need to manage risk in a rather different way than for the final product.

It is important to separate those requirements that are critical to basic performance and safety—such as material choice—from those that you know can be addressed one way or the other in later design iterations.

The result of this is a leaner shortlist of regulatory demands that captures only what matters most, enabling you to put forward a “minimum viable” device design that focuses on achieving early clinical feasibility.

In that way, you can give developers and regulators confidence that the clinical trial device is fundamentally safe, without perfecting every aspect as if it were a final commercial product, thereby avoiding project slippage or budgetary overshoot.

Sophie Meredith is an experienced project leader in TTP’s Biosensing team. She has a Ph.D. in biophysics and has worked on a range of projects involving the development of optical systems and implantable devices for applications in biological sensing. Dr. Meredith specializes in regulated developments and supporting clients to navigate ISO 13485 quality and ISO 14971 risk management processes and the regulatory framework. She leads projects from proof-of-concept through to controlled manufacture and design verification to enable first-in-human clinical trials.