Comment: How to avoid the pitfalls of MedTech

Failure to launch a MedTech product is a very real risk - around three quarters of innovations do not make it to market.

Common challenges to gaining market approval are usually governed by high-level standards (MDR, ISO, ASTM, MedDev, Risk Management, Biocompatibility) and there are well-travelled paths to overcome them.

However, other potential problems during the innovation process often go unrecognised until it is too late. These “hidden” pitfalls can not only stall a project, but also do real harm to a MedTech company’s bottom line.

A sound knowledge of both well-known and less commonplace obstacles will enable you to anticipate and plan for them, and help achieve the end goal of securing market approval for your life-changing medical device.

Specification complexity

The number of design requirements or engineering standards that guide design and development efforts varies depending on the complexity of the device.

For example, ISO 14630:2012, relating to non-active surgical implants, has 29 separate design requirements, while ISO 16061:2021, for instruments used in conjunction with non-active surgical implants, might comprise up to 96 design requirements. Below these, each device type has additional standards with specific design requirements.

To avoid delays or rejection of the technical file, create a list of standards and design requirements at the outset, to illuminate initial constraints so solutions can be factored in throughout the innovation process.

Risk

Design requirements and risks are closely related; every feature and function of a medical device has an inherent risk of causing harm.

An effective top-level design risk assessment must connect each risk to the equivalent design requirement. For example, ISO 14630 states that the shape and dimensions of a surgical implant should be equivalent to the reference implant to satisfy the design attributes of ISO 14630 (5.j).

This basic example captures the connected risk to the design requirement:

·       Hazard: implant shape and dimensions cause injury to the patient

·       Hazardous situation: sharp edge unintentionally cuts patient’s soft tissue during insertion

·       Potential harm: damage to tissues and bodily fluids (including severity levels)

Unique identifiers

Include the Unique Device Identification (UDI) reference on device labelling as early as possible to avoid delaying the design and development file, tech file submission or pre-production.

In the US, the Global Unique Device Identification Database (GUDID), contains a minimum 24 required attributes; the European Database on Medical Devices (EUDAMED) has 59. Early identification of these attributes is key when registering a device.

Different countries and jurisdictions have distinct databases, rules, requirements and filing formats, which should also be understood.

Biocompatibility

A nuance of the biocompatibility standard (ISO 10993) is often overlooked.

Part 1, relating to toxicity, does not mandate testing but requires a risk-based approach. If a device uses materials, processes and processing materials with well-established biological safety, a risk assessment may be adequate to meet the standard.

However, each regulatory agency and notified body (NB) may have different interpretations of the standard and risk, so it is essential to undertake an analysis of the countries in which the device will be launched.

If testing is necessary:

·       Plan for the quantity of samples in the test protocol so time and costs are understood

·       A lab's capability for implant testing should be agreed upon in the protocol

·       Consider potential customs and shipping delays if sending samples to overseas labs

Balancing benefits

It is impossible to eliminate all risks when designing and developing medical devices, therefore try to eliminate certain risks and mitigate others to a level ‘as low as reasonably possible’, then weigh the residual risk against clinical benefits.

If the benefits set out in the risk management (or clinical evaluation) report do not outweigh the risks, the product will be rejected, so this assessment should be conducted during the design inputs phase and rerun often, with increasing formality, throughout the development process.

Preclinical testing

Preclinical testing can be time-consuming and expensive, so should only be conducted when it is necessary to reduce risk.

Start risk assessments early to determine testing requirements and methods and plan for conditions where testing is mandated regardless of the risk level.

Allow the risk evaluation to guide the testing.

Go vegan

A requirement of ISO 22442-1 in medical device design and production is, where possible, to replace materials of animal origin (MOAO) with other materials. Seek a contract manufacturer who is already certified to ISO 13485.

If MOAO must be used, include it in the risk management file and produce a risk/benefit assessment. Note that MOAO inclusion may still preclude approval in certain countries.

Conclusion

By addressing potential pitfalls from the outset, using a strategic approach that leverages innovation theories and practices, innovators can streamline processes, minimise delays, optimise the path to market approval – and transform patients’ lives with their innovative MedTech solutions.

Dr Stuart Grant, design engineer and MedTech innovation management consultant

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