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Obstacles that medical device innovators face



Innovating in the medical device industry: common challenges and strategies to implement

Technology offers exciting possibilities for innovations in medical devices.

Despite its scientific or clinical merits, a new idea may not translate into product development and market uptake.

From a laboratory concept to a physical product is not straightforward.

Issues may arise from the technology itself, the environment, or user interaction.

The product development process is prone to unexpected obstacles when manufacturers fail to see the process holistically from the start.

Even a seemingly minor issue can lead to a lack of approval, a delayed launch, low uptake, or even a risk to life.

Reports suggest FDA recalls due to patient harm have spiked in recent years.

Here are five of the most common pitfalls, as well as actions you can take to avoid them.

1. Forgetting all the interactions the device has with people and the environment

It is imperative to consider how requirements may differ in different clinical situations and cultures.

New technologies cannot be forced into healthcare environments without affecting the workflow.

When designing a new device, it is essential to know the end user’s perspective on how the device is going to interact with their processes and environments.

By failing to grasp the end user’s perspective, it may be impossible to maximize the capabilities of a new device.

Consider the following: The risk is particularly high with novel devices that might disrupt or destabilize existing medical practices.

Barriers to use should be identified by a team of insight specialists and addressed upfront, with the rollout strategy and/or design adjusted to accommodate challenges.

Guidance from experts can help map the potential complexity of healthcare environments based on different user scenarios and ergonomics.

Depending on the setting, this might include additional equipment being used or the reasoning behind the setup of a workstation.

Then a happy medium can be found between the use case and the environment case.

2. User issues hinder uptake or introduce risk

Ten years ago, a high number of adverse events associated with infusion pumps led to a spate of product recalls, prompting the launch of the FDA’s Infusion Pump Improvement Initiative.

It transpired that the issues were not linked to a specific manufacturer, pump type or use environment.

However, confusing on-screen user instructions were a widespread problem which may have led to improper programming of medication doses or infusion rates.

What’s more, on many pumps the ‘power’ button was located next to the ‘start infusion’ button, potentially leading to accidental shutdown.

It illustrates a fundamental point: product usability is as crucial to product success as technical design and functionality.

Observing how people use devices and incorporating the results into the development process are essential.

This can be done through market surveys, focus groups, and other approaches.

As a rule, however, direct observation by design team members with clinical and domain expertise is the most effective method.

Further, the design team needs to consider multiple user groups that the product may have to satisfy.

Ideally, the needs and demands of the full spectrum of stakeholders, at all stages of the product lifecycle, should be considered.

This includes maintenance teams and sales and distribution partners as well as patients and medical professionals.

3. Development hits a roadblock

Product development involves competing disciplines and requirements.

Teams and individuals often focus on their individual responsibilities without considering how the system functions as a whole.

Some problems that could have been fixed easily turn into big problems that require a lot of time and effort to solve.

Consider this : The more departments, and the people within them, collaborate, the more likely it is that such problems will be identified early on.

Through modern ways of working, barriers between different disciplines and phases of development can be broken down, enabling better communication and visibility.

Coordination of collaborative, interdisciplinary planning sessions at the onset of a project contributes to more seamless development that focuses on a shared goal for all parties.

4. It gets too expensive

New medical devices enable groundbreaking treatment protocols that improve outcomes and quality of life for patients.

In the long run, these devices can make treatments more efficient and cost-effective.

In the short to medium term, they can be extremely expensive. There aren’t just costs associated with the device itself, but associated expenses like training users.

Therefore, lowering material and assembly costs will result in a higher chance of widespread adoption.

All too often, however, this opportunity is missed because the transfer to manufacturing phase isn’t considered until the end of the development cycle.

Consider this: Bringing this to the front-end engineering and development phase unlocks new possibilities.

Any first-generation product, whether consumable or durable, will not be completely cost-optimised.

In many circumstances there is significant value in being first to market and, if sales live up to expectations, production costs can be considered later.

However, there needs to be clarity surrounding which cost reduction opportunities will be pursued in the future.

In this way, the architecture of the product and the regulatory approach can be optimised for future releases to accommodate changes.

5. Regulation and quality planning

Often, medical devices fail at the final stage of development.

Failures at MHRA, FDA and EMA are a risky and costly game, large amounts of time and money have already been spent.

Here are some of the most common deficiencies in FDA reports:

  • Inadequate procedures for corrective and preventive action

  • The investigation of device failures; complaints related to the possible failure of a device/ labelling or packaging to meet any of its specifications were not reviewed/ evaluated / investigated where necessary

  • Non-conforming product; inadequate controls have been established to control non-conforming product

  • Failure to comply with FDA guidance documentation guidelines.

When submitting a 510(k) submission, invalid predicate devices can be selected that aren’t exactly the same as the subject device or aren’t even commercially available.

Likewise, Human Factors and IEC:62366 adherence are becoming increasingly important.

To overcome these problems, cross-team fertilisation is critical to ensure regulatory awareness early in the process.

To get engineering teams on track, both the FDA and EMA offer pre-submission meetings.

Looking ahead is better than looking back

Product development is not an easy linear process, but it can be considered as an end-to-end process as long as the complexity is acknowledged.

The journey from concept to regulatory approval and widespread use is challenging.

They can, however, be managed – even avoided – through strategic interdisciplinary collaboration at an early stage in the process.

Consider how a device will be used, distributed, paid for, evaluated, monitored, and updated, identifying potential problems.

The fact that a device works does not guarantee success.

By taking deliberate steps to bridge the gap between concept and uptake, you increase your chances of success.

The approach reduces risk, while increasing the likelihood of commercial success and delivering benefits to all the people involved in the use and delivery of the product.


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