Carl Hewett, mechanical engineering consultant at Sagentia, examines some of the common pitfalls in the medical device innovation process.
Advancements in digital, data and biomedical technologies offer exciting potential for medical device innovation. Yet just because a new idea works from a scientific or clinical perspective, it doesn’t necessarily mean product development and market uptake will follow.
Transitioning a device from laboratory concept to physical product is not a straightforward linear process. It’s complex and dynamic, influenced by various social and technical factors. These can be related to the technology itself, the environment and user interaction and perception.
It’s no secret that unexpected challenges can derail the process when manufacturers fail to take a holistic view of the product development cycle from the outset. Yet it happens time and time again. Seemingly small issues can escalate, resulting in lack of approval, delayed release, poor levels of uptake or even risk to life and FDA recall. Recent reports suggest there has been a spike in such recalls during 2019.
Here are six of the most common pitfalls, and steps that can be taken to avoid them.
1. 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.
The false triggering of EpiPens is another example of risk rooted in user factors. The literal comprehension of ‘pen’ instils a false sense of familiarity, counter to the intended use workflow. The orange spring cap resembles a ballpoint click and the blue removable safety cap resembles a needle exit point. So, it’s easy for a first-time user to remove the protective needle cap and click the spring button, inadvertently pricking their thumb.
In a use case scenario where a patient suffering anaphylactic shock is unable to administer the EpiPen personally, an inexperienced helper may harm themselves and deny the patient a critical dose of epinephrine.
These examples underline a fundamental point: product usability is as pivotal to product success as technical design and functionality.
Solution: Observing user interaction directly and integrating resultant insights into the development process is essential. Knowledge can be gathered through market surveys, focus groups and design research activities or previous case studies representing the Voice of Customer (VoC). But direct observation by product designers with clinical understanding and subject matter expertise is hard to beat.
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.
2. Supporting environment oversights
Social forces have a significant role to play, and it’s useful to consider the full breadth of potential stakeholders as outlined above. However, environmental factors and end user perception are also paramount.
It’s important to think about how requirements might vary in different clinical situations and cultures. For instance, it is hard to force new technology into healthcare environments and deliver results unless the workflow around it also changes. My colleague Tim Frearson recently wrote about modern infusion pumps with digital maintenance logs being returned to technical teams with handwritten labels simply saying ‘broken’. This underlines the importance of understanding the processes and environment into which a new device will fit, and how end users perceive the interaction. Without this, its full value may not be realised.
Solution: This risk is especially high with novel devices that may disrupt or destabilise existing practice. In this situation, barriers to use should be identified and addressed upfront by a team of insight specialists, with the rollout strategy and/or design adjusted to accommodate challenges.
Expert guidance can help map the potential complexity of healthcare environments in line with various user scenarios and ergonomics. This might cover additional equipment used in the same setting or the rationale for workstations being set up in a certain way. With this knowledge, product designers can aim to strike a happy medium between the use case and the environment case, optimising interaction between the two.
3. The development process stalls
A product development lifecycle is a multifaceted journey involving competing disciplines and requirements. A lack of cohesion between and within these can represent a serious vulnerability.
Siloed working practices, where teams and individuals focus on specific areas of responsibility without regard for the wider system, are a common problem. It means glitches which might have been easily rectified can escalate until they become a major issue which takes a lot of time and energy to resolve.
Solution: When departments, and the individuals within them, work more collaboratively such problems are more likely to be identified at an early stage. Embracing modern ways of working can break down the barriers between different disciplines and development phases, enabling better communication and visibility. When product managers coordinate collaborative, interdisciplinary planning sessions at a project’s outset, it fosters more seamless product development where all parties focus on a shared end goal.
4. Production costs fall out of tolerance
New medical devices can facilitate breakthroughs in treatment protocols that enhance patient outcomes and quality of life. Over time, they can improve treatment efficiency and cost-effectiveness. However, in the short to medium term, they are almost inevitably associated with higher costs. It’s not just the cost of the device itself that must be considered, but associated expenses such as training users.
It follows that any measures taken to drive down material and assembly costs result in a higher chance of widespread adoption. Yet all too often, opportunities to do this are missed because transfer-to-manufacture considerations aren’t factored in until the latter phase of the development cycle.
Solution: Finding ways to bring this forward to the front-end engineering and development phase unlocks new possibilities. For instance, manufacturing engineers might be able to facilitate scalability, streamline routes to manufacture or introduce multifunctional components, significantly enhancing efficiency and cost-effectiveness.
It is perfectly natural that a 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. This enables product architecture and regulatory approaches to be optimised for efficient accommodation of changes in subsequent releases.
5. The device can’t keep pace with change
Futureproofing is vital to maximise the longevity of devices in the digital age. Widespread transformation is yet to impact the healthcare sector, but it will happen. Devices under development today need to be futureproofed accordingly, for instance with embedded connectivity that can be activated later. With digital strategy now at the heart of many development roadmaps, cyber risk has become a significant concern. Redundant connectivity in devices is often rooted in a lack of adequate cybersecurity measures, which will be addressed over time.
It’s important that devices can be upgraded, updated and modified quickly and easily so they don’t risk becoming irrelevant before their anticipated end of life. There are other factors to consider too, from the shift towards personalised medical care to the increasing lack of tolerance for single-use plastics.
Solution: Understanding these wider trends and anticipating the influence they may have in the next five to ten years is hugely beneficial. It allows a design authority to create a development roadmap highlighting Minimal Viable Product while forecasting future SKUs that help ensure longevity and long-term relevance.
6. Regulation and quality planning
Many medical devices stumble at the final stage of the process. Navigating FDA and EMA failures is a risky and costly game - much has been invested and the stakes are high. The most common medical device deficiencies in FDA reports include:
- lack of, or inadequate, procedures for corrective and preventive action
- investigation of device failures; complaints involving the possible failure of [a device] [labelling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary
- nonconforming product; procedures have not been [adequately] established to control product that does not conform to specified requirements
- failure to comply with FDA guidance documentation guidance.
In 510(k) submissions, invalid predicate devices can be selected that are not equivalent to the subject device or not even in the market. And let’s not forget the increasing importance of Human Factors and IEC:62366 adherence.
Solution: Cross team fertilisation to ensure regulatory awareness early in the process is critical to overcome these problems. One simple measure to get engineering teams on track is to utilise the Pre-Submission meetings offered by both the EMA and FDA. You can find out more about this in a free whitepaper recently released by our sister company TSG Consulting: How to get the most out of the FDA Pre-Sub meeting program.
Conclusion: Put insight before hindsight
While product development is not a straightforward linear journey, it is helpful to consider it as an end-to-end process, providing the complexity is acknowledged.
The journey from concept to FDA approval and widespread use is fraught with challenges. However, they can be managed – even avoided – with strategic interdisciplinary collaboration at an early stage in the process. It’s important to consider how a device will be used, distributed, paid for, evaluated, monitored and updated, identifying where problems might arise.
All of this can be managed more strategically and effectively with input from specialists at a project’s inception. Combining the expertise of professionals such as manufacturing and usability engineers with mechanical, electronic and software engineers enables problems to be predicted and addressed before they have a serious impact. Cutting corners and relying on assumptions rather than robust insights can result in deep rooted problems that harm progress.
Evidence that a device works is no guarantee of success. But taking purposeful steps to bridge the gap between concept and uptake helps stack the odds in your favour. It reduces risk, while increasing the likelihood of commercial success and delivering benefits to all stakeholders.
