When a medical device manufacturer wishes to provide new treatment options to patients, there are many things to consider. Along with design there is compliance, pricing, marketing and distribution to name but a few. All of these related tasks and activities can be delegated to manufacturers? various departments and agencies to make sure that the device ?happens?. But what about the people who are going to use the devices? Should they get involved? When? Why?

Human Factors (HF) is a discipline that aims to optimise the way patients interact with one another and their environment. When applied to medical devices in production, HF-focused research studies can help manufacturers identify which areas of the device perform well in a daily setting and which need improvement. According to a recent BSI report, carrying out early stage HF research may also be a key defence against badly designed medical devices and reduce risk further down the line:

Adverse events over the past two decades have shown disturbing trends in post-market events that are attributable to design issues regarding the user interface (UI) of medical devices.

Source: The growing role of human factors and usability engineering for medical devices: What’s required in the new regulatory landscape.

That?s not to say that well-established devices can?t benefit from HF research: Yes, a specific drug may already be on the market, but the method for administering that drug?could potentially?be improved. From an inhaler to an insulin pump, the devices available to administer medication are always evolving, but in order to do so their usability needs to be tested by the people who one day might use them. And that?s why HF research is so crucial.

In a nutshell: medical device manufacturers would benefit from factoring HF into their overall product development strategy. In the next part of the article, we will look at the following:

The process of commissioning participants for HF research projects usually starts when the design house for a specific product reaches out to a recruiter with their spec.

This should help the recruiter build up a detailed profile of the kind of participant they?need and their incidence rates and how easy or difficult they will be to find. The recruiter will then typically undertake participant screening ? talking to each potential recruit to check that they are the ideal fit. This can be a time-consuming process which must be carried out in a logical and also sensitive manner.

Sensitivity

For example, some participants will be very matter-of-fact about their disease and their current medications while others may be more restrained. Some are happy to take a screening call whilst on the train, but some are not willing to share information about how they currently inject their medication within earshot of strangers. As part of the screening process, recruiters may need to ask patients their height and weight in order to calculate their BMI ? all of this is clearly personal information and good recruiters must be sensitive to the patient while ensuring the requirements of the study are met.

In order to get the right devices into the hands of the right patients, meeting quotas is critical. Some of the medical devices in development will be life changing for the patients they are targeted at.
For example: it is essential that instructions for use are clear to those with cognitive impairment. It?s critical that people with arthritis (and therefore limited dexterity in their hands) find self-injection pens really easy to use. Who is a better judge of this than the person with that restriction?

Compliance

Of course, meeting quotas is not simply about gaining feedback from a wide range of users to ensure that new technology is the very best that it can be. The numbers must satisfy governing bodies such as the FDA, CE and Canada Health too.
It follows then that the people testing the prototypes and their Instructions For Use (IFUs) reflect the potential end users. Chronic diseases don?t only occur in right handed males, aged 18-59 with high educational attainment, which can lead to some pretty tricky quotas. If poorly planned, recruiters may find themselves trying to recruit a left handed, female patient, aged over 75 with specific pump experience.

When testing the usability of certain devices, the needs of children and adolescents must also be taken into consideration. This is necessary for the development of suitable treatment options, but due to recruitment restrictions this can be a more difficult quota to achieve. There are several rules around recruitment of minors, and once they have been recruited, assent must be gained from them as well as consent from their guardian. It goes without saying that these procedures should be in place to protect vulnerable participants but it can mean the quota is more demanding.

Ultimately – failure to meet quotas is not an option if manufacturers are to make the devices the very best they can be.

Where agencies add value

To overcome potential obstacles that more difficult quotas could generate, forward planning is a must. This is where the professional recruiter?can use their know-how to? mitigate against?risk. For example,?they?will ensure?that the 75 year old arthritic patient receives sufficient help to travel to the central location facility, or over-recruiting in case a participant is taken ill and can?t attend on the day. Yes, this may increase the overall cost of the study but when you take into account everything required to ensure that a study takes place ? facility management, translation, transcription, screeners and on-the-day calls to participants ? it makes sense to provide these safety nets. One participant no-show can derail the whole study with the associated cost implications.

Human Factors research is undoubtedly complex. Manufacturers must take time and care to produce clear quotas and to react proactively to the research outcomes. Participants must be willing to donate their time, and to part with sensitive information, usually for modest financial reward. Recruiters themselves are often under a great deal of stress as they balance the needs of their clients with increasingly creative ways to reach some of the most vulnerable members of our society.

Towards a common goal

So why go to the trouble of Human Factors research? Ultimately, because everyone involved wants the same result: to create positive outcomes for patients. Whether that?s enabling an adult with Diabetes to lead a fuller life or lowering hospital admissions, the aim is to get better technology into the open market. This is why we understand just how important it is that each study is a success.

CMR Recruit is a standalone participant recruitment service from Creative Medical Research. To learn how we could save you time, money and stress on your next recruitment project, please call Hayley Algar, Director of Participant Recruitment, on 01473 832 211, or drop Hayley an email.