Perplexed clinical investigations medical expert

Bridging the gap — ensuring that clinical investigations work in practice

Well-designed clinical investigations are at the core of meeting medical device regulatory requirements under the MDR. More than ever before, the MDR requires manufacturers to have a detailed understanding of how to produce high-quality clinical evidence to support their products.

Despite this, access to medical expertise remains limited across the medical device industry. This is unfortunate not only because medical experts have so much to contribute to the structural design of clinical studies. It is also a problem because medical professionals are better placed than anyone to understand how a clinical investigation would function in practice.

Great clinical investigations combine two crucial elements:

  • a robust design that ensures the production of quality data that is free from bias and adequately addresses the hypothesis
  • an ability to be seamlessly implemented in practice

Much has been said about robust study design with perhaps too little focus on how effectively investigations can be implemented in practice. A theoretically sound study design means nothing if clinical investigators are unable or unwilling to engage with it. Incomplete investigator compliance with data entry requirements will almost certainly lead to problematic gaps in data collection that compromise the integrity of the entire investigation. It also leads to missed deadlines as patient recruitment falls behind, with an associated increase in study costs.

When modern medical device design focuses so strongly on human factors and ethnographic research that examine how effectively a device meets the demands of its users, why isn’t the same approach taken with clinical trials?

Being a clinical investigator is not easy. Investigators are often busy clinicians who are managing multiple competing priorities. It is the job of the investigation design team to take measures to aid investigators in entering data and working with the trial.

Methods that can facilitate investigator compliance include:

  • Minimising datapoints. Collect only the information that is absolutely necessary to address the study hypothesis and/or objectives
  • Use an electronic CRF. Using a digital rather than paper-based data entry process means that data can be entered from anywhere (including smartphone and tablet), reducing disruption to investigator workflow.
  • Have a fair remuneration structure. While always ensuring that the principles of healthcare compliance are adhered to, fairly remunerating investigators for time and effort expended while working on the trial is an effective way to encourage engagement.
  • Integrate the trial into standard care. Levels of investigator compliance are likely to be far higher if engagement with the trial causes no, or minimal, disruption to standard clinical activities.

Good clinical investigation design requires a combination of scientific and medical expertise. Working with healthcare professionals who have direct experience as clinical investigators is the best way to ensure that your trials are optimally designed for maximum investigator engagement.

Mantra Systems has a team of expertly-trained medical professionals who are specialists at designing clinical investigations for PMCF and MDR compliance strategies. Whether working to demonstrate conformity to Annex I General Safety and Performance Requirements, updating PMCF systems to MDR standards or seeking to streamline your evidence portfolio, consult with a member of our team to discuss your requirements.

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    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

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    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a medical device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on software as a medical device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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