How right-sized, efficient, and cost-effective trial technology solutions can get your devices to market faster.
A question we hear a lot from our medical device and MedTech customers is, how can I get my devices to market faster?
In our 14 years of experience working on medical device and MedTech trials, we’ve found the answer can be distilled to five success factors. All factors are based on technology and have had a profound impact on study execution once implemented.
By adopting these five success factors, you will enable greater efficiency , reduce timelines, and ultimately accelerate time to market.
1. Reduce or Remove Paper
A 2020 survey on the State of Medical Device Product Development and Quality Management found that more than 50% of medical device companies still use paper.
When it comes to paper, many think that it’s cheaper, quicker, and easier than implementing eClinical solutions. This could be true for an initial pilot study with a small number of patients, but once device studies start to scale, and they scale quickly, the hidden administrative costs associated with paper start to materialize. In fact, a cost comparison between the two approaches often finds electronic solutions are less expensive than paper.
Many medical device companies resist making the switch to electronic solutions to avoid additional regulatory hurdles, namely FDA 21 CFR Part 11. However, the reality is that if you send documents via email, have servers that store electronic documents, or sign paper documents then upload them, you should already be ensuring compliance with 21 CFR Part 11.
Sponsors who switched from paper to eClinical solutions in their studies noted four key advantages:
- Reduced costs by 50% per participant vs. traditional onsite study methods
- Increased trial recruitment and diversity due to the ability to capture data remotely
- Higher participant compliance, resulting in more data collected
- Improved data quality which lead to fewer data entry errors
Though there may be initial challenges when switching to electronic solutions, the longer-term benefits are substantial.
2. Use ‘Right-Sized’ Technology
The process of implementing ‘right-sized’ technology requires a technology partner who genuinely cares about your study’s success. Medrio works hand-in-hand with our customers, tailoring our technologies and services to meet your study’s precise needs, speed, and specifications.
‘Right-sized’ technology is easy to understand and adopt. Medrio solutions are built with the end user in mind, and our intuitive, drag-and-drop platform supports our guided autonomy approach, allowing us to provide a unique balance of support and autonomy to each customer. We’ve worked with organizations that have used our training and onboarding services to enable totally independent study builds from scratch. We’ve also worked with customers who prefer to sit back and let us complete the study build while they focus on other priorities. Our guided autonomy approach ensures we provide the technology and support that’s the exact right size for your study.
‘Right-sized’ technology does not require specialized staff. Our technology platform is programerless, meaning no specialized programming or coding capabilities are required. Additionally, our solutions have pre-built integrated workflows so all of our solutions- including platforms such as EDC, eConsent, and ePRO – interact with one another seamlessly. As a result, internal IT teams are less burdened, and third-party spending is reduced.
When looking for ‘right-sized’ technology, make sure you really need every bell and whistle. And if you don’t, consider asking yourself if you’ve found the right technology partner. Most importantly, you’ll want transparent pricing and predictable costs, so you’re not paying for things you don’t need.
3. Reuse Technology
Unlike pharma studies, the development process for medical device trials benefits greatly from iteration. In other words, there’s an opportunity to save time and money by reusing or repurposing existing workflows, forms, queries and functionality. By taking advantage of the ability to reuse, for example, previously built diaries or ePRO questionnaires, your team can dramatically improve subsequent study build and start times, while also reducing costs. Essentially, reusing technology saves your team from having to duplicate work which directly impacts getting your device to market faster.
4. Apply Integrated Solutions
In 2020, the Tufts Center for the Study of Drug Development found that a majority of sponsors were using at least four different solutions or platforms in their studies to obtain basic trial data. Building your eClinical technology stack this way increases costs, complexity, study delays, and inevitably frustration.
In contrast, Medrio’s solutions provide a much more streamlined experience. We provide a single user interface with a consistent look and feel across solutions, so you don’t have to learn more than one. Also, our solutions are fully integrated, so you don’t have to use expensive APIs to transmit data. Your patients can receive notifications and view instructions for at-home collection or procedures via our participant portal. And to round out our solution suite, we offer an integrated CTMS and eTMF through one of our technology partners.
When making the switch to electronic solutions, prioritize ones that are already integrated to save yourself from headaches and having to learn how to use multiple systems.
5. Prepare for Mid-Study Changes
In our experience, our MedTech customers typically undergo at least one mid-study change during the course of their trials. A Tufts study done in 2021 found that the average time to resume a study after a mid-study change was 35-40 days. That’s almost two months where your study is offline! During Those two months costs aggregate, staff are left to wait, and you lose eligible subjects.
Medrio has a proven approach to mid-study changes. For every study, we build three different environments: a development, a test, and a live environment. The mid-study change is first built in the development environment, then undergoes testing in the test environment. Once the change is functioning properly, it’s pushed to the live production environment. Because we build and test in separate environments, there’s no production downtime during a mid-study change.
As a result of our intuitive drag-and-drop interface, mid-study changes can be made very quickly, typically within hours or days. Our average mid-study change takes just 7 hours to implement; a significant improvement from the industry-standard 35 to 40 days. This turnaround time helps preserve study continuity, save costs, and of course, get your device to market faster.
If you apply our five factor approach: reducing or removing paper; using ‘right-sized’ technology; reusing technology; applying integrated solutions; and preparing for mid-study changes, you will reduce your costs while getting your devices to market faster.
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- Deloitte. Digitalization of clinical trials. How new technologies enhance the future of healthcare. Inside Magazine, Issue 19, Nov 2018, pp 98-101.
- Tufts CSDD, Impact Report: Drug Developers Respond to Evolving Clinical Data Demands With New Strategies, Tactics; March/April 2020;22(3).