Clinical evidence is crucial, not only for the safety of patients, but for the success of the product on the market. Having a clear clinical strategy can be crucial to shortening the time from development of the product to reaching the market - and thus reducing the risk of costly delays.
"Many start too late. Clinical development should be initiated as early as possible - ideally at the concept stage," says Alejandro López, Quality & Regulatory Medtech/IVD, Compliance Consultant at Plantvision.
What is clinical development?
Clinical development is a systematic process aimed at ensuring the safety, performance and clinical utility of a medical device - that is, that it does what it is intended to do, safely, for the patient population for which it is intended.
The process involves several steps:
- Planning: Based on the intended purpose of the product, a clinical evaluation plan and clinical strategy are developed. This provides direction for development and sets the stage for collecting the right data and methods for that collection.
- Clinical evaluation: a continuous, systematic process of generating, collecting and analyzing clinical data.
- Clinical trials: studies in which the product is tested on human subjects to validate its safety and functionality in practical use.
- Data analysis and reporting: The results of the trials are analyzed and documented in a report - a key component to obtaining marketing authorization.
- Continuous monitoring: After launch, further clinical data are collected through post-market surveillance and clinical follow-up.
"Clinical evaluation is continuous and applies not only to new development products but also to MDR transition products, products undergoing significant design changes, and in existing products with expanded indications or when identifying new risks under continuous surveillance," explains Alejandro.
Why is clinical development so important?
In addition to being a requirement of the European Medical Device Regulation ( MDR 2017/745 ), a well-planned clinical strategy helps to:
- Identify and manage risks early in the development process.
- Reduce the risk of delays and costly failures.
- Supporting design and development decisions.
- Ensure robust clinical data for regulatory approval.
- Gaining the trust of stakeholders.
- Speed up time to market and improve the market potential of products
"By investing in a well thought-out clinical strategy, the manufacturer can save both time and money - without compromising quality or compliance," emphasizes Alejandro.
The most common pitfalls - and how to avoid them
A recurring problem is that manufacturers start working on clinical development too late. This often leads to surprises at the final stage, when clinical data is suddenly needed but not available.
"Always start by defining the intended purpose of the product. This is the basis for the whole clinical strategy," says Alejandro.
Other common pitfalls include:
- Lack of internal coordination: Effective collaboration between R&D, marketing, risk management, manufacturing, QA/RA and clinical development is crucial.
- Unrealistic timelines: By understanding early on whether a clinical trial will be required, more realistic planning can take place.
- False or unproven clinical claims: All clinical claims must be validated with clinical data - otherwise you risk expensive and lengthy trials.
Choosing the right data collection strategy is also critical. Clinical data does not always need to be collected via new clinical trials - literature reviews, user data, or equivalent evidence from similar products can sometimes suffice.
"Different routes can be used depending on the country, the risk class of the device and the data available. In the US, for example, it is still possible to claim equivalence with another device under the 510(k) route. In the EU, on the other hand, an agreement with the other manufacturer is basically required - something that is very difficult to obtain," says Alejandro.
The challenges: Regulatory framework and strategy
Two of the biggest challenges facing manufacturers today are:
- Interpreting and navigating the regulatory framework - What does 'sufficient clinical evidence' actually mean? There are no simple answers, and requirements can be interpreted differently depending on the product, the market and the regulatory authorities involved.
- Choosing the right approach to clinical development - How to collect the data needed, in a way that is cost-effective, time-optimized and regulatory sustainable?
"There is no standard solution. A winning clinical strategy must be adapted to the product's intended purpose, existing data, risks and market objectives," explains Alejandro.
A changing field - and a chance to position yourself
Clinical development is an area that is rapidly growing in complexity. At the same time, it is one of the most important tools for creating competitive advantage, increasing sales and achieving desired results. It involves collecting data to prove that the product is safe, performs as intended, and provides a clinical benefit. Only after evaluating the data can conclusions about the outcome be drawn.
Being able to help more manufacturers take control of their clinical development, not only to meet regulatory requirements, but to create better products and a stronger position in the market, is a strong motivator for Alejandro and his colleagues.
"It is ultimately about patient safety - but also about innovation, efficiency and long-term success," concludes Alejandro.
