The importance and relevance of a sound clinical strategy
In the context of regulatory compliance, it should be evident that a well-defined clinical strategy can be the key to meet regulatory compliance and eventually gain market access. For many start-up companies, this stage is overlooked as it may appear as an unnecessary cost and extra steps. On the contrary, failing to plan early can become significantly more expensive and time-consuming. Without proper planning, medical device companies may unexpectedly run out of both time and money, facing unforeseen challenges and requirements during the clinical development process.

Note that these points also apply to legacy devices that are transitioning to meet the newer and more stringent regulatory requirements such as MDR and IVDR.

Benefits of a robust clinical strategy
As mentioned earlier, having a thorough clinical strategy provides medical device companies with various benefits, including:

• Cost-efficiency - since a robust clinical strategy will outline and explore the approach of the clinical development, medical device companies will have a clearer understanding of the whole process, leading to fewer unforeseen changes that can prove to be costly in the future.
• Regulatory compliance - a good clinical strategy will not only consider all the regulatory requirements but health economy and market aspects throughout the whole clinical development process. Given the complexity of the whole process, having a clinical strategy ensures that every step of the way in regulatory compliance is appropriate for the medical device as well as its classification.
• Risk mitigation - clinical strategies should consider every possible risk and concern that may be encountered along the development process of the medical device, as these are inevitable. More importantly, this also provides medical device companies with the foresight and risk mitigation measures required in case problems arise in the future.
• Faster market entry - all the benefits of having a clinical strategy and adhering to it will ultimately lead to a faster market introduction and entry.
• Prioritising patient safety - with a clear and thought-out strategy, medical device companies can focus on what truly matters—developing a well-documented product that improves patient health while maintaining safe usage in every aspect.

Risks and pitfalls of neglecting clinical strategy
From the perspective of medical device manufacturers, it is understandable that some, if not most, are looking to go through the validation phase (often including clinical investigations) process as fast as possible, while incurring the least costs along the way. A common pitfall is that companies are not proactive in planning. Commonly, companies realise the need when the process starts to become complicated due to unexpected challenges. When this occurs, medical device companies without adequate regulatory knowledge and support may have to go back and redo part of their documentation. While this may not sound like a major issue, if the companies have already completed the documentation, rewriting these means that they will have to redo the whole process, or even change their methodology and approach. In the end, this leads to considerable losses in both time and money. 

Without a sound clinical strategy, data collection and data analysis can also be compromised, leading to poor quality of collected data, ultimately undermining the credibility and the overall quality of the study.

Jeanette Demorney, Director of Clinical Development at Key2Compliance, emphasises the risk of medical device companies becoming overly focused on product development, leading to them overlooking regulatory compliance aspects of the clinical development process.

“I remind the companies that this is not simply a technological product, it’s a medical device. They are often so engaged with product development that they tend to neglect and forget the clinical and medical aspect of the development process. Sometimes, there are only a few months remaining before the technical documentation is submitted to the notified body, but the clinical evidence is still lacking.”

The significance of expert CRO guidance for clinical strategy
With medical devices having great variation, and with different classifications all having different regulatory requirements, there is never a one-size-fits-all strategy. In one way or another, the clinical strategy approach is tailored to the needs of the medical device company. Key2Compliance, as a MedTech Contract Research Organisation (CRO), can provide a customised, 360-degree approach to clinical strategy.

Although companies have in-depth knowledge of their product and industry, the expertise of external industry professionals remains crucial. Since the process is often multifaceted, companies benefit from the perspective and experience of many experts, not just those operating within their industry. This is due to the overlaps in the industries, and having the guidance of a team coming from different backgrounds will ensure that all bases are covered.

As mentioned previously, it is a common, yet treacherous, misconception that the clinical development process is not difficult. With expert guidance, medical device companies can minimise, or even eliminate, risks causing delays and loss of resources. 

Maria Lindgren, Director of Clinical Strategy of Key2Compliance, also notes the increased overall complexity due to the new regulations. 

"[The importance of clinical strategy] has really increased. There are more and stricter requirements in the regulations. With the IVDR, testing can no longer be done only in-house, part of it needs to be done in a clinical environment. It will be a major challenge to get all these done, and IVD companies need to be even more strategic in proving their product and getting it out in the market. That’s where we can help with our network, knowledge and experience."

Formulate your clinical strategy with Key2Compliance
At Key2Compliance, we understand how complex, challenging, and exhausting the clinical development process can become. Our team of experts can help you formulate a clinical strategy appropriate for your product and with regulatory compliance in mind, helping you introduce your product to the market sooner!

Learn more about how Key2Compliance can help you!

 PROFILES/INTRODUCTION

Jeanette Demorney is the Director of Key2Compliance Clinical Development business area. She comes from a solid background in healthcare and Life Science sectors, previously holding the role of a lead nurse. She was also a coordinator of a research group at Sahlgrenska University Hospital, served as the Medical Affairs Manager in a medical device start-up company, as well as fulfilling the roles of a project manager and a business development manager in a CRO.

Maria Lindgren is Director of Clinical Strategy, offering strategic advice, senior consulting services on clinical strategy, performance/clinical evaluations, and clinical investigations. Prior to joining Key2Compliance, Maria held positions at Sigrid Therapeutics AB and Modus Therapeutics AB. Additionally, she served as a research scientist and taught multiple courses at Stockholm University. While Maria specialises primarily in the performance/ clinical evaluation and investigation of medical devices, her background includes substantial experience in drug and medical device product development.