State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new devices or those that have been on the market for a long time, physicians can help manufacturers overcome many of these challenges.
With notified bodies increasingly employing physicians and clinical reviewers with expertise in specific therapeutic areas, it is important for manufacturers to utilize their in-house physicians appropriately to match the increasing expectations and expertise of notified bodies.
SOTA Challenges for Manufacturers
New state of the art requirements under MDR and IVDR are creating challenges for manufacturers. Some of the most common hurdles we see include:
Finding the Right Balance
When it comes to state of the art, the regulation does not require a discussion of the most technologically advanced solution but the one that is most commonly used in practice. Providing this context requires finding the right balance between too much and too little relevant information.
One approach manufacturers have tried is casting a wide net to include all potentially relevant literature to describe SOTA. This is not what notified bodies are looking for. Clinical reviewers have time restrictions and targets to meet, so they don’t have the capacity to review volumes of literature. Copying and pasting journal articles or other content will only overwhelm reviewers and result in questions for clarification and overall delays, especially when they can’t quickly find the answers to their questions.
Devices in the lower classification groups also face this challenge because there may be multiple indications and a variety of user groups to consider. Manufacturers with lower-risk devices will also have to adjust to the new SOTA requirements under MDR because they didn’t have the same regulations under MDD. Another disadvantage to this approach is that it is not cost-effective and requires a lot of time to execute. Covering too broad of an area for SOTA is more expensive than it needs to be and produces a result that does not align with notified body expectations.
On the other hand, an approach that is too restrictive also does not meet the regulatory requirements. Including only your own device in SOTA will almost certainly result in notified body findings. You must define where the device sits in the clinical care pathway and how it relates to the other device options and therapeutic alternatives.
It’s important to remember that notified body clinical reviewers have expertise in their respective fields. They will know if key elements of SOTA are missing because they are aware of the current best practices in their various specialties. However, they can’t advise you about what’s missing—it’s up to you to fill in the gaps.
Inadequate Literature Reviews
Literature review is one method used to understand SOTA. However, when improperly performed, the results can be inadequate. The staff performing the literature review must have enough knowledge and experience to know what search terms to use and what questions to ask to formulate the literature search protocol. They must also have awareness of the specific field because SOTA is constantly changing. Every clinical study adds a brick of knowledge that may need to be considered.
Citing consensus documents is a common practice manufacturers employ with SOTA, but the reality is that the information is out of date by the time they are published. This approach is not enough to satisfy notified body expectations. Guidelines and recommendations may also be out of date a few years after their publication and not reflective of day-to-day clinical practice.
SOTA for Acquisitions
Larger manufacturers that acquire smaller companies don’t always have deep knowledge of the devices that were developed prior to acquisition. This can be a challenge when it comes to presenting the context for the state of the art. In these cases, working with a qualified individual from the acquired company or outsourcing to a team that has device-specific expertise may be the best approach.
SOTA for Legacy Devices
Devices that have been on the market for decades often don’t have a SOTA rationale readily available. In these cases, manufacturers are still required to demonstrate where their devices fit in the big picture.
→ Dive deeper: Our on-demand webinar, “An Intuitive Approach to Quantifying the Benefit-Risk Ratio” explores how having a solid state of the art strategy better prepares you for quantifying and calculating the benefit-risk ratio.
How Physicians Can Help Scope SOTA
As a learned intermediary between manufacturers and patients, physicians have a unique perspective that benefits all parties.
Informed Literature Review
Physicians can develop questions to inform the SOTA search for researchers. Developing the right questions to base the literature search upon is a critical step to ensure that the clinical literature review protocol will be appropriately focused. Physicians have a field understanding of devices and how they affect patient care. This is one reason that involvement from a physician is a key component of making SOTA accessible and easy for clinical and technical reviewers to read.
SOTA Rationale for Legacy Devices
Physicians can help manufacturers reinvent SOTA for older technology when that documentation does not exist. They can also provide an explanation of what the device does, how it is used in practice, and its role in the clinical care pathway.
Describing Potential Clinical Pathways
SOTA must encompass more than just the subject device. Physicians are aware of the various options and alternatives beyond the manufacturer’s own device because they are involved with discussions that happen with patients on a regular basis. Physicians can help manufacturers see the bigger picture of daily practice that includes all potential clinical pathways, such as using the device, pharmaceuticals, surgery, or taking no action.
Comparing Safety and Performance of Devices
Physicians can help manufacturers overcome the challenge of measuring the safety and performance of their own devices and those of their competitors. Notified bodies expect to see measurable and objective outcomes. However, extrapolating appropriate clinical end points is difficult for engineers and nonclinicians. Physicians can help bridge this gap through their field experience by creating benchmarks for comparison to feed into the benefit-risk discussion.
When Physicians Should Be Involved
It’s not uncommon for manufacturers to bring physicians in after a device has been developed because they need to fulfill regulatory requirements. However, involving physicians from the beginning of device development through marketing and post-market activities is the best practice for ensuring seamless regulatory approvals.
- Intended purpose statements
- Defining target populations
- Literature searches
- Benefit-risk analyses
- Post-market studies
When you integrate physicians into the organization and process, they will be able to provide quick answers to the right questions. Without this integration, you may get responses that are out of context or not aligned with regulatory expectations.
How RQM+ Helps
When your team is overwhelmed, RQM+ is here to help with services such as:
- SOTA for newly acquired devices
- SOTA for legacy devices
- Acting as a supplement to the medical director
Our integrated team provides clinical and regulatory expertise that encompasses the big picture of MDR and IVDR. In-house clinicians provide the unique perspective that only physicians can provide to bridge the gap between manufacturers and patients. With former notified body leaders on the team, we know what reviewers expect to see and we apply those insights to every project we take on.
One of the benefits of having a solid state of the art strategy is that it will help prepare you for quantifying and considering the overall benefit-risk ratio. To take a deeper dive into this important assessment, watch our on-demand webinar, “An Intuitive Approach to Quantifying the Benefit-Risk Ratio.”