Understanding a physician's view on risk
Insights from a Let's Talk Risk! conversation with Dr. Elisha Patel
Note: this article highlights key insights gained from a conversation with Dr. Elisha Patel as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
Key takeaways
Physicians focus on the risk of the procedure and outcomes: a physicians1 generally focuses on the overall risk of the medical procedure, not just the risks associated with a medical device. In a typical procedure, many different medical devices are used. Physician focus is on the treatment outcome while minimizing the overall risk to their patients.
Physicians tailor the benefit-risk conversation to an individual patient: a conversation about benefits and risks of a procedure generally occurs in the context of an individualized treatment plan for each patient. The nature and extent of medical/surgical intervention depends on many factors such as co-morbidities, lifestyle, demographics and socio-economic determinants of health. Patient anxiety is also a factor. The physician has to consider these factors when developing a treatment plan and communicating it to the patient. As an example, benefit-risks of a tooth extraction vs. root canal treatment needs to be evaluated and communicated in a way that leads to the most desirable decision for the patient.
Physicians expect medical devices to be safe and effective in their hands: once a medical device is authorized by regulatory authorities as safe and effective, physician’s expect it to be suitable for use during the procedure. They are generally aware of device-related risks and instructions for safe use. But they do not necessarily focus on these instructions, warnings or precautions before each procedure. Their expectation is that a medical device will function safely, as expected. That is why it is very important to consider usability and interaction with other devices during early design and development.
Physicians generally do not directly communicate with device manufacturers: It is not uncommon for medical devices to malfunction during use. If a device-related issue is discovered during the procedure, a physician will typically include it in their notes. In some cases, they may escalate it to their superiors, especially in a hospital environment. Generally, the administrative staff handles reporting of complaints to the manufacturer and/or regulatory authorities if required. As a result, device manufacturers generally do not get direct, first-hand information from the physicians. It is important, therefore, to include physician input and potential concerns early during the design and development process so that appropriate risk mitigation strategies are considered and implemented. It is also important to continue gathering physician input, to the extent possible, during the post-market phase. However, medical/clinical assessment during the post-market phase is generally done by internal experts with competence in the medical procedure.
Generating real world evidence on clinical benefits/risks is becoming a necessity: medical device regulatory are increasingly focusing on clinical evidence to support benefit-risk evaluation. Clinical evaluation, for example, is a key requirement of EU-MDR, the new medical device regulation in the European Union. We need to look at registries, clinical literature, patient reported outcomes and other sources of real world data to generate clinical evidence for regulatory approvals. There are challenges associated with real world data in term of quality and compliance. It is a good idea to engage with regulatory authorities to seek early feedback on your real world data and evidence generation plans. We expect to see a lot more focus and movement in this area.
About Dr. Elisha Patel
Elisha Patel is a qualified dentist with degrees in both biomedical sciences and dentistry. Her clinical experience includes her tenure as a dental surgeon in the National Health Services (NHS) system of healthcare in the United Kingdom. Currently, she is an associate consultant in the medical evidence practice at a leading consulting firm.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
We will use the term “physician” as a general category of medical professionals, which may include surgeons and other professionals with advanced medical training.