Author: Jorge Figueira
Quality Compliance Engineer
Jorge has an Industrial Engineer degree and a Master's in Quality Systems. He has 19 years of experience in quality management and is responsible for our QMS and keeping Thrive compliant with key standards. Jorge oversees the medical device strategy service for our clients.
Introduction
The healthcare industry has witnessed a significant transformation with the introduction of wearable medical devices as they provide an abundance of health data not thought possible in the past. The development and growth of these types of devices are paramount in supporting healthcare providers to deliver more personalised and effective care. Key benefits of these devices include not just improved patient outcomes but reductions in healthcare costs and enhanced patient engagement.
However, developing and launching a successful wearable medical device isn’t necessarily a simple task. It requires a well thought out strategy that takes into account various factors such as regulatory compliance, market research, user experience, and technology advancements. A clear comprehensive strategy that considers all of these aspects can streamline the process of creating effective and innovative devices that meet the needs of patients and healthcare providers.
Read on to hear from Thrive’s Quality Compliance Engineer, Jorge Figueira as he explores the key significance of having a medical device strategy, the importance of keeping regulatory requirements at the forefront of your mind, mitigating risk and much more.
Firstly, what are the differences between a wellbeing device and a medical device?
Jorge: Wellbeing devices and medical devices ultimately differ in their intended use and regulatory requirements. Wellbeing devices which are also known as consumer health devices, are usually designed to help individuals track and manage their health and wellness. They are typically used for self-monitoring and self-care purposes, such as tracking physical activity, sleep patterns, and nutrition. Examples of wellbeing devices include fitness trackers, smart scales, and sleep monitors. These devices are not intended to diagnose, treat, or prevent medical conditions, and they are not subject to the same level of regulatory oversight as medical devices.
Medical devices on the other hand, are designed to diagnose, treat, or prevent medical conditions and are therefore subject to strict regulatory oversight to ensure their safety and effectiveness. Medical devices can range from simple devices to complex devices, such as pacemakers and MRI machines. They are also classified based on their intended use and the level of risk associated with their use, with higher-risk devices subject to more stringent regulatory requirements.
How do you transition a wellbeing product into a medical device?
Jorge: It’s essential to first begin by determining the intended use of the product you want to design. This involves identifying the user need for the device, whether it’s for more general wellbeing support or to support a medical condition that would be used for diagnoses, treatment, or prevention. Once this has been defined, the next step is to then assess the regulatory requirements that apply to medical devices in the target market. This includes identifying the appropriate regulatory classification, determining the necessary testing, and documentation requirements.
The next stage should be designing and developing the device according to those regulatory requirements that have been previously defined. This phase must also determine the use of appropriate design controls and risk management processes. This might also involve conducting additional testing, such as biocompatibility testing and clinical trials, to demonstrate the safety and effectiveness of the device.
The next part of the process would then be preparing for regulatory submissions to be shared with regulatory authorities for approval. This may include providing documentation of the device's design and development, testing results, and clinical data. And then finally, the last thing to consider would be establishing quality management systems to ensure ongoing compliance as this is a key part to establishing robust quality management systems, including processes for post-market surveillance, adverse event reporting, and corrective and preventive actions. In order to ensure that the device is as safe and effective as possible for its intended medical use, it is imperative that all applicable requirements are met through this process.
Who needs to consider regulatory requirements as part of their future project plan?
Jorge: Companies that are manufacturing wearable products that are considered to already be on that borderline with medical devices that have features such as measuring heart rate, blood pressure, or other physiological parameters. Companies selling such devices need to be vigilant about regulatory requirements as they can easily fall into the category of medical devices due to similar capabilities and features between the two.
In this case I would advise considering regulatory requirements as part of their future project plan. Any device that intends to diagnose, treat, or prevent a medical condition, is likely to be classified as a medical device and subject to regulatory oversight. This is why developing a regulatory strategy is key to ensuring compliance with essential regulations to avoid costly mistakes.
How could a medical device strategy mitigate risk?
Jorge: This process can help mitigate risks in several ways. Firstly, it ensures safety and effectiveness and minimises the risk of harm to patients or users as all the necessary safety and performance standards would be met throughout this process. It also prevents risk of potential costly mistakes, because failing to comply with regulatory requirements can result in delays in product development and approval, as well as costly recalls and legal liabilities.
Compliance with requirements is a prerequisite for market access in many countries which is important to bear in mind, to ensure clients can market and sell their device in their target markets, maximising potential reach and revenue. Additionally, demonstrating a commitment to safety and compliance can enhance a company's reputation and trust with regulators, healthcare providers, patients or users and allow them to differentiate themselves from competitors.
When and why would you need to consider a medical device strategy?
Jorge: You should consider a medical device strategy if you are considering developing or marketing a medical device, or have a wellbeing device which is close to becoming, or you would like it to become, a medical device. As this comprehensive plan forms a clear outline for the key steps to take you through development in order to market such a device.
This strategy is critical as it supports the process of developing successful and safe devices. A well-planned strategy can also identify potential risks and ensure that the necessary measures are in place to mitigate them. Additionally, it can help you to navigate the complex regulatory environment by simplifying it and breaking it down so it's much more digestible. Medical devices are subject to stringent regulations, and as mentioned previously, failure to comply with these regulations can result in significant damage.
At Thrive, we offer comprehensive support and services to help clients develop and implement a successful medical device strategy. Find out more here
What are the benefits of investing in creating a medical device strategy?
Jorge: There is an abundance of benefits to having a well-defined medical device strategy. It provides a structured roadmap to market your medical device, and it can also simplify complexities on regulatory requirements. A medical device strategy can also streamline a typically long process and reduce additional costs.
Also, facilitating regulatory compliance in the creation of your device reaffirms safety and efficiency which ultimately enhances market success. The strategy also allows you to identify the target market, review the competitive landscape, and identify unique selling points which would allow you to optimise marketing strategy and increase the chances of commercial success.
Why should you think about regulatory requirements early on?
Jorge: Preparing for anything ahead of time in this case is beneficial as it will save a lot of time and capital in the long run. Addressing regulatory requirements can put you in a much stronger financial position, reduce delays in production and ensure all necessary requirements are met. If you’re considering making a medical device it’s important to address this as early as possible as this is a critical step in the process of development. If a device fails to meet regulatory requirements, it can create delays with high cost, prevent the device from being brought to market, and potentially affect how stakeholders view your brand - which is exactly what you need to avoid.
It’s no surprise regulatory requirements can be complex and time-consuming to navigate but by thinking about them early on can ensure you have the necessary resources and expertise in place to streamline the regulatory process. Also, because device regulations vary from country to country, thinking about this ahead of time can allow you to develop a device that meets the necessary regulations for multiple markets, facilitating international market access and increasing the device's potential market size.
Conclusion
If you need support in navigating the complex process of regulatory approval, we’ve got you covered. Read more on our medical device compliance strategy here. This service is intended for anyone who wants to bring a medical device of any risk level classification to market, whether it is in the pre-prototype or prototype stage.
Do you have an idea for a wearable product? When you’re ready to progress your vision, we can assist you across all areas that cover research, innovation, and concept generation. We also can support you in prototyping physical and digital systems, designing Machine Learning and AI approaches, and production management.
Get in touch with us here if your goal is to help change the world for the better through evolving incredible ideas into successful products in the health and wellness space.