The safest way to bring ideas to the market

Written by: Cátia Rodrigues, QA & RA Coordinator

When you're a child and you think about what do you want to be in the future, you always think about ways that you can change the world to a better place by being a doctor, a fireman, or even a singer. But you never think of becoming an engineer right? I've never heard a kid saying "I want to be an engineer" "I want to do Regulatory Affairs". But it is only when you grow up that you find the power within these jobs and within small companies like Adapttech.

Nowadays technology is present in so many aspects of our day that it becomes impossible to separate it from health. With the help of technology and specialized fields such as Biomedical Engineering, everyone can now take advantage of fast methods of diagnostic, cutting-edge treatments, and procedures that are as minimally invasive as possible. We've now come to the time that, besides using our knowledge and resources to improve diagnostic and treatment, we can improve the general quality of life of the patient through many years.

But at what cost do these technologies come to the market? We've seen in the later years a boom in new medical devices and companies in the market releasing not only devices to be used inside the clinic, but also in the daily life of the patient, which makes us think that releasing a new device is easy after you develop the technology. But is it that easy? Well, it shouldn't be.

Any new technology has a level of risk associated with it. As an example, having a badly translated sentence in the instructions for use can cause enough confusion that leads to a bad use of the device and in the worst case, in hurting the patient.

In the case of most Class I Medical Devices (that present a low risk to the patient/end user), they can be almost automatically placed in the market, which leaves the responsibility of making the device safe and appropriate to the manufacturer. With the rising demand of the market, the easy way to go is to prove your medical device is a Class I low-risk and assume everything is going to be fine for the lifetime of the device, but a simple Google research will tell you otherwise. Planning your risk management is also planning for the success of your device in the market as well as avoiding unpleasant surprises with your customers. Minor incidents, even though considered minor and not meaningful for product recall, can ruin a relationship with a customer and with other known partners as well as the confidence of your company, potentially breaking the confidence for future products the company might want to release in the future.

Another aspect that helps you plan for your success is always having the customer's interests and vision in mind. This does not apply only after you develop your first prototype and starting trials with patients, it is a mindset that should come when planning your product and the vision of the company. When you're ideating, it is important to make yourself some questions and to adapt your product as you go with it:

• Is there any market interested in this type of product?

• In what way is this product saving time and money to the interested stakeholders?

• In what way is this different from everything that is currently done in the market? (And with this question, an intensive investigation of technologies and products that are placed in the market and that are patented should be done.)

• What is the real problem that I'm eliminating by developing this technology?

• What is the impact of inputing this technology into the patient's life or in a clinical routine?

• In what way can I improve the impact and interest of the product and broad the fit of it?

The process of validating your ideas with the important stakeholders is important through all your design control, as you create your requirements, as you work on a prototype and as you develop. A way to do this is through usability tests, for example, you can validate your features, the flow of your user interface, the overall user experience and take that feedback not only through your design and back end but to your risk management as well. This is the best way to make sure that your product fits the clients' needs and expectations and to make your device enjoyable and bulletproof, filling in the real needs of the market you're selling to.

So now that you have a fully functional product, ready to go to the market, can you stop worrying? No, not yet! A very important aspect that goes through all the regulations is Post-Market Surveillance. Post-Market Surveillance is mainly about how to handle feedback and complaints coming from your clients or other 3rd parties, and you need to make sure that while you correct the issue, you're also learning from it and you're also preventing it from ever happening in the future and making sure that it is not a risk issue that can be harmful to someone. But Post-Market Surveillance is also about making sure that your product is evolving as the world of technology is. You cannot expect that a device that is wonderful in 2000 will still be wonderful in 2021, otherwise, we would all still be using a Nokia 3000. It is important that your engineers have in mind that they should research new technologies released, new patents, and trends in the market. Competition is also a source of inspiration, not just competition.

Finishing off by going to where I started, I know now that although Regulatory Affairs only seems like a mandatory bureaucratic part of the process, it is the most profitable way to make sure that the ideas of great minds are well placed in the market and are going to change the lives of the ones that most need it. Giving Adapttech's goal of “Improving the quality of life for people with physical limitations through the use of innovative and smart wearable technologies," a meaning.