“Smart, interactive and automated devices ergo ‘electronic’ are the future of drug delivery devices”
Drug Development Delivery’s latest issue features Nemera’s article titled: magazine includes an article from Nemera: ‘Mapping the regulatory strategy to better navigate electronic drug delivery device development for patient safety & security’
Smart, interactive and automated devices ergo ‘electronic’ are the future of drug delivery devices. And thanks to drug delivery digitalization, patients might have the opportunity to significantly improve their treatment adherence. In this article, our team addresses some of the consequential questions like: How do these advancements mitigate risks of cybersecurity? How do these advancements meet regulatory requirements? And why it’s crucial to understand the regulatory requirement thoroughly from the beginning of product development. Read more!
In accordance with the growing interest toward the electronics in drug delivery devices that offer real added values in comparison to mechanical devices, it is absolutely crucial to understand the regulatory requirement thoroughly from the beginning of product development. Patient safety has to be the priority while patient security must be the key driver of the electro-medical devices’ development.
The article includes different stages:
- ELECTRONICS ALTER STAKEHOLDERS’ PARADIGM & TRENDS IN DRUG DELIVERY DEVICES
Along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve. As a matter of fact, there is a clear interest in electronic drug delivery devices for a wide range of reasons. Patients need smart, interactive, and automated devices to help them administer their treatment on a regular basis in the home setting, without the need of other peoples’ assistance. Indeed, it is without a doubt there is a strong digital adoption by patients as they want to become more independent. Moreover, through drug delivery digitalization, patients may have the opportunity to significantly improve their treatment adherence, which has become one of the major issues in self-administration today. For instance, patients’ adherence in glaucoma treatment can be as low as 37%.1 Nevertheless, through digital reminders, some studies show that patient adherence can be multiplied by three.2 In addition, as there is an increase in the number of new molecules, there is an obvious need of advanced delivery systems to help patients administer their drugs in the most convenient way possible. As a matter of fact, newly developed molecules, such as biologics and formulations with high viscosity, can require specific administration conditions. Consequently, the electronics are increasingly used to obtain this specific condition. Taking wearables as an example, these devices are developed to help patients inject viscous formulations that require time-consuming drug administration. This situation thus explains why industrial players continue innovating in digitalized health solutions.
Different healthcare stakeholders will be able to benefit from the emerging trend of electronic drug delivery devices. Patients may improve their quality of life as they can better monitor their chronic diseases. In addition, both healthcare providers and caregivers may also have the possibility to check their patients’ adherence and compliance to optimize treatment efficacy. Researchers have a high interest in monitoring patient behavior to obtain more reliable data, particularly in the case of clinical trials. At last, the data that will be generated by the electronic devices will help pharmaceutical companies and payers to also access better quality of statistical analysis on patient behavior. Moreover, this may help them to better adapt their solutions to the real needs of the patients.
- UNDERSTANDING THE COMPLEXITY OF THE REGULATORY EXIGENCE
In spite of the fact that electronic devices offer real added value and opportunities, there is a slower adoption of this innovation trend than expected due to various factors: one of them being the exigent and thorough regulatory requirements that have to be completely well interpreted. In fact, the regulatory requirement for electronic device development can be split into three categories, namely concerning mechanical, hardware and software, human factors, and cybersecurity.
- CONSIDERING HARDWARE & SOFTWARE FACTORS IN ORDER TO COMPLY
- TAKING INTO ACCOUNT REGULATORY DEVIATIONS TO STAY ON-TRACK
- OPTIMIZING DEVICE USABILITY THROUGH HUMAN FACTORS VALIDATION TESTS
- MITIGATING THE RISKS OF CYBERSECURITY TO ULTIMATELY ENSURE ELECTRONIC DEVICE CONFORMITY
- MEETING REGULATORY REQUIREMENT TO EVENTUALLY LEVERAGE PATIENT SAFETY & SECURITY
The full article:
- ‘Mapping the regulatory strategy to better navigate electronic drug delivery device development for patient safety & security’
The full issue of the magazine:
Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generics industries. Nemera offers a comprehensive portfolio of products and services across ophthalmology, nasal, inhalation, dermal, transdermal and parenteral delivery. Nemera’s vision is to be the most patient-centric drug delivery device company. Nemera always puts patients first, providing high-quality solutions that have a demonstrable impact on patients’ health
Nemera’s newly branded Insight Innovation Center, with offices in North America and Europe, provides consultative services to support your overall device strategy. Providing user research, Human Factors, User Experience design, and Design for manufacturing, the Insight Innovation Center can help customers navigate their device strategy for both novel and platform solutions. Users are at the center of everything that we do in our effort to always put patients first.