With lifestyles evolving and corporate cultures embracing work-from-home concepts, technological advancements and simple internet connectivity are transforming society. Healthcare is no exception. Globally, modern healthcare technologies and medical devices are gaining popularity. According to a report by Fortune Business Insight, the market of global medical devices is predicted to grow from $455.34 billion in 2021 to $657.98 billion in 2028 at a CAGR of 5.4% between 2021-2028.
The idealism underpinning home-based or distance-care structures has been around for a while, but their growing popularity can be attributed to a focus on reducing operational costs rather than satisfying patient-driven needs. In addition, out-of-hospital consultation and remote diagnostics have taken center stage due to the pandemic's impact on medical practices to reduce the danger of viral transmission and hospital loads.
As a result, the value of a multibeneficial process has been heightened, including lower clinical overhead, increased efficiency, faster transactions, and greater convenience for all stakeholders. When we consider the changes in the healthcare organizations due to COVID-19 related events and the recent progress toward distant care, it's clear how swiftly the medical device ecosystem is changing.
This post discusses the changing features of the medical device design process and how the drive toward more home-based and distance-care may continue to evolve in a post-COVID future.
The Changing Face Of Medical Device Design
Ideation And Conceptualisation Of Products
Medtech innovation begins with evaluating and discovering a market with an untapped or unmet demand or a more effective way to fulfill such needs. These requirements could include anything that provides a solution, such as a new or improved method of monitoring health, improved care delivery solutions, gadgets or technology to improve administration, or anything else that promotes health and human life.
Prioritization Of Costs and Additional Risk Mitigation
There is a changing trend in who uses the medical gadget as part of a concerted effort to reduce total cost. Clinical professionals, nurses, and medical technicians, for example, are now in charge of equipment that physicians and surgeons formerly managed. User interfaces are designed to be easier to use and more intuitive than in the past, allowing less experienced employees to use them more readily.
As a result, establishing varied levels of interface operability to accommodate the user's range of ability and training is critical. Furthermore, different parameters should be adjusted, allowing clinicians to define and lock the restrictions on procedural protocols if necessary. For example, Med-techs can access everyday setup and operations controls to reduce mental fatigue, while nurses can supervise and monitor only vital metrics during their shifts.
Recent device designs take into account these changing user requirements. For example, mobility is critical to saving capital investment expenditures among sporadically used instruments shared between operating rooms, wards, and other point-of-care (POC).
Improving Compliance For Medical Device Companies With Complex Operations
Modern medical device manufacturers rely on distributed teams and supply chains to accelerate product development and launch, including design partners, contract manufacturers, and tiered component suppliers. According to a report, companies that have embraced new technology and cloud-based systems can improve product capabilities, and regulatory compliance objectives.
Digital treatments, medical diagnostic equipment, implantable devices, and disposable devices are just a few of the many technologies in the life sciences industry attempting to solve problems while delivering higher throughput and preserving compliance.
Medical device and equipment makers face numerous hurdles as they progress from early idea and design to commercialization in the present pandemic crisis. Better designs and quality procedures to counteract the effects of Covid-19 can only be achieved by embracing a newer and higher quality standard pushed by leadership and adopted by everyone involved in the product realization process.
Verification And Validation Are Necessary
To gain a successful market share, any medical equipment must meet the functionality, usability, and reliability requirements. Aside from these factors, end-users consider the effectiveness and safety of equipment they use to address a specific ailment or condition. This is why iterative testing of these medical devices through verification and validation is critical.
Verification
Verification is an internal procedure that determines whether a design output complies with the requirements, specifications, or regulations provided in the design input.
Validation
Validation is internal to the external procedure that determines whether or not your product meets the needs of targeted people.
The medical device verification and validation process guarantees that the device is aligned with the needs of targeted consumers and that it delivers the intended solution. It also aids in determining whether all of the standards have been met. It aids in meeting regulatory compliance and developing high-quality products with improved production processes.
Medical devices come in various shapes, sizes, and levels of complexity. The regulatory environment drives verification and validation (V&V), which must adhere to international standards.
Standardized V&V operations can improve the approval process and streamline the manufacturing process. The V&V process can also benefit from automated testing, diagnostic approaches, and data collection systems.
Final thoughts
The lines between pharmaceuticals, medical devices, software, and patient data are becoming increasingly blurred. Patients expect Amazon-level service in every part of their life; physicians demand data from numerous sources in one location, and payers require better real-world outcomes and lower financial burdens.
Design becomes a CEO-level topic for pharmaceutical and medical device manufacturers when these two themes converge. It's tough to create a product—and, more importantly, a good patient experience—that stands out in an increasingly crowded market without first-class design.