Regulatory shifts, as well as a focus on device usability and connected devices, are changing research and development processes for the medical device industry.
George I’ons and Gareth Walker
The medical device design and manufacturing industry needs to innovate and evolve to meet today’s demands and regulations. The regulatory landscape will continue to impact medical device design and manufacturing. For example, the ramifications of a broadening understanding of what qualifies as a “combination product” will continue to affect the industry. Devices which have traditionally been viewed as a separate drug and device are now being perceived as combination products: an active pharmaceutical ingredient and a medical device are seen as one.
This raises unique regulatory challenges. In our work at Owen Mumford, we are already seeing refillable reusable devices being viewed in this manner. The impact from a regulatory point of view will continue to affect the medical device industry through to 2016 and into the future. In fact, market researchers at Technavio predict that the global drug device combination products market is set to grow at a compound annual growth rate (CAGR) of 11.95% over the period 2014-2019.
There has also been a noticeable shift in the way new combination products are being produced. These products are now increasingly dependent on a close working relationship between the companies developing and manufacturing the device, and the pharmaceutical companies producing the drug.
We are seeing our already close relationships with customers become deeper, requiring clearly understood roles in the relationship and greater levels of collaboration. This is necessary to generate device solutions that are optimized for the needs not only of specific formulations and patient groups, but also in supporting pharmaceutical partners’ internal needs. These needs can relate to procedures, documentation, and regulatory submissions. It can also extend to operational aspects, such as implementing final assembly solutions. Working in an open and collaborative environment has the added benefit of facilitating communication, opening opportunities for greater innovation and faster decision-making—thereby improving time to market.
One element that is expected to continue to mature throughout 2016 is device usability. Since the purpose of a medical device is to enable the patient to receive their medication as and when needed, usability is a key factor to consider in the design of a device. This year in particular, we’ve seen the progression of the safety syringe market. The market is expected to reach $6.496 billion by 2019, developing at a CAGR of 9.7% during the forecast period from 2013 to 2019. It’s anticipated that there will be notable increase in use throughout Europe and a greater demand for safety syringe products not just into 2016 but in the coming years.
With the increase in demand for safety devices, the move to disposable devices is also expected to continue. This is primarily driven by usability, since the more an individual uses a drug, the more likely it is to go into a disposable format. A disposable format can offer far fewer user steps which ultimately increases usability and convenience benefiting the end-user.
This moves us onto the discussion around introducing electronics into devices. For example, talk of connected devices is well under way and is expected to continue in 2016. However, there are concerns around patient privacy, cost, environmental concerns around disposal of electronic components, and end-users often preferring a simpler approach to self-treatment. How connected devices will actually operate in a real world patient setting is still the subject of debate. The conversation has most definitely started and will likely continue to be a key focus in the coming year.
According to Deloitte’s research on connected health, mHealth market growth is predicted to reach $21.5 billion globally by 2018, with a growth per year of 54.9%.
While it’s not yet clear how connected devices will operate in a patient setting, it is known that end-users are increasingly after a simple approach to self-management. Using human factors engineering, we look to assess the usability of a device before it’s manufactured. We carry out user studies that include patients and healthcare professionals who test the prototype. From this feedback, Owen Mumford can then produce another prototype that addresses any issues found during the study, and improves the device for the end-user.
Our 3D printing capabilities mean we can now produce prototypes more rapidly with increased accuracy. We’re constantly trying to tailor a device to the end-user and by including these user studies at an earlier stage in development, we can produce concepts faster. This is something that we will continue to see throughout 2016. Carrying out user studies at an earlier stage of device design allows you to solve usability issues and identify areas to develop, earlier in the design journey.
George I’ons is business development manager at Owen Mumford, a leader in medical device design and manufacturing.
Gareth Walker is human factors specialist at Owen Mumford.
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