Medical devices: the road to the finished product is not easy
Medical devices: the road to the finished product is not easy
Interview with Jakob Däscher, CEO, IMT Information Management Technology AG
These days, many groups make various demands of medical device developers: manufacturers, users, patients and government agencies. Given all of these interests and concerns, the developers face many challenges. In this interview, we put some of them under the microscope and examine how they can be sidestepped or entirely avoided.
In this interview with MEDICA-tradefair.com, Jakob Däscher talks about the medical device development process, discusses the stumbling blocks for manufacturers and developers and details the role the networking of devices and the influence of consumer electronics play in this case.
Mr. Däscher, what constitutes good design for a medical device?
Jakob Däscher: There are three aspects that are important in my opinion. First of all, the device should be aesthetically pleasing and reflect the current tastes, similar to how it works in consumer electronics. To this effect, physicians and medical staff are also consumers and prefer to purchase and use an attractive device.
Secondly, when it comes to devices with a graphical user interface – technically all of today’s devices- usability is essential. It goes hand in hand with an intuitive design that is easy to learn and operate for users, as is the case with today’s mobile devices. Medical device standards also greatly emphasize usability to avoid operating errors.
The third aspect dictates that good design also need to be functional. That is to say, a device must clearly present its functions for the respective application area and not needlessly distract from them.
What was your guiding principle behind the development of the "bellavista" ventilator apparatus?
Däscher: In addition to the three aspects mentioned above, we - IMT as the development partner and imtmedical as the medical equipment manufacturer – wanted to deliver a better ventilator performance for patients because, from a research point of view, there is still a lot of room for improvement and doubts as to what is truly "comforting" for patients when they need to be ventilated. Our second guiding principle pertained to ensuring that staff members are able to easily operate the device without being specialists.
The more different requirements are made to a single device, the more complex its construction and design become. This affects, for example, its controls and its electronics.
What are some of the challenges of this type of development?
Däscher: The device development process becomes more complex with an increased number of different requirements the equipment is intended to meet. A lot of requests from different groups such as product managers, physicians or nursing staff flow into this process. In the case of "bellavista", a relatively inconsistent state of research also contributed to the high complexity of the device requirements. Our clients need to have a clear vision of what the device should accomplish for the market they mean to address.
In addition, the requirements for the device approval are getting increasingly complex as well, which also makes its development more difficult. Our clients have to disclose a much wider range of information for the approval process and they expect our help and know-how to ensure the approval of their products.
What do today’s medical device manufacturers emphasize when they are developing a device?
Däscher: Oftentimes it is not enough to just have technical expertise. Customers also expect knowledge about specific market segments and areas of application. When we develop an ophthalmic operating microscope, we obviously also need to understand eye mechanisms and the corresponding surgical techniques.
What’s more, service providers like IMT also need to have a big enough team to handle this task. A major medical device project requires between 20 and 30 engineers with a diversified knowledge. In our case, this means expertise in software, hardware, mechanics, quality control, project management, and production. The latter is quite important because we have to assist clients in implementing series production.
Are certain products or product groups more difficult to develop than others?
Däscher: I do not view this issue from a product group point of view but rather in terms of the application, which involves particular difficult aspects. In the case of ventilation, for example, the control system is a difficult area because it directly affects the quality of the ventilation. This is something that is noticeable for the patient and verifiable via measurement technology. Once again, the problem in this case is that there is not enough basic research.
In ophthalmic optics, this pertains to precision for instance. In this case, we need to be able to control instruments and lasers in the micrometer range. This is very difficult.
The are many stumbling blocks in the way towards a successful product. Product designers help manufacturers early on to evade them.
At what point during the development process do you see the biggest potential stumbling blocks for manufacturers?
Däscher: At the start of the development, many clients do not have a clear idea of the specific function and user requirements of the device. We need to develop them together. Usually, you also have to make concessions in functionality or purpose to avoid blowing the budget. Things get difficult if the purpose and user requirements change even slightly afterward. Normally, the development subsequently becomes larger, broader and more expensive.
What’s more, the development of a reliable, approved and premium medical device involves increased investment costs that typically exceed one million Euros. This is an especially difficult endeavor for small companies and startups.
There is an increasing desire for medical device networking. Is this a problem for developers?
Däscher: Generally, you could say that users and industry want networking, the exchange and availability of data, though the practical feasibility is a different story. While it is technically feasible, it actually falls through due to organizational issues, especially at hospitals. From the user’s point of view, networking should be a readily available option because we know Bluetooth and wireless LAN from mobile devices. Meanwhile, IT departments take a more skeptical view due to safety concerns pertaining to data loss or unauthorized access. This has a major bearing on an efficient, sensible networking of devices.
What are the current trends you see in medical device development?
Däscher: The functionality and complexity of seemingly “simple“ devices continue to increase. Just think of heart rate monitor wristbands for example. Eventually, people get the idea to transfer the data to other devices, to a smartwatch or smartphone, for example, that subsequently require an app to do this. You then want users to be able to analyze this data, display it in statistics and store it in the Cloud. In doing so, this product becomes more and more complex, yet these are all functions that are nowadays incorporated into medicine. This is also where networking and safety play an important role again. And that is why this subject is also very exciting for us as developers: to determine today’s market opportunities and how they can be implemented in medical technology.