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1 Introduction

As products are becoming increasingly complex, the product design and development (PDD) processes are also evolving into collaborative multidisciplinary team processes. This creates new challenges, both for product development, but also in project management. In the case of medical devices, this is further complicated by rigorous specifications and regulatory requirements [1], as well as the fact that the development process requires strong interaction with multiple individuals, with the concept of end-user depending on the specific device. It is this important to understand how the PDD process can be planned for and managed in the case of medical devices, whether they are a single biometric device or a complex information coordination system [2]. This chapter follows previous studies on product design specifications [3], wireless networks for health monitoring [4], evaluation of vital signs monitoring systems [5], communication platforms for medical data [6], embedded microelectronics [7], and performance evaluation of ZigBee networks [8].

The first section describes the life cycle of novel medical devices in the current context of increased complexity and performance demands.

The second section focuses on the laboratory development stage, with the goal of obtaining a fully functional product, although typically not optimized for production and not sufficiently competitive for the market. The actors and their respective roles are described, namely in the framework of user-centered design, with emphasis on the development team. In fact, for a successful outcome, a plethora of different people have to become involved in the project.

It is also important to establish how to get from user wants and needs to partial product design specifications (PDS). These need to be understood by people from different areas, requiring agile and effective communication among team members. The PDS are partial due to the fact that many specifications only need to be defined (and in fact, can only be defined due to insufficient knowledge) at the industrial productification stage.

Some specifications must even be jointly specified by team members of different expertise. Thus, an analysis is provided in the third section on the multidisciplinary integration within the development team and communication between this team and the different other actors that are essential for a successful product development process.

In large projects, and particularly when multidisciplinary teams are involved, the role of coordination becomes pivotal, and it is very important to understand some of the characteristics of how that can be effectively achieved. This is the goal of Sect. 14.4.

Section 14.5 describes a survey conducted with several people involved in medical devices development projects. These individuals were selected in order to cover the different profiles that are established in Sect. 14.3 (researchers, practitioners, managers). Although the number of surveyed professionals is small, the survey provides some interesting information on their different perspectives.

Finally, in Sect. 14.6, a case-study is succinctly described, where several different areas of expertise were brought together in a multidisciplinary team, working close together with different healthcare professionals, resulting in a health support system that includes biometric devices, communication networks, and information systems technology.

2 Life Cycle of Novel Products

Developing new products is a complex process, and multiple methodologies have been proposed over the years by different authors on how to approach this systematically. However, a major obstacle is the highly variable nature of the process. In the specific case of medical devices, new products u?sually take considerable time before reaching the market, not only due to the development stage, but also certification, setting up distribution channels, and many other necessary steps. Despite the wide range of possibilities, in most cases there are two main phases within the development process.

2.1 Main Phases

Medical devices are typically developed either by:

  • Companies within the scope of their business plan;

  • Research teams at Universities or R%&D Centers within the scope of their ongoing research activities on healthcare or a specific research project.

These two cases may appear very different at first sight. However, in both cases there are, almost inevitably, two different development stages; see Fig. 1. The first stage results in a fully functional device but not optimized to be market competitive. A second stage is required, where many specifications and product features are revised, a?nd several aspects which could (or had to) be left open are defined.

Fig. 1
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Stages in the life cycle of novel medical devices

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The difference between these two stages being conducted wholly within a single company or the first stage in a research unit and the second in a company (either through patenting or through a spin-off or a start-up) pertains essentially to:

The extent of communication between the teams intervening in those two stages;

  • Agility of the transfer process;

  • Ability to retain members of the first stage team in the second stage team.

  • After the industrial productification stage, come all other stages of a product life cycle, such as distribution, end-of-life handling, etc., undoubtedly important, but outside the scope of this chapter. Obviously, these later stages may have a large impact into decisions made for the development of subsequent versions of the product or future related products.

2.2 Focus of This Study

This work focuses on the first development stage, conducted by a research team, in cooperation with different clinical professionals, pursuing a fully functional, albeit laboratory-state, prototype.

3 The Laboratory Development Process

Only within the scope of laboratory development, there is much to understand regarding the different actors involved and what their role is in the process of going from the market needs to product concepts and subsequently product specifications.

3.1 Actors and Roles

One of the key features of current development practices in the field of medical devices is the involvement of health professionals from the start. This type of collaborative development, following widespread approaches such as living labs, translational research, or the most traditional sub-contracting the advice of expert healthcare professionals, is currently regarded as most effective and followed by the major companies in the field.

Independently of the degree of interaction between the development team and the end-users, these two main groups are vital elements of the process, as shown in Fig. 2.

Fig. 2
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Typical actors involved in the laboratory-stage product development cycle of novel medical devices

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Thus, on one side, we have the development team, responsible for the scientific development and technical implementation of the prototype solution.

For most medical devices, development teams have to incorporate researchers from a variety of fields, such as electronic engineering, computer science, biomedical engineering, materials engineering, design, and social sciences. The formation and inner working of these teams is further explored in §3.2.

On the other side, we have end-users (various healthcare professionals and patients), marketing professionals, and decision makers (e.g. health provider facilities administrators):

  • Medical doctors. They are the key interface between scientific research and field practice. Thus, they must be an integral part of the development, from concept development and selection, setting PDS (including technical and non-technical requirements), and product validation (including field trials). Their opinions will be collected by decision makers and thus they must find added value in the new products compared to previous solutions (if they exist). Their level of involvement and contribution to the project will naturally affect their opinion of the product.

  • Nurses. Very often they will be the ones using the device. Even if not, they will be responsible for one of the following: setting it up, making it available to doctors, or giving it to patients. Their role is pivotal and their opinions should be collected from early development stages. It is important for them to validate the device.

  • Technicians. Important to establish the physical placement/embedding of devices and equipment in the facility, interacting with existing computer networks and communication grids. Any changes required on the existing infrastructure or service practices will be difficult (due to the strict requisites and certifications in healthcare) and should be planned well in advance.

  • Patients. It is vital to develop medical devices in a user-centered approach. In many cases, users are doctors or nurses, but often they are patients. In these cases, they should be involved from the earliest development stages.

  • Market analysts. They should provide detailed information about current and upcoming technologies and solutions, trends in the specific field of the product being developed, and should also be involved in setting some PDS (e.g. cost).

  • Communication and media advisors. Not only should they be involved in planning dissemination and advertising of the developed product, but they should create a plan for enticing the media, particularly for highly innovative devices.

On the end-user side, all these professionals are coordinated essentially by a few decision makers, such as hospital administrators (or board), or private healthcare facilities owners. These decision makers often have a technical or medical background, but will collect advice from their key staff on most decisions about the selection of health technologies or investing in new products. The bridge between the development team and all other actors, including the decision makers, marketing, and healthcare professionals, has to be coordinated by the project leader.

3.2 The Development Team

As previously stated, development teams have to incorporate researchers from a variety of fields:

  • Electronic engineering: sensors, actuators, communication hardware/protocols, data processing.

  • Computer science/Information Systems: data communication, data storage, data mining, security protocols, user interfaces.

  • Biomedical engineering: usability, hardware, medical data acquisition and interpretation.

  • Materials engineering: materials selection, device housing/casing, user interfaces.

  • Design: user profiles, concept development, ergonomics, aesthetics, interfaces, device housing.

  • Social sciences; user-perception of devices, user needs, questionnaires and interpretation, epidemiological aspects.

Obviously, the composition of the team is highly dependent on the specific device, but currently most devices will require tackling at least some of the competences listed for each of the fields of expertise above. It is thus not surprising to find teams will be based on the above listed competences, in some cases complemented by others with specific expertise.

One should notice that the only reason the development team roster above does not include clinical staff and medical doctors is because this discussion assumes the team is working cooperatively in close collaboration with those professionals, following the development approaches listed in §3.1.

3.3 Understanding Wants and Needs

On the earlier stages of the development process, methods such as Ethnographic Research and Voice of the Costumer can be employed to assess and understand user wants and user needs. These methods can help translating the ‘needs and wants’ of the user into product requirements and features. If the project is planned and implemented following a user-centered approach, identifying the best methods to be used for this purpose should not be a problem.

3.4 Product Design Specifications (PDS)

Pugh is one of the key authors dealing with this issue in depth [9]. He compiled a comprehensive list of types of specifications, in a wide range of aspects of the product development process. In this work, namely in §4, we analyze and classify the PDS, based on Pugh’s list, which we believe helps in selecting specifications for a particular project. A better understanding of specifications and their role on the product development process is required, particularly in the current trend of faster obsolescence and increasing complexity of products [10].

The team will have to define a set of PDS at the early laboratory development stage. However, this will only be a partial PDS, since: (a) the team does not have sufficient understanding of the problem and sufficient definition of the solution to set some of the specifications at this stage, and (b) there is no need to establish specifications that will not affect the final output of the laboratory development process.

During the laboratory development stage, the key PDS to set are those that have a direct impact on the selection of concepts and solutions, selection of technologies (such as a communication standard), or usability. This is shown schematically in Fig. 3.

Fig. 3
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Setting product design specifications at different development process stages. See text for interpretation and discussion

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In Fig. 3, PDS are represented with respect to when they are set along the development process, considering two large stages: laboratory development and industrial productification. A bold PDS border implies a primary PDS, whereas dashed lines imply secondary PDS. Also, some PDS are shown stretching between phases, which implies they are either: (1) set in the first stage and revised in the second, or (2) preliminarily considered in the first stage, but only fully defined in the second stage.

As an example, while ergonomics is important at an early stage, since it will come into play in concept selection and in the validation of the conceptual solution with end-users, aesthetics and finish can only be specified when materials, manufacturing processes, and cost are being defined.

Note that although the assessment in Fig. 3 categorizes PDS as being of primary or secondary importance in the specific framework of medical devices, this is quite subjective and dependent on the specific product. It also does not mean the secondary PDS do not require considerable attention. The assessment was essentially based on personal interpretation of current trends in development of medical devices from the analysis of multiple recent and ongoing projects in the area [11].

From the analysis of Fig. 3, one can state that the majority of what were labeled the most important PDS are set during the first stage of development, even though a little over half of them have to be revised in the second stage. Conversely, only a couple of the most important PDS are set in the second stage. It is also interesting that only about one third of second phase PDS can be left open during the first stage, while the others must be at least preliminarily considered in the first stage. Finally, about three fifths (circa 60%) of the PDS fall in the second phase, which means they can only be fully set during that stage of the development process.

3.5 The Product Development Cycle

Within the laboratory development stage, a full product development cycle will take place. In the framework of this chapter, the important aspects to consider are the involvement of end-users early and throughout the process, as represented in Fig. 4.

Fig. 4
figure 4

Simplified product development cycle for the laboratory-stage development of medical devices and involvement of different actors along the development cycle. Circle size represents the level of involvement in each stage

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4 Multidisciplinarity

4.1 Multidisciplinary Integration Within the Development Team

Working in multidisciplinary teams offers several advantages to the researcher. One of these is the quick access to expertise in complementary areas of knowledge. Another is the possibility to debate decisions with colleagues that have different perspectives (and possibly, conflicting opinions). Equally important is the ability to tackle much more complex challenges than those which could be handled by a single individual, even if highly gifted.

However, such teams do not always work well, and it is frequent to observe personal incompatibilities develop between team members, often creating the need to replace individuals. As previously mentioned, communication among team members is a key factor. Aside from personality traits which can inexorably lead to conflicts, the main pitfalls have to do with team coordination, namely the need to:

  • Clearly establish roles/responsibilities in the team;

  • State the expertise each member adds to the team;

  • Have team members frequently describe their individual work in (also frequent) team meetings.

One of the important aspects of multidisciplinary team interaction is language. Here we consider essentially technical terminology. It is vital to ensure that all team members are aware of specific technical terminology used by others. Also, some consensus must be reached regarding adoption of technical terms which might vary among scientific areas. It can be mitigated by frequent meetings and formally setting the terminology to be used by the team.

4.2 Tasking and Scheduling

Stating that tasking and scheduling is important in this type of development projects is redundant. However, having multidisciplinary teams increases the complexity of the planning effort. First, as previously described, tasks must be very well defined and the role of each individual explicitly set for each task. Second, responsibilities must be assigned for every task, and it falls on the project leader to monitor task progress and intervene when necessary. Team members should not have to police each other. Last, while some tasks can be developed simultaneously, many will require input from other tasks. Almost any delay may cause other tasks to be put on-hold, possibly affecting the overall project schedule, and consequently, the predicted time to market.

Thus, compared to traditional project tasking and scheduling efforts, multidisciplinary teams for development of medical devices require additional care both in initial planning and in workflow monitoring.

4.3 Communication with Actors Outside the Development Team

There are clearly two different levels of communication here. On the one hand, multiple channels of communication are beneficial for the development process, namely between researchers and end-users. Examples are frequent meetings between the people responsible for collecting medical data (electronics or biomedical engineers) and doctors. Similarly, researchers working on devices with which healthcare professionals have to physically interact, need to meet with nurses, conduct brainstorming sessions, and perform preliminary tests with nurses, doctors, and possibly patients. These communication channels must work very effectively, and thus should be formally established jointly by the project leader and decision makers (e.g. hospital administrators).

On the other hand, the project leader is also responsible for communicating with the decision makers, market analysts, and media advisors. By having an overall view of the development project and being able to decide which information to release at each moment, the project leader has a pivotal role in lubricating the flow of information, simultaneously ensuring that confidential or sensitive information is not released untimely or unintentionally. There should be no direct independent communication between researchers and the decision makers and media advisors. Otherwise, their incomplete knowledge of the overall project, coupled with the fact that they are usually not aware of the long-term plans and strategy behind the development process, can lead to complicated communication mishaps.

4.4 Coordinating the Development Team

Following the discussion in §4.1 through §4.3, it becomes obvious that coordination of the development team requires a particular profile. The project leader has to supervise the development work, which makes a technical background highly desirable so he can articulate with the researchers and make decisions when necessary. He should be actively engaged in the development, but not supervise any of the tasks himself (e.g. brainstorming, field tests).

One of his main activities is coordination of the development team. This implies monitoring progress, but more importantly establishing boundaries, rules, roles, and responsibilities. He should assume a little more than his share of the blame for delays or the inability to fully reach intended development goals, and accept a little less than his share of the credits, recognizing the researchers’ effort and congratulating individual achievements.

He must ensure team members learn to value the input of others, that they work cooperatively rather than competitively, and to be humble in their work. He should ensure no team member leaves questions unasked simply for fear of appearing ignorant.

Finally, it is often possible to delegate coordination of specific aspects of the development to the second most senior researcher (with extreme care to ensure that roles and responsibilities are understood by all), freeing the project leader for other tasks.

4.5 Coordinating the Overall Project

The role of coordinating the overall project is not trivial. This essentially includes:

  • Monitor individual task progress, making swift changes to the workplan or redefining goals;

  • Coordinate the research team, ensuring effective and efficient cooperation and communication channels (within the team and also external);

  • Balance laboratory-stage development with the need to move on to productification to achieve a useful product time-to-market;

  • Maintain frequent contact with decision makers and, when appropriate, with media advisors;

  • Solve the plethora of problems that unexpectedly appear during development of medical devices (many common to any engineering project).

In the case of medical devices, the two main challenges relate to obtaining results within useful timeframes and usability issues (whether the device is employed by medical doctors, nurses, or patients).

5 Survey

The discussion so far in this chapter follows from the individual experience of the author in a series of research & development projects in this field. Despite the fact that this discussion has attempted to be unbiased and provide a bird’s eye view of the entire process, it inexorably conveys a personal perspective. In order to provide a wider and even more unbiased outlook, a survey was conducted based on a questionnaire answered by people involved in different medical devices development projects. These individuals were selected in order to cover the different profiles previously described in Sect. 14.3 (researchers, practitioners, managers).

5.1 Survey Model

The questionnaire was purposefully made very simple. It contained only 4 questions. It is important to note that no statistical significance will be derived from this preliminary study; the number of people who answered the survey was small, since its main purpose was to validate if there are significant asymmetries in the perspective of the different people involved in the process.

The survey was conducted face-to-face with each of the individuals listed; names were omitted and only profiles are listed for each person inquired. First, the Fig. 2 diagram was shown, with indication to identify if any relevant profiles were missing. All those inquired have indicated no additional profiles, with the single exception of a healthcare provider, who pointed out that investors and insurance companies are vital parts of the creation of new medical devices, although the latter only become key actors at the productification stage.

Subsequently, the questionnaire included three questions, each to be answered in a matrix with multiple options. These questions pertained to:

  • Which of the groups (development team, medical staff, marketing, and coordinators/managers) have to deal with the most critical challenges in the process?

  • Who has to become convinced by the developed solution?

  • At which point of the development process (early or late stage) should each actor become involved?

The answers to each of these three questions were analyzed and the respective results are shown in the following section.

5.2 Survey Results

The first question aimed at identifying the level of challenges that each of the the four identified groups (development team, medical staff, marketing, and coordinators/managers) have to deal with the most critical challenges in the process. In the survey, a rating between 1 and 4 had to be assigned to each of these groups. The results of the survey for different individuals, covering a range of professional profiles, are shown in Fig. 5. These profiles were, respectively, the global project coordinator, a systems engineer, a project scientific manager, a programmer, an electronics engineer, a medical doctor, a nurse, and a hospital administrator. In addition to the individual plots, the average value for each group is also represented.

Fig. 5
figure 5

Assessment of the degree of challenges, in a 1 to 4 scale, facing each of the 4 key groups typically involved in the development of medical devices. Each line corresponds to one inquired individual. The diamond symbols represent the average value for each group

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We can see in Fig. 5 considerable similarities between the opinions of the inquired professionals. In fact, all those inquired agree on the level of challenges facing the development team, and there is almost unanimity regarding challenges on the users’ side and also the interface/management aspects. Even regarding marketing/communication, opinions vary only within a range of 25%. Clearly, among those who answered the survey, the latter is seen as the aspect less challenging at the laboratory stage development (as one could expect). Conversely, major challenges are associated with both the technical development team and the project coordinator and managers.

Subsequently, people were asked to rank between 1 and 4 who has to become convinced by the developed solution so that it is considered successful (at the laboratory development stage, obviously). Results are shown in Fig. 6 as cumulative columns, using different colors for each of the inquired profiles.

Fig. 6
figure 6

Assessment of who has to become convinced by the laboratory-stage developed solution (with obvious implications on subsequent development stages)

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In Fig. 6 we can identify again a reasonable consensus between the different inquired individuals. In fact, the overall ranks for each profile follow the general trends of individual answers. One should notice how project coordinators and managers tend to highlight the importance of the opinion of medical professionals, whereas researchers have a more homogeneous view. Opinions vary regarding marketing people, which can be explained by the fact that this varies considerably on a case-by-case basis, depending on the specific medical device being developed. The same applies for different areas of expertise among the development team.

However, the results follow expectations, namely that doctors, nurses, and healthcare facilities managers/administrators are those whose opinion will be critical when a decision is made regarding taking the project to the next level.

Finally, people were asked to indicate when along the development process (still considering only laboratory-stage development), each of the identified profiles should be involved in the project. The results are shown in Fig. 7.

Fig. 7
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Results regarding the suggested timing for involvement of the different profiles in the laboratory-stage product development process for medical devices

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Based on the individual input from all those inquired, the average timing and the respective standard deviation were calculated, for each of the profiles previously identified. Those values are represented in Fig. 7. In this figure, the bottom line of the plot corresponds to people being involved in the project from its very beginning. Conversely, the line at the top indicates a profile that should be involved in the project only after some preliminary development, typically after a first prototype is built or, at least, after a conceptual solution has been designed but not yet implemented. Thus, the higher we move on the vertical scale, the later should be the involvement.

It is important to emphasize again that these results have no statistical significance, nor do they attempt to be representative of all medical device development processes, which can vary tremendously in terms of complexity, technical level, scope, and goals.

The opinions of those inquired were relatively consensual in that highly technical researchers must become involved at the earliest possible time, and that doctors and nurses should become involved earlier than patients. However, it was suggested that some basic grinding be done before they are involved. Also, decision makers, such as hospital administrators, should be involved only after some preliminary work has been done.

5.3 Analysis and Discussion

The results shown in Figs. 5–7 illustrate the different opinions among the several individuals that are usually involved in the product design and development process of medical devices. This was expected from the fact that almost all those involved will only have immediately contact with a part of the entire process. Probably only the project coordinator is aware of the entire network of competences that contribute in some way to the process. However, despite the differences in opinions that were detected among the inquired profiles, the trends are similar, and there is clear consensus regarding the different roles that different groups have in the development process.

Understanding the expectations and the perspective of medical staff and decision makers is important to facilitate the development of projects in this field. Although this preliminary survey has enabled identifying some of those aspects, further work is clearly warranted.

6 Case-Study

Although the discussion above follows from personal experience through the involvement in several projects related to medical devices, with varying degrees of complexity (and ambition), as well as team size, a case-study project is useful to illustrate it.

From 2007 through 2010 a new concept for mobile health was explored in the scope of the Mobile Health Living Lab project in Guimarães, Portugal. It aimed at increasing mobility of patients in hospitals and their homes through continuous remote monitoring of vital signals, using wireless sensor networks (WSN). These networks are characterized by several features, such as self-organizing capabilities, short-range broadcast communication and multi-hop routing, frequently changing topology due to fading and node failures, and power limitations [12]. This solution has been selected due to similarities with scenarios tackled by other research groups, such as the SMART system [13] and a monitoring system developed at University of Texas [14]. These approaches are in contrast to solutions based on body area networks (BAN), which primarily collect data from wearable sensors and relay them to another network, such as the CodeBlue [15], BlueBio [16] and AID-N [17] systems.

The need was initially identified through discussions between decision makers and doctors at a healthcare provider and researchers from a university research center. It initially conceived the use of several support technologies and multiple support devices. It evolved along the first few months to a specific conceptual system design, including the need to develop hardware and software applications, narrowing the aims and goals, and defining project boundaries. During these 3 years, it involved researchers from all areas described in §3.2 (and others), and the different healthcare professionals and end-users in the roles described in §3.1. The system architecture is represented in Fig. 8.

Fig. 8
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Simplified view of the system architecture developed and implemented in the case-study project

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It is important to mention that the proposed architecture was designed for this specific type of use scenario. For example, in the case of intensive care units, where the use specifications and requirements are very different, but also where patients only move within a very restricted area, other solutions have been identified [18]. Only to illustrate the variety of applications within this field, one can mention also remote rescue and care [19], or disaster scenarios [15–17]. A plethora of other cases can be found in the literature [20].

The developed sensors, network gateways, applications, user interfaces, etc., are being field tested at the Guimarães Private Hospital (Grupo AMI – Assistência Médica Integral) and have been recently showcased in many media sources, including national television. This project paves the way for future innovation in the area, highlighting the advantages of user-centered development and synergic cooperation between universities and companies, and will have practical effect on the quality of healthcare for many patients.

7 Concluding Remarks

This chapter presents some considerations about the coordination of multidisciplinary teams for the development of medical devices. The different people that usually become involved in the process, even at a laboratory development stage, have been identified and their role discussed. The results from a small survey on this topic were presented and discussed, in order to provide a very preliminary assessment of the different perspectives held by different professionals who have participated in several medical device development projects.

Clearly, there are major challenges in today’s development of medical devices that are related to the interface between all the different individuals involved in the process. The high complexity of products requires larger and more multidisciplinary teams. Effectively coordinating these efforts and managing the overall development project is not trivial, and can be a vital aspect in achieving a successful project. But this becomes increasingly problematic in the user-centered development framework that characterizes modern product development. In addition to researchers and technicians, end users (doctors, nurses, and even patients) are involved in early development stages, creating new challenges.

Vital aspects which could not be discussed here include medical device certification, and the different paradigms of developing medical devices within companies or in a university setting. These issues, and some aspects which could not be tackled in great depth, should be further explored in future work. An obvious example is expanding considerably the number of surveyed individuals for the discussion of Sect. 14.5.