There has been a surge in academic and business interest in software as a medical device (SaMD). SaMD enables medical professionals to streamline existing medical practices and make innovative medical processes such as digital therapeutics a reality. Furthermore, SaMD is a billion-dollar market. However, SaMD is not clearly understood as a technological change and emerging industry.
This study aims to review the landscape of SaMD in response to increasing interest in SaMD within health systems and regulation. The objectives of the study are to (1) clarify the innovation process of SaMD, (2) identify the prevailing typology of such innovation, and (3) elucidate the underlying mechanisms driving the SaMD innovation process.
We collected product information on 581 US Food and Drug Administration-approved SaMDs from the OpenFDA website and 268 company profiles of the corresponding manufacturers from Crunchbase, Bloomberg, PichBook.com, and other company websites. In addition to assessing the metadata of SaMD, we used correspondence and business process analysis to assess the distribution of intended use and how SaMDs interact with other devices in the medical process.
The current SaMD industry is highly concentrated in medical image processing and radiological analysis. Incumbents in the medical device industry currently lead the market and focus on incremental innovation, whereas new entrants, particularly startups, produce more disruptive innovation. We found that hardware medical device functions as a complementary asset for SaMD, whereas how SaMD interacts with the complementary asset differs according to its intended use. Based on these findings, we propose a regime map that illustrates the SaMD innovation process.
SaMD, as an industry, is nascent and dominated by incremental innovation. The innovation process of the present SaMD industry is shaped by data accessibility, which is key to building disruptive innovation.

UNASSIGNED: Innovation is broadly defined as the act of introducing a new product, idea, or process. The field of surgery is built upon innovation, revolutionizing technology, science, and tools to improve patient care. While most innovative solutions are aimed at problems with a significant patient population, the process can also be used on orphan pathologies without obvious solutions. We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.
UNASSIGNED: Utilizing the framework of the innovation process akin to the Stanford Biodesign Program, 1) the parameters of the clinical problem were identified, 2) previous solutions and existing technologies were analyzed, newly invented solutions were brainstormed, and value analysis of the possible solutions were carried out using crowd wisdom, and 3) the selected solution was prototyped and tested using 3D modeling, iterative testing on 3D prints of actual-sized patient parts, and eventual implementation in the patient after regulatory clearance.
UNASSIGNED: A 3D-printed external bioresorbable splint was chosen as the solution. Our patient underwent airway reconstruction with \"trachealization of the esophagus\": esophageotracheal fistula resection, esophagotracheoplasty, and placement of a 3D-printed polycaprolactone (PCL) stent for external esophageal airway support at five months of age.
UNASSIGNED: The innovation process provided our team with the guidance and imperative steps necessary to develop an innovative device for the successful management of an infant survivor with Floyd Type I tracheal agenesis.
UNASSIGNED: We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.The importance of this report is to reveal how the innovation process, which is typically used for problems with significant patient population, can also be used on orphan pathologies without obvious solutions.

Analyzing the impact of a sustainability agenda in research and innovation on system transition is a critical research topic. This literature stream aims to examine how research and innovation can deal with wicked-problems at a dynamic system level to create more sustainable future systems. However, this study addresses two main issues in the current sustainability transition literature. First, the literature to date offers little insight into concrete implications for the management of innovation processes at the organizational level. Second, sustainability is often addressed as per se desirable. While the concept of Sustainable Innovation (SI) can valuably contribute in addressing the first issue by providing essential features to analyze business management procedures and their broader implications on socio-technical systems, it falls short in addressing the second issue. Essential aspects of sustainability, such as the responsibility for potential future trade-offs through innovation, are not strategically integrated into the current framework. This study argues that without strategic integration of responsibility, there is a risk of contributing to a partially-sustainable-\"irresponsible\"-socio-technical system change as a result of business innovation activities. Therefore, an extended innovation process model for sustainability to embed responsibility at the core of innovation activities is required. For this purpose, the framework of Responsible Research and Innovation (RRI) is utilized. This paper reports on findings from a systematic literature review of a representative sample of empirical studies from the SI and RRI literature. Thereby, the goal was to extend the understanding of management opportunities within innovation processes for sustainability through the implementation of RRI principles, in order to create sustainable socio-technical systems.

Dramatic changes in societal approaches to people with intellectual and developmental disabilities (IDD), and the services and supports they receive are reflected in a new paradigm that we name the shared citizenship paradigm. The shared citizenship paradigm (1) incorporates an updated and contemporary set of values and beliefs about people with IDD and their right to participate fully in all aspects of life and society; (2) is characterised by a holistic approach to IDD, a contextual model of human functioning, disability rights principles and person-centred implementation strategies; (3) incorporates the exponential growth in knowledge about the causes and characteristics of IDD and factors influencing the elimination of barriers to positive outcomes for people with IDD; and (4) is reflected in international covenants, such as the United Nations Convention on the Rights of People with Disabilities (UNCRPD), and in international policy goals and associated personal outcome domains.
We conducted a preliminary survey on the cross-cultural status of the shared citizenship paradigm with a small purposefully sampled international group of professionals known to have extensive knowledge, experience, and publications regarding their country\'s current IDD-related policies and practices.
One or more paradigm components were evident to a moderate degree in the respondents\' countries, and the paradigm is being used to provide individualised services and supports, to guide organisation transformation and systems change, and, to a lesser degree, to frame evidence-based inquiry.
Core components of the shared citizenship paradigm are present internationally. To further enhance implementation and confirmation of the paradigm, we propose implementation strategies and confirmation techniques.

To develop the next generation of healthcare innovators, students at all levels of education should be trained and encouraged to employ innovative and entrepreneurial approaches to deal with complicated challenges of today\'s health system. Applying innovation and entrepreneurship training to solve complex problems and focus on solution design has recently become common in medical universities all over the world. This paper clarifies the role of hackathons as an innovative educational approach in healthcare education systems. We propose a process model concerned with organizing hackathon events in the healthcare education system. This model can be used in the academic and practical design of hackathons for innovation purposes.

The purpose of this paper is to examine biopharma innovation ecosystems (IEs) through the lenses of a stakeholder model. In doing so, this work aims to answer the following research question: which stakeholders are required in an IE within biopharma industry and what are their main roles in the IE value creation. The research strategy was designed according to the grounded theory methodology. By applying this methodology, data were collected through verbatim interviews with several stakeholders. Both data collection and data analysis phases were carried out concurrently up to saturation where all data were identified and their consistency across the many forms was reached. The thesis of the paper intends to prove that biopharma IEs consist of a multilevel and longitudinal set of key stakeholders. Furthermore, by investigating the Lombardy case study, it explains the role of each stakeholder with regards to the comparative advantages required in the engagement with the IE. In addition, arising from a holistic view of the biopharma IEs, this research traces the biopharma IE dynamics through the analysis of the IE\'s driving forces. This paper represents one of the first heuristic attempts to analyze in-depth biopharma IE from a holistic perspective. The paper findings can be considered to be an impactful extension to biopharma IEs world-wide. This broader scope is well supported by expert interviews as a central part of the methodology and by the investigated scientific literature.

UNASSIGNED: The aim was to gain insight in the preferences of people with type 2 diabetes mellitus regarding the moments and methods of patient participation in the development and application of eHealth, and which factors influence this.
UNASSIGNED: A digital questionnaire with both closed and open questions was distributed via various online platforms and the newsletter of the Diabetes Association in the Netherlands. Information was collected on: 1) willingness to participate; 2) preferences about the method of participation; 3) influencing factors on participation, including motivation, competence, resources, social influences, and outcome expectations; 4) background characteristics.
UNASSIGNED: 160 questionnaires were analysed. More than three quarter of the respondents intend to be involved in patient participation. Most respondents prefer solo participation methods over group participation, respectively 93% and 46%. Half of the respondents feel that they have sufficient knowledge to participate, and 40% feels that they can provide valuable input. As compensation for participation, participants prefer to use new technologies for free.
UNASSIGNED: As people with diabetes type 2 differ in their preferences for moments and methods of participation, it is recommended to offer different methods of participation and types of compensation in the process from development to application of eHealth.

The process of adopting innovation, especially with regard to precision farming (PF), is inherently complex and social, and influenced by producers, change agents, social norms and organizational pressure. An empirical analysis was conducted among Italian farmers to measure the drivers and clarify \"bottlenecks\" in the adoption of agricultural innovation. The purpose of this study was to analyze the socio-structural and complexity factors that affect the probability to adopt innovations and the determinants that drive an individual\'s decisions. Preliminary results found high levels of adoption among younger farmers, those that had a high level of education, those with high intensity of information, with large farm sizes, and high labor intensity. A logit model was used to understand the role played by labor intensity and perceived in the adoption process. In light of the Common Agricultural Policy Reform post 2020, the findings suggest relevant policy implications, such as the need to increase awareness of PF tools and foster dissemination of information aimed at reducing the degree of perceived complexity.

This paper examines how established firms use their core competences to diversify their business by exploring and ultimately developing green technologies. In contrast to start-ups dedicated to a green mission, diversifying into green markets by developing new products based on existing core competences has proven to be challenging. This is because the exploration processes to find a match between green technology opportunities and internal competences is complex and new to most established firms. This paper gains insights into exploration processes for green technologies and the learning modes and outcomes linked to these processes. We examined exploration processes at the microlevel in an embedded case study of an engineering firm using a combination of the \"fireworks\" innovation process model and organizational learning theory. First, we found that developing green technologies involves a long-term exploratory process without guarantee of (quick) success and likely involves many exploration failures. Second, as exploration unfolds along multiple technology trajectories, learning occurs in individual exploration paths (on-path), when new paths are pursued (path-initiation), and when knowledge from one path is spilled over to subsequent paths (across-paths). Third, to increase their chances for success, firms can increase the efficiency of exploration by fostering a failure-friendly organizational culture, deliberately experimenting, and purposefully learning from failures.

Although leadership has been studied extensively, most research has focused on the political and military spheres. More recent work has also examined the role of leadership in sectors such as manufacturing and technology, both areas where it is essential to encourage and nurture innovation. Yet, in the health sector, where innovation is now high on the policy agenda in many countries, there is a paucity of research on how leadership can foster a culture of innovation. In this perspective, written for those seeking to foster innovation in the health sector, we offer a narrative synthesis approach of eight theories and concepts that have been empirically shown to support innovation through all phases of the innovation process.