# To Develop Capabilities for Patient-Specific Devices Through the Configuration of Product Life-Cycle Management Strategy

Clara Gualdrón, Israel Garnica, Javier Gómez

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## To cite this version:

Clara Gualdrón, Israel Garnica, Javier Gómez. To Develop Capabilities for Patient-Specific Devices Through the Configuration of Product Life-Cycle Management Strategy. 19th IFIP International Conference on Product Lifecycle Management (PLM), Jul 2022, Grenoble, France. pp.474-483, 10.1007/978-3-031-25182-5_46. hal-05420896

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# To Develop Capabilities for Patient-Specific Devices Through the Configuration of Product Life-Cycle Management Strategy

Clara Isabel López Gualdrón(✉), Israel garnica, and Javier Mauricio Martínez Gómez

Universidad Industrial de Santander UIS, Cra 27 Calle 9, 680006 Bucaramanga, Colombia
clalogu@uis.edu.co

**Abstract.** Technological shifts have changed the conception of new medical devices, such as orthopedic surgical devices. From a traditional approach to a flexible manufacturing concept for developing new products like patient-specific implants (PSI), biomodels, and surgical guides. However, process development becomes increasingly complex compared to traditional standards if a personalized product is required. Consequently, the configuration of the product's life-cycle management (PLM) was analyzed as a business process strategy considering technological implementation tools to achieve goals such as quality, cost, and time. Through this research, an innovation model has been defined to develop a PLM strategy. Process areas, as well as actors, tasks, and practices, had been defined. Those had guided the building of a reference framework for medical device development by case studies. From our sample, some were concepts while others were evaluated in a relevant environment. These cases were developed iteratively to reach a certain technology readiness level (TRL). Thus, practices applied as well as performance was observed. The research addresses value creation in new product development and how building capabilities were consolidated by PLM implementation. As a result, team members generated artifacts with an intermediate-high degree of personalization. Also, it was possible to define a flexible process based on-demand analysis. Additionally, training for low-cost technological integration could provide tools to produce viable products in local markets. Therefore, improvement opportunities and forward applicability in real scenarios must be addressed.

**Keywords:** New product development · Flexible factories · Product life-cycle management · PLM · Technology development capabilities

## 1 Introduction

The technological shift has been integrated into the real world by mixing physical and biological systems. This situation allowed us to alter reality and therefore our environment. So current reality has been the result to put together new studies of materials and technologies. Those had been applied to subjects like personalized products or bio-printing, redefining how processes, products, and value creation must be conceived, as
mentioned by the World Economic Forum (WEF) [1]. Among technological trends, there are enabling technologies [2], additive manufacturing, and tailored product development [3]. Those trends could be integrated into a business strategy by implementing practices from 4.0 industries [4].

However, there is no business unless a value is perceived. Value creation, in the context of a new product design (NPD), is based on intellectual capital, process modeling, and operation management [5]. To maximize efficiency, information technology (IT) solutions are implemented to reduce time and cost in development, then increased customer satisfaction. A positive impact of IT on NPD throughout development can be attained in different ways: former projects on databases, project management applications, CAD/CAE/CAM tools, and interconnectedness among multidisciplinary faraway actors [6].

Likewise, in NPD different kinds of information must be managed based on inputs and outputs. Because different actors generated all sorts of data, a strategy must be outlined to control how the process flows, which activities must be carried on, and when collaborative work takes place among roles. Faced with this gap, product data management (PDM) as part of the PLM strategy has been configured like a business process strategy [7]. As an open innovation capability, PLM has been implemented in technology-based organizations for NPD as a collaborative framework [8]. Through PLM, data flows through in-out in a safe, reliable, and orderly way, to manage the creation and exchange of info related to the development of the NPD process [9]. Thus, PLM is a business strategy that integrates people, processes, and information to handle product maturity [10].

PLM is aligned with the concept of direct digital manufacturing (DDM) [11], allowing a network from dispersed resources like additive manufacturing technologies [12], to expedite development for NPD aimed at customization. A positive effect reported for implementing PLM was intermediate-high tailored NPD, time, and cost-saving [13]. PLM helps to define a flexible manufacturing process based on demand by supporting: human capital renovation and training with specific skills, technological resources management[14], and manufacturing control [15].

Previous advances offer flexibility to develop NPD, which is promising in the healthcare sector. Delimiting its application, a current problem noticed by researchers is how to develop medical devices (MD) for surgical procedures [16] in a low-income context [17]. For surgery, each patient requires a specific medical device (SMD) according to his/her biological topology, such as patient-specific implants (PSI), surgical guides for cutting, positioning, or drilling; and biomodels [18].

Despite PLM advantages in healthcare, few studies related to it have been found. Those were associated with: management by commercial PLM software of heterogenic data from neuroimaging and biomedical data in a laboratory [19]; offering 3d visualization for surgical pre-planning on a web-based platform for surgeons [20]; designing a framework to theorize relationships among actors in PSI development [21]. Those reports show how technological change could impact the conception of new SMD, although few studies explain how PLM solutions during NPD could be implemented in organizations with scarce resources [22].
Based on the previous outlook, we started with manufacturing trends like capability, customization, and PLM, then how could be relevant in SMD for surgical assistance in orthopedic, maxillofacial, or plastic surgery.

Thus, the statement research question was: **How a PLM strategy could be con-figured to cope with building capabilities for using enabled technologies in SMD development that support complex surgical assistance?**

The description of this scenery intervened to shape the innovation strategy model proposed. Depiction of its main components was presented in the following sections, and how practices guided the construction of an innovation framework as a reference for SMD development for surgical assistance in our context.

## 2 Methodology

To achieve the building of development capabilities in SMD some concepts were inter-cepted for a theoretical foundation. Those were: the value drivers model [23]; the inno-vation capability model in firms [24]; and the PLM visualization model for SMD [25]. Thus, it was possible to involve capabilities such as technological development, manu-facturing, and management; with value creation while the NPD's development evolves through process areas. Value definition was oriented on three milestones: first, the value discovery, to define who create it; second, the value proposal, to define how value is cre-ated by building capabilities and who made each activity; and third, value configuration, to obtain value by device materialization in each study case.

The first milestone, the value discovery, was related to technological development capability. In the beginning, epidemiology of traumatic injuries on the skull and leg was observed, as well to see among health staff who is involved and what kind of difficulties faces to offer well treatment. In the Plastic Surgical Department at Hospital Universi-tario de Santander, it was made an epidemiological profile with a sample convenience. Among the etiology, the vast majority were trauma; other causes were related to cancer or congenital disorders. According to medical experience, each case was examined to diagnose whether or not an SMD was required.

In the second milestone, the value proposal, it was defined how actors involved in SMD exchange data and how they relate with each other. Thus, the PLM visualization strategy was employed to build research and development (R&D) capability, throughout process areas, each one responsible step by step in NPD decisions making. The previous process was non-linear and iterative. As more case studies were involved, the strategy reach maturity.

R&D and PLM strategies were oriented towards value configuration by layers. Each layer is consecutive and represents a capability; to develop technology, make it opera-tional, and manage all participant processes. In the R&D stage, the state of art in SMD was oriented toward competitive surveillance from similar companies and its patents. To reach SMD, enabling technologies were selected by low-cost considerations to config-ure a system of systems (SoS) by incorporating: computer-aided tools (CAx) for design, reverse engineering (RE) for patient geometry rebuilding, and additive manufacturing (3DP) to obtain iterative SMD for medical preplanning or surgical support. For PLM strategy configuration, a free PDM was selected to centralize data (support, training,
and each study case), control data versions, formalize the format process, support dif-
ferent roles (collaborator, administrator, viewer), and allowed non-designer users a 3d
data visualization. As a theoretical framework, designers and physicians collaborate by
cocreation through design thinking methodology, as well learning-by-doing LBD and
self-training, skills that depend on the kind of SMD that each case required by when:
before, during, or after surgery.

In the third milestone, value configuration was achieved by: joining efforts to develop study cases depending on etiology. With every case, learned lessons were clarified on requirements and parameters, by proposing as practice a requirement library to allow reuse from previous knowledge. Another practice was to conform multidisciplinary teams by case. Thus, students from designing worked together with health staff or students, like physicians specializing in plastic surgery or orthopedic. Those students were members of research groups, INTERFAZ and GRICES, at Industrial Design School and Medicine School respectively, both from Universidad Industrial de Santander.

Once a case was evaluated as pertinent by epidemiology profile, students from GRICES presented each case’s necessities to development members. Then INTERFAZ centralized data and execute the development. First roles were assigned, subsequently, the case’s scope was delimited by time, resources, explicit requirements, and the kind of SMD. As consulted by the literature, four kinds of products were developed to materialize technological development and manufacturing capabilities: virtual preplanning, biomodels, surgical guides, and PSI [18]. INTERFAZ was dealing with how to design and build SMD, meanwhile, GRICES was responsible for thinking about surgical steps and how those must be taken into consideration in the final SMD. Depending on the risk, each functional requirement was checked in iterative steps among participants before surgery. Ethical considerations were evaluated in each study case, allowed by the university ethics committee in medical specialization projects.

3 Results

In the workflow, the process flows step by step identifying roles, tasks, and technology.
Some practices applied are described below.

*Technological and Competitive Surveillance:* To understand the state of art in each SMD was required, as well as the value creation. This surveillance helps in research and development practices, as well as to detect potential ideas through process innovation practices in NPD. Voice of the literature (VoL) was oriented to looking for reported SMD and its performance. While the voice of publication (VoP) was conducted to identify key information by patent review. For each study case, surveillance showed us key details, so concepts generated by development teams could maintain a level of inventiveness distinguish from known SMD to get innovative potential in students’ proposals.

*Enabling Technologies:* A technology assessment was proposed to configure a CAx architecture, to guarantee technology development capabilities therefore operational capabilities. Thus, the value configuration related to DDM and 4.0 industries could be viable by technological appropriation. However, it demanded an SoS by selecting each resource for compatibility and low cost, both software, and hardware. So, enabling technologies such as RE/CAx/3DP configure an SoS that could make a project viable.
Different projects, each one a case study, were developed by R&D, in some of those, SoS alternatives were implemented. Only with LBD and accumulative experience in each iteration, was possible to select an SoS according to performance. Due to the previous amount of data, it was necessary to configure a collaborative strategy to govern multidisciplinary information through PDM.

**Workflow and Process Steps:** A collaborative framework was proposed to enable knowledge transfer and data flow associated with three scenarios: research, development, and service. Employing a collaborative data management platform PDM, it was possible to structure key activities in a custom SMD development with actors and process areas. Thus, decisions making from start to end in each activity was delimited to understand, step by step, a filtering process to achieve the requirement accomplishment for the final product. Also, PDM allows us to secure communication channels among actors, and to keep patients' data privately.

**Design Thinking (DT):** The methodology applied in each study case looked to solve complexity in SMD. DT was also crucial to establishing a common vocabulary among designers, and physicians, to help them to empathize with each other's skills. It was implemented because of the value proposal, meaning expectations from the idea must be met

<figure><img src="image_4.png" /><figcaption>**Fig. 1.** Framework for building capabilities on SMD development by a PLM strategy.</figcaption></figure>
in the final SMD. In the design process, medical knowledge was traduced on requirements and parameters, to help designers to cope with detailing aspects like tolerances, draft angles, and material performance, among others.

As a result of previous practices for SMD development, a framework in the initial phases of the product life cycle was proposed in Fig. 1. Relations between actors happened according to the case scope, meaning that a case study could be done only if at the research level capabilities were achieved. Thus, development could be accomplished, although decisions must be checked. To meet initial expectations, requirements were formalized in formats. Thus, iterative development was necessary for co-creation, to get a final SMD version, and finally to release for surgery.

Results derived from the previous framework showed us that deployment of innovations through the R&D process could finish on incremental innovation as well as efficiency and satisfaction. The value creation in the NPD process was enhanced through knowledge internalization in SMD creation, like how enabling technologies must be used, or when co-creation is needed. Collaboration between physicians and designers helped to achieve accurate SMD. Each process demanded empathy, trial-and-error, with LBD, and flexibility to iterate through the DT process.

<table><caption>**Table 1.** Cases and products description developed by this strategy.</caption><thead><tr><th rowspan="2">Service request</th><th rowspan="2">Case</th><th rowspan="2">Surgical treatment</th><th colspan="2">Virtual product</th><th colspan="3">Tangible product</th></tr><tr><th>Biomodel</th><th>Pre-planning</th><th>PSI</th><th>Surgical guide</th><th>Biomodel</th></tr></thead><tbody><tr><td>Diagnostic</td><td>Tibial plateau trauma</td><td>Fracture reduction</td><td>22</td><td></td><td></td><td></td><td>22</td></tr><tr><td rowspan="5">Surgical guides</td><td>Craniosynostosis</td><td>Cranial defect correction</td><td>1</td><td>1</td><td></td><td>1</td><td></td></tr><tr><td>Orbital-malar trauma</td><td>Fracture reduction</td><td>2</td><td>2</td><td>2</td><td></td><td>2</td></tr><tr><td>Severe polytrauma pseudoarthrosis</td><td>Reconstructive surgery</td><td>1</td><td>1</td><td></td><td></td><td>1</td></tr><tr><td>Maxillary retrognathia</td><td>Le Fort 1</td><td>3</td><td>3</td><td></td><td>3</td><td></td></tr><tr><td>Mandibular Fracture Sequelae</td><td>Segmental mandibulectomy</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td></tr><tr><td rowspan="3">Patient-specific implant (PSI)</td><td>Cranioplasty</td><td>Bone defect reduction</td><td>3</td><td>2</td><td>3</td><td></td><td>3</td></tr><tr><td>Type B hemipelvic fracture</td><td>Fracture reduction</td><td>1</td><td></td><td>1</td><td></td><td></td></tr><tr><td>Maxillary partial edentulism</td><td>Insertion of implants or prostheses</td><td>1</td><td></td><td>1</td><td></td><td>1</td></tr><tr><td colspan="2">Total of SMD required</td><td></td><td>35</td><td>10</td><td>8</td><td>4</td><td>30</td></tr></tbody></table>

Thus, value configurations were materialized in different case studies depending on complexity, as summarized in Table 1. It also showed the service requested, the
type of surgical treatment proposed, and the virtual and physical products obtained. That led to defining a flexible manufacturing process that adjusts to tailored production. SMD was produced to reduce uncertainty in surgical treatment, so the case studies had different customer requests. Those could be categorized as orthopedic, referring to leg trauma; or plastic surgery for skull and jaw injuries. The orthopedic cases were studied just for diagnosis and training by biomodel visualization. Instead, plastic surgery cases required not just diagnosis by biomodel, but also virtual surgical preplanning, cutting guides, and/or PSI. Thus, two kinds of products were observed: the first one was virtual intangible 3D biomodels (35 in total), and virtual surgical pre-planning (10 in total); and the second one was detailed design to obtain tangible SMD by 3Dp: biomodels (30 in total), PSI (8 in total), and cutting guides (4 in total).

In this sense, the value configuration through a workflow is adaptable to each case study according to its requirements. Thus, personalization criteria were how the value configuration was oriented to create value. The value chain was also incorporated to consolidate the first approach to value configuration. Thus, management capability was oriented by PLM strategy, to allow building capability by development stages and accumulative knowledge. As a result, different products, tangible, and intangible, were obtained. Those SMD were achieved on a natural scale (1:1) so that would be applicable in surgery. However, PSI was an exception, due to limitations in available technologies: our 3D printing hardware could not print on clinical material. So, PSI was obtained for geometrical comparison models and accuracy performance. On the other hand, biomodels and surgical guides, which required minor risk, were printed to verify geometrical accuracy and fitting on bone defect correction. So, some case studies could reach a certain maturity level of TRL because some artifacts could be used in relevant environments.

<figure><img src="image_5.png" /><figcaption>Fig. 2. A product development process model and its practices adjusted to TRL [14].</figcaption></figure>
Figure 2 visualizes how a common process, even considering a diverse kind of SMD, could be oriented to make it repeatable.

Based on our experience, case studies were carried out consequently to physicians’ expectations. TRL technology maturity reference framework [26, 27], ranging from level 1 to 9, was used to establish case study development. Thus, to reach a higher rank, practices were built to be followed up. Until TRL-5, practices were related to research; from TRL-6 onwards, practices were related to technology development.

In such a way, Fig. 2 shows the process in a particular case study where a female patient needed jaw reconstruction by using allograft. TRL-1 outlined technological surveillance to realize the state of the art. TRL-2 defined a plan and suitable SoS according to the case study. TRL-3 defined virtual reconstruction from a computer tomography CT into a 3D biomodel, by Invesalius®. TRL-4 runs through SMD design in CAD such as Rhinoceros®, and mechanical strength simulation in CAE like Ansys®. TRL-5 specified 3D procedures to obtain a model by 3DP by using a slider like Cura®. All data was centralized by using GrabCAD® PDM. TRL-6 specified a biocompatible material to obtain an SMD. TRL-7 involved laboratory tests on asset material behavior and pre-surgical verification. TRL-8 analyzed SMD in relevant environments like surgical settings. Finally, TRL-9, a business model could operate by manufacturer compliance.

# 4 Discussion and Conclusions

SMD such as biomodel, virtual surgical pre-planning, cutting guides, and PSI, were defined based on surveillance results. To build capability development for SMD several case studies were carried out. Literature reported that these devices can reduce surgical time by up to 22%, therefore, infection and anesthetic exposure; also, SMD help in decision-making by changing pre-surgical steps by up to 60% [28]. Biomodels could reduce time development and provide real-scale information, overcoming CT limitations [29]. Surgical guides reduce average errors from 6 to 7 mm, down to 1 or 2 mm, in cutting or drilling trajectory [30].

However, creating value in complex subjects like orthopedic and surgical assistance, it was required iteration, LBD, and collaboration. To achieve maturity, a strategy was outlined, to build capabilities and thus offer value for physicians and patients, as well as to build innovation capabilities in technology development for SMD. A workflow that compromised PLM process areas lead step by step an R&D process, where a low-cost SoS for enabled technologies was deployed to assist specialized activities: to get virtual reference biomodels with RE from CT; CAD models; 3DP files; and data management. All those activities, by using free or public software. Other software technologies could obtain suitable results but costs increase.

Management capability was built through the initial PLM stages (ideation, definition, realization) through its process areas. To achieve it, a workflow of processes for technology development was proposed as a framework from Figs. 1 and 2, as well as deliverables by steps and roles (collaborator, editor, viewer) among design and healthcare staff [25, 31]. Despite the viability of case studies and the use of a PLM strategy integrated with low-cost SoS, to provide further service in TRL 9, it is important to consider compliance costs. Those deliberations rely upon a higher risk for SMD. Additional
work will require better technologies and infrastructure, Then, the integration of a new SoS for manufacturing should be evaluated.

**Acknowledgements.** The authors wish to express their gratitude to the work team from research groups at Universidad Industrial de Santander: INTERFAZ at Industrial Design School, GRICES at Medical School, specifically MD Genny Melendez, MD Jose Luis Osma, and MD Diana Navarro. In addition, to the cooperation between MINCIENCIAS (Ministry of Science, Technology and Innovation) and the Government of Santander, who provided great support.

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