Skip to main content
PLOS One logoLink to PLOS One
. 2022 Jul 21;17(7):e0270092. doi: 10.1371/journal.pone.0270092

A framework for effective face-mask contact modeling based on finite element analysis for custom design of a facial mask

Yun-Jae Kwon 1, Jin-Gyun Kim 1,*, Wonsup Lee 2,*
Editor: Marko Čanađija3
PMCID: PMC9302758  PMID: 35862372

Abstract

A novel contact model is presented to efficiently solve a face-mask contact problem by using the finite element (FE) method for the optimized design of a custom facial mask. Simulation of contact pressure for various mask designs considering material properties of the face allows virtual evaluation of the suitability of a mask design for a person’s face without conducting empirical measurement of the face-mask contact pressure. The proposed contact model is accomplished by combining three approaches to reduce the calculation cost of simulating the face-mask contact: (1) use of a simplified and modifiable mask model that applies a spline curve to design points; (2) reduction of the FE model of the face by applying static condensation; and (3) application of a contact assumption that uses the Lagrange multiplier method. A numerical case study of a medical mask design showed that the proposed model could calculate the face-mask contact pressure efficiently (0.0448 sec per design). In a pilot usability experiment, the measured contact pressure was found similar values (range of mean contact pressure: 0.0093 ~ 0.0150 MPa) to the estimated values (range of mean contact pressure: 0.0097 ~ 0.0116 MPa).

1. Introduction

A facial mask must fit properly to sufficiently protect its wearer, so it must be designed considering the characteristics of its contact with the face (face-mask contact). An improperly designed mask can allow air leakage or exert excessive pressure on the face that can lead to discomfort, rashes, and injuries [15]. Lee et al. [6], and Schereinemakers et al. [4] emphasized that an oxygen mask for fighter pilots needs a proper fit to the face for safety as the oxygen mask supports an effective and comfortable oxygen supply to the pilot at a high altitude where oxygen is lacking. During the course of the COVID-19 pandemic, many studies on the design and testing of facial masks reported that the fit of the mask to the face has a significant effect on health and safety [79]. While the facial mask is commonly used in the daily lives of people, it needs to be properly designed to both protect people from respiratory disease and to provide comfort during long-term use.

A facial mask designed considering anthropometric information and 3D morphological images could increase user satisfaction with fit, comfort, safety, and usability. A 3D scan image of the face has been usefully applied in the ergonomic design of facial masks as it provides various information, including anthropometric facial dimensions (e.g., length, width, circumference, and any other point-to-point or surface lengths) and morphological information (e.g., arc, cross-sectional curvature, surface, area, and volume). Lee et al. [3] developed an ergonomic design of the oxygen mask for Korea Air Force (KAF) pilots based on an analysis of anthropometric characteristics, contact between 3D face scan images (n = 336) and morphological features of the mask. The proposed design showed 33% to 56% lower discomfort, 11% to 33% less contact pressure, and a more satisfying fit for KAF pilots than those of the existing pilot oxygen masks created considering the facial characteristics of U.S. Air Force personnel. Morrison et al. [10] proposed a method of designing a custom mask based on 3D facial scanning and 3D printing techniques to supply oxygen stably to a child who had craniofacial anomalies.

The finite element (FE) analysis method has been applied to consider the deformation of the face and mask for realistic estimation of the face-mask contact characteristics. FE analysis is a computing technique for numerical approximation regarding morpho structural changes of the FE model, which is generated based on a 3D object or a 3D scanned human body part. The FE model is formed based on a finite number of small elements (say, triangulated meshes) and information on material properties (e.g., Young’s modulus, Poisson’s ratio) [1113]; and the FE analysis can estimate the biomechanical responses (e.g., deformation, stress, contact pressure) to a particular force applied to the human body [14, 15]. As for the face-mask studies, Bitterman [16] simulated the contact pressure between FE models of a pilot’s face and an oxygen mask design, which were prepared through 3D scanning and FE modeling processes. However, the face is simply assumed as a rigid body, unrealistically, while the oxygen mask was modeled as a deformable object in the study. Yang et al. [17] used LS-DYNA, a popular commercial software for FE analysis, to estimate the contact pressure of a respirator worn over a human headform, which was 3D scanned and FE modeled. The respirator is FE modeled as a single-layered shell element (thickness = 2 mm) with silicone-like material properties (Elastic Modulus: 2 MPa, Poisson’s Ratio: 0.499, Density: 1 g/cm3); and the FE model of a headform was simplified as a single-layered shell element (thickness = 5 mm) with material properties of the soft-tissue (Elastic Modulus: 2 GPa, Poisson’s Ratio: 0.35). Dai et al. [18] and Lei et al. [19] extended Yang et al.’s work by applying a more realistic headform created with a consideration of the multi-layered anatomical structure such as skin, soft tissue (e.g., muscle, fat), and bone. The computational results of the contact pressure were compared with experimental results measured using the Tactilus freeform sensor system (Sensor Products Inc., Madison, N.J.) and found similar results in the contact pressure (mean difference: 0.013 MPa). Lastly, Gök [20] and Gök et al. [21] performed the face-mask contact analysis with a simple FE model, and the results showed the edge shape of a mask can reduce the contact pressure and protect people from respiratory droplets that can cause the infection of the COVID-19.

Despite the reliable results of the face-mask FE analysis, the application in the industries has not been widespread and has a lot of obstacles. As the primary reason, it is difficult to employ the conventional FE analysis in the design process of a consumer product as it costs time and effort to create multi-layered FE models for hundreds or thousands of head data to consider the morphological variabilities of a target user population [3, 27]. Therefore, to increase the utility of this method in the product design process, an accurate and low-cost FE method is required for the practical application of contact estimation to find the best design candidates within a manageable time.

This study aimed to develop an effective face-mask contact model which can satisfy the procedural simplicity, computational efficiency, and industrial applicability to design a facial mask based on 3D scanned images of the face and the FE analysis. In the face-mask contact analysis, this study uses the contact pressures over the face calculated according to the shape of the mask, as an indicator of discomfort, air leaking, and usability that are useful information in the product design process. Section 2 (Data preparation for the finite element analysis) introduces FE modeling of the face with simplified anatomical structure and mesh topology and explains the use of a spline curve to simplify the facial mask. Section 3 (Face-mask contact model) presents the mathematical model of face-mask contact analysis, considering the model reduction [22, 23] to accelerate the computational efficiency. Section 4 (Numerical studies) provides a numerical example of the face mask design for one person through a pilot study, and the reliability of the proposed method has been investigated by measuring contact pressure using force-sensitive resistor (FSR) sensors. The essential idea of this study is illustrated in Fig 1.

Fig 1. Concept of a novel design approach for a facial mask based on finite element analysis, illustrated with an example face image.

Fig 1

2. Data preparation for the finite element analysis

The FE-based models of the face and a mask are required for further face-mask contact analysis and to search for the optimal mask design. The FE-based face and mask models both consist of 3D morphological (e.g., nodes, elements) and mathematical (e.g., stiffness matrix) features, which are used in the development of the face-mask contact model in Section 3. Techniques of a template model registration (TMR) and generation of a surface from a point cloud are applied to simplify the computation of contact between face and mask. This section presents the theory and process of FE modeling.

2.1. FE model of the face

2.1.1. Preparation of 3D template-registered images of the face

3D scanning is used to collect images of the face, and then it is represented as a point cloud of vertices and a triangular mesh that represents connections among them. This process represents a complex geometric object as a set of triangles, and 3D scan images require the editing procedure to repair its mesh errors (e.g., holes, improper triangle meshes, floating parts, intersecting triangles), in general, using 3D image processing software [24, 25]. Then, 3D locations of anthropometric landmarks (e.g., sellion, the nasal root point at the sagittal plane; ectocanthion, the lateral corner of the left and right eyes; and promentale, the most protruded point of the chin at the sagittal plane) are found on the surface of the 3D face images [6, 25]. Lastly, all 3D face images are aligned based on the anthropometric landmarks; thus, their orientations become the same. Once the 3D face images are post-processed, TMR is applied to the post-processed 3D face images to build a computationally efficient FE model. During the 3D scanning procedure, a fine density of vertex points is randomly generated to form the surface of a target object; therefore, 3D face scan images are inconsistent in the number of vertices and in the topology of the mesh structure [26]. To compare the results of face-mask contact analyses for different faces, the mesh structure of 3D face images needs a reformation to become topologically corresponded to each other by applying TMR [2527]. Also, TMR can lead to efficient computation in further face-mask contact analysis as the number of meshes as well as the mesh topology of the 3D face images can be optimized. A landmark-based TMR approach proposed by Lee et al. [28] was applied in this study. First, a template face image is roughly aligned to each post-processed 3D face image by adjusting its size based on the anthropometric landmarks using the bounded biharmonic weights (BBW), a mesh deformation algorithm [29]. Then, a non-rigid iterative closest point (ICP), a 3D image registration technique [30], is used to reduce the surficial differences between the size-adjusted template image and each target face scan image. This process yields template-registered face images that consist of a reasonable number of vertices with a particular mesh topology.

2.1.2. Simplification of the FE model of the face

In this work, the shell-type elements are used to describe the template-registered face image, which is a thin surface (Fig 2). This approach creates a great advantage in the computational cost as a 3D face image can directly be applied to the FE model without considering anatomical layers such as soft tissue and bone.

Fig 2. The template-registered face image concept of a single triangular shell element.

Fig 2

Face-mask contact is assumed as a linear elastic and static problem for cost-efficient computation. The FE model is then considered to calculate the static deformation of the face. This task requires a stiffness matrix that represents the geometric data and material properties. The formulation of the FE stiffness matrix can be derived from the following principle of virtual work:

VδϵτdV=StδvtdSt+iNiδvfc(i), (1)

where τ, δϵ, and δv are stress, virtual strain, and virtual displacement, respectively. V and St are body volume and a surface under pressure. f and t are the nodal load and surface traction, respectively. Those can describe the external contact force from mask to face in this problem. The Ni is the number of nodal loads. Eq (1) represents the energy equilibrium between internal virtual work (left-had side), and external virtual work (right-hand).

A displacement within an element can be assumed by a polynomial and nodal displacement. The element-wise displacement is defined as

u(e)=H(e)u¯(e),ϵ(e)=B(e)u¯(e), (2)
δu(e)=H(e)δu¯(e),δϵ(e)=B(e)δu¯(e), (3)

where H is the displacement interpolation matrix and B is the strain-displacement matrix. The superscript e denotes a single element number. The shape function can be changed to a selection of the type of FE element.

As presented in Fig 2B, the displacement vector u¯ is a collection of a triangular shell nodal displacement vector and it can be defined as

u¯i(e)=[u¯xi(e),u¯yi(e),u¯zi(e),θ¯xi(e),θ¯yi(e)]T,i=1,2,3, (4)

where i denotes a node number (1, 2, or 3) in a triangle shell element. The displacement of a node can be defined by three transformations and two rotations except the in-plane rotation, and thus the three-node FE shell element has total of 15 degrees of freedoms (DOFs). The DOF implies the number of independent displacements that can express a configuration or a state of a body.

By substituting Eq (2) and (3) into Eq (1), the element-wise virtual work is obtained as

eNeV(e)B(e)TD(e)B(e)dV(e)=eNeSt(e)H(e)Tt(e)dSt(e)+iNiH(e)fc(i), (5)

where Ne is the number of elements used to the entire surface of the face. Eq (5) accounts that the response of a body u¯ can be defined as the assemblage of the response of elements, and based on it, the body can be discretized by a set of elements.

The stiffness is defined by the left-hand side of Eq (5). As a simple approach, the shell element can be built by summing plate bending stiffness Kb, plane stiffness Kp, and shear stiffness Ks as

K(e)=Kb(e)+Kp(e)+Ks(e), (6)
Kb(e)=V(e)Bb(e)TDb(e)Bb(e)dV(e),Kp(e)=V(e)Bp(e)TDp(e)Bp(e)dV(e),Ks(e)=V(e)Bs(e)TDs(e)Bs(e)dV(e), (7)

where D is the elasticity matrix for plate bending (Db), plane (Dp), and shear (Ds) defined as

Db=Eh312(1ν2)[1ν0ν1000(1ν)/2)],Dp=E(1ν2)[1ν0ν1000(1ν)/2)],Ds=κG2,G=E/(2(1+ν)), (8)

where v is Poisson’s ratio, E is the elastic modulus, and h is the thickness of the shell element.

Then, through the assembly process, the linear static equation of the face model can be expressed by

Kfu¯f=ff, (9)

where Kf is the stiffness of the face, u¯f is the displacement of the face, ff is the external force applied on the face, and the subscript f denotes the face. According to Eq (9), the deformation of the face FE model u¯f is calculated as a solution of FE analysis when the force ff is imposed by contact with the mask over the face.

The derivation shows that the configuration of mesh, material properties, boundary condition, and external load are the main parameters of the FE model, and thus the realistic results of the FE model depend on the reliability of these parameters. The proper mesh configuration, one of the important factors affecting accuracy, has been generated by TMR in this study. A Young’s modulus of 0.03 MPa and a Poisson’s ratio of 0.49 are used as material properties of soft tissue in this study by referring to previous studies [27, 3137]. The thickness of the shell element was defined as 2 mm. The fixed boundary condition is applied at an open edge of the face (e.g., the boundary of the 3D scanned image of the face), and only an external force is considered as the contact force (Section 3.2).

2.2. Parametric model of the facial mask

This study proposes a simply adjustable model of the mask composed of a set of nodes generated along a reference line created based on reference points. The proposed mask model uses three strategies. First, to simplify and reduce the cost of analysis, only the part of the mask that contacts the face is considered. Second, a reference line is created by fitting a spline curve to a few reference points (Fig 3A) to adjust the form of the mask efficiently; therefore, different forms of the mask can be automatically generated and evaluated in a face-mask contact simulation. Lastly, the 3D form of the mask consisting of equally distributed nodes is generated along the reference line. A set of cross-section nodes (Fig 3A) is used to define a custom form of the mask in this study. By placing the multiple cross-sections on normal planes of the reference line with an interval of about 1.0 mm, the 3D form of the mask can be created, as shown in Fig 3B. Note that the number of cross-sections varies according to the size and form of the reference line. The proposed approach of generating the mask’s form is used in the FE analysis of the contact between a face and multiple mask designs described in Sections 3 and 4.

Fig 3.

Fig 3

(a) Reference line generated considering reference points and an example of cross-section, (b) 3D form of contact surface of a mask, composed of multiple cross-sections.

A piecewise cubic spline curve [38] was used to express the reference line as a proper interpolation method in this study. A spline curve is a collection of the 3rd-order polynomials; it can represent a complex curve without overfitting. A piecewise cubic spline curve is created at each division, which is defined as an interspace between two reference points of the mask. Note that the number of spline curves is the same as the number of divisions. Eq (10) to (18) sequentially explain the piecewise cubic spline function for the generation of a complete form of the mask.

First, the one-dimensional cubic spline function can be written as:

S(p)(k)=a3(k)p3+a2(k)p2+a1(k)p+a0(k),k=1,2,,n1, (10)

where k is the kth division between two reference points p(k) and p(k+1), and p is a point in the kth division defined as p(k)pp(k+1). S(p)(k) is the kth piecewise cubic spline function, which consists of n−1 internal points (k = 1,2,…,n−1) and two endpoints (k = 0,n). Thus, the number of the cubic spline function is n. The second derivative of Eq (10) can be expressed as a first-order Lagrange polynomial

S(p)(k)=g(k+1)pp(k)l(k)g(k)pp(k+1)l(k),l(k)=p(k+1)p(k), (11)

where l(k) is the kth section length. g(k) and g(k+1) are the second-derivative terms at p(k) and p(k+1), respectively. The integration result of Eq (11) can be written as

S(p)(k)=g(k+1)(pp(k))22l(k)g(k)(pp(k+1))22l(k)+c1, (12)
S(p)(k)=g(k+1)(pp(k))36l(k)g(k)(pp(k+1))36l(k)+c1p+c0=g(k+1)(pp(k))36l(k)g(k)(pp(k+1))36l(k)+App(k)l(k)Bpp(k+1)l(k), (13)

where A and B are the unknown constants. The two endpoints p(k) and p(k+1) can determine A and B. Substituting them into Eq (13) yields Eq (14), which can provide a cubic spline curve.

S(p)(k)=g(k+1)[(pp(k))36l(k)l(k)(pp(k))6]+g(k)[(pp(k+1))36l(k)+l(k)(pp(k+1))6]+g(k+1)pp(k)l(k)g(k)pp(k+1)l(k). (14)

where g(k) and g(k+1) are defined from the reference points, but second derivative terms g(k) and g(k+1) are unknown in general. To define them, a continuity condition of all the joint points is considered. The first derivative of cubic splines then fulfills the tangential continuity

S(p(k))(k)=S(p(k))(k1), (15)

to yield

g(k+1)l(k)+2g(k)[l(k)l(k1)]+g(k1)l(k1)=6[g(k+1)g(k)l(k)g(k)g(k1)l(k1)]. (16)

Eq (16) gives the second derivative terms for all the sections, and the cubic spline curve is obtained by substituting the Eq (16) solution into Eq (14). But before that step, the boundary conditions are required for the endpoints S″(p(0))(0) and S″(p(n))(n−1). In the case of the mask, the reference line is closed loop; thus, a periodic condition can be applied:

S(p(0))(0)=S(p(n))(n1),S(p(0))(0)=S(p(n))(n1),S(p(0))(0)=S(p(n))(n1). (17)

A three-dimensional cubic spline can be obtained by combining three independent cubic spline functions:

P(p)(k)=[Sx(p)(k),Sy(p)(k),Sz(p)(k)]T, (18)

where P(p)(k) is three-dimensional curve, and Sx(p)(k), Sy(p)(k), Sz(p)(k) are cubic spline functions to represent a basis of P(p)(k).

3. Face-mask contact model

The FE contact analysis generally includes two time-consuming procedures: finding contact areas and imposing contact constraints [39]. In this study, to achieve efficient and effective processing of the mathematical problems, five assumptions related to the face-mask contact are considered. First, the face-mask contact is considered a two-body contact problem. Second, the contact area does not change over time, and the mask exerts a constant contact pressure on the face. Third, the face-mask contact is a static problem, which is a time-independent problem; and situations of detachment, sliding, or friction of the mask over the face are not considered. Fourth, we mainly focused on the principle of contact pressure generated only along with the mask’s pushing (Z-axis) direction, caused by the mask’s elastics. Lastly, the mask has stiffer elasticity than human skin. Thus, the face is flexible, but the mask is assumed as rigid. These assumptions enable time-efficient computation of the face-mask contract analysis that is sufficiently effective for product design.

3.1. Model reduction

This study proposes a static condensation technique associated with a method of selection of master nodes for reduction of the computational cost. Static condensation [40] is a well-known matrix technique that reduces a matrix’s size by considering a few master nodes. The nodes of the face that contact the mask (interface nodes) are considered master nodes, and the others are defined as slave nodes. For the first step, the mask’s nodes (blue points in Fig 4A) are placed near the face. Second, the master nodes of the face (red dots in Fig 4B) are identified as the nearest element to the mask’s nodes. Third, the proposed procedure of the master node selection is applied for various design cases of the mask. Fig 5A illustrates the variation of the mask’s design created by adjusting the reference points of the mask along the X-axis direction. Finally, the complete set of master nodes (red dots in Fig 5B) concerning various mask designs are selected, then the remaining nodes (black points) are defined as the slave nodes.

Fig 4.

Fig 4

(a) Mask’s nodes (blue) and (b) mater nodes of the face (red), which consist of contact elements.

Fig 5.

Fig 5

(a) Variation of the mask design and (b) the complete set of the master nodes that cover the variation of the mask design.

Using the identified master and slave nodes, the FE model of the face explained in Eq (9) is decomposed as

Kf=[KsKcKcTKm],u¯f=[u¯su¯m],ff=[fsfm], (19)

where the subscripts m and s denote the master and slave term, respectively, and the subscript c presents a coupling node in the off-diagonal term. From the first row of Eq (19), the displacement of the slave nodes can be defined as that of the master displacement vector only:

u¯s=Ks1[fsKcu¯m]. (20)

It is clear that the face-mask contact is only defined in the master node region; therefore, using Eq (20) with fs = 0 condition, the original displacement vector u¯f can be defined as

u¯f=Tu¯m=[Ks1KcI]u¯m, (21)

where T is a transformation matrix. Finally, using the transformation matrix, we obtain the reduced equations as followed:

Kru¯r=fr, (22)
u¯r=u¯m,Kr=TTKfT,fr=TTff, (23)

where the subscript r denotes a reduced system of the FE face model. Eq (22) clearly shows that the size of the stiffness matrix is reduced as same to the number of master displacement vector. Thus, the better effective computation is expected with small number of the master nodes than the case with the full nodes. In addition, the static problem under fs = 0 condition, Eq (22) provides the same solution to Eq (9) without loss of accuracy.

3.2. FE modeling of the face-mask contact

The uncoupled static equation of the face and mask can be expressed by recall Eq (9):

[Kr00Kγ][u¯ru¯γ]=[frfγ], (24)

where the subscript γ denotes the mask model. Kγ, u¯γ, and fγ are the stiffness of the mask, the displacement of the mask, and the external force applied on the mask, respectively. In addition to this term, the definition of face-mask contact is built based on the following two conditions. (1) The Lagrange multiplier method [39], which is one of the popular contact simulation techniques, is used for the simulation of the contact effect between two bodies. (2) A node-to-node discretization method for reducing computation with a simple contact equation. The following term defines the face-mask contact model used:

CrTu¯r+CγTu¯γ=df,[Kru¯rKγu¯γ]+[CrΛCγΛ]=[frfγ], (25)
Λ=[λ(1),λ(2),,λ(Nc)]T,Cr=[Cr(1),Cr(2),,Cr(Nr)],Cγ=[Cγ(1),Cγ(2),,Cγ(Nγ)], (26)

where Cr and Cγ are Boolean matrices that choose face-mask contact nodes out of the list of face or mask nodes, respectively. df is the vector of initial distances between a face node and a corresponding mask node (say, contact pair). Since the mask is assumed as the undeformable body (u¯γ=0) in this study, thus df describes the deformation of the contact area of the face (Eq (28)). N is the number of DOFs and Λ is the Lagrange multiplier vector presents contact force. From Eq (26), the augmented contact formulation is obtained as

[Kr0Cr0KγCγCrTCγT0][u¯ru¯γΛ]=[frfγdf], (27)

then simplified to Eq (28) with u¯γ=0:

[KrCrCrT0][u¯rΛ]=[frdf], (28)

which calculates the reduced displacement of the face u¯r by using the initial distance df and the external force fr.

To quantify the mask’s fit, we calculate the contact pressure per node (nodal pressure).

fp(j)=λ(j)/A(j)=λ(j)/s=1Nsa(s)3, (29)

where the superscript j denotes the jth contact node. Ns is the number of surfaces that share a selected node. fp(j) and A(j) are the nodal reaction force vector and the sum of areas a(s). Several cases for nodal pressure calculation are illustrated in Fig 6.

Fig 6. Various cases of pressure calculations.

Fig 6

(a) One element case. (b) Five elements case. (c) Two nodes case.

4. Numerical studies

In this section, the proposed design method was tested by considering two-step numerical problems. First, to demonstrate the adequacy of the face-mask contact effect and to exhibit characteristics of the proposed method, the structure of reference points for an initial mask design was considered. Second, to investigate the computational efficiency and applicability of the proposed method, the optimal design of the mask was sought by diversifying the designs and by analyzing the contact pressure. One of the authors participated in the present study to show expected outcomes through the proposed methods by providing a 3D scan image of the face and self-conducting usability testing. Ethical approval was not sought for the present study. A FE face model composed of 5,303 nodes and 104,963 elements was as in Section 2.1. The stiffness matrix for the face FE model Kf consisted of 31,818 DOFs and was prepared as a sparse matrix to minimize the data size. The algorithm was coded using MATLAB (MathWorks, Inc., Natick, MA, USA) and executed on a personal computer (Intel i7-8700K CPU, 64 GB RAM).

4.1. Study on the structure of reference design points

A study on the determination of the minimum necessary number of reference design points that can be of help to the best practice of the face-mask contact simulation was conducted. Firstly, eight reference points (Fig 7A) obtained by measuring a commercial medical mask were found. The necessary nodes of a mask (Fig 7B) were initially generated along the cubic spline curve created considering the structure and number of the mask’s reference points (Section 2.2). By applying the face-mask contact model presented in Section 3, the face-mask contact pressure was visually expressed, as shown in Fig 7C. The calculated contact pressure (e.g., average: 0.0092 MPa, maximum: 0.0319 MPa, as illustrated in Fig 7C) was distributed along the contact area of the mask under the condition of pushing the mask (e.g., 3 mm) toward the face. However, some areas that show zero contact pressure (0 Mpa) could occur due to the poor fit of the mask to the face (Fig 7C). This result may indicate that the spline curve was not properly drawn because the locations of eight reference points were not optimized or the number of reference points was not sufficient. In a real mask-wearing situation, an improper design can cause discomfort or pain by increasing the mask’s contact pressure on the face and can allow oxygen leakage through uncontacted areas.

Fig 7.

Fig 7

(a) Initial design of the mask generated by the cubic spline function computed using eight reference design points, (b) mask nodes along with the initial design, and (c) contact pressure result.

The poor fit of the mask was solved by increasing the number of reference points and relocating its Z-axis positions. The modified reference line was generated by adding four more reference points at the side of the nasal root and side of the lip (Fig 8A and 8B), where the face-mask contact was not properly made in the previous case. The re-calculated contact pressure (Fig 8C) showed the average and maximum values as 0.0101 MPa and 0.0282 MPa, respectively (note that it was 0.0092 MPa and 0.0319 MPa, respectively, in the eight reference points case). By increasing the curvature of the line, the result also showed a more equally distributed pressure with fewer uncontacted areas compared to the previous outcome.

Fig 8.

Fig 8

(a) A modified design of the mask generated by the cubic spline function that used 12 reference design points (blue boxes: added points), (b) mask nodes along with the initial design, and (c) contact pressure result.

4.2. Study on design optimization based on face-mask contact model

Then, a parametric study was performed to determine the optimal form of the mask for a particular participant’s face. The mask’s fit to the designated face was varied by adjusting the locations of the mask’s reference points, and then contact pressure was estimated to determine the mask design that showed the best fit. Each reference point was adjusted based on a predefined number of steps (e.g., five steps by adjusting a point two-step toward the left and right directions from an initial location) and moving magnitudes (e.g., 3 mm) along the X-axis directions as shown in Fig 9A. Only reference points in the cheek area were adjusted in this study, and a total of 625 design candidates were tested; three are illustrated (Fig 9B and 9C). A reduced stiffness matrix composed of 1,045 master DOFs (3.3% of the total DOFs) and 30,125 slave DOFs was used to achieve computational efficiency. For the design of all 625 candidates, the time to calculate contact pressure calculation increased with the size of the stiffness matrix; it took about 28 s (0.0448 s/design) when the reduced stiffness matrix was used, but 361 s (0.5776 s/design; 12.9 times longer) when the original stiffness matrix design candidates. In addition, the average contact pressure was found to be 0.0097 ~ 0.0116 MPa throughout the designs.

Fig 9.

Fig 9

(a) Variation of mask design, (b) examples of mask nodes, and (c) results of the contact pressure (illustrated).

A preliminary usability evaluation was included in this study to investigate the applicability and practicality of the proposed method. The selected best and worst mask designs for the participant’s face were prototyped, then tested with the participant to evaluate the usability in terms of the fit and contact pressure. First, the design appropriateness of each design candidate was examined by analyzing the magnitude and distribution of the estimated contact pressure. This study assumed that a mask design showing a lower average value and lower standard deviation in the contact pressure is the most appropriate. Of the 625 design candidates, the best and the worst were then 3D-printed to test the conclusions of this study (Fig 10). Eight force-sensitive resistor (FSR) sensors (Seed Technology, Inc., South Korea) were attached at facial locations (nasal root, nasal side, cheek, chin side, and chin) to measure the magnitude and distribution of the contact pressure. By wearing a fabric face mask over the 3D-printed designs, those were naturally fitted to the face. The measured contact pressure of the best design averaged 0.0093 MPa (standard deviation: 0.008), whereas that of the worst design was 0.0150 Mpa (standard deviation: 0.009) (Fig 10C).

Fig 10. Contact pressure experiment of prototyped mask design and its result.

Fig 10

(a) Best design (Left) and worst design (Right). (b) Eight force-sensitive resistor sensor’s location. (c) Contact pressure result of the eight locations.

5. Discussion

This study introduced a novel face-mask contact model based on finite element analysis to design a facial mask. Rather than applying the conventional FE analysis approach that prepares the geometric shape models of the body part and a contact object as realistic as possible, this study used simplified models of the face and mask in order to find the best design quickly in product design practices. The contact pressure resulting from virtually wearing a mask over the 3D scanned face was used as the evaluation metric of fit in this study, while the deformation of the contact objects is used as a fit estimator of the FE analysis in general. The contact pressure can indicate the level of discomfort, air leakage, and usability by comparing it with the actual contact pressure measured by FSR sensors. This study made three technical considerations to achieve time-efficiency of both contact pressure analysis and design customization. First, the FE model of the face was defined as a single-layered shell; thus, the face models can be quickly prepared from the 3D scanning of the face without conducting a complex process that conventional FE modeling requires. The TMR method was applied to construct a well-distributed structure of the nodes efficiently and to provide consistency in FE analyses for different faces. Second, the reduced stiffness matrix was used to decrease the computational cost effectively. Third, the adjustable model of the mask was proposed to automatically search for the optimal design through FE analysis by adjusting the number of reference points and their locations.

To effectively describe the face-mask interaction, the human face is modeled using a single-layer finite shell element, and the mask was approximated using a rigid line. Further reduction of computational cost is available by using static condensation, which is a well-known technique to reduce FE models [40]. In this manner, the face-mask contact can be simulated around a small contact area. As a result, only 3.3% of total DOFs in the numerical model (Chapter 4) were required to compute the contact pressure. The advantage of the proposed approach increases when the representative design should be computed for certain target user groups of over thousands of people; in this case, the approach of using a specific FE face model that considers an individual’s anatomic characteristics (e.g., the thickness of soft tissue, the shape of a bone, material properties) might be inefficient. It should also be noticed that considering human biological uncertainties and various nonlinearities is difficult, although specific FE faces modeling is employed. On the other hand, the proposed algorithm can provide numerous reasonable results in a short computation time.

The face-mask contact model proposed in this study was found that it is effective and practical in terms of the time and cost of designing and evaluating facial masks. A total of 625 mask design candidates were systematically assessed using the virtual fit simulation that uses the proposed face-mask contact model. Then, the fit simulation automatically seeks the optimal form of a mask for an individual face in no time (28 seconds for 625 design candidates) by calculating the contact pressure. Also, compared to the previous face-mask contact studies [19], the contact pressure predicted in the fit simulation showed similar order to that obtained through the pilot usability study in terms of the average (mean difference: 0.0005 MPa) and variation (range: 0.0087 to 0.0804 Mpa). It could explain that the face-mask contact model might be appropriately designed based on the aforementioned technical considerations. Moreover, the present study would be effective in terms of the cost in the product design process as the product design generally requires a cost-consuming physical prototyping phase to test the usability of designs. On the other hand, the proposed method of virtually testing and searching for the most appropriate design candidates in terms of the fit and contact pressure could save the time and cost of iterative prototyping and testing in the product design process [41].

This study concentrated on the efficiency of the face-mask contact analysis by simplifying the FE model with appropriate assumptions, but further studies on the following issues are needed to enhance the method. First, only one face was tested through the pilot study to validate the proposed FE model; but the similarity between the experimental and simulated results with various faces should be further studied to advance the FE model more accurately and reliably. Second, to design a mask product for a particular target population, the proposed face-mask contact model needs to quickly provide a proper design guideline based on engineering information in a mask design process. In further work, the probability functions for design parameters such as the face, material properties, and device shape will be considered using the sampling method and metamodeling in the computation step. Thus, a stochastic result regarding the contact pressure can be found, and the most proper mask shape for the target user population can be systematically obtained.

The proposed algorithm provides various research potentials as follows. First, in the proposed method, the FE mesh quality and the reliability of the material properties are the major factors of accuracy. The proper mesh quality can be achieved by TMR with the 3D scan images. However, in this work, the same material properties are used at all locations in the face, and this uniformity may cause an inaccurate calculation of contact pressure. Dividing a face model into several areas that have different material properties (such as bone-dominant and tissue-dominant) is a remedy to handle this issue. Using the proposed method, virtual fitting results over thousands of people can be easily obtained in a short time, and then the best virtual prototype can be identified by comparing the estimated contact pressures. Therefore, the probability-based design software (or framework) to find an optimal shape for target user databases could be developed based on the proposed algorithm. In addition, we only focused on the face-mask interaction in this work, but the proposed method could be extended to various wearable devices such as earphones, AR glasses, smart watches, etc. However, the contact assumptions considered in this work are valid only if wearable devices are much stiffer than the skin and undergo small deformation. Other contact approaches to cover two flexible bodies are required if the deformation of the wearable devices becomes significant.

6. Conclusion

The main theme of this study was to use numerous 3D human images to check the fit of design candidates quickly in a product-design process. The combination of data parameterization by template model registration, contact pressure estimation by FE analysis method, and computation simplification by static condensation techniques was proposed and applied to achieve reliable and efficient calculation of the face-mask contact pressure. The proposed method may contribute to the ergonomic design of a facial wearable product such as various types of masks (e.g., medical mask, dust-proof mask, gas mask, protective mask, sports mask), and goggles (e.g., protective goggles, sports goggles, virtual reality headset) that require a good fit and comfort to provide health, safety, and satisfaction to users. Also, the proposed method could contribute to developing an engineering design tool (e.g., CAD) or automated manufacturing, which can effectively support practitioners in a product design and development process.

Data Availability

The data relevant to this study are available from Figshare at: https://doi.org/10.6084/m9.figshare.20055167.v1 (10.6084/m9.figshare.20055167)."

Funding Statement

Acknowledgement - This research was jointly supported by the National Research Foundation of Korea (NRF) grants funded by Korea Government (2020R1F1A1050076 and 2021R1A2C4087079). Initials and grant numbers - WL: 2020R1F1A1050076 - JGK: 2021R1A2C4087079 Full name of each funder - the National Research Foundation of Korea (NRF) (URL: https://www.nrf.re.kr/eng/index) Did the sponsors or funders play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript? - NO. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

References

  • 1.Brill AK. How to avoid interface problems in acute noninvasive ventilation. Breathe. 2014. Sep 1;10(3):230–42. [Google Scholar]
  • 2.Janson DJ, Clift BC, Dhokia V. PPE fit of healthcare workers during the COVID-19 pandemic. Applied ergonomics. 2022. Feb 1;99:103610. doi: 10.1016/j.apergo.2021.103610 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3.Lee W, Yang X, Jung D, Park S, Kim H, You H. Ergonomic evaluation of pilot oxygen mask designs. Applied ergonomics. 2018. Feb 1;67:133–41. doi: 10.1016/j.apergo.2017.10.003 [DOI] [PubMed] [Google Scholar]
  • 4.Schreinemakers JR, Westers P, van Amerongen P, Kon M. Oxygen mask related nasal integument and osteocartilagenous disorders in F-16 fighter pilots. PLoS One. 2013. Mar 7;8(3):e56251. doi: 10.1371/journal.pone.0056251 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Signori D, Bellani G, Calcinati S, Grassi A, Patroniti N, Foti G. Effect of face mask design and bias flow on rebreathing during noninvasive ventilation. Respiratory Care. 2019. Jul 1;64(7):793–800. doi: 10.4187/respcare.06269 [DOI] [PubMed] [Google Scholar]
  • 6.Lee W, Jeong J, Park J, Jeon E, Kim H, Jung D, et al. Analysis of the facial measurements of Korean Air Force pilots for oxygen mask design. Ergonomics. 2013. Sep 1;56(9):1451–64. doi: 10.1080/00140139.2013.816376 [DOI] [PubMed] [Google Scholar]
  • 7.Duda S, Hartig S, Hagner K, Meyer L, Intriago PW, Meyer T, et al. Potential risks of a widespread use of 3D printing for the manufacturing of face masks during the severe acute respiratory syndrome coronavirus 2 pandemic. Journal of 3D Printing in Medicine. 2020. Sep;4(3):135–47. [Google Scholar]
  • 8.O’Kelly E, Arora A, Pirog S, Ward J, Clarkson PJ. Comparing the fit of N95, KN95, surgical, and cloth face masks and assessing the accuracy of fit checking. PLoS One. 2021. Jan 22;16(1):e0245688. doi: 10.1371/journal.pone.0245688 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9.Shaheen E, Willaert R, Miclotte I, Coropciuc R, Bila M, Politis C. A novel fully automatic design approach of a 3D printed face specific mask: Proof of concept. PLoS One. 2020. Dec 3;15(12):e0243388. doi: 10.1371/journal.pone.0243388 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 10.Morrison RJ, Van Koevering KK, Nasser HB, Kashlan KN, Kline SK, Jensen DR, et al. Personalized 3D-printed CPAP masks improve CPAP effectiveness in children with OSA and craniofacial anomalies. In Combined Otolaryngology Spring Meetings. April 2015. Apr 22 (Vol. 22, p. 26). [Google Scholar]
  • 11.Hughes TJ. The finite element method: linear static and dynamic finite element analysis. Courier Corporation; 2012. May 23. [Google Scholar]
  • 12.Zhang Y, Kwok TH. Customization and topology optimization of compression casts/braces on two-manifold surfaces. Computer-Aided Design. 2019. Jun 1;111:113–22. [Google Scholar]
  • 13.Zienkiewicz OC, Taylor RL. The finite element method for solid and structural mechanics. Elsevier; 2005. Aug 9. [Google Scholar]
  • 14.Liao H, Chen L, Liu M, Chen J. Sealing mechanism study of laryngeal mask airways via 3D modelling and finite element analysis. Scientific Reports. 2022. Feb 21;12(1):1–1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Pirhan Y, Gök K, Gök A. Comparison of two different bowel anastomosis types using finite volume method. Computer Methods in Biomechanics and Biomedical Engineering. 2020. Jun 10;23(8):323–31. doi: 10.1080/10255842.2020.1722809 [DOI] [PubMed] [Google Scholar]
  • 16.Bitterman BH. Application of finite element modeling and analysis to the design of positive pressure oxygen masks. School of Engineering, Air Force Institute of Technology, Wright-Patterson Air Force Base:OH; 1991. Dec 1. [Google Scholar]
  • 17.Yang J, Dai J, Zhuang Z. Simulating the interaction between a respirator and a headform using LS-DYNA. Computer-Aided Design and Applications. 2009. Jan 1;6(4):539–51. [Google Scholar]
  • 18.Dai J, Yang JJ, Zhuang Z. Sensitivity analysis of important parameters affecting contact pressure between a respirator and a headform. International Journal of Industrial Ergonomics. 2011. May 1;41(3):268–79. [Google Scholar]
  • 19.Lei Z, Yang J, Zhuang Z. Headform and N95 filtering facepiece respirator interaction: contact pressure simulation and validation. Journal of occupational and environmental hygiene. 2012. Jan 1;9(1):46–58. doi: 10.1080/15459624.2011.635130 [DOI] [PubMed] [Google Scholar]
  • 20.Gok K. Investigation of the use of silicone pads to reduce the effects on the human face of classical face masks used to prevent from COVID-19 and other infections. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering. 2021. Oct;235(5):1742–7. [Google Scholar]
  • 21.Gök K, Selçuk AB, Gök A. Computer-aided simulation using finite element analysis of protect against to coronavirus (COVID-19) of custom-made new mask design. Transactions of the Indian Institute of Metals. 2021. May;74(5):1029–33. [Google Scholar]
  • 22.Kim JG, Boo SH, Lee CO, Lee PS. On the computational efficiency of the error estimator for Guyan reduction. Computer Methods in Applied Mechanics and Engineering. 2016. Jun 15;305:759–76. [Google Scholar]
  • 23.Kim JG, Park YJ, Lee GH, Kim DN. A general model reduction with primal assembly in structural dynamics. Computer Methods in Applied Mechanics and Engineering. 2017. Sep 1;324:1–28. [Google Scholar]
  • 24.Lee W, Yang X, Jung H, You H, Goto L, Molenbroek JF, Goossens RH. Application of massive 3D head and facial scan datasets in ergonomic head-product design. International Journal of the Digital Human. 2016;1(4):344–60. [Google Scholar]
  • 25.Lee W, Lee B, Yang X, Jung H, Bok I, Kim C, et al. A 3D anthropometric sizing analysis system based on North American CAESAR 3D scan data for design of head wearable products. Computers & Industrial Engineering. 2018. Mar 1;117:121–30. [Google Scholar]
  • 26.Lee W, Jung H, You H. Application of 3D Human Body Template Model for Ergonomic Product Design. Journal of the Ergonomics Society of Korea. 2020. Jun 1;39(3). [Google Scholar]
  • 27.Lee W, Kim JG, Molenbroek JM, Goossens RH, You H. Estimation of facial contact pressure based on finite element analysis. In International Conference on Applied Human Factors and Ergonomics 2019. Jul 24 (pp. 657–667). Springer, Cham. [Google Scholar]
  • 28.Lee W, Jung H, You H. Development of a 3D Template-registered image database of Korean heads for ergonomic product design. 2020; 39(5), 437–451. [Google Scholar]
  • 29.Jacobson A, Baran I, Popovic J, Sorkine O. Bounded biharmonic weights for real-time deformation. ACM Transactions on Graphics. 2011. Jul 25;30(4):78. [Google Scholar]
  • 30.Besl PJ, McKay ND. Method for registration of 3-D shapes. In Proceedings of SPIE 1611, Sensor Fusion IV: Control Paradigms and Data Structures 1992. Apr 30 (Vol. 1611, pp. 586–606). [Google Scholar]
  • 31.Choi AP, Zheng YP. Estimation of Young’s modulus and Poisson’s ratio of soft tissue from indentation using two different-sized indentors: finite element analysis of the finite deformation effect. Medical and Biological Engineering and Computing. 2005. Apr;43(2):258–64. doi: 10.1007/BF02345964 [DOI] [PubMed] [Google Scholar]
  • 32.Chopra K, Calva D, Sosin M, Tadisina KK, Banda A, De La Cruz C, Chaudhry MR, Legesse T, Drachenberg CB, Manson PN, Christy MR. A comprehensive examination of topographic thickness of skin in the human face. Aesthetic Surgery Journal. 2015. Nov 1;35(8):1007–13. doi: 10.1093/asj/sjv079 [DOI] [PubMed] [Google Scholar]
  • 33.Kalra A, Lowe A, Al-Jumaily AM. Mechanical behaviour of skin: a review. Journal of Materials Science and Engineering. 2016;5(4):1000254. [Google Scholar]
  • 34.Lee W, Kim JG, Molenbroek JM, Goossens RH, Jung H, You H. Contact pressure analysis for wearable product design. In Congress of the International Ergonomics Association 2018. Aug 26 (pp. 163–169). Springer, Cham. [Google Scholar]
  • 35.Luboz V, Promayon E, Payan Y. Linear elastic properties of the facial soft tissues using an aspiration device: towards patient specific characterization. Annals of Biomedical Engineering. 2014. Nov;42(11):2369–78. doi: 10.1007/s10439-014-1098-1 [DOI] [PubMed] [Google Scholar]
  • 36.McKee CT, Last JA, Russell P, Murphy CJ. Indentation versus tensile measurements of Young’s modulus for soft biological tissues. Tissue Engineering Part B: Reviews. 2011. Jun 1;17(3):155–64. doi: 10.1089/ten.TEB.2010.0520 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 37.Xu M, Yang J. Human facial soft tissue thickness and mechanical properties: a literature review. In International Design Engineering Technical Conferences and Computers and Information in Engineering Conference 2015 Aug 2 (Vol. 57045, p. V01AT02A045). American Society of Mechanical Engineers.
  • 38.Moin P. Fundamentals of engineering numerical analysis. Cambridge University Press; 2010. Aug 30. [Google Scholar]
  • 39.Wriggers P. Computational Contact Mechanics. Laursen TA, editor. Berlin: Springer; 2006. Oct 6. [Google Scholar]
  • 40.Guyan RJ. Reduction of stiffness and mass matrices. AIAA Journal. 1965. Feb;3(2):380. [Google Scholar]
  • 41.Lee W, Jung D, Park S, Kim H, You H. Development of a virtual fit analysis method for an ergonomic design of pilot oxygen mask. Applied Sciences. 2021. June;11:5332 [Google Scholar]

Decision Letter 0

Marko Čanađija

4 Apr 2022

PONE-D-22-05499A framework for effective face-mask contact modeling based on finite element analysis for custom design of a facial maskPLOS ONE

Dear Dr. Lee,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by May 19 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Marko Čanađija

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at 

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf.

2. Please note that PLOS ONE has specific guidelines on code sharing for submissions in which author-generated code underpins the findings in the manuscript. In these cases, all author-generated code must be made available without restrictions upon publication of the work. Please review our guidelines at https://journals.plos.org/plosone/s/materials-and-software-sharing#loc-sharing-code and ensure that your code is shared in a way that follows best practice and facilitates reproducibility and reuse.

3. Thank you for stating the following in the Acknowledgments Section of your manuscript: 

[This research was jointly supported by the National Research Foundation of Korea (NRF) grants funded by Korea Government (2020R1F1A1050076 and 2021R1A2C4087079).]

We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. 

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: 

 [Acknowledgement

- This research was jointly supported by the National Research Foundation of Korea (NRF) grants funded by Korea Government (2020R1F1A1050076 and 2021R1A2C4087079).

Initials and grant numbers

- WL: 2020R1F1A1050076

- JGK: 2021R1A2C4087079

Full name of each funder

- the National Research Foundation of Korea (NRF)

(URL: https://www.nrf.re.kr/eng/index)

Did the sponsors or funders play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript?

- NO. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.]

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide.

Additional Editor Comments:

Some reviewers have proposed several papers for inclusion in the bibliography. Please include those papers only if they are related to the topic of the manuscript.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: I Don't Know

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This manuscript studied the face-mask contact behaviour using finite element analysis. As claimed by the authors, the motivation of this study is to provide guidelines to optimise the design of face masks. In my opinion, the paper can be accepted, provided the following concerns are addressed.

The background and motivation need enhancement.

This paper's efficacy heavily depends on several assumptions. The simplified model is subsequently adopted, which reduces computational effort. I am curious about how the authors verify the result. I will suggest putting more emphasis on the verification part.

Will the implanted electronics affect the contact performance?

Other scholars have also looked into mask-airway contact behaviours. For example, Liao H, et al. Sealing mechanism study of laryngeal mask airways via 3D modelling and finite element analysis[J]. Scientific Reports. What are the difference, mainly the benefits, of using the approaches developed in this paper?

The paper needs thorough proofreading to remove the grammatical error.

Reviewer #2: The authors performed “FE model of the face” but I couldn’t FE model outputs (stress and deformation) in manuscript. They should be showed the outputs.

Today, computer aided finite element analysis (FEA) was used to solve processes simulations of COVID-19 and other infections and biomechanics [1-5]. The authors should be cited the following references to enrich of paper.

References

1. ERDEM M, GOK K, GOKCE B, GOK A (2017) NUMERICAL ANALYSIS OF TEMPERATURE, SCREWING MOMENT AND THRUST FORCE USING FINITE ELEMENT METHOD IN BONE SCREWING PROCESS. Journal of Mechanics in Medicine and Biology 17 (01):1750016. doi:10.1142/s0219519417500166

2. Pirhan Y, Gök K, Gök A (2020) Comparison of two different bowel anastomosis types using finite volume method. Computer Methods in Biomechanics and Biomedical Engineering 23 (8):323-331. doi:10.1080/10255842.2020.1722809

3. Gök K, Selçuk AB, Gök A (2021) Computer-Aided Simulation Using Finite Element Analysis of Protect Against to Coronavirus (COVID-19) of Custom-Made New Mask Design. Transactions of the Indian Institute of Metals. doi:10.1007/s12666-021-02227-4

4. Gok K Investigation of the use of silicone pads to reduce the effects on the human face of classical face masks used to prevent from COVID-19 and other infections. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering 0 (0):09544089211019581. doi:10.1177/09544089211019581

5. Gok K, Erdem M, Kisioglu Y, Gok A, Tumsek M (2021) Development of bone chip-vacuum system in orthopedic drilling process. Journal of the Brazilian Society of Mechanical Sciences and Engineering 43 (4):224. doi:10.1007/s40430-021-02959-w

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2022 Jul 21;17(7):e0270092. doi: 10.1371/journal.pone.0270092.r002

Author response to Decision Letter 0


19 May 2022

The responses to the comments are also provided as an enclosed file (revision note.docx).

Editor comment

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf.

⇒ We have checked and corrected the style of the manuscript.

2. Please note that PLOS ONE has specific guidelines on code sharing for submissions in which author-generated code underpins the findings in the manuscript. In these cases, all author-generated code must be made available without restrictions upon publication of the work. Please review our guidelines at https://journals.plos.org/plosone/s/materials-and-software-sharing#loc-sharing-code and ensure that your code is shared in a way that follows best practice and facilitates reproducibility and reuse.

⇒ As we are preparing the technology for a commercial purpose, we would not want to share our system directly. But, mathematic algorithms for the core concept of our technology have been explained in the manuscript clearly and anyone in this field might easily understand and apply the concept in their studies.

3. Funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

⇒ The acknowledgement section is removed in the updated manuscript. And there’s no updates for the current Funding Statement.

4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide.

⇒ We have published our data resulting from the FE simulation shown in our study, and here is the DOI number: http://dx.doi.org/10.13140/RG.2.2.21674.49607.

Reviewer 1

1. The background and motivation need enhancement.

⇒ We have enhanced the background by making detailed descriptions in the introduction. More relevant studies have been added in the 3rd paragraph of the introduction. The 4th paragraph of the introduction has been newly added, and the 5th paragraph of the introduction has been updated to emphasize our motivation for the study.

2. This paper's efficacy heavily depends on several assumptions. The simplified model is subsequently adopted, which reduces computational effort. I am curious about how the authors verify the result. I will suggest putting more emphasis on the verification part.

⇒ In our study, the verification was performed through an experiment of measuring the contact pressure using the FSR sensors, which is described in the Numerical Studies section. The values were compared using their mathematical order. Since the measured data was generated from the different masks and face shapes, we found that the contact pressure level and distribution of the algorithm are well-matched with the reference data. For example, the results of the contact pressure analysis in other papers indicate that the contact pressure shows a value between 0.001 MPa to 0.1 MPa in the cases of face-mask contact analysis found in the previous studies. And our results showed similar order to that obtained by the experiment in terms of the average (mean difference: 0.0005 MPa) and variation (range: 0.0087 to 0.0804 MPa), as discussed in the discussion section. However, as we tested for the one face through the pilot study, the similarity between the experimental and simulated results with various faces should be further studied to define the FE model more precisely. We newly added the 4th paragraph in the discussion to explain limitations and future studies.

3. Will the implanted electronics affect the contact performance?

⇒ Our proposed method simply calculates the contact pressure only between two surfaces (body surface and product surface) data without considering the mass of the human body or product. Therefore, the effect of the implanted electronics contacting inside of the human soft tissue is unavailable to estimate through our method.

4. Other scholars have also looked into mask-airway contact behaviours. For example, Liao H, et al. Sealing mechanism study of laryngeal mask airways via 3D modelling and finite element analysis. Scientific Reports. What are the difference, mainly the benefits, of using the approaches developed in this paper?

⇒ The goal of the presented method is to solve the face-mask contact problem efficiently using the simplified FE model and FE analysis procedure. Our method can compute the contact pressure of hundreds of cases in a short time. Thus, product designers can understand the contact pressure characteristics easily by changing design parameters. The quantified information resulting from our method can guide designers to obtain the best shape of a designated product quickly.

5. The paper needs thorough proofreading to remove the grammatical error.

⇒ We found the grammatical errors and the manuscript was proofread.

Reviewer 2 comment

1. The authors performed “FE model of the face” but I couldn’t see FE model outputs (stress and deformation) in manuscript. They should be showed the outputs.

⇒ The displacement and stress commonly used as estimators in FE analysis were considered in our mathematic process (equation 1); but, we used the contact pressure as an indicator of discomfort, air leakage, and usability. As the FE model can be verified by using the contact pressure as it can also be measured by sensors in a real situation. Also, this study didn’t calculate the deformation to reduce the computational load in the proposed procedure. Therefore, displacement and stress were not used in our framework. The following figure shows stress, displacement, and contact pressure showing a similar trend. We have added about this issue in the 5th paragraph of the introduction and the 1st paragraph of the discussion sections.

2. Today, computer aided finite element analysis (FEA) was used to solve processes simulations of COVID-19 and other infections and biomechanics [1-5]. The authors should be cited the following references to enrich of paper.

⇒ We have cited the mentioned papers in the introduction.

Attachment

Submitted filename: 3. revision note.docx

Decision Letter 1

Marko Čanađija

6 Jun 2022

A framework for effective face-mask contact modeling based on finite element analysis for custom design of a facial mask

PONE-D-22-05499R1

Dear Dr. Lee

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Marko Čanađija

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors have honestly answered my concerns. The paper brings some novelty. I have no further comments.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

**********

Acceptance letter

Marko Čanađija

28 Jun 2022

PONE-D-22-05499R1

A framework for effective face-mask contact modeling based on finite element analysis for custom design of a facial mask

Dear Dr. Lee:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Marko Čanađija

Academic Editor

PLOS ONE


Articles from PLoS ONE are provided here courtesy of PLOS

RESOURCES