Biomedical Device Industry Research Articles

Biomedical Applications Based on Marine Collagen Obtained from the Jellyfish Species Rhizostoma Pulmo Extracted from the Black Sea

Abstract Due to its unique properties, collagen is used in various emerging fields such as the pharmaceutical and biomedical device industries, as well as in related fields: nutraceuticals, cosmetics, food, beverages and nutritional supplements. Marine gelatin, one of the biomaterials involved in food and medicinal research, is denatured collagen produced from acid, alkaline, or enzyme hydrolysis. Gelatin is a crucial ingredient for the food, pharmaceutical, medical, biomedical focusing on versatile applications. Jellyfish collagen is a valuable resource for bioplastics and biomaterials used in various health sectors. Recently, marine organisms have been considered viable sources of collagen because they do not harbor transmissible diseases. In particular, fish biomass, as well as the catches of other types of organisms, such as small fish, jellyfish, starfish, sea urchins, sponges, possess a significant content of collagen. The collagen extracted from the species Rhizostoma pulmo from the Black Sea basin is also part of the bioresources that can be used to obtain natural marine collagen from this type of invertebrates. The use of discarded or hither to unused biomass could contribute to the development of a sustainable collagen extraction process with a positive impact on the ecosystem. In the future it is desired to approach a world strategy that minimizes the amount of waste and that supports all three general objectives of sustainability: sustainable economic well-being, social well-being and environmental protection.

Antimicrobial PDMS Surfaces Prepared through Fast and Oxygen-Tolerant SI-SARA-ATRP, Using Na2SO3 as a Reducing Agent.

Poly(dimethylsiloxane) (PDMS) is an attractive, versatile, and convenient material for use in biomedical devices that are in direct contact with the user. A crucial component in such a device is its surface in terms of antimicrobial properties preventing infection. Moreover, due to its inherent hydrophobicity, PDMS is rather prone to microbial colonization. Thus, developing an antimicrobial PDMS surface in a simple, large-scale, and applicable manner is an essential step in fully exploiting PDMS in the biomedical device industry. Current chemical modification methods for PDMS surfaces are limited; therefore, we present herein a new method for introducing an atom transfer radical polymerization (ATRP) initiator onto the PDMS surface via the base-catalyzed grafting of [(chloromethyl)phenylethyl]trimethoxysilane to the PDMS. The initiator surface was grafted with poly[2-(dimethylamino)ethyl methacrylate] (PDMAEMA) brushes via a surface-initiated supplemental activator and reducing agent ATRP (SI-SARA-ATRP). The use of sodium sulfite as a novel reducing agent in SI-SARA-ATRP allowed for polymerization during complete exposure to air. Moreover, a fast and linear growth was observed for the polymer over time, leading to a 400 nm thick polymer layer in a 120 min reaction time. Furthermore, the grafted PDMAEMA was quaternized, using various alkylhalides, in order to study the effect on surface antimicrobial properties. It was shown that antimicrobial activity not only depended highly on the charge density but also on the amphiphilicity of the surface. The fast reaction rate, high oxygen tolerance, increased antimicrobial activity, and the overall robustness and simplicity of the presented method collectively move PDMS closer to its full-scale exploitation in biomedical devices.

Factors Affecting Adoption of a Telemedicine Device by Primary Care Health Workers in the Philippines

Background and Introduction. The RxBox is a telemedicine device that measures and transmits vital signs to remote experts. It has been deployed to primary care health centers (PCHC) in the Philippines serving disadvantaged populations, to decrease morbidity and mortality due to common diseases and poor access to care. Factors affecting its adoption by healthcare workers is unknown. Materials and Methods. The study determined social and behavioral factors that affect adoption of a telemedicine device into the clinical workflow using the Unified Theory of Acceptance and Use of Technology (UTAUT) framework. This is a mixed methods research using review of records, survey and focused group discussions. Results and Discussion. RxBox telemedicine devices were installed in 79 primary care health centers (PCHC) and were used a total of 15,705 times within the study period. An ordinary least squares regression analysis using the combined site and individual-level data showed that among the UTAUT parameters, only compatibility, facilitating conditions, and social factors have significant relationships with intent-to-use of the RxBox. The innovation assisted primary care health workers in their clinical responsibilities, improved the stature of their PCHC in the community, and helped in the care for patients. Training and technology support after deployment as well as encouragement by peer and champions (the PCHC physician, local government leaders) reinforced continuous use after training. Users described the experienced improvements in quality of services provided by the PCHC and the consequent benefits to their patients. Conclusions. These factors should be accounted for in designing strategies to reinforce health workers' attitudes and enhance support towards acceptance and use of novel telemedicine devices into clinical routine in local health centers. Lessons are immediately useful for local leaders in low- and lower middle-income countries that suffer disproportionately from unnecessary maternal deaths and mortality due to non-communicable diseases. This contributes to the body of knowledge and should bolster national-level advocacy to institute an enabling policy on telehealth Information Communication Technology (ICT) and use of Filipino innovations towards health systems strengthening. Results can be used by implementers, evaluators, and regulators of health ICT, especially in resource-poor settings. Likewise, the study can encourage more research in the field to spur more dynamic local health ICT and biomedical device industries.

Intelligent optimization system for powder bed fusion of processable thermoplastics

Powder bed fusion (PBF) represents a class of additive manufacturing processes with the unique advantage of being able to fabricate functional products with complex three-dimensional geometries. PBF has been broadly applied in highly value-added industries, including the biomedical device and aerospace industries. However, it is challenging to construct a comprehensive knowledgebase to guide material selection and process optimization decisions to satisfy the product standards of various industries based on a poor understanding of process-structure-property/performance relationships for each type of thermoplastic. In this paper, an intelligent optimization system is proposed to establish quantitative relationships between process parameters and multiple optimization objectives, including mechanical properties, productivity, energy efficiency, and degree of material degradation. Polyurethane is considered as a representative thermoplastic because it is sensitive to thermal-induced degradation and has a relatively narrow process window. Material and powder properties as functions of temperature are investigated using systematic material screening. Numerical models are created to analyze the interactions between laser beams and polymeric powders by considering the effects of chamber thermal conditions, laser parameters, temperature-dependent properties, and phase transitions of polymers, as well as laser beam characteristics. The theoretically predicted features of melting pools are validated experimentally and then utilized to develop quantitative relationships between process parameters and multiple optimization objectives. The established relationships can guide process parameter optimization and material selection decisions for polymer PBF.

Investigation on Micro-milling of Ti–6Al–4V Alloy by PCD Slotting-Tools

Ti–6Al–4V is characterized by various protruding characteristics and has been found extensive applications in aerospace, biomedical device industries and other fields. However, these properties in turn bring about the increase in cutting forces, make the chips intractable to control and also shorten the tool service life, etc. A preliminary exploration of micro-milling of Ti–6Al–4V by PCD slotting-tool (MST-PCD) was launched in this paper. The most prominent advantage was the PCD slotting-tools could reach a higher linear velocity even the spindle speed was lower, which can strongly ensure the strength and stiffness of micro cutters and suppress the vibration occurrence due to the high spindle speed. The machining processes of using PCD slotting-tool and carbide micro-end mill (MEM-WC) was compared in detail. The wear experiments were conducted to confirm the effectiveness and advantage of MST-PCD. The cutting forces and surface quality, as well as the effects of tool wear on these output responses were investigated. Then model establishment and multi-objective parameter optimization were performed based on the orthogonal experiment results. Finally, verification experiments were also carried out to confirm the effectiveness of the developed models and MST-PCD. The findings in this paper can also be applied to other difficult-to-machine materials.

Tracking Defects and Microstructural Heterogeneities in Meso-Scale Tensile Specimens Excised from Additively Manufactured Parts

The commercialization of additive manufacturing (AM) is underway in the aerospace and biomedical device industries [1, 2]. However, most metal parts produced by AM are limited to non-critical applications, since the various processes produce internal porosity, anisotropy, and microstructural heterogeneities [1, 3]. It has been implied that small-scale mechanical tests can advance measurement standards for AM applications by probing the effects of defects and heterogeneities on mechanical properties at more appropriate length scales [4, 5]. Traditionally, small-scale techniques have been used to characterize location- and orientation-specific mechanical properties in wrought materials [6-10]. A common method for excising mechanical test specimens from bulk parts with negligible influence on specimen integrity involves electrical discharge machining (EDM) [11]. This work demonstrates that excising meso-scale tensile specimens from additively manufactured parts enables tracking of sub-surface and visible features of interest (porosity and microstructural heterogeneities) throughout the entire gauge section such that the individual contributions to deformation behavior can be assessed.

Noble microfluidic system for bioceramic nanoparticles engineering

Bioceramic nanoparticles have many potential applications within the biomedical device industry. However, these applications demand a precise control of their sizes, shapes and morphology which play a main role in most properties. In this work, we report a new route for the synthesis of hydroxyapatite nanoparticles using a microfluidic device. The process is carried out by continuous laminar flow through the device. The obtained nanoparticles have showed same properties (composition, length, orientation, roughness) than those produced by conventional methods, however, our device can afford to fine tune the structure via simple engineering, i.e., produce nanoparticles of different size only by varying the flow velocity. In addition to the efficiency and novelty of this system, the optimization of personnel costs makes it very profitable economically.

A Review of Decellularized Extracellular Matrix Biomaterials for Regenerative Engineering Applications

Biomaterials are a cornerstone technology of the biomedical device, tissue engineering, and regenerative medicine industries. While traditional biomaterials are fully defined synthetics, growing evidence supports the use of extracellular matrix-based biomaterials produced through the decellularization of organs, tissues, or cell cultures. These materials are particularly advantageous as they largely retain the structure and the biochemical nature of the original tissue, properties that are often difficult to reproduce with synthetics. Indeed, there are many FDA-approved and clinically used extracellular matrix-based materials that are generated through decellularization processes. In this review, we first describe methods of decellularization used to produce these materials and their associated advantages and limitations, discuss the current use of extracellular matrix-based materials in regenerative engineering applications, describe the areas where current research is occurring, and forecast areas where impactful research may appear. The regeneration of tissues often requires a scaffold material to support and guide the cells that are performing the repair. Often, these materials are manmade and lack many of the key features present in native tissue. However, a tissue can be processed to remove its cells (a process called decellularization), leaving behind a scaffold of proteins and polysaccharides known as the extracellular matrix. These decellularized matrices are attractive scaffolds for use in regenerative medicine applications, and they are the subject of this review.

Selling stem cell based biologics and salesforce alignment for the biomedical device industry

Purpose – The purpose of this paper is to discover best practices for selling stem cell based biologics and ensuring proper sales force alignment in the biomedical device industry. Design/methodology/approach – This research is based on an immersion into the industry as well as several formal, semi-structured interviews and dozens of informal interviews of surgeons, medical staff and medical device salespersons and managers. Data were also collected and analyzed from wipricepoint.org. The factors analyzed were the number of discharges, average charge per procedure, median age, male/female patient ratio and total hospital charges per year. Findings – Secondary data can augment primary data collection to determine the most lucrative markets for salespersons to target their efforts. In addition, the data when combined with sales force specific data can help optimize sales force alignment. Insights into the industry are also given such as how to overcome objections to the use of stem cell based biologics for spinal surgeries. Research limitations/implications – Much of the findings are specific to only one industry (medical device sales). However, we do present a generalized process for analyzing a key source of secondary data that could be beneficial to any hospital-serving industry. Originality/value – Within the medical equipment industries, approximately 58 per cent of sales territories were either too large or too small (Zoltners and Lorimer, 2000). This paper shows how secondary data sources can be obtained and analyzed to better focus sales force effort.

Mechanical, microstructural and thermal properties of a 50:50 at.% nickel–titanium alloy subjected to a dieless drawing process

It is widely recognized that hot working, grain structure, degree of deformation and crystal orientation can have a significant effect on the thermomechanical properties of Nitinol, the shape memory alloy of nickel and titanium, widely used in the biomedical device industry. In the current work, a novel hot-working process was applied to Nitinol rods with subsequent material hardness testing, electron backscatter diffraction (EBSD) and differential scanning calorimetry (DSC) analysis performed to determine the mechanical properties, grain texture and transformation temperatures of the processed Nitinol. The properties of the processed alloy, as ascertained by the aforementioned techniques, were compared to the as-received material. It was established that processing the material had the beneficial effect of softening the material from the as-received condition, making the material suitable for subsequent forming operations, such as cold drawing. EBSD results showed a strong preference towards a 〈101〉 texture in the processed material with some preference also towards a 〈111〉 texture. The results of the DSC analysis, which measured the transformation temperatures of the processed Nitinol material, showed a significant reduction in the austenite finish transformation temperature of the processed material compared to that of the as-received material. Tensile tests carried out to determine changes in the superelastic behaviour of the material due to the dieless drawing process corroborated and emphasized the results of the hardness tests, EBSD and DSC analyses. The process has resulted in a material with lower transformation temperatures, higher ductility and reduced tensile flow stress. The upper loading plateau begins at a lower strain and is present over a longer strain range.

The Impact of Product Portfolio Strategy on Financial Performance: The Roles of Product Development and Market Entry Decisions

Innovation is one of the most important issues facing business today. The major difficulty in managing innovation is that managers must do so against a constantly shifting backdrop as technologies, competitors, and markets constantly evolve. Managers determine the product portfolio through key decisions about product development and market entry. Key strategic questions are what portfolio strategies provide the greatest reward. The purpose of this study is to understand the relative financial values of each component of a product portfolio. Specifically, the paper examines the short‐term and long‐term financial impacts of product development strategy and market entry strategy. These strategies reflect two critical tensions that must be balanced in product portfolio decision making and essentially determine a firm's product portfolio. In doing so, the paper also investigates how a firm's capabilities drive each component of a product portfolio.From the empirical analyses in the context of the biomedical device industry, the paper found important insights regarding product portfolio strategies. First, a large product portfolio helps a firm's financial performance. In particular, the pioneering new products have strongest impacts on short‐term performances, and nonpioneering mature products do not provide significant contribution. Second, the results indicate a persistent first‐mover advantage. The first‐to‐market new products yield not only an immediate effect, but also persistent long‐term effects, suggesting that it is important to be first in the market even though there may be short‐term losses. Third, the results suggest the need to balance between “mature” and “new” products. Also, firms need to balance “first‐to‐market” and “late‐entered” products. Because a new or pioneering product requires more resource, it may hurt other products in the portfolio. Thus, without support from mature or follower products, new products and pioneering products alone may not increase firm sales or profit. Fourth, from a long‐term perspective, the paper found that the financial market only rewards a firm's overall capability to deliver new products first in the marketplace. Thus, short‐term performance is mainly driven by product‐level innovativeness, whereas firm‐level innovativeness enhances forward‐looking long‐term performance. Fifth, the paper also found that pioneering new products are driven by integrating both primary and complementary technological capabilities. And nonpioneering new products are mainly driven by the capabilities in primary technology domain. These results provide important insight into the relative value and timing of return on investment in radical versus incremental innovation and alternative market entry strategies. By understanding the performance trade‐offs of these different factors in the short and long term, one can develop better guidelines for optimizing innovation strategies, and their dependence on both external and internal environmental conditions.

Shape-Memory and Shape-Changing Polymers

This article is a perspective that introduces several review articles in the field of shape-memory and shape-changing polymers. It is intended to emphasize the versatility of these materials as active, smart polymers as well as highlight the potential impact of these materials. The biomedical device industry commonly attracts these materials; however, examples for non-biomedical applications, such as origami structures and their recent attention are also discussed.

Enhanced stabilization of collagen-based dermal regeneration scaffolds through the combination of physical and chemical crosslinking

The use of collagen in the biomedical device industry has led to major advances in soft tissue repair. This is attributed largely to the favourable biological and physiochemical properties of collagen. Regenerative medicine and tissue engineering favoured the use of this biomaterial and various commercial products have become available in the past few decades. This study aims to develop a collagen and chondroitin-6-sulphate dermal regeneration scaffold with enhanced resistance against enzymatic degradation. Frozen slurries (0.5% collagen) were dried under vacuum, coated with silicone, crosslinked and then thoroughly rinsed. The scaffolds were subjected to a range of quantitative and qualitative tests that included: scanning electron microscopy analysis, collagenase enzymatic degradation, and cytotoxicity assessment. Scaffold resistance to enzymatic degradation was manipulated after dehydrothermal treatment by employing combinations of crosslinking agents, such as glutaraldehyde and/or carbodiimide, with or without the presence of L-lysine. Results indicate that highly porous (mean pore diameter of 87.3 µm), bioactive, non-cytotoxic tissue engineering matrices were obtained. Enhanced stability of these scaffolds was achieved through extensive crosslinking and suggests the potential to prevent in vivo wound contraction sufficiently.

Estimation of the strength of adhesion between a thermoresponsive polymer coating and nitinol wire

As polymer coatings become more widely used in the biomedical device industry, both to improve biocompatibility and as coatings for localised drug delivery, quantitative methods to measure the adhesive strength between coatings and substrates become a very important consideration. The aim of this study was to take a method for estimating the interfacial fracture toughness of a film to a flat substrate and apply it to Nitinol wires used in the production of medical devices. An investigation into the affect of surface roughness on the fracture toughness was also conducted. For the present study, a thermoresponsive based Poly (N-isopropylacrylamide) polymer was coated onto nitinol wire substrates and the adhesion strength between the polymer and wire was measured using a nanoindentation technique. Different surface treated nitinol wires, with different surface topography and roughness were used, and the affect of these surface properties on adhesion strength was investigated. Results showed that it was possible to apply the delamination technique to wire samples and obtain fracture toughness values. Results also showed that the surface roughness is an important parameter that can affect the adhesion between a coating and the substrate. It was found that, as the average surface roughness increased so also did the adhesive strength between the coating and wire sample.

Two approaches to effective ventilation system design for the biomedical device and pharmaceutical industries

This paper provides two alternative solutions to the difficult task of providing adequate ventilation to operations found in the biomedical device and pharmaceutical manufacturing industries. The first approach involves a two-tier strategy that includes an isolation chamber and an appropriately designed local exhaust hood. The second approach involves the design of modular, walk-in hood. Mechanical and electrical design and development criteria for each option are delineated, and advantages and limitations are elucidated for both systems. Future efforts will target the testing of these two approaches under laboratory conditions to assess the merits of each.

The validation of injection moulding rapid tools applicable to the biomedical device industry

Since the introduction of Rapid Tooling (RT) in the early 1990s; eliminating the costly and time consuming practice of machining metal tools and dies has been the goal of the industry. This demand for faster, less expensive, high-performance tooling solutions has resulted in more than a dozen processes being developed worldwide. Although only a minority of these have established commercial success, the EOS Gmbh and 3D systems Selective Laser Sintering (SLS) processes are the two major developers in this bracket. This paper presents an overview of the validation procedures currently associated with injection moulds for biomedical devices and considers if these procedures are applicable and indeed suitable for rapid tools.

ARE BIOMEDICAL RESEARCH CLUSTERS EMERGING IN SINGAPORE? AN EXPLORATORY STUDY

Innovation and new product development in the biomedical device industry is a complex process requiring interface between medical sciences, precision engineering and information technology. Further challenges are added by the presence of stringent regulatory requirements (e.g. FDA), health economics, outcome considerations, intellectual property issues, and complex nature of market where highly influential intermediaries (medical doctors) not only make product selection for end users (patients) but also contribute to product development. As a result, only a few biomedical device innovations succeed in reaching the market and fewer become commercially successful. A unique characteristic of this industry with regards to innovation and new product development is the importance of research collaboration between the clusters of universities, small and medium sized enterprises (SMEs), hospitals and medical doctors (lead users). The evidence of this is seen in the largest and probably the most established biomedical cluster in San Francisco Bay area, which is home to 31 universities and over 700 life sciences companies [California Healthcare Institute and PricewaterhouseCoopers (2000)]. These clusters of innovation are observed to be contributing significantly to regional economies of the US. Hence many nations as well as biomedical device multinationals are recognizing the importance of these new sources of innovation (i.e. universities, SMEs and users) and their collaboration. From this angle, the authors in this exploratory study examined biomedical device innovations taking place in select countries in Asia-Pacific and compared that with the innovation output of Singapore from a sample population of 33 000 patented innovations over a four year period (2000–2003). In addition, an attempt was made to understand the factors that are important for successful commercialization of biomedical device innovations from Singapore universities, through a questionnaire based survey of a sample of 50 researchers, and in-depth interviews with a sample of five venture capitalists and five medical doctors (lead users). The findings based on this study indicate that (1) Singapore university researchers appreciate the need for collaborative research with the industry but are sceptical about the present environment and process in Singapore. (2) Only a third of surveyed researchers have motivation to commercialize their innovations. (3) Medical doctors are more comfortable teaming up with universities than with the industry. (4) Industry has short-term perspective of research collaboration. The authors' recommendations are to (1) Encourage co-invention teams between universities, industry, and hospitals (medical doctors and clinicians), (2) Build a long-term co-invention culture through collaborative leadership, (3) Attract investment in local biomedical device R&D and production, and (4) Help Singapore universities and researchers appreciate Asia-Pacific market opportunities.

Biomedical engineering: A platform for research and innovation in ultrasound

An undergraduate or graduate degree in biomedical engineering prepares students to solve problems at the interface between engineering and medicine. Biomedical engineering encompasses evolving areas such as advanced medical imaging for diagnosis and treatment of disease, tissue engineering for designing and manufacturing biological implants for damaged or diseased tissues and organs, and bioinformatics for determining which genes play a major role in health and disease. Biomedical engineering academic programs produce graduates with the ability to pursue successful careers in the biomedical device industry or to obtain advanced degrees leading to careers in biomedical engineering research, medicine, law or business. Biomedical engineering majors take courses in biology, anatomy, physics, chemistry, engineering, mathematics and medical product design and value life-long learning. Students learn to work effectively in interdisciplinary teams comprised of individuals with diverse social, cultural and technical backgrounds. Biomedical engineering is becoming increasingly important in imaging and image-guided research. Some examples of innovative ultrasound technology under development are ultrasound devices to accelerate the dissolution of blood clots, advanced surgical instruments with ultrasound guidance and ultrasound contrast agents for targeted drug delivery. Biomedical engineering is a great career choice for technically minded individuals who endeavor to work on applied problems that are medically relevant.

Biomedical Device-Associated Infections in Surgical-Critical Care Patients

ISSUE: Each year, over 8000 medical devices enter the U.S. market. A small number of these devices fall within the high-risk (class III) category, requiring careful FDA review. The explosive growth of the biomedical device industry has lead to several problematic issues for infection control practitioners, including implementation of appropriate surveillance strategies and development of effective interventional practices reducing the risk of infection. PROJECT: This project was developed as an educational exhibit, discussing the microbial etiology, pathogenesis, and risk factors associated with infection in biomedical devices. The exhibit would serve as a focus for discussion of device-related infections in both surgical and critical-care patients. In addition to identifying the scientific basis for infection, the exhibit was developed as a vehicle for reviewing specific evidence-based strategies for reducing device-associated infectious complications. RESULTS: The exhibit was presented at hospital-staff venues involving nursing and medical/surgical clinical practitioners. An effort was made to incorporate specific patient-care episodes within selected case discussions. Following review of this exhibit, the healthcare professionals were able to: 1) identify major microbial pathogens associated with biomedical device-associated infections in high-risk patients, 2) discuss the microbial pathogenesis and risk factors associated with device-associated infections and 3) identify strategies for prevention and management of biomedical device-associated infections. LESSONS LEARNED: The rapid increase in the development and implementation of new invasive biomedical technologies requires that infection control practitioners become familiar with these innovative devices, the risk factors predisposing infection, and appropriate interventional strategies to reduce the risk of infection in surgical/critical care patient populations.

Morphology and gas barrier properties of thin SiOxcoatings on polycarbonate: Correlations with plasma-enhanced chemical vapor deposition conditions

Plasma-enhanced chemical vapor deposition of SiOx coatings on thermoplastics provides a viable route for production of transparent composite materials with high fracture toughness and high gas barrier properties, which are important considerations in the food packaging and biomedical device industries. By examining several series of systematically varied SiOx/polycarbonate composites, we have identified design correlations between coating characteristics (thickness, density, surface roughness, and O2 transmission) and deposition conditions (time, power, pressure, and flow rates). Of particular interest is the observation that the thermal activation energy for O2 permeation through these composites increases (by up to 17 kJ/mol) as their barrier efficacy increases.