The Role of Industry in Developing New Ceramics
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George W. Tysowsky, dds, mph Robert Gottlander, dds
Development of dental technology and materials has advanced at a rapid pace in recent years. Developed and introduced for all segments of the profession, innovations have affected operative materials, equipment, and, most importantly, clinical and laboratory processes. Changes and advancements in these areas are influenced by the dental manufacturing industry’s constant assessment of new trends, market changes and needs, and patient care objectives. The challenge has been for dental product manufacturers to respond to collective professional demands, whether laboratory or clinical, and with faster and more predictable results. At the same time, industry strives to maintain a structured, systematic development plan that will ensure quality products within specific financial guidelines. A complex and multifaceted process, product development—including that for ceramic materials—spans years, from the time ideas are conceptualized until a prototype is created and from the time production methods are upgraded until the time validation studies are conducted. The sequential efforts involved in bringing new ceramic products and equipment to market represent significant undertakings by scientists, chemists, and engineers throughout the development cycle. These endeavors also must account for the perspectives of end users and academics, all of whom have a stake in how concepts are realized in practical applications, and, of course, patients. Further, meticulous studies by independent and in-house researchers are conducted to validate the efficacy and safety of new ceramic materials. All of this time and effort affects the cost of product research and development. Delivery of ceramic products, equipment, and processes that drive the profession demands innovation, fulfillment of specific needs and expectations, and a sufficient profit margin. Ultimately, it demands delivery of ceramic products and processes that are good for the progress of both the profession and industry and most importantly beneficial for patients. For these combined reasons, theoretically good and potentially useful innovations may not come to fruition. When the cost for research and development of a product cannot be justified by opportunities for financial and clinical benefits, then the choice to realize a different product or innovation is made.
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The Role of Industry in Developing New Ceramics Therefore, open relationships and discussions among industry, end users, and universities are essential to ensuring that the ceramic products that are conceptualized will be properly, efficaciously, and successfully used by professionals. While industry helps to identify and define the allceramic needs and wants of the profession, as well as to develop product and process concepts internally, it is most successful in these endeavors when it collaborates and cooperates with other stakeholders. During the initial stages of development of a ceramic product, and later to encourage diffusion through education (eg, workshops and dental schools), industry relies on universities, advisory boards, and key opinion leaders. In fact, the involvement of universities and professional organizations is key in executing education and clinical processes as well as providing training in how materials should be used to optimize function and esthetics. For example, translational research at the university level can be the basis for instructions and protocol for end users so they know how products will benefit them and their patients. A key to success in industry is keeping the health and well-being of patients at the forefront when establishing long-range plans. Education is an important aspect of taking new technology to the market. Unfortunately, many new innovations are not fully integrated into practice or undergraduate academic programs until they have been withdrawn from the market. In the end, the significant steps involved with research and development of ceramic products are those grounded in person-to-person interactions, knowledge transfer, and respect for established guidelines and best practices. The remainder of this chapter outlines and explains the manner through which successful manufacturers have changed dentistry by introducing new products along with techniques and processes for their application. This chapter discusses the importance of the industry in the development of the ceramic materials that are available now and provides future perspectives. Emphasis is given to the debate on new technologies that rapidly change the material business and how this may potentially affect business in the dental field.
Best Practices in Research and Development Dental companies spend significant resources on evaluating customer needs to fuel innovations that facilitate new techniques and procedures. A formal project/product management system is among the best practices for product research and development. It safeguards the likelihood that 20
a potential product concept can be developed, scaled up, and properly tested for appropriate application in the marketplace. Formal project/product management systems encompass systematic phases, along with the appropriate checks and balances to ensure the delivery and use of appropriate products in a clinical or laboratory environment.1–3
Project/product management systems Several opportunities and challenges are inherent to the process of product research and development. Many brilliant ideas encounter obstacles that prevent their final development or introduction to market. Project ideas must be initially validated, after which their ability to be produced on a significantly large scale in a profitable manner must be verified. Simultaneously, they must be evaluated to ensure compliance with all biologic, legal, and clinical requirements for appropriate application. A formalized project/product management system structures product and innovation developments in a systematic way, ensuring that each phase can be expanded while still maintaining the initial product design requirements. These management systems control product development processes so that a concept can progress through and complete its entire development cycle yet undergo design review at each phase with an emphasis on validating and verifying that the product fulfills the original goal. A successful system provides an appropriate structure for the entire development process, ultimately resulting in a successful product in the marketplace.
Product development phases Project/product management systems include several phases, from managing a product concept to full implementation of manufacturing to a successful market launch (Box 2-1).
Feasibility and definition In the feasibility and definition phase, which is the first step of a product development process, it is necessary to clearly define a product concept and assess all potential risks and barriers to its development and upscaling. A specific definition of the concept is created for use as a benchmark of all other upscaling phases. This ensures that the final developed product matches the original goal and market requirements. During the feasibility and definition phase, testing and manufacturing potential also are assessed, along with any expected biologic implications. In this phase, a patent as-
Best Practices in Research and Development
Box 2-1
Project management process
Phase 1: Feasibility and definition Phase 2: Product/process development Phase 3: Premanufacturing Phase 4: Manufacturing Phase 5: Marketing and sales launch
sessment is initiated to evaluate product protection or potential conflict of a new technology in the marketplace. Based on a successful review of these potentials, the concept can advance to the next phase.
the development of some of the currently available ceramic materials.
Product/process development
The premanufacturing phase is also critical, because it verifies that all relevant criteria of a product concept can be met. A pilot batch of the proposed product is manufactured under simulated conditions to demonstrate that the product can be manufactured under appropriate financial and practical conditions. Development of the appropriate pilot batches enables full testing, including physical property testing, preclinical verification, biologic certification, and patentability assessment. Reliable and reputable manufacturers involved in establishing testing protocols do so to ensure that products will be successful and perform as expected and intended when used in the dental laboratory or clinical environment. Therefore, their clinical or laboratory trials and studies are comprehensive. This critical phase verifies that a product concept can be commercially viable and produced for market launch in an efficient manner while still meeting all safety and regulatory requirements. As with all phases of development, a design review is conducted to reconfirm that validation and verification results support the original product concept and that the idea still has merit and relevancy to the profession.
Another significant phase is product/process development, which involves the first development and testing to demonstrate that a product idea has the potential to progress to the envisioned concept that will be required for market introduction. This phase may involve development of tests and creation of prototype formulas that can be tested with preclinical methods to demonstrate viability as a potential product. Manufacturing plays a critical role in this phase, because many ideas can be created in a laboratory setting but are difficult to manufacture to full capacity. It is therefore critical for industry to demonstrate not only that a product concept has merit but also that it also has the potential to be fully manufactured in a productive and profitable fashion. Based on the success of developed tests and produc足tion concepts, a formal design review is completed to ensure that, with each phase, the product concept is validated to meet the original concept. With appropriate completion of this phase, a project or product manager can describe the customer benefits, the manufacturing potential, the market opportunities and expectations, and the economic impact of the proposed invention. The manager also can reconfirm that the project is relevant to the original target or goal. Market research is necessary to define the market potential and relevance of a product, including a first assessment of training needs and marketing activities. It is at this time that the developer can explore possibilities for bundling the new product or innovative technique with others. For example, the applicability of ceramic materials to chair足 side computer-aided design/computer-aided manufacture (CAD/足CAM) processes and the potential for cooperative arrangements with dental laboratories were instrumental in
Premanufacturing
Manufacturing After successful validation of the preproduction phases, a full manufacturing upscaling takes place. This includes development of final packaging and instructions for use, final registration with the appropriate governmental bodies, and validation and verification that the produced product meets all requirements of the original product design. Final clinical studies are also completed utilizing formally manufactured products to ensure the appropriate safety and relevancy of the product for its final clinical applications. 21
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The Role of Industry in Developing New Ceramics Formal design review ensures that the final product meets its design requirements and can fulfill the intended market application. Based on the successful completion of this phase, the product can be released commercially.
Marketing and sales launch This critical phase acknowledges that all preparation activities have been completed in the final development of a product or innovation and that the new product fulfills design expectations and customer needs. The product is released commercially, and its fulfillment of product objectives is monitored. Customer feedback is essential during this phase to ensure that the product launch is successful and that the design has met its goal. Positioning of the product within the marketplace affects this phase, particularly the manner in which marketing communication is presented. Although the product, innovation, technology, and technique solutions developed may be applicable worldwide, messages may be tailored based on geographic area, financial considerations, and other factors. For example, although the indications and applications of a product may be the same, the characteristics that impact a professional’s treatment choices may be different. In the United States and Europe, choices may differ based on the procedures covered by insurance. In the United States, the esthetics and shading of ceramic materials differ from those in most of Europe. However, the material solutions required by the profession are the same. Therefore, corporate partnerships have been instrumental in developing marketing strategies and subsequently bringing new ceramic products to market. These collaborative arrangements help to determine how products should be positioned and used by the dental profession, which likewise helps to establish and define the corporate partnerships themselves.
Essential Steps for Transforming Ideas into Completed Products Of paramount importance to launching ceramic products that satisfy professional and patient requirements is collaborating with end users to assess trends and needs. Establishment of advisory groups, cooperation with dental schools, and information gleaned by company representatives through the sales process provide avenues by which manufacturers can collect and compile data about industry needs. Trend and market reports are compiled and repeat22
edly vetted to curtail high monetary costs and sensitive resource expenditures that are inherent to the product development process. To conserve investment of financial and human resources on the back end (ie, scientific research and development), deliberate energy is expended during initial planning and conceptualization stages. It is therefore not by coincidence that market leaders with sought-after and reputable ceramic products and equipment remain at the forefront throughout the years. Insightful and genuine interest in the end user helps to ensure that professionals and patients receive and benefit from the appropriate ceramic products and processes for the indication. Although a complex process, the ultimate motivation for producing high-quality ceramics is not complicated. Industry plays a key role in the treatment and health of patients. If this essential criterion is fulfilled, other requirements of the product research and development process—such as realizing a positive financial impact for all involved—can be achieved. When ideas and concepts are transformed into a completed product, it is an essential step to dedicate significant time to assessing which solutions might benefit patients. Successful product research and development should be based on adapting solutions to satisfy patient needs, not adapting patients to products that already exist that might not fulfill their requirements. True innovation and development of ceramics, therefore, are predicated on clear and honest input from various members and segments of the profession.
Relationships between industry, universities, and professional organizations The relationship among industry, professional organizations, and universities helps to define the future of the profession. The focus of these interactions ranges from conceptualizing and validating products to creating solutions for the manner in which innovations are used (eg, procedural techniques and processing). High-quality research is costly, and millions of dollars are involved. From the funding of research staff to in-house testing, and from external in vitro testing to clinical trials, much of the burden of funding ceramic product research is borne by manufacturers. To satisfy current and future expectations, dental product manufacturers seek partnerships with universities and research centers to perform testing and validation. This collaboration enables manufacturers to continue to drive new technologies and areas of product development.
Essential Steps for Transforming Ideas into Completed Products If one entity’s scope of involvement is limited, another group can bridge the gap. For example, while universities are invaluable for basic research contributions, industry and professional organizations can help to define future, longterm ceramic product and equipment needs and translational research requirements. To this end, manufacturers invest heavily in interacting directly with professionals to determine how they practice dentistry and what technologic and ceramic product solutions they need. Interestingly, the needs perceived by university-level researchers may differ from the needs of individuals in clinical and laboratory practice. Further, the role of each group in the research and validation process differs. The tests and studies needed to evaluate the safety and efficacy of a product depend on the product itself. Whereas products that do not directly impact patient health and safety can be studied in a purely scientific manner, others (eg, implants) require verification that they will not harm patients. Universities provide a means for testing of ceramic products that have not been approved but also require stringent review and oversight from a university-based human subjects committee to satisfy approval processes. Research on any level requires significant financial investment. Ideally, dental product manufacturers pursue relationships that, in the long term, are fiscally responsible and mutually beneficial to both the university and industry. The task is daunting, particularly considering the funding required by universities to undertake research projects and a manufacturer’s need to balance and control expenses. However, the cornerstone of productive and relevant industry-university relationships is the balance of relational capital; mutual trust and respect are the currency that helps to ensure unbiased and credible interactions and testing, regardless of financial or product support. The university and its faculty and researchers must maintain a comfort level with the ability of the relationship to foster, encourage, and support its objectives. These objectives include working with and testing new ceramic products in a manner that will facilitate dissemination of valid information through published work as well as provide a basis for academic thought, study, and professional career development (ie, master’s and doctoral level). It is therefore incumbent on industry to allow universities to publish their research findings and test results, regardless of the potential effect on the company or product. Equally important is the role of universities in working toward the acceptance and adoption of new technology throughout the profession. Dentists characteristically— although not always—remain faithful to the techniques and products they learned and used during dental school, even after they have been in practice for a few years. Be-
cause dentists may be adverse to change, product placement, research, and training at the university level can help drive innovations throughout the profession. Without question, cultivation and dissemination of know ledge about ceramic materials and processing techniques are fundamental responsibilities of academia. Industry has demonstrated numerous examples of financial and intellectual support for this role through sponsorship and partnership of university research, education and training programs, and professional development. Several high-ranking university leaders and administrators began their careers and established themselves throughout the dental industry as a whole as a result of combined academic-industry pursuits. Among them are deans and department chairs at universities and centers.
Corporate partnerships In the present day, it has become more difficult for dental product manufacturers to remain on the leading edge of technology and product innovations while simultaneously keeping all research, development, and manufacturing under one roof. As a result, in recent years the dental industry has witnessed consolidation among different manufacturers to best leverage their strengths and capabilities. In other instances, the landscape of dental product development has changed to include partnerships between like-minded but diversely capable—and regionally or globally present— companies. These changes acknowledge the fact that for manufacturers to maintain their leadership positions in any given area, they must focus on that category, leaving specialization in a complementary area to a different entity. It is through partnership between manufacturers of complementary products and technologies that each is better enabled to present the newest innovations to the marketplace. Additionally, when different dental product and equipment manufacturers—as well as distributors—focus on their core competencies, the overall costs of researching, developing, verifying, and distributing a product, whether monetary or in terms of human effort, can be minimized. For example, during the development of ceramic materials, manufacturers must consider how materials will be used clinically, how they will be processed in the laboratory or chairside, and how to direct end users to the other materials and technologies necessary for properly adopting the new materials. It is no longer possible for one company to produce and provide all of these components in a beneficial way. In the development and diffusion of such ceramic innovations as Ivoclar Vivadent’s lithium disilicate (Fig 2-1), 23
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The Role of Industry in Developing New Ceramics Fig 2-1 Scanning electron microscopic (SEM) image of CAD-processed lithium disilicate (IPS e.max CAD, Ivoclar Vivadent).
10 µm
a
c
b
d
Fig 2-2 E4D Dentist System for CAD/CAM restorations (E4D Technologies). (a and b) Design center, NEVO intraoral scanner, and laptop. (c) CAD model. (d) CAD restoration. (Courtesy of E4D Technologies.)
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Essential Steps for Transforming Ideas into Completed Products
a
b
Fig 2-3 (a and b) Omnicam system and intraoral scanner (Sirona). (Courtesy of Sirona.)
Fig 2-4 SEM image of leucite ceramic material.
combined with laboratory and chairside CAD/CAM systems, corporate partnerships have been instrumental. For example, E4D Technologies, a company that manufactures high-technology equipment for CAD/CAM restorations, focuses on the equipment and software for creating predictable and successful restorations (Fig 2-2). Likewise, Sirona’s CEREC CAD/CAM systems also provide a means for designing and processing ceramic restorations (Fig 2-3). However, the success and diffusion of either of these innovations are dependent on the availability of suitable ceramic materials that can be processed via CAD/CAM (Figs 2-4 to 2-6). The quality of daily technical support is also vital to acceptance of new products and processes, as dental professionals must develop skills to understand and work with the systems. By demonstrating and offering solutions
50 µm
that address multiple areas of end-user concerns, corporate partnerships such as those between Ivoclar Vivadent, Henry Schein, E4D, 3M ESPE, Planmeca, and Sirona facilitate product marketing, acceptance, and integration throughout the profession (Fig 2-7). Additionally, while there were once differences between the materials and technology used in Europe, the United States, and elsewhere, the dental marketplace is now global. Consolidation, conversion, and globalization of the dental marketplace have made it more expensive to develop new ceramic materials and innovative technologies. Corporate partnerships among dental companies help to resolve the challenges inherent to bringing complete solutions to users worldwide.
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The Role of Industry in Developing New Ceramics
10 µm Fig 2-5 SEM image of feldspathic ceramic material.
Fig 2-7 Ceramic CAD/CAM blocks.
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2 µm Fig 2-6 SEM image of zirconia material.
Quality Assurance
Quality Assurance
tions is required for manufacturers who intend to market their products on a global basis.
In recent years, a trend among some dental product and equipment manufacturers has been to introduce products to the marketplace before they have been thoroughly tested. However, major manufacturers of ceramic materials adhere to rigorous protocols to ensure that their products are tested and evaluated before release.4–7 Although there is always pressure to meet deadlines to realize a proposed market launch timetable, both the manufacturer and the professionals using its products are better served if ample and trustworthy information is available first. When manufacturers follow the previously described project/product management phases, checks and balances are inherently enforced with the objective of ensuring quality, efficacy, and safety. University and independent evaluation groups focus on the key criteria for material and equipment success. By conducting validation studies and providing input that guides the final development of a product, manufacturers and their partners establish product quality, relevance, and performance. Standardized in vitro tests and calibrated clinical trials conducted under strict conditions represent other mechanisms in the quality assurance process that demonstrate how products and equipment will perform in a generalized dental practice or laboratory environment. Even when funded by the manufacturers, research conducted at universities and independent facilities can be trusted, particularly when the nature of the sponsorship is fully disclosed. Once a product is introduced to the market, additional scientific and evidence-based research can be conducted. Of course, the availability of reliable and trustworthy information is predicated on appropriate use of the materials and equipment, in accordance with the manufacturer’s instructions.
Design control
Regulatory requirements Regulatory requirements help to facilitate quality assurance measures. Regulatory requirements for device manufacturers influence all stages of product development, from product design to production to postmarket surveillance. For medical devices intended for the US market, the good manufacturing practices of the US Food and Drug Administration (FDA) regulations (21 CFR part 820) apply.8 For most international markets, International Organization for Standardization (ISO) 13485 is the standard for quality management systems.9 The intent of both 21 CFR part 820 and ISO 13485 is similar, but the requirements contain some differences; therefore, a thorough understanding of both regula-
Although the research phase of product development begins with free-flowing ideas designed to address the problems and challenges faced by the industry, once a manufacturer commits to allocating resources for new product development, the need for design control begins. Compliance with regulatory requirements is evidence based; therefore, all documentation relating to the design must be structured to show that the intent of the regulations was met. This documentation encompasses a design history file inclusive of all reports, analyses, and reviews in accordance with regulations.
Design input Beginning with design input, which details all requirements for the finished device so that designers can create it as expected, the technical specifications and measurable characteristics of a product are outlined. Design input specifically identifies all of the standards, including international standards (eg, ISO), that apply to the device. Whether for test methods or work methods, or for defining quality management systems and laboratory practices, the standards are applied to ensure compliance and marketability worldwide. Designers should be very familiar with all of the standards pertaining to the device they are developing and be cognizant at an early stage of the markets in which the device is intended to be sold. Design input is reviewed by a panel representing all facets of the product development process (marketing, quality control, regulatory, and production).
Design verification and validation Standards and regulations for dental ceramic materials involve two phases in the design control process that are frequently misunderstood: (1) design verification and (2) design validation. Throughout the design process, which is usually conducted in stages, the design input is revisited to confirm that the designers are developing a product that meets the original requirements, that is, that design inputs are consistent with design outputs. This process is called design verification and must be documented in accordance with regulations.8 If amendments are required, they are incorporated into a revised design input, further testing is conducted, and subsequent design verification is performed.
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The Role of Industry in Developing New Ceramics Design validation, however, involves a more complex process and analysis of the finished product, manufactured under actual conditions to determine if the device will meet user needs. Design validation planning should occur at a very early stage in development and should be done by people with knowledge of the actual use of the device in a clinical or laboratory setting. Design validation testing should be conducted by persons representative of the user of the device on production units under actual or simulated conditions of use.8 For dental ceramics, validation testing is usually carried out by the dental technician, with some additional input provided by the clinician. The validation test protocol must provide enough detail to the evaluator so that the results can be compared to identified acceptance criteria to prove whether or not the device meets user requirements. In particular, the ceramic material must meet the indications for use and user requirements for the manner in which it will actually be used. Such questions examined during this process may include: • Can and will users actually understand the instructions for use? Are instructions written in the proper language (perhaps with translations) and with the correct terminology? • Can and will users understand the product labeling? • Does the product perform the way the user expects it to? • Do the fired shades match the shade guide? Design validation may also include clinical studies and/ or a review of the critical research literature to determine whether the device will perform as expected in a clinical situation. Dental ceramics are used in a variety of clinical applications, from single crowns to long-span fixed partial dentures. All indications should be thoroughly discussed in the design validation summary report, including proper justification from the literature if necessary.
Design review Design review is the process that identifies successes and failures encountered during the design process so that a “go” or “no go” decision can be made with respect to the design project. Design review is conducted by representatives of all functions concerned with the design stage, including an individual who does not have direct responsibility for the design stage. Once approved, the development and production process continues to the next stage, as previously described.
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Process validation Once a device design has been finalized, regulations also require that manufacturers control the transfer of the design to production.8 This is an extremely important step that cannot be taken lightly. Prior to the sales release of any dental ceramic material, the members of the production line must be fully trained and equipped to make the product. This includes the need to identify and validate those processes from which the output cannot be 100% tested. Likewise, any computer software used by the manufacturer that may impact the device must be fully validated. Process validation is a system of specialized testing and statistical analysis that provides the manufacturer with a high level of assurance that all of the output of any process that cannot be 100% verified will meet specification. It requires a manufacturer to understand and define the acceptance criteria for all aspects of production and develop in-process tests and controls to prove conformance to the specifications. Once the process is validated, manufacturers are required to control and monitor the process in order to revalidate if something changes.
Production process Production and measuring equipment must also be carefully qualified before it may be used for the production of medical devices. Installation qualification, operation qualification, and performance qualification are common practices wherein manufacturers identify specifications and parameters for equipment prior to purchase. On arrival of the equipment, testing is documented as evidence of proper installation and operation. Ceramic manufacturers may also collect ongoing process data to monitor the ongoing performance of the equipment. The qualification step also incorporates the equipment into the manufacturer’s calibration and preventive maintenance systems, which also are required by the regulations. From a production standpoint, regulatory requirements influence the raw materials incorporated in products, which are specified throughout the design process to meet identified standards. These standards may be published industrywide or reflect internal quality assurance measures established by the manufacturers themselves. Such standards dictate the quality, composition, and manner of processing for any raw materials used, including those purchased from outside parties or obtained in conjunction with selected vendors.
Role of Industry in New Product Training As a result, to ensure that raw materials and product components will satisfy the specified requirements, dental product manufacturers require vendors and suppliers to engage in rigorous qualification and evaluation processes to provide a high level of assurance that they can meet the needs of the manufacturer. Some dental product manufacturers perform this due diligence based on risk analysis or assessment of several key factors. These include the criticality of the product or material a vendor is supplying and how much control a manufacturer will need over it. Following vendor selection, a quality inspection may also occur on receipt of materials to ensure compliance with specifications, after which subsequent product-processing specifications are enforced and validated through ongoing testing. Regulatory requirements further mandate that evidence be provided to document that different steps in the entire production process, including device packaging and labeling, have been checked independently and released (ie, reviewed during production compared to the specifications for each component and production phase). This process safeguards the likelihood that all aspects of a product or material will meet all specifications prior to being introduced to commerce.
Approval and Certification Processes Product registrations are required before new ceramic materials are introduced to the marketplace. These requirements differ from country to country, although some countries offer reciprocity to devices cleared in the United States. In the United States, most device registration is governed by a section of the Food, Drug, and Cosmetic Act that affects premarket notification.10 When manufacturers plan to market a new medical device in the United States, they must request permission from the FDA to do so. This process involves proving that the product is substantially equivalent to an already cleared product or device; in areas where the new product is not completely identical or the new design raises new issues of safety and effectiveness, manufacturers must prove that the product has been tested, risks have been minimized, and the product will perform as expected. Given the scope of the FDA’s regulations, manufacturers of ceramic materials and innovative technologies must adhere to rigorous product development processes (as previously described) to receive clearance for commercialization. Additionally, manufacturers also can demonstrate their commitment to quality by receiving ISO 13485 certification.9 This distinction indicates that a company adheres to a quality management system, one that meets and maintains internationally accepted standards for ensuring con-
sistent quality in product design, development, production, installation, and service. In addition to ISO 13485 certification, the most reliable route to global product registration is adherence to product-specific international standards. ISO is a voluntary organization whose members are recognized authorities on standards. The ISO standard for dental ceramics is ISO 6872.11 Most standards are established in a format that outlines basic requirements for the device, such as minimum compressive strength, minimum flexural strength, maximum solubility, biocompatibility requirements, and labeling and instructions. The standards also describe specimen preparations and testing methodologies, which are important so that all manufacturers of the same type of products are compliant with the same standard based on the same criteria. In the end, it is important that manufacturers support all claims they make for the medical device with evidencebased testing. Device labeling encompasses more than the label on the device itself. Manufacturers are responsible for ethically representing their devices to the market and not overstating or recommending off-label uses. The registration process includes a careful review of all labeling and instructions for use, and once clearance is granted, manufacturers are expected to control their literature and marketing efforts so as to accurately represent the cleared device.
Role of Industry in New Product Training As previously noted, many dentists continue using the products and techniques they were introduced to in dental school, even many years into their professional careers. If they have experienced success with a product and the manufacturer has maintained a long-term relationship and commitment with the university, then it is likely that practicing dentists will remain loyal to products and materials offered by that particular manufacturer. This presents challenges for marketing new ceramic materials and high-technology innovations. Making inroads toward current and future practicing dentists requires brand recognition as well as education and training.12–14 Whereas dental students previously graduated and shortly thereafter established their own practices—thereby starting their dental product purchasing behavior—today’s world is different. Many dentists are now working a greater number of years in group or franchise practices where purchase decisions are made by someone else or at a corporate level. The gap between knowledge of the materials used in dental school and knowledge of emerging and innova29
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The Role of Industry in Developing New Ceramics tive dental ceramics creates marketing, education, and training challenges for dental material manufacturers and distributors. Established and experienced dentists often learn about new ceramic materials and techniques at trade shows, seminars, or manufacturer-sponsored events. Key opinion leaders who have used the product introduce examples of successful cases and provide instruction regarding proper protocol and treatment indications. The caveat about manufacturer-sponsored education, however, is the real or perceived influence of dental companies on content that is presented as part of educational training. Today’s savvy dental professionals are more skeptical of marketing and education messages and avoid being pushed toward a specific product. They would rather focus on understanding the application of types of solutions to different clinical or laboratory problems. For instance, dental professionals may prefer education about ways in which different conditions can be treated using available solutions and based on the scientifically researched criteria rather than brand-specific instruction. New technology and ceramic material innovations achieve widespread adoption in the marketplace through education. However, the costs of designing, sponsoring,
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and conducting training and education programs to ensure the proper use and application of ceramic materials and technologic innovations require financial and intellectual investment by the dental industry. Partnerships among the dental industry, universities, and professional organizations facilitate the allocation of resources for the creation of worthwhile education and training venues.
Conclusion The commercial development of ceramic products and technology is complex and requires a formalized process that ensures a systematic progression from a concept to the complete fulfillment of requirements as well as the ability to successfully manufacture and market a relevant product. New ceramic technologies are rapidly advancing, and the challenges of regulatory and appropriate design testing have become more complicated. An appropriate project/ product management system, combined with strategic, like-minded, and respectful partnerships, ensures the relevancy and quality of new ceramic products and their ability to appropriately fulfill customers’ needs and expectations.
References
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8. Food and Drug Administration, Department of Health and Human Services. Quality system regulation. 21 CFR §820. Washington, DC: Government Printing Office, 2012. 9. International Organization for Standardization. Medical devices. Quality management systems. Requirements for regulatory purposes. ISO 13485:2003. Geneva: ISO, 2003. 10. Federal Food, Drug, and Cosmetic Act, 21 USC §301–399. Washington, DC: Government Printing Office, 2012. 11. International Organization for Standardization. Dentistry. Ceramic Materials. ISO 6872:2008. Geneva: ISO, 2008. 12. Jahangiri L, Choi M. A model for an integrated predoctoral implant curriculum: Implementation and outcomes. J Dent Educ 2008;72: 1304–1317. 13. Mattheos N, Ivanovski S, Sambrook P, Klineberg I. Implant dentistry in Australian undergraduate dental curricula: Knowledge and competencies for the graduating dentist. Aust Dent J 2010;55:333–338. 14. Jalbout Z, El Chaar E, Hirsch S. Dental implant placement by predoctoral dental students: A pilot program. J Dent Educ 2012;76:1342– 1346.
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