IPD is an integrated product development management system driven by market and customer needs. At its core, a cross-departmental team of people from marketing, development, manufacturing, service, finance, and procurement manages the entire product development process, from customer needs, concept formation, product development, and market launch, all the way through the life cycle. Through the IPD management system, product development can pay more attention to the needs of customers, speed up the market response, shorten the development cycle, reduce scrap projects, reduce development costs, improve product stability, producibility, service and so on.

As domestic enterprises pay more attention to and invest in the field of medical device design and development, industry colleagues are paying more and more attention to more advanced design and development models, concepts and methods, and IPD is one of them. In addition, when talking about enterprise design and development in the industry, it is generally necessary to talk about Huawei IPD and Mindray IPD, which seems to have become a trend. In fact, the product design and development platform of Xiaobian's former owner can also see the shadow of IPD, which is just absorption, digestion and integration in the research and development process of the enterprise. In the offline sharing activities organized by Xiaobian, when designing and developing the theme, the sharer also slightly mentioned the relationship between IPD and medical device design and development, using the following figure as an example. For medical device industry colleagues reference learning.

IPD is a large-scale systematic product design and development tool. Xiaobian does not recommend domestic start-ups to import IPD at great cost. It is already very rare for start-ups to run and use the ISO 13485 system process well. After all, the IPD process requires strong enterprise resources (funds, team personnel). Of course, for medical device practitioners, it is necessary to pay attention to and learn advanced concepts and methods. It is also very good to be able to integrate some of them into the enterprise process and use them in practice.

How to use IPD in the medical device industry?

Medical devices refer to instruments, equipment, appliances, materials or other articles used in the human body alone or in combination, including required software. According to safety, it can be divided into low-risk devices, medium-risk devices and high-risk devices. Among them, low-risk devices are mostly low-value consumables, including bandages, gauze, sponges, disinfectants, etc.; moderate-risk devices include in vitro diagnostic instruments, imaging diagnostic instruments, and home medical devices. High-risk devices are devices that are implanted into the human body to support life and are potentially dangerous to the human body, and most of these devices are high-value consumables. It mainly includes heart stents, artificial heart valves, spine, artificial joints, crystals, life support equipment, medical imaging equipment and so on. Of course, IVD is also a medical device.

A. medical device industry development status

In recent years, with the release of relevant national industrial policy dividends, the pace of domestic substitution of medical devices in China has accelerated, and the market structure tends to be optimized but still unbalanced. The "14th Five-Year Plan for the Development of Pharmaceutical Industry" proposes to focus on the development of new medical imaging, in vitro Diagnosis, tumor radiotherapy, wearable monitoring, TCM diagnosis and treatment, and other fields of medical devices, and proposes to accelerate the application of artificial intelligence and other information technologies in the field of medical equipment, it is conducive to the high-end and intelligent development of medical devices.

In addition, with the expansion of my country's medical insurance coverage, the growth of medical visits and the construction of a multi-level medical institution system, the scale of the terminal market of my country's medical device industry will also expand. The construction of the medical device industry chain is relatively perfect, and the development of sub-sectors has different characteristics. In addition, the domestic medical device industry presents many enterprises, small, scattered situation, the industry concentration is low. Industry concentration, the domestic medical device industry concentration is much lower than the pharmaceutical industry.

From the perspective of the industrial chain, the upstream is dominated by various raw material suppliers and corresponding technology research and development enterprises. Midstream to all kinds of medical equipment, consumables related manufacturing enterprises. Downstream is dominated by various medical institutions, scientific research institutions, third-party inspection centers and C- end users. The construction of the domestic medical device industry chain is relatively perfect, and will gradually penetrate into the more high-end market in the future. Medical equipment occupies the largest market share, and the future development potential of domestic brands is huge.

Artificial crystals, orthopedic products, coronary intervention and other technologies are more mature, and the clinical demand is higher, the domestic brand competition is strong, in the short term will face a higher collection pressure. Low-value consumables market competition is more adequate, product optimization and upgrading or development opportunities. The market size of individual segments of the in vitro diagnostics market is limited, and the technology development is at a mature stage, with fierce competition.

Emerging market opportunities have brought about an upsurge of domestic going out to sea, and local enterprises have further opened up the international market: with the development of the epidemic in recent years, China's local medical device enterprises have gradually been accepted and recognized by the global market. The medical device market set off a wave of mergers and acquisitions, a number of sub-track situation is good, with the gradual spread of volume procurement, so that the mature business of medical device enterprises face growth bottlenecks.

II. Development Prospect of Medical Device Industry

1, high-end medical device products localization rate increased.

Domestic has emerged in some sub-areas of high-end substitution of enterprises, some high-end domestic medical devices have been qualified for import substitution. Coupled with the continuous improvement of the review and approval system for domestic medical devices, it is expected to accelerate the listing of innovative medical devices by domestic enterprises from the approval process, and encourage domestic enterprises to invest in innovative research and development of medical devices.

2. Integration of medical devices and emerging technologies

With the continuous deepening of the digital economy, China's medical device industry enterprises to accelerate the integration with the Internet. Such as oxygen machines, ventilators, oximeters and other medical device products online channels have a large space for development. With the continuous development of artificial intelligence medical devices, it has broad prospects in the fields of auxiliary decision-making and health management, and has become a new direction in the field of medical devices.

3. Increased industry concentration

In the fields of high-value consumables, diagnosis and treatment equipment, the development period may face financial pressure. Accelerating the development of medical device enterprises and realizing large-scale operation will be an important trend of future industrial development. With the intensification of industry integration, enterprises that shape product competitiveness with R & D investment are expected to stand out, and enterprises with scale advantages, brand advantages and product competitiveness will achieve a steady increase in market share.

How does the medical device industry use IPD?

IPD integrated product development is to ensure the effective allocation of human resources for product development and product development from the perspective of enterprise process reorganization and product reorganization. IPD is not only a set of theoretical models, but also a set of successful product management and R & D management practices, from the two aspects of process restructuring and product restructuring to achieve the goal of shortening the time to market, improving product profits, effective product development, and providing greater value to customers and shareholders. Domestic well-known medical device enterprises, such as Antu Biology, Qinbang Biology, Mindray Medical, etc., have conducted IPD consulting and training services with the industry's experienced consulting company-Keji Pipeline. So, in the medical device industry, how to use IPD to achieve enterprise development more, faster, better and less?

Product development is investment behavior

Many enterprises are used to looking at product development and technology development from the perspective of technology. IPD reminds us to look at product and technology development from the perspective of investment first, emphasizing the management of product development and technology with investment concepts and methods, mainly reflected in: portfolio analysis and management of product and technology development, and investment decision review in the process of product and technology development. Use the VOC process to promote cross-departmental process optimization of products, brands, services, and marketing, and then gain insight into the voice of customers in all aspects, provide customers with a better experience, and ensure that development does the right thing.

The initial stages of the medical device development process involve careful planning, extensive research and thorough documentation. It is important to consider opportunity and risk analysis to make the process more distinctive. A risk analysis is essential to determine whether progress can be made in subsequent phases. Because medical equipment is a special commodity, it has its own uniqueness and general commodity attributes. Uniqueness is mainly because it is applied to people, the design is directly related to whether it can play a cure, whether it can be safe and effective, but it also has the characteristics of general goods.

However, in addition to regulations and standards, it also includes three aspects of design as general commodity design and development: functional and performance design; engineering and structural design; packaging design (appearance). Manage product development and technology through investment concepts and methods to achieve commercial success.

Market-based innovation

With the maturity and improvement of the medical equipment evaluation system, China's medical device industry has ushered in a golden period of development, and domestic substitution has become a major trend. Especially in the process of replacing general-purpose equipment to special-purpose equipment, taking the monitor market as an example, Meirui Medical accounts for 64.80 percent of the market share, realizing domestic substitution and so on. From product imitation to technological innovation, and then to the creation of domestic independent brands is the only way for the development of China's medical equipment industry in the future.

IPD emphasizes that product innovation should be based on the market, that is, innovation should be carried out on the basis of sufficient market analysis, product planning and technical planning. Before development, it is necessary to implement market management (MM,Market Management) and demand management processes, and fully carry out demand management and market management activities such as demand collection, demand analysis, competition analysis, market positioning, product planning, technical planning, etc. In the process of product development, it is necessary to correctly define market demand and product concept and implement customer-centered design.

Under the background of volume procurement, enterprises lacking core technology and differentiated innovation ability can hardly avoid the situation of homogeneous competition and low-price competition, and are gradually eliminated by the market. Medical device companies can only be invincible if they strengthen their own innovation "hard power" and continue to improve their cost control capabilities.

Platform-based asynchronous development patterns and reuse strategies

The development of new products is an important internal business of domestic medical device enterprises. If we can develop products that meet the needs of the market in a relatively short period of time, it will greatly improve the competitiveness of medical device products and market share. Through product planning, technology planning and platform planning, the three major plans cooperate with each other. When developing many products of the entire series of medical devices, they should be developed on the basis of a common product platform. Further, they can be developed asynchronously in layers and time according to the final products, platforms, modules/components and key technologies, so as to realize the reuse of common modules/components (CBB,Common Building Block) as much as possible without sacrificing differences.

Build a systematic product platform, technology platform, CBB (common building block) to improve the reuse rate of design and form shelf technology. Speed up product delivery and reduce the complexity of back-end product production, through technical research management, from technical planning to technology development, so that technology development services product development. Establish a technology development environment and technology development process focused on breakthrough innovation to accomplish breakthrough innovation. Clarify the relationship and assistance mechanism between the four projects of product development, technology development, product pre-research and technology pre-research. Ensure that things are done correctly and leverage the platform to develop products "as quickly as possible.

Separation of technology development and product development

Medical device development is the process of transforming a medical device design into a commercially viable product. In the medical device industry, product development engineers must follow all stages of medical device development, comply with strict regulatory requirements and fully document their work. It starts from the planning stage and needs to formally document the design plan to describe the development process according to regulatory requirements, so it will bring a certain degree of risk.

Medical device companies should carefully follow regulations, risk management and assessment processes, and meet product application scenarios and user needs. And the implementation of asynchronous development mode, technology development and product development to achieve separation is a good solution. Specifically, before the product development needs, key, common technology modules or technology platforms are developed by a dedicated team and technology transformation is realized, which can greatly reduce the risk of product development, speed up the product development cycle, and facilitate the breakthrough and progress of key technologies.

Cross-sectoral collaboration

Due to the functional barriers between departments, coupled with the complexity of medical device product development and the requirements for speed, it is difficult to guarantee the quality and speed of product development by relying on the division of labor between departments. Therefore, the medical device industry needs to set up cross-departmental teams to be responsible for product development decision-making, planning, management and implementation, according to cross-departmental processes. Work in a collaborative manner to ensure efficient communication, coordination and decision-making.

As a set of advanced R & D management mode, the foundation of IPD's success is the close cooperation between functional departments and various teams to complete their respective responsibilities. The team setting in the IPD system is related to company size, industry characteristics, technical characteristics and degree of diversification. In general, it is divided into a decision-making team and an executive team. The decision-making team is divided into a portfolio management team and a technical management team. The executive team is divided into market management/product planning team and R & D team. Some larger enterprises may also have investment review teams and demand management teams.

Structured parallel development process

If medical device companies lack a structured process, then each product development approach will be different, which will lead to two situations: First, there is no accumulated experience to refer to, and there is no example to learn, so when the project is getting bigger and bigger, the development cycle time becomes longer and longer. Second, when someone comes up with an improvement method or trick, there is no way to standardize it and apply it to other projects, and it is difficult to measure its process and improve it.

Therefore, in order to manage the huge and complex medical device product development activities, it is necessary to establish a development process with reasonable structure, clear level and standardized definition, and strike a balance between unstructured and over structured, so as to ensure the quality and efficiency of product development, and will not restrict innovation. Moreover, various technical activities and functional activities of medical device product development should be operated in parallel as much as possible, and professionals from all aspects should participate as soon as possible to standardize the management of product development activities. Establish a full process system that is guided by road sign planning, product planning and PDC product portfolio, product development and listing, and life cycle (market life cycle). To shorten the development cycle and ensure quality.

Equal emphasis on product line and capability line

With more and more product categories and new products of medical device enterprises, it is necessary to establish horizontal product line organization (here refers to product line R & D organization, which can be further extended to product line management organization) and vertical capability line (resource department) in R & D organization, strengthen the market orientation, autonomy and leadership of product development project of product line R & D organization, and strengthen the resource construction of capability line to continuously improve the professional ability in various fields, and support the product line R & D team to achieve the horizontal operation of the whole process, the introduction of competitive products, rapid response to the market. Make good use of incentive and growth mechanisms, combined with project management, especially multi-project management mechanisms. Ensure that every product development project will not be unsuccessful due to the development of its own reasons.

Professional talent echelon construction

Medical device product development is the most fundamental need for various categories and levels of talent protection. To this end, enterprises must systematically plan, train, motivate and retain R & D talents, build a two-way development channel for technology and management, and establish a professional talent echelon. To ensure the effective operation of the R & D system and promote the success of product innovation. In addition, in order to ensure the realization of the new management model, the company's organizational structure and performance management model are designed accordingly to ensure the implementation of the new system in the company.

In terms of organizational structure, it is no longer limited to project management within the R & D department, but builds a company-level product development project management mechanism, changes the functional management organizational structure, and establishes a heavy matrix management model. In terms of performance management, based on the heavy matrix management and balanced scorecard, a two-way performance management evaluation model with "vertical and horizontal" balance is established. Vertical is the administrative management line to ensure capacity building, horizontal is the business management line to ensure business success, the establishment of the company's capacity improvement and product line business development mechanism.

IV. Summary

Enterprise process can not be a process and process, product development must be the main process, while the research and development production, marketing, procurement, marketing, financial management, project management, quality management and performance management activities into the mainstream of product development, in order to achieve the whole process, the unified management of all elements. To achieve more, faster, better and less product development in order to achieve commercial success.

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Tips: persistence is a belief, focus is an attitude! Find like-minded friends to do something useful for the medical device industry.

[recommend] In the field of medical device design and development in industrialized society, there is indeed a gap between the concepts and methods (imitation and reverse engineering) of most domestic medical device enterprises and the product design of international advanced medical device enterprises that cannot be ignored. The concepts and methods of the "Medical Device Design and Development Control Manual", which has been translated and published by the small team for more than 10 years and organized by colleagues in the domestic business community, are at least 10 years ahead of most. What domestic colleagues need is to learn, use, and gradually catch up after practice, and design and create first-class products to serve the public.