No room for error in today’s medical industry

Overcoming common engineering challenges to minimise costs and speed time to market

The pressure for engineering departments to rapidly develop novel medical devices and instruments to meet market needs and generate revenue is amplified by the current state of the global economy. Simultaneously, public pressure for the FDA to protect patients from defective and low-quality devices means intensifying regulatory scrutiny. These outside influences make it more important than ever for development teams to avoid any potential obstacles to a successful product design project. 

Anticipating potential roadblocks early in the design process allows engineers to rapidly identify and address issues, avoid costly re-designs and bring products to market quicker. While each new project brings its own set of obstacles and opportunities, there are three common steps that if not properly executed often challenge the product development process: 1) defining requirement specifications; 2) managing changes; and 3) integrating the entire system. The following tips for overcoming these challenges can help medical product original equipment manufacturers (OEMs) and start-up companies minimise costs and smooth the regulatory approval process.

The development of requirement specifications is a fundamental starting point for product design. To determine the requirements for a particular device, a large number of stakeholders must be involved, including marketing, regulatory, safety and technical personnel. It is often difficult to satisfy each group and create a device in line with cost, development timeline and product size requirements for market success. Further, conflicts between parties can severely delay the product design process.

It is therefore necessary to identify where certain features and functions can be eliminated without sacrificing marketability. Each performance requirement, from throughput to operating environment, affects the features and functions that will be required within the medical device or instrument. In turn, these features and functions affect cost, time to market and product size.

As an example of the tradeoffs that may need to made in a laboratory automation system, the ability to conduct upfront processing of a sample may not be worth the cost to an end user. In some cases, money and time are better spent developing faster robotics and fluidics to increase downstream throughput. Fully understanding the value of certain functions to the end user is critical to designing a device or instrument that will be successful in the marketplace.

Utilising a template of potential features and functions for similar devices can streamline the requirements definition process. Drawing on knowledge from past development projects, or working with a partner that has the relevant experience with a particular type of product, can speed the development process and ensure that no necessary features and functions are left out. A general feature and function template can be tailored by the design team for an instrument’s specific purpose.

To ensure the most comprehensive template of features and functions, companies should conduct customer focus groups and market surveys to find out what challenges customers face and which automated processes would increase efficiency in the field. This feedback can verify that certain features should be incorporated in the device.

Once a comprehensive template has been established, the next step is to begin trading off features and functions. Through brainstorming sessions, design engineers and stakeholders should work together to eliminate features and functions that will add significant cost, time to market or size to an instrument, carefully considering how much end users are willing to invest for certain requirements. Further, an experienced development group or external partner can leverage prior project experiences to identify features and functions that will be necessary and those that may be eliminated to satisfy cost, size and time-to-market stipulations.

After the features and functions tradeoffs are made, it is important to ensure that the product’s features and functions meet each stakeholder’s objectives and to verify that the engineering teams’ conceptual ideas mesh. This can be achieved through a comprehensive design review, which assembles all members of the project team. Often, the most important stakeholder objective is the cost target for the device or instrument. A thorough review of the features and functions and conceptual ideas for the design will give a better understanding of how much the final product will cost. Further, the team should review the initial design concepts for each module and ensure they are compatible with one another.

Once the initial design concepts have been developed, the project team must ensure the architecture of the device or instrument can support its features and functions. Thus, a thorough architecture review should follow the initial design review and include members from the mechanical, electrical, software and systems teams as well as regulatory and safety experts. To use a building analogy, there are a number of ways to construct a house, but it can look like a colonial, Victorian or contemporary model. An architecture review can ensure the right building blocks are put in place to meet the product’s objectives.

Finally, end users can provide valuable input on initial concepts. Following the architecture review, companies should put together a hard model or foam core markup of the concept, which will allow them to go into the field with a focus group. This end user verification can ensure the product will meet their needs.

Recently, KMC Systems worked with an OEM developing an automated processor for preparing bacterial samples for identification and drug testing, they had to identify areas where features could be sacrificed to keep the product at an appropriate price point for end users. Ultimately, the systems engineer recognised that automating the inoculation of the test sample was not worth the time for development or the additional costs that it would require. Further, the company set up end-user interviews that confirmed that this process would not be worth the added cost. Because the OEM recognised the need to trade off the inoculation process, the product was able to be successfully introduced into the marketplace in a timely and cost-effective manner.

While adequate definition is crucial to reducing change during development, change is inevitable as companies often continue to learn what features and functions can be traded off and what end users expect throughout the entire design phase. Changes during the product development process often present a challenge to OEMs and start-ups, leading to increased costs and time-to-market delays.

When change does occur, companies must first understand what is driving it in order to properly manage it. The three major drivers for change during product development are: market needs, technical challenges and cost targets. Each cause requires different steps to avoid even further increasing costs and slowed development schedules.

Market needs are a common driver of change for medical device and instrument projects. If end user studies reveal that a particular feature is not as important as anticipated, for example, alterations to the product design should be made to increase the marketability of the device. When marketing influences product development, companies should use a stage gate process to manage these changes.

A stage gate process provides a roadmap for companies to take products from ideas to commercial realities and is comprised of set tasks that must be completed before a project can move to the next stage. Each stage should also require management approval. For example, a common stage gate process for a new medical device or instrument could be comprised of the following four stages: 1) Specification, Planning and Concept, 2)Development, 3) Verification and Production Transition, 4) Production, 5) Post Production. Incorporating these checks and balances into each of these product development phases ensures that management and marketing teams remain involved to identify any changes to market needs before the product moves too far along into the process.

Another common driver of change is implementing unfamiliar technologies within a device or instrument. If a module needs to be included in the design of the device and the engineering team lacks the relevant experience to rapidly develop it, valuable time can be lost from the product development process. To manage this and minimise wasted time use breadboards and prototypes to become familiar with its functionality. Early-stage tools, such as basic off-the-shelf software, can also help manipulate the device to perform basic functions and determine if it will meet objectives. Working with an external partner who has a suite of early stage tools can also give companies access to a wider range of experienced engineers than could be maintained in-house and mitigate the risk associated with implementing new technologies.

During the product development process, certain modules within a system turn out to be more costly than expected and change becomes necessary to keep a product affordable. When cost is the driver of change, frequent design reviews centered around specific modules can help meet targets. Involving both design and management teams in these reviews keeps all stakeholders abreast of potential cost increases and allows the group to brainstorm areas where other features and functions can be traded off to reduce cost.

Regardless of their cause, changes during the development process must be properly managed through proper communication between all members of the technical team and stakeholders. Program management is a key factor in properly dealing with change and ensuring time, money and resources are not wasted. A well-documented product requirement definition can also help the program manager and teams stay focused on their roles and responsibilities when change occurs.

The system integration process can be a major obstacle to delivering devices and instruments to market on time and on budget. This stage is one of the most critical steps in the development process because it compiles all of the subsystems to ensure the device or instrument works properly as a whole.

Often, complex medical systems are the result of work from many internal groups or outside partners. While communication between internal groups is critical, coordination of outside partners, including software, disposable, industrial design and user research teams, is also crucial to ensuring a successful system integration. When these collaborators fail to communicate, the developed components may not be compatible with each other. There are many strategies development teams can employ to help smooth system integration.

Initially, detailed requirements and interface documents can help keep internal and external groups on the same page leading up to integration. Groups performing different segments of product development, including mechanical, fluidics, systems and software, need detailed information about each component to ensure the system will interface well. Not anticipating that certain elements of the design may not work together until system integration commences can be extremely costly as entire subsystems may have to be re-designed.

Additionally, regular meetings with all engineering teams leading up to integration are critical to successful product development.  This will ensure each team is aware of what subsystems will need to work together (interface), decreasing the chance of major malfunctions during integration. 

Lastly, enlisting the help of an experienced partner to manage a collaborative development team can further smooth the system integration phase. A partner with relevant experience in product design can act as a valuable resource for companies struggling to manage internal teams.

While defining requirement specifications, managing change and system integration represent a few steps where engineers commonly encounter roadblocks, each device or instrument comes with its own set of challenges and opportunities. Anticipating and developing strategies for these challenges can significantly cut costs and speed time to market.