Originally Published IVD Technology October 2004
Manufacturing equipment and supplies
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| An automated assembly system by Kinematic Automation Inc. (Twain Harte, CA). |
As the IVD industry has evolved during the past few years, IVD manufacturers
have begun to see key areas that require their focused attention. With increased
opportunities for IVD products in emerging markets, a competitive edge is crucial
to a manufacturer’s long-term success. An IVD company either gains or loses
this competitive edge during the initial decision-making process when developing
a new product.
Since creating a competitive edge must always be a goal, IVD manufacturers must
define a reliable and consistent method to achieve it. Manufacturers can accomplish
this goal by creating a controlled environment that will ensure proper steps
are taken. In this environment, an IVD company can assemble a solid team to
reach its goals. This team atmosphere will allow companies to select the proper
materials, processes, and manufacturing methods.
A Controlled Development Environment
It is easy to take many decisions for granted during the frenzied pace of the
initial design and development phase. The desire to make it work often outweighs
other factors. IVD manufacturers must not trivialize such other factors if they
are to achieve a predictable, profitable, and successful product life cycle.
If IVD manufacturers are to consider and account for all aspects of product
development, they must establish a controlled environment. Utilizing milestones
to mark progress and manage process evolution is crucial. Although difficult,
it may be necessary to anticipate and create points at which the project must
achieve scalability for it to move forward.
However, a product that gains an initial advantage due to time-to-market or
advances in technology can potentially fail if IVD manufacturers cannot scale
production to meet demand. There are many areas in a product and its manufacture
that can cause this failure. Manufacturers can prevent such conditions if they
ask the appropriate questions during the development process. IVD companies
should also be prepared to respond to the answers in a positive manner, even
if the conditions are less than desirable. Companies can easily identify and
track such question points in a master schedule.
Supplier Teams
IVD products may only sustain long-term success through the support of a solid
team. Consisting of suppliers and in-house company staff working closely together,
a smoothly integrated team will have significant impact on the ability to maintain
a competitive advantage.
In creating a solid base of vendors, all aspects of the organization need to
be properly connected. IVD manufacturers should select vendors that satisfy
not only the engineering and technical requirements, but also manufacturing
and procurement needs.
Because every IVD manufacturer depends on various suppliers, properly creating
this group is key. It is easy to select suppliers of material components or
processes based only on the specific physical attributes or process activities
required. Many times, the ability to provide the components or supplies in a
timely manner outweighs all other considerations. Manufacturers should retain
their focus on the long-term goals during each decision point in the project.
Regulatory Compliance
IVD manufacturers must factor the need to comply with multiple levels of regulations
into each decision during the design and development of the product. Many markets
may remain closed if manufacturers cannot meet certain regulatory requirements.
IVD companies can mitigate many of these requirements through product design
and process selection. Vendors may also affect regulatory compliance.
IVD manufacturers should approach each vendor relationship as if it will be
key to their long-term success. With increased regulatory requirements, the
ability to reverse a poor decision may be reduced. Once through the regulatory
process, manufacturers may find it difficult if not impossible to make certain
product or process changes. If the required change is due to a supplier’s
failure, the product may be doomed. The problem may not be in sourcing an alternative,
but rather in the time and effort needed to gain approval for the change.
Selecting vendors that can provide solutions for future regulatory requirements
is difficult. Since predicting the next phase of regulations is nearly impossible,
IVD manufacturers should be absolutely certain about the support from the vendor
team. If the vendors have participated in many projects that required regulatory
compliance, they may likely provide solutions when new requirements emerge.
Materials, Processes, and Manufacturing
IVD manufacturers should address these three main product-related areas. Manufacturers
need to consider the impact that each may have on the other. Many choices can
affect the flexibility and range of options in other segments of the process.
IVD companies must consider together the raw materials, types of processes,
and means of manufacturing. Moving in a direction driven by only one of these
variables may negatively affect the outcome.
A subcomponent of the manufacturing process that IVD manufacturers often overlook
is product packaging. Packaging decisions can dramatically affect production
options. Manufacturers must consider the target market and end-user appeal.
Along with these important factors, selecting a packaging style that is easily
automated should be a priority as well.
As with every other facet of the project, teamwork is crucial. Making sure that
marketing and manufacturing are integrally involved in each decision can prevent
costly mistakes. Having suppliers of the packaging materials working closely
with equipment suppliers is also important. At this point in a project, the
quality of a team and the openness of communication will have a significant
impact on decision making.
Raw Materials
Selecting raw-material components that function properly is a key consideration.
Other questions are equally important. IVD manufacturers must consider the stability
of a vendor’s processes. This will help to ensure a smooth path to providing
verifiable quality controls.
IVD manufacturers should also consider a supplier’s ability to scale up
in support of product growth. If a vendor becomes limited in its capacity, it
is essential to have an alternative. If possible, manufacturers should not source
materials from a single supplier. If an alternate source is unavailable, then
a strong relationship must be in place with the one critical vendor.
In addition, material format may affect manufacturing choices downstream. If
a material will never support a continuous process (e.g., reel-to-reel), then
larger work areas for batch processing may be required. This approach can also
increase unit cost and complicate quality assurance issues. This reinforces
the need to keep all project elements integrally related.
Process Requirements
Many products currently being manufactured contain processes that IVD manufacturers
have embedded without full consideration. Manufacturers may have determined
such processes by the format of the raw materials used during product development.
In many cases, an IVD company chooses a process to satisfy expediency, without
considering the long-term impact. Parallel efforts to define production techniques
while still in development are beneficial and may prove instrumental in the
overall project success.
Defining steps for creating processes as milestones in a project schedule can
minimize problems due to oversight. Establishing the proper emphasis will ensure
that IVD manufacturers integrate each step in a timely and efficient manner.
Manufacturing Options
The parallel path will lead to selecting automation partners long before IVD
manufacturers realize the need for equipment. In choosing this direction, manufacturers
should tie together all three areas. As with raw-material selection and basic
process creation, IVD companies must consider early on the ability to automate.
In most cases, the processes required to manufacture a product can be automated.
The benefits of considering this path early are substantial. With the proper
input from automation suppliers, IVD manufacturers may simplify the equipment
design. This early involvement can potentially provide significant savings in
machinery and product costs.
A source of equipment cost increase is the mechanical design tolerances of the
device. If loosened by only a few thousandths of an inch, this requirement can
have a significant impact on the process equipment. This impact can be in machine
cost, machine complexity, yield, and throughput.
In-Process Inspections
Another area that should receive careful consideration during the design process
is integrating real-time inspections of the automation equipment. As with tolerance
concerns, properly applying the available options can improve process controls.
If an IVD manufacturer designs a product to allow for automated inspections
at each critical step, the ability to maintain consistent performance is enhanced.
With the improvements that are now available in vision hardware, this is a much
more cost-effective choice. In many cases, the accuracy and speed of the new
vision systems can justify the added expense. By utilizing the available vision
technology, IVD manufacturers may realize 100% in-process inspections of critical
steps.
Integrating sound quality assurance into the process will also aid in regulatory
compliance. Even if a particular IVD product does not dictate mandatory performance
assurances, the need is no less real. The ability to deliver a consistent level
of quality may be the only competitive advantage available.
Automation Partners
IVD manufacturers should review as many product design decisions as possible
with their automation partners. If a manufacturer is working in an established
organization, the choice of several vendors may be available. If an IVD company
is operating in a start-up environment, it will need to work through a selection
process. If existing automation partners do not possess the necessary technical
expertise, they may suggest alternative resources.
IVD manufacturers can simplify this process by identifying the key areas of
concern. Manufacturers should make sure a vendor is properly sized for the project
and organization. A vendor’s ability to provide equipment in support of
the project’s timeline can be critical. Failure to discuss this issue can
lead to delays and missed opportunities.
In many instances, it may also be necessary for a vendor to supply important
validation activities. Working with a vendor that has an established process
for providing the necessary testing and documentation will ease this requirement.
Verifying this capability early on can reduce the amount of in-house staff effort
required to complete the validation of the equipment.
Proprietary Knowledge
Many vendors hold patents or specific process capabilities that are unique to
them. Building on such proprietary knowledge can enhance a competitive advantage.
Other times, IVD manufacturers will need to develop the processes and equipment
in a simultaneous environment. This is where teamwork becomes paramount for
success.
An automation partner that has specific technical expertise can be extremely
valuable to developing a product. IVD manufacturers must consider procuring
automation equipment a long-term commitment. Production machinery will likely
be in operation for more than 10 years. The financial stability of the company
cannot be overlooked in determining the ability to provide support for the equipment
many years down the road.
Although capability and experience are important, the ability to build a relationship
with a vendor can also have an impact on success. As IVD manufacturers interview
potential candidates, they should give careful consideration to personalities;
not so much the individual personalities, but a vendor’s approach to doing
business. Finding a vendor that fits one’s corporate philosophy can help
to minimize conflicts and disagreements.
Conclusion
As fierce competition drives the IVD industry further into producing commodities,
only the well-organized manufacturers with well-planned products will survive.
Those companies that achieve and maintain a competitive advantage through a
well-planned and -controlled environment, that recognize the impact each aspect
of a product and its manufacture has on the others, and that create a strong
team together with their vendors will have a chance.
Ford W. Garratt,
Kinematic Automation Inc. (Twain Harte, CA)
Copyright ©2004 IVD Technology
