Besides "early collaboration," what tip do you have for medical device designers
developing a new project that is specific to your area of the industry?
Dennis
Repella, Ph.D.
Medical Device Consultant, Cyanta Analytical Services
As
part of early collaboration, all company departments affected by the new
project need to be involved at the onset. It sounds like a simple thing to do
but internal communication is often one of the most difficult obstacles to
overcome. Setting up departmental expectations and objectives at this time is
also key successful device development. Additionally, a legal review of the
resulting device and its labeling is important to determine that there are no
patent or trademark issues to resolve.
An
important early collaborator is the FDA. The FDA Headquarters has small
business contacts who can provide information regarding your particular
product, including Guidance Documents. This information can help organize and plan
the product development activities and determine if special physical and
chemical tests, and/or clinical studies are needed in a 510(k) or PMA
submission.
Contacting
FDA at the start of a project is especially important for Combination Products
(a product which contains both a drug and device component). Contact the Office
of Combination Products (OCP) at 301-796-8930 and they will direct you to the
center responsible for reviewing your product and provide information to help
structure your submission.
Robert
A. Mitchell
Technical Manager, Fort Wayne Metals
Research Products Corp.
 |
Fort
Wayne Metals produces medical grade wire, strands and cables for mechanical
subassemblies that provide articulation, steering, torsion and tensioning as
well as other functions demanded by today’s medical and surgical devices.
Medical device designers understand their project needs very well but may reach
out to a vendor to gain their expertise in order to meet project goals.
Typically the functional requirements are known but how to achieve them is
unknown. A vendor should be selected based on a demonstrated record of success
with similar projects. Budgets and timelines are tight. Designers have to
communicate their needs to their subcontractor at the earliest stages of a
project. The needs should include functional, test, budget, timing and future production
expectations. After all, the designer has to eventually integrate the project
into a wider corporate environment if the project is to be commercially
successful. Designers are well served by communicating how a vendor’s
contribution to a project is required to perform in the finished device or
system. The designer should require the vendor to prepare a project protocol
reflecting the vendors understanding of all requirements. The designer can
quickly gauge whether the vendor understands the application and has the
engineering, manufacturing and test capabilities to deliver.
Tero
Kähkönen
Vice President, Customized Products Business, VTI Technologies Oy
For
over 15 years VTI has designed and supplied customized products for medical
device manufacturers with zero field returns. Thanks to this solid and in-depth
experience VTI knows what are the main success factors to run joint development
projects. The MEMS element, or the MEMS sensor, plays a crucial role in many of
the medical devices and must add value through improved device performance
and/or thanks to better cost-efficiency. However, in order to succeed and to be
able to develop and offer the right MEMS solution, one that truly adds value,
there are a certain amount of questions to be answered in the very early stages
of the development project.As
a general guideline: the more information the MEMS supplier can get from the
very beginning, the better the end result will be. In order to build a
preliminary requirement specification, a MEMS supplier needs to know what the
customer wants to measure and in what kind of environment. It is good to be
clear on what is a “must have feature” and what is just a “nice to have”
feature. Are there design limits or
requirements concerning, for example, the size, electrical interface,
contacting and packaging?
One
important aspect is to know what the device manufacturer wants or is able to do
himself – is a bare MEMS sensing element die what is
needed, or is it a ready plug-and-play sensor component? This provides the
scope for the project: what will be done by the device manufacturer, what will
be designed, manufactured and supplied by the MEMS solution supplier, and what
eventually will be done by a third party or other subcontractor. Knowing the
technical requirements, project scope, estimated production phase volume and
project schedule, the MEMS supplier can propose the commercially and
technically optimum solution for the customer's need.
Maybe
more than in any other industry, confidentiality is always required in these
high value medical device projects. When choosing the right MEMS supplier,
medical device manufacturers must consider whom they want to trust. With its
proven track record, solid reputation and market leader position, VTI
Technologies knows what confidentiality is all about.
Peter F. Ladwig, Ph.D.
Staff Engineer, Hutchinson Technology, Inc.
 |
As a precision component manufacturer with access to a
variety of techniques, the best tip I can give to designers is to understand
the capabilities of the materials and manufacturing processes that can be used
to produce device components. This
understanding can have a significant influence on device design. For example, a small metal component may be
manufacturable via machining, grinding, stamping, forming, electroplating, electroforming
or chemical etching; each with their own advantages and weaknesses (as shown in
the table below). Designing a part without
specific processes in mind may lead to unnecessary cost and project
delays. Designing a part without
considering a range of applicable processes may unnecessarily constrain a
design and the resulting device performance and cost. A similar case can be made for various classes
of materials. Expert medical device designers use their understanding of a wide
variety of processes and materials to tweak the design throughout the lifecycle;
often capitalizing on the advantages of one material and process set for
prototypes and another for volume manufacture.
In addition, expert designers may employ combinations of materials and
processes on a single component; such as chemically deburring or roughening a
machined part.
Joel Mach
Sr. Applications Engineer, Microchip Technology Inc.
 |
Consider your power goal.
It seems like everyone is concerned about power consumption, these
days. The simplest way to lower power
consumption is to lower the operating voltage and/or the current
consumption. Today’s microcontrollers
(MCUs) commonly operate at 1.8V, have sleep currents as low as 20 nA, and feature
dynamic currents as low as 50 µA/MHz.
Many MCUs can source 20 mA from an I/O pin, so a serial EEPROM, sensor
or other external circuit component can be powered directly from an I/O pin and
left completely unpowered when not needed.
Newer MCUs have a Peripheral Module Disable feature that allows
peripherals, and their associated special function registers, that are not being
used by the application to be left unpowered.
At times when the microcontroller’s CPU is waiting for a peripheral to
complete an operation, a blocking function will be implemented. Instead of having the CPU continue to execute
code, the MCU can enter an Idle mode where the CPU will be disconnected and the
peripherals will continue to operate normally.
Doze is another low-power mode where the peripherals continue to operate
normally but the CPU is clocked at a lower frequency. For more information on this topic, visit www.microchip.com/lowpower.