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?
Medical Engineering Manager, Colder Products Company
Business Manager, New Business Development, Zeon Chemicals
One resource sometimes overlooked by medical device designers tackling a new project is the expertise of the technical staff employed by the raw-materials manufacturer. Designers who choose to consult with the manufacturer’s engineers at the beginning of the project can get a better appreciation for design features that have been used successfully with that material in the past, as well as any material limitations that will need to be accounted for in the new device. During the part-design phase, the supplier’s team can also provide valuable insight into the raw material’s drug compatibility, its mechanical strength and the capacity for sterilization that will affect the finished product. Finally, in a project’s early stages the technical staff can provide guidance and recommendations on mold design that will be useful in getting the product to market quickly and within budget. While manufacturers provide a certain level of technical information in their brochures and on their websites, actually collaborating with someone who knows the raw material inside and out offers many benefits. The input of the technical staff can go a long way toward helping eliminate trial and error, and can save designers a good deal of time in the latter stages of the project.
VP of QA/RA and Acting VP of Engineering, Pro-Dex Inc.
A key element is to design new products with regulatory guidelines in mind. This includes factors such as material biocompatibility, sterilization validation, design verification testing, and process validation. It also involves complete documentation for the design history file.
The most efficient and effective way to do this is to follow a Concurrent Engineering approach to product development where QA/RA plays a central role in all new projects.
This allows medical device designers to first understand the regulatory requirements of each new product, and then evaluate the administrative and financial impact those requirements have on the development process. This evaluation may include special testing, registrations, licensing, design dossiers, and approval from regulatory agencies.
Given the importance of regulatory guidelines in designing and developing medical devices, QA/RA’s core involvement in new product development can ensure that all products are safe, effective, and reliable once they reach the operating room or doctor’s office.
Dr. Patrick Collins
Technical Business Development, Mecmesin
First, focus on the patient. Who is going to receive the treatment? Is it an adult or a child? What is the device going to be used for and where is it going to be used?
Consider the actual device mechanism. For example, needle-free multi-use injection devices which inject drugs under pressure need to be activated within a certain force range.
For needle hubs which attach to syringes and other medical devices, the force or torque required to disassemble the push/pull taper Luer or threaded Luer lock connectors must be high enough to avoid failure in operation and to ensure a hermetic seal, yet low enough to enable quick and easy engagement
Select a test system. Computer-controlled force systems offer the highest degree of repeatability and accuracy together with in-depth analysis capability.
Are there any ISO, ASTM or other standards that apply to your test, if there are, they may help determine your system requirements.
Ensure the software you use has automatic statistical calculations for finding trends in batches of samples or identifying outliers and a real-time test data display for immediate feedback.
Invest in grips and fixtures which minimize the risk of sample slippage and ensure accurate repeatable results.
Operations Director, Triteq
The best tip I have is ‘don’t forget the patient’. This may appear to be an obvious factor to consider, but it is very useful to keep coming back to a patient-centric view when developing medical devices.
A development team can become very focused on some small detailed technical issues, which they are trying to resolve, for example a performance characteristic. It is always useful to consider the question what difference does it make to the patient and their treatment? Sometimes this gives insight, which allows specifications to be safely relaxed or alternative solutions to be developed, even though this can result in the need to update many associated design documents.
It may also have an impact on ergonomics of the design.
Is the patient in the hospital bed going to see the back of the equipment as it
is being used by the doctor? If the normal warning labels are fitted there will
they potentially distress the patient? Is there a better alternative
position? This is an example of how simple consideration of the patient’s
viewpoint can make a significant difference.”
Industrial Design Manager, Triteq
Don’t forget about people. It is often the case that Medical Devices start life with a medical need that provokes investigation into diagnosis, treatment, control or cure. It is people centered; yet there is probably no area of product development where ‘User Centered Design’ is more critical and less considered.
Many times the development process is progressed through one technical challenge after another, with the end result being unfit in terms of ergonomics, ethnographics and emotive needs. What do we get? Products that seem careless, are often tactless and are therefore next to useless.
It should not be so difficult to put ourselves in the shoes of others. Therefore, as much as we must concentrate on the functionality of the machines we design, for the sake of people, we must remember people.”