Defining your user needs is crucial to get on the right track before diving into design and development of your medical device. So...
Of course, the more questions you add, the better. At least, you should cover these 10 questions in order to have a better idea of the needs of your user regarding their medical device.
The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.
In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.
The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.
Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.
Subsection j) of 21 CFR part 820 says:
Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”
DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.
Here are some key interpretations of the DHF guidance that medical device companies should take note of:
Below, we’ve listed the steps of the design controls process and what documents should be included with each step:
It’s difficult to predict the success of a new product. Even the largest, most mature companies have created products that fail to gain market acceptance and profitability. And as we’ve seen in numerous industries, product success can’t be guaranteed by financial investment or process optimization.
With the need to move fast in the light therapy market and an inability to guarantee success through any means, we continue to seek ways to manage the inherent risk in product development.
There is a gap between user wants and user needs and while it is easy to assume that the difference might not be clear, taking an empathetic approach creates a finer line between the two. Although Creative Directors are problem-solvers at their core, they achieve this by building data-based frameworks for visualizing how best to serve their target audience.
It is no longer about market data assessment and sales hands-off alone; there is a need to properly distinguish between user needs and wants while choosing how best to attend to those needs and paying just enough attention to user wants. Understanding the user metrics for this analysis and insight might seem daunting, especially when the aim is to improve product experience directly, but taking a design-thinking approach helps make better sense of the process.
Popularized by IDEO, Design Thinking is a human-centered, empathy-first approach to creativity and innovation. Its underlying principle focuses on user needs, aspirations, wishes, concerns, and frustrations in attempting to solve their problems. Interestingly, Design Thinking focuses on the most important view from which problem-solving should be approached; the users. When problem-solving is approached from a user’s point of view, it allows for uncovering novel insights into the product’s user flow, thereby finding the right solution to the right problem.
The Design Thinking process is quite similar to the Agile methodology of Product Management; as a matter of fact, Design Thinking helps to materialize the otherwise abstract concept by allowing ease of iteration and faster user-testing processes. Implementing design thinking in product management makes it easy to consider expedient user experience factors. Top on the list includes:
Companies employing design thinking are allowed to release products more often, gather meaningful customer feedback, and validate a product’s use and vision in a marketplace while sustaining a high level of customer satisfaction, as one release builds on another to add features customers desire most.
Implementing design thinking into product development can be broken down into 5 steps:
Most of the companies jump straight to point #4, which is a terrible mistake.
To make things clear, structure your tasks: build up a framework, define both focus points and sticking points of your research, and remember that most questions have two answers — the one that appeals to business and speaks to a customer.
Think like a detective when starting a product development cycle, and ask these questions:
Who is going to use your product? What are their habits and preferences? It is essential to understand real user needs and how they are addressed without your product. Define the key problems and set your sights on them. What’s the context of use? What is their motivation behind using your product, and how can you inspire them to make the most out of it?
Think big. What is the place of your product in the ecosystem? Sometimes it may be just a part of greater service. Keep in mind the environment of use since it creates a general customer experience.
Whether you like it or not, time is vital for your project. “Done” is better than “perfect.” That’s why it’s important to keep the scope of your project in mind, to limit it to essential things for a quick market release.
What is the real value of the product for your customer and your business? What issues does it address, and in what way? Why did you create it, and what’s its role in the company development?
These questions are essential for creating a general perception of the main problem you are solving for your client: it’s so easy to get side-tracked with a load of on-demand, seemingly effortless tasks. Besides, it’s impossible to solve a problem that doesn’t exist, so why carry an extra burden? When details are pushing you to the limit, take an imaginary step back and see the problem from a different angle. Visualize the role of a certain detail in the general canvas of your work. It does not mean you have to bury your project under piles of documentation. We all know that red tape is more about restricting rather than making things easy, and freedom is essential at the initial stages of any project. This is how innovation is born; under conditions of free thought, bright vision, and sheer inspiration.
Here is the official FDA regulation for design controls pertaining to design inputs, as found in Part 820.30(c):
Each manufacturer shall establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
ISO 13485:2016 also covers this topic in section 7.3.3 Design and Development Inputs:
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management
These inputs shall be reviewed and approved.
Requirements shall be complete, unambiguous, and not in conflict with each other.
There are several terms used interchangeably when referring to design inputs:
Medical device product development should be a holistic process that builds upon itself as the project progresses.
Rushing the product to the market isn’t a recommended best practice in medical device development. Spending time in design inputs will really benefit your project. In device development, establishing design inputs can easily take up to 20% of the entire project timeline.
Writing design inputs takes practice and dedication. Also, design inputs should not just be the responsibility of one person. It’s a team effort. When a team is involved, you get the benefit of everyone’s opinions and experience.
You also should consider all sorts of other sources to help you define design inputs:
It’s important to remember that user needs should be established first in order to inform design inputs. Your goals when defining design inputs include:
You have to consider all types of sources and resources for design inputs. Your design inputs need to be comprehensive, covering all aspects of your medical device.
This is the second part of a set of three articles. For more information, check https://medium.com/@kaiyan_medical/part-1-3-the-design-history-file-d681a7945968 with the introduction to DHF.
The device master record (DMR) is the compilation that contains all the information and specifications needed to produce a medical device from scratch to finish. Should include the instructions for all manufacturing processes, drawings, documented specifications, and, packaging requirements. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device.
The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which handles record-keeping requirements for medical device companies.
When the FDA audits your medical device company, you will be expected to produce a DMR that complies with 21 CFR Part 820.181. Here’s the full text of that part for reference:
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
d) Packaging and labeling specifications, including methods and processes used; and
e) Installation, maintenance, and servicing procedures and methods.
The main purpose of the DMR is to centralize a record of the production process in a way that distinguishes it from the design process. A product engineer might design a silicone part for a medical device and include it in the design outputs portion of the design history file, but the DMR would also include specific instructions for manufacturing the part, including what mold to use, equipment specifications and production methods.
The good news is that the FDA requires you to only reference the mandated items, not duplicate them. If you’ve been organized in creating your DHF, you’ll be able to easily reference that location in your DMR.
The difference between the DHF and the DMR is about design vs device. The design history file is focused on capturing the history of the design and ensuring that it was done according to FDA regulation. The device master record is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.
An industrial designer develops the concepts for manufactured products, such as machines, medical devices, toys, electronics, and more. They combine art, business, and engineering to make products that people use every day. They work in offices in a variety of industries. Although they design manufactured products, only about 29% of industrial designers are employed directly by manufacturers.
An industrial designer will typically do the following:
Industrial designers generally focus on a particular product category. For example, some design medical equipment, while others work on consumer electronics products. Other designers develop ideas for new bicycles, furniture, housewares, or snowboards. They imagine how consumers might use a product and test different designs with consumers to see how each design looks and works.
Industrial designers often work with engineers, production experts, and marketing specialists to find out if their designs are feasible and to apply their colleagues’ professional expertise to their designs. For example, industrial designers may work with marketing specialists to develop plans to market new product designs to consumers.
Original article from careerexplorer.com
