Risk Management made easier on Unifize
Clarissa explains the criticality of risk management in the medical device sector, emphasizing patient safety. With Unifize, they've streamlined risk management, integrating their documentation and analysis seamlessly. The platform facilitates creating input-output matrices, linking design choices directly to user needs and demonstrating the impact on safety, thus simplifying compliance and ensuring a clear path to safe, effective medical solutions.
Transcript

[00:00 - 00:06]
As a senior quality engineer and in general, one of the most important things for quality is risk management, especially in the medical device space.



[00:07 - 00:14]
So you really have to focus on, how can this product go wrong and how we're going to make sure that it's safe for the patient.



[00:14 - 00:21]
You know, and that's the most important thing. You can have these innovators and create these beautiful, wonderful devices.



[00:21 - 00:45]
If there's an error or if something happens with it and you have somebody, you know, God forbid, die or something terrible happened to them, you know, you really need to think about how we're going to protect the patient because that's why we all got into medical device, right? You want to make the world better for people. You want to make things that are going to make people's lives better. And one of the ways to do that is through risk management.



[00:50 - 01:31]
Very basic level, you have a device and you look at every specification you have your user needs, right? Why did you make the device the way it is? You know, how is this going to help the user, How is it going to help the patient? And you take those user needs and you break them down into requirements and further into specifications the best way that I have to explain that is, for example, you know, yes, you want something to be able to be easily disconnected, right? There's lots of ways of doing that. You could have something that screws down to hold it together and then you unscrewing it, removes it. But for example, in surgery, a surgeon doesn't want to do that.



[01:31 - 01:46]
You know, the product development side, you get to say, oh, how about a button? Or how about a switch, a clip on and off and, you know, it can be really easy to get overwhelmed by all these possibilities of solutions for a single requirement or a single user need.



[01:47 - 02:15]
And that's where risk measurements or risk controls can help you, Yeah, it might be great to have this button or switch or whatever, be able to solve this problem. But is that solution going to cause more problems how are you going to be able to control those risks down? I have the FMEA in my head, but you know, you have your user need, your requirement, your specification, which is usually something that you want to be able to measure.



[02:15 - 02:37]
And so then from there, you know, you look at your hazards, hazardous situations and your harms. So, you know, making sure that you're designing it right. If we're talking about DFM or design FMEA and so you say, okay, so we have this this saw blade slot, for example, it has to be a certain width and height.



[02:37 - 03:03]
What happens if you designed it wrong, If it's not the correct, You know what are ways can that affect the patient. So, in this example of surgery, you know, you might have difficulty being able to make the cuts you need to with those blades. You might have difficulty being able to get the exact angles you need. And okay, so now you have your hazardous situation, your hazard.



[03:03 - 03:12]
What about your harm? You know, what we really care about and what the FDA and these other regulatory bodies care about is how that affects the patient.



[03:12 - 03:41]
If you're not able to do what you need to do, what are the issues with the patient? Is it going to be a delay in treatment? Is it going to be pain or they're going to have issues with their quality of life in the future? all of the different harms that could happen to a person because of this one feature right. And so once you have that, you also need to connect to, you know, you're required by law to control all of those risks down to as far as possible.



[03:41 - 03:47]
You know, you need to do tolerance stacks, any kind of verification and validation.



[03:47 - 04:14]
So you have to have various types of tests, you know, where tests, user validation, other verification activities to make sure that what you've designed is correct. And based on that, you can make an educated decision in order to bring your occurrence level down. I forgot to mention risk, you know, on the basis part is defined as occurrence times severity, and that's how you get your risk number.



[04:14 - 04:27]
And so, for example, one of your harms might be a mild annoyance to the patient, but if it's going to happen every time, then you really need to figure out a way to control that down and reduce the risk.



[04:27 - 04:37]
That's primarily kind of the basis of risk control is trying to reduce the occurrence by doing all of your due diligence to be able to make something that's safe and effective for the patient.



[04:37 - 04:50]
So through using Unifize, we are able to define our risk, our risk definitions and maintain all of our documentation and our specifications there.



[04:50 - 05:31]
And so in some places you can store your risk documentation and your risk analysis. You know, as a document process and keep that separate. But if you want to go further, you know, you can make your own input output matrix matrices through Unifize. You know, you can have a process where you define each of these design choices and specifications, connect them to your user needs, and then you're able to show the outputs of those, you know, which is really important to be able to see, you know, what's the problem you're trying to fix the user need and your requirement and how you are creating what you are creating to fix that.



[05:31 - 05:33]
And so you're able to track that in Unifize,

Unifize Results

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

Related Case Study Videos

00:44
Transitioning from an existing eQMS to Unifize
Highlighting the transition from a traditional eQMS to Unifize, Jesse Kolstad lauds the platform's flexibility and advanced capabilities. With its user-friendly interface and transformative features, Unifize has brought about significant operational improvements at Biovation Labs.
02:35
How Unifize made me a hero in my company
Jesse Kolstad shares how Unifize has amplified his impact and recognition at Biovation Labs. The platform's transformative capabilities have led to substantial operational enhancements, making its users, like Jesse, pivotal contributors to the company's success.
00:43
How Erica uses Unifize on a daily basis at work
In this video, Erica details her daily use of Unifize in managing various quality assurance processes at her workplace. She explains how the platform aids in overseeing finished good releases, tracking sale keys, and maintaining standard operating procedures. Erica highlights the convenience of storing and accessing artwork on Unifize, emphasizing the platform's efficiency in managing document revisions. She notes that while managing revisions was challenging with other systems, Unifize simplifies this process, making it more manageable and less time-consuming. This video showcases Unifize's effectiveness in streamlining complex quality control tasks, underscoring its value in a professional setting.
01:36
Closing the loop- Traceability and lot tracking using Unifize
Denis Machoka elucidates the intricate process of traceability and lot tracking at Harmonic Bionics, especially for their robotic devices. He details the meticulous tracing of parts, their consumption, and potential issues. Denis highlights how Unifize is instrumental in ensuring precise tracking and updating of materials consumed during the device development.
00:35
How we use Unifize to manage SOPs and their revisions
In this video, Erica discusses the practicality of Unifize in managing and updating Standard Operating Procedures (SOPs). She appreciates the platform's robust feature that meticulously tracks revisions, highlighting its significance in an environment where procedures are frequently changing. Erica points out that Unifize is particularly useful in overseeing these changes, ensuring that every modification is clearly documented and traceable. She emphasizes the convenience of being able to instantly access any SOP, as all documents are centrally stored in Unifize. This capability not only saves time but also enhances the accuracy and efficiency of managing operational processes. Erica's insights illustrate how Unifize serves as a vital tool in maintaining up-to-date and accessible SOPs, crucial for the smooth functioning of quality assurance processes.
01:14
Hear about things in real-time and start conversations early on with Unifize's mobile capabilities
Tedd Carr discusses the significant advantage brought by Unifize's mobile functionality to The Will-Burt Company. With a web and cloud-based system, Unifize's mobile app enables their sales force to initiate quality conversations and address customer concerns instantly while on the move. This real-time communication capability has proven to be a valuable tool, fostering timely discussions and swift issue resolution, and is especially praised by those who often work remotely or travel.
01:41
Understanding trends by connecting data on Unifize
Jesse Kolstad accentuates Unifize's prowess in connecting data to discern trends. With robust data integration and analytical capabilities, Unifize offers valuable insights into operational trends, paving the way for data-driven decisions at Biovation Labs.
01:24
Why Unifize’s unique approach to collaboration helped Harmonic Bionics
Denis Machoka discusses the unparalleled collaborative approach of Unifize, highlighting its ability to centralize and streamline conversations, reducing the traditional reliance on emails. He praises its efficiency in consolidating information and contrasts it with the inefficiencies of managing multiple systems in other platforms.
02:27
How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and efficiency.
01:28
A paradigm shift in managing quality collaboratively with Unifize
Wilson discusses the significant shift towards collaborative quality management introduced by Unifize. It emphasizes the enhanced cooperation between departments, leading to a more integrated and effective approach to quality control. The speaker credits Unifize for fostering a culture of shared responsibility and streamlined communication, which has been instrumental in improving their product's quality and compliance.
01:02
What are the compliance standards followed at Adaptive Health
In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.
02:28
Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.
01:31
How long did it take to get up and running with Unifize
Mikala discusses the quick, intuitive setup process of Unifize and contrasts it with the lengthy, complicated setups of other systems. She highlights the system's immediate usability and minimal onboarding requirement, emphasizing its efficiency and user-centric design. Mikala also touches upon the ease of integrating Unifize into their existing workflows, the smooth transition experienced by the team, and how the software's intuitiveness has enabled quick adoption and immediate improvement in their operational processes.
01:51
Breaking organisational silos with Unifize: Centralizing knowledge and achieving organisational alignment
Jesse Kolstad emphasizes Unifize's instrumental role in dismantling organizational silos at Biovation Labs. By centralizing knowledge, the platform promotes a unified information hub, fostering organizational alignment and consistent collaboration, ensuring everyone operates in harmony.
01:24
What is the challenge with managing a QMS actively
In this video, Wilson delves into the challenges of actively managing a Quality Management System (QMS). They reveal how manual processes, over the years, made the QMS cumbersome, deterring the team from utilizing it fully for new product development and quality control. Highlighting a shift towards an electronic QMS to mitigate these issues, the speaker underscores the importance of a QMS in improving business operations, controlling quality output, and fostering continuous improvement, stressing that an efficient QMS is vital for operational success.
03:46
Comparing Unifize to other eQMS software
Clarissa Archer narrates Harmonic Bionics' journey in searching for an optimal QMS. Evaluating various systems, they prioritized features like change control, product lifecycle management, and electronic signature compliance. While they considered prominent systems like Master Control, ETQ, and Greenlight Guru, their quest for seamless collaboration was paramount.
02:15
The core problem Seth was facing at Efco
Seth Bozman discusses the pivotal challenges he faced at Efco before integrating Unifize into their workflow. Central to his testimony is the struggle with tracking and managing information, particularly the return of documents and data from the shop floor. Seth outlines how the Unifize platform provided a solution that streamlined communication, ensured document return, and enhanced overall efficiency. This video offers a candid look at the transformative effect of Unifize on Efco's operations, spotlighting the importance of digital solutions in modern manufacturing environments.
03:23
About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
01:25
Enhancing traceability and improving visibility and accountability with Unifize
This video showcases Unifize's capabilities in boosting traceability, visibility, and accountability within organizational processes. The speaker illustrates how the platform fosters a transparent environment where tasks and responsibilities are clear, enhancing overall operational efficiency.
05:44
How Unifize helps quality leaders take better decisions on Out of Specs
Jesse Kolstad revisits a challenging situation from his early days at Biovation Labs — a significant backlog of Out of Specifications (OOS) cases. Determined to enhance the OOS process, Jesse embarked on a deep dive into the existing procedures and systems. He emphasizes the value of having a clear understanding and the ability to trend data, showcasing Unifize's instrumental role in bringing clarity and improved decision-making.

Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

View More Case Studies
Video icon

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

Video icon

Here’s how Harmonic Bionics slashed time to market by 80%

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Video icon

Will-Burt's game changing boost to quality process cycle times

Learn how The Will-Burt Company was able to implement and adopt a new quality management system across 8 collaborating teams in less than a day and streamline internal / supplier non-conformances, customer complaints (VOCs), internal / supplier audits, 8D reporting, corrective actions and preventive actions.