How Unifize's no-code configuration speeds up implementation
Clarissa Archer emphasizes the significance of adaptability in Harmonic Bionics' choice of a QMS. With Unifize, they could shape the software to their specific needs, bypassing the rigidity of traditional systems. The power to make direct adjustments without relying on external teams was a game-changer for them, speeding up processes significantly.

[00:00 - 00:20]
And what I really enjoyed about Unifize is the fact that we could configure the program to be what we needed it to be rather than trying to work against a program to make it fit into what, for example, we'd want a Design History File to look like we were able to configure Unifize to design it, how we needed it and how we wanted it.

[00:20 - 00:26]
As a part of the configuration of a new process, one of the great things is that I'm able to build these things myself.

[00:26 - 00:34]
I don't need to submit a work order or submit an IT ticket and have the Unifize team build it for me, you know, between two and four weeks.

[00:34 - 00:56]
You know, it's something that I can go into and it's really easy to have the buttons and ability to say, okay, for example, I have a change order. What else does that require? Okay, I need text boxes to explain, what? Each thing needs to go in there. And so I can easily, you know, from a grouping of options, drag and drop, I'm biomedical engineering.

[00:56 - 01:14]
I didn't take a whole lot of software. So much more on the mechanical side of that. So for me, it was so easy to say, Oh, yes, I need to. TextBox, let me drag it over here. Let me arrange it how I need to and write in descriptions and what I need, you know, And another important thing is getting approvals.

[01:14 - 01:34]
You know, you can describe a change order all you want, but you need to make sure that you're getting the proper approvals. So being able to go with advanced approvals and say, okay, here are the options of people that I need to have approve and being able to say, you know, I don't care necessarily who it is, you know, sometimes you might have a problem where, you know, oh, somebody is on vacation.

[01:35 - 01:55]
And in typical other programs, I would see, you know, that person was requested as a signature they either need to, log in on vacation, which nobody wants to do, or completely cancel that change order and go back to the preliminary, which, again, huge waste of time. You know, that can add several days on to a simple change order.

[01:55 - 02:02]
But with Unifize, I can say, okay, I need this to be from a group of product development, create a group with all those users in it.

[02:02 - 02:17]
In that program say, okay, I need somebody from product development to sign here. So I worked with, but I can also have these other people who can look at the conversations and look at everything and Unifize and understand what's going on to sign if I need to as well.

[02:17 - 02:23]
And so it's so simple to be able to drag and drop as many times as you need

Unifize Results

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

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

Managing Product Lifecycle with Unifize
Delving into Harmonic Bionics' evolution, Michael Hogan speaks about the company's transformation from a small team of college students to a structured entity. As they scaled, the pressing need for robust documentation and product management became evident. The journey underscored the significance of an efficient QMS, ensuring streamlined operations and clarity in decision-making.
The ROI of a collaborative, configurable eQMS
Denis Machoka elaborates on the ROI derived from Unifize as a collaborative eQMS. He underlines that true ROI is reflected in compliance, data accessibility, and the defense of information. Denis commends Unifize's capabilities in showcasing regulatory control and its adaptability to adjust control levels based on data sensitivity.
Collaborating with vendors using Unifize
Michael elaborates on Harmonic Bionics' systematic approach to documenting design outputs, emphasizing their reliance on definitive documents such as step files and PDFs. He offers a peek into his daily routine, which frequently involves addressing quality notifications on Unifize, collaborating with vendors, and updating specifications. Through his narrative, the importance of Unifize in streamlining vendor interactions and ensuring accurate design documentation becomes evident.
Minimising the impact on IT while implementing Unifize
The Will-Burt Company strategically chose Unifize to alleviate their IT department's workload. Tedd Carr appreciates that Unifize's team handled everything from installation to launch, ensuring minimal IT involvement. This approach not only streamlined the implementation process but also allowed their IT staff to focus on other critical internal tasks, marking a significant internal shift towards efficiency and resource optimization.
Connecting the dots- managing a DMR & DHF on Unifize
Denis Machoka emphasizes Unifize's prowess in managing DHF and DMR data, highlighting the platform's traceability, accessibility, and real-time status updates. He appreciates its ability to keep users informed about the latest file versions, preventing potential confusions. Denis also touches upon his AI background and experience with IBM.
Unifize's lightning fast customer support
Jesse Kolstad lauds the unparalleled responsiveness of the Unifize support team. He recounts instances where he received almost instantaneous assistance, highlighting their record response time of just 12 minutes. Jesse values the platform's collaborative capabilities, allowing him to make real-time changes with both his team and the Unifize support team. The genuine partnership feeling resonates throughout his experience, showcasing their commitment to customer success.
About Harmonic Bionics, an early stage med device company
Clarissa Archer sheds light on Harmonic Bionics, a robotics startup. Their flagship product, Harmony SHR, assists rehabilitation for those with shoulder impairments due to neurological or muscular issues. Initially research-driven, the company now emphasizes quality assurance, aligning with FDA regulations and recommended ISO standards.
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.
How Unifize speeds up approvals around product specifications
In this video, Jesse Kolstad of Biovation Labs elaborates on the intricacies of product specifications, from dosage forms to market presentations. He underscores the comprehensive role Unifize plays in the process, highlighting the platform's capability to manage, collaborate, and monitor all aspects of finished products. Jesse reflects on the transformative shift from traditional email-based approvals to the more efficient system provided by Unifize.
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.
Why it was easy to win the hearts and minds of engineers about Unifize
Denis Machoka reveals how Unifize's simplicity and instant information accessibility resonated with engineers at Harmonic Bionics. The platform's integrated conversations enabled engineers to quickly grasp expectations and engage in substantive discussions, streamlining communication and boosting efficiency.
Moving away from CCPs to Preventative Controls with Unifize
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Michael Hogan, a mechanical engineer at Harmonic Bionics, paints a vivid picture of the company's origins. He recounts the early days when it was just a group of grad students from the Renew Robotics Lab passionately working on rehab robotics. Their flagship device, Harmony, emerged from these efforts, aiming to revolutionize the recovery process for stroke patients.
Avoiding the mistake of thinking you need a complex QMS software to scale
Denis Machoka addresses misconceptions in QMS, emphasizing the value of easily accessible information for compliance. He challenges the notion that larger, more complex systems are inherently better, suggesting that simplicity and efficiency should be the focus.
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.
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
How Biovation uses Unifize to create traceability and take better decisions
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How to digitally transform your MedTech company without slowing things down
Denis Machoka recounts his pursuit of a swift digital transformation for Harmonic Bionics, leveraging the latest technologies. Drawing from his transformational background, he emphasizes achieving goals rapidly with minimal effort and gauging the team's adaptability to fast-paced changes and technological innovations.
Establishing Accountability and taking faster decisions with Unifize
Tedd Carr expresses how Unifize transformed The Will-Burt Company's approach to quality management. The previous system, a chaotic mix of emails and ad-hoc methods, lacked clear ownership and accountability, leading to prolonged issue resolution times. With Unifize, they have consolidated five systems into one, establishing defined accountability and enabling rapid task completion—what once took weeks or months now concludes in days, significantly optimizing their operational efficiency.
How Unifize helped reduce our training time and costs
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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

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.

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.

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.