About Michael Hogan & Harmonic Bionics
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.
Transcript
Related Videos
Unifize Results
10x
Speed to compliance
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
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
00:56
Improving accountability
In this video, Dave Anderson emphasizes the unique approach Unifize brings to improving accountability within teams. By fostering direct, personal interactions over generic software notifications, Unifize encourages a culture where problems are not just flagged but solved collaboratively. Dave highlights how the platform's emphasis on smaller, focused groups and one-on-one conversations enables a more intimate and effective problem-solving process. This method contrasts sharply with traditional email chains, offering a real-time, engaged approach that ensures everyone is directly accountable and involved in the resolution process.
01:12
Onboarding and adopting Unifize
This video outlines the swift and efficient onboarding process to Unifize for managing corrective actions, risk assessments, and change control within their quality management system. Highlighting the collaborative effort with the Unifize team, the speaker details how they were able to upload historical data and fully implement these crucial aspects within just three to four weeks—a timeline significantly shorter than anticipated. This rapid deployment, compared to previous experiences with other systems, underscores Unifize's ease of adoption and its immediate impact on enhancing the company's quality management processes.
01:41
How Unifize speeds up change control
Jesse Kolstad emphasizes Unifize's prowess in managing change, navigating the challenges of either over-documentation or under-documentation in some companies. With features like versioning, Unifize ensures comprehensive tracking, offering unparalleled visibility and accountability in change management at Biovation Labs.
01:42
Why is Carol using Unifize now
In this video, Carol Wilson from Efco shares her transformative experience with Unifize, highlighting how it revolutionized their document management process. Facing a daunting challenge of retrieving ten-year-old certification documents for a government audit, Carol discusses the inefficiency of their previous system, where critical documents were buried in emails or physical files, leading to weeks of searching by multiple team members. She outlines how Unifize streamlined this process, allowing for easy access to documents through purchase orders, significantly reducing search time and improving efficiency for the entire team.
00:46
Adopting a new system in an institutional knowledge based shop floor
Dave Anderson shares insights on the challenges and successes of implementing Unifize in a shop floor rich with institutional knowledge. He discusses the initial resistance to change and the skepticism towards adopting new systems. However, Dave highlights the transformative moment when team members begin to use Unifize, noting the ease and efficiency it brings to processes previously burdened by paperwork. This video illustrates the journey from hesitation to acceptance, showcasing the significant improvements in workflow and productivity with the adoption of digital solutions.
04:23
Moving from MasterControl to Unifize
In this insightful video, Erica reflects on her transition from using MasterControl to adopting Unifize for quality management. She shares her journey of growth and adaptation with Unifize, highlighting its superior efficiency in document handling and management. Erica notes the stark contrast between the two systems, pointing out how Unifize simplifies document uploads and centralizes management with just a click. She also touches on the benefits of Unifize's collaborative capabilities, allowing seamless integration with external partners like contract manufacturers. Erica's narrative emphasizes Unifize's user-friendly interface and its effectiveness in streamlining quality control processes, which were previously cumbersome with traditional methods like email or Dropbox.
01:43
Why Slack and Teams can't replace a collaborative eQMS like Unifize
In this video, quality leaders from a popular nutraceutical manufacturer, Adaptive Health share their experience on using communication tools like Slack and Microsoft Teams to manage quality. They emphasise on the fact that these tools disconnect the collaboration from the data, leading to greater redundancies affecting their product launch process. They also share their experience on using Unifize to manage their quality processes end-to-end, and how it improved their collaboration and data management tremendously not just within their organisation, but across their partner organisations as well. Watch this video to know more about why Slack and Teams cannot replace a powerful collaborative eQMS solution like Unifize.
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.
01:52
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
01:00
Why does Seth consider Unifize's Customer Support, urgent?
In this video, Seth highlights the exceptional customer support provided by Unifize, detailing his interactions with the team and their responsive, solution-oriented approach. He appreciates the platform’s ability to address urgent requests swiftly, enhancing Efco’s operational efficiency. Seth’s experience underscores Unifize’s commitment to customer satisfaction and its impact on streamlining workflows and resolving issues quickly.
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.
00:56
What happens when QA people develop software
This video offers insights into the unique perspective brought to software development by quality assurance professionals. It suggests that a focus on collaboration and flexibility, typically lacking in traditional QMS software, is essential for creating a system that truly meets the needs of all users. The speaker reflects on the importance of designing quality management tools that are not only about data storage but also about enhancing the user experience and operational efficiency.
02:12
How smaller groups lead to 70% faster actions
In this video, Dave Anderson from Efco shares his transformative experience with Unifize, emphasizing how the platform fostered smaller, more efficient discussion groups to swiftly address problems. By enabling seamless collaboration and record-keeping online, Unifize ensured that all stakeholders stayed informed and engaged, leading to a remarkable 70% improvement in action response times. Dave highlights the significant reduction in administrative overhead, from managing paperwork to leveraging Unifize’s streamlined processes, showcasing the platform's impact on enhancing productivity and resource allocation.
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.
01:25
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.
01:33
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
01:08
Problems with managing quality using Excel and Word
The video outlines the inefficiencies and limitations encountered when managing quality systems through traditional tools like Excel and Word. The speaker describes the struggle with document control, lack of true automation, and the inability to effectively implement reminders or systematize processes for quality management. This approach proved unwieldy, manual-intensive, and required significant personnel oversight, posing challenges for a small company with limited quality assurance resources. The transition to Unifize is depicted as a crucial move to alleviate these burdens and enhance the quality management process.
02:39
Why Unifize's approach to collaboration is transformational
Describing the communication challenges Harmonic Bionics faced in the past, Clarissa Archer praises Unifize for its centralized approach. Unlike previous tools where information often got lost in the shuffle, Unifize provided a consolidated platform that made tracking and acting on feedback more streamlined, especially during multitasking.
00:58
Does Efco comply to any external standards
Dave Anderson discusses Efco's approach to compliance standards, emphasizing that while not formally ISO certified, Efco's processes mirror ISO principles of record-keeping and operational consistency ("say what you do, do what you say"). He highlights Efco's adherence to ASTM standards for manufacturing, from threaded products to welding, and the training of welders to AWS standards. This ensures a high level of quality and readiness for certification, despite not having pursued formal ISO certification due to not yet seeing the need for it.
00:59
They key to configurability- make it simple & easy
Denis Machoka extols the straightforward configurability of Unifize, contrasting it with the complexities of other systems. He appreciates its pre-configured design, likening it to object programming. Denis believes Unifize's inherent simplicity is testament to its creators' deep industry understanding and their aim to simplify user experience.
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.
