Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
Transcript

00:00 - 00:18
When you're talking about speed to market, you know, return on investment and speed to market, you have to look at the effort. It's going to take you to put the quality system in place. Are you going to go and have a person who is going to know every nuance about your configuration?



00:18 - 00:28
Because that's what it takes for most other companies. You will need to know all of the workflows in detail to know exactly where they are, touch points, on what level of security you expect for each of them.



00:28 - 00:47
You're also going to need an IT component of it because most of the systems will need a local client of some IT support. You're also going to a need level of access. Cost is also a consideration that you need to have. Are you going to have cost that is going to support that? Most of the systems are high cost, high maintenance.



00:47 - 01:01
When you look at those front end costs and configuration efforts that you need to put, it drives the cost of the final product. Now you're going to still be compliant, but you spent a lot of energy doing that.



01:01 - 01:17
On the other hand, you have Unifize, which out of the box it can be applied. Out of the box, without a lot of configuration, you can still get the level of compliance that you need. Now, you don't need IT to be involved. You leave the configuration of the system with QA.



01:17 - 01:23
Now you've changed the responsibility, it's no longer IT getting in the middle of it, but you have now QA driving it.



01:23 - 01:46
Who would you rather have? You'd rather have QA driving it than have IT involved in it? Because that's another component you have no control over. So I think the best way and we had this experience with Unifize was to have QA drive and once QA drove it, it was easy for QA to make the adjustments without necessarily getting somebody else to do the configuration.



01:46 - 01:52
Somebody has to update somebody else to go the back and forth is really quite.



01:52 - 02:12
system that we, I have used in the past involved going back to the customer and having a project manager that managed all the changes. So, QA would go into an isolation, they would make recommendations. They would have a meeting, that meeting would drive a decision which would go into the configuration team.



02:12 - 02:33
Then the configuration team would have another discussion about the changes are asking before the changes can be made. So if I'm a Lean Six Sigma person or somebody who just wants to get there directly, I'm cutting to the chase. I'm giving the tool directly to the QA organization who are making and are responsible for the data.



02:33 - 02:40
I would rather have the right people configure the system than have others involved who may not have a stake in the system.



02:40 - 02:59
in terms of time to market, those two systems may get you there, but one is going to get you there faster because it goes directly For us it took four weeks for the other systems that I've worked with. It took us almost a year. Part of that is because the decision makers sometimes when not available, they took a vacation.



03:00 - 03:25
Sometimes the project managers that were involved scheduled calls and those calls were not decisions were not made during those calls. So those decisions were punted forward. Sometimes the configuration did not work. That meant they had to go back and reassess those meetings and circles and cycles that you go through are taking time while Unifize comes out of the box, has everything that you need.



03:25 - 03:37
QA was in control of it. They are showing you how to do it. Access is provided and everybody can use it. As soon as everyone is in the system. It's no brainer.

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

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.
03:46
Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
00:38
About Seth and his role at Efco
Seth Bozman introduces himself and his role at Efco, detailing the company’s operations and his responsibilities in managing scrap and rework. He discusses the transition from traditional methods to utilizing Unifize, highlighting the platform's impact on improving data analytics, reporting, and operational efficiency. This video provides a personal insight into Seth's professional journey and the transformative effects of Unifize on his work at Efco.
03:00
What attracted us the most about Unifize
Tedd Carr recounts The Will-Burt Company's extensive search for the ideal quality software, vetting over 30 options before discovering Unifize. The decisive factor was Unifize's user-friendly interface, akin to social media, that required minimal training and ensured swift adoption across their teams. This ease of use, combined with comprehensive onboarding support at no extra cost, distinguished Unifize as the superior choice, fostering its enthusiastic embrace within the company.
01:25
Taking faster decisions on Non-Conformances with Unifize
Jesse Kolstad underscores the agility Unifize brings to decision-making on non-conformances at Biovation Labs. The platform fosters rapid issue identification and enhances collaboration for swift resolutions, ensuring effective and timely corrective actions.
02:11
How we manage change on Unifize
Michael offers a behind-the-scenes look into the engineering practices at Harmonic Bionics. He talks about his reliance on tools like SolidWorks for computer modeling and Apache subversion for version control. Despite a limited software stack, there's a hands-on approach to their work, encompassing tasks from debugging robots to prototype development. Michael underscores the systematic approach they follow in documenting design outputs, hinting at the role of Unifize in this process.
05:38
How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.
03:53
The ROI of Quality Management Systems
Jesse Kolstad delves into the significant ROI of quality management systems, underscoring efficiency gains and cost savings. Unifize emerges as a pivotal tool in optimizing the ROI of quality management, demonstrating tangible benefits at Biovation Labs.
02:43
About Wilson and Applechem
Wilson introduces Applechem, detailing their focus on innovation in cosmetic ingredients. He emphasizes their commitment to developing high-quality, cutting-edge products that cater to the evolving needs of the cosmetics industry. This introduction sets the stage for understanding Applechem's market position and Wilson's role in steering the company towards its goals.
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.
01:49
Why Slack is not the best system for managing quality
In this detailed video, Erica delves into the unique messaging and document management features of Unifize. She explains how Unifize facilitates specific conversation threads, such as for finished goods, artwork, or ingredients, allowing immediate access to relevant documents within these discussions. Erica contrasts this with Slack, where uploading and sharing documents is more cumbersome and lacks the context provided by Unifize's integrated system. She emphasizes how Unifize's layout enables users to quickly view dialogues and understand ongoing issues without extensive explanations. Additionally, Erica highlights Unifize's ability to hold users accountable and convey urgency in tasks, a feature she finds lacking in Slack. This video effectively showcases how Unifize streamlines communication and document management, enhancing productivity and clarity in workplace collaborations.
02:45
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.
01:13
Managing retentions with Unifize
Jesse Kolstad underscores Unifize's role in effectively managing product retentions at Biovation Labs. The platform simplifies tracking, ensures adherence to retention policies, and enhances compliance, making retention management more streamlined and reliable.
01:08
Moving away from CCPs to Preventative Controls with Unifize
Highlighting the shift to preventative controls, Jesse Kolstad values Unifize's visibility and supplier management. Unifize seamlessly aligns with food safety, optimizing supplier evaluations and quality control at Biovation Labs.
00:55
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.
01:36
Managing Incoming Material and Lot Tracking on Unifize
In this video, Clarissa discusses the challenges and solutions for managing incoming materials and lot tracking using Unifize. They emphasize the difficulties faced in quality assurance, especially when parts or products do not meet inspection standards. The video illustrates how Unifize streamlines this process by enabling easy tracking of lots, keeping essential documents like certificates of conformance and material certificates organized. The speaker highlights the convenience of having all relevant information, such as lot numbers and PO numbers, scanned and stored in Unifize, facilitating efficient tracking and inspection. They conclude by praising Unifize's collaborative features, which significantly enhanced their team's engagement with the new Quality Management System (QMS).
01:04
How the Unifize team helped build our customisations faster
In this engaging video, Erica offers a fresh perspective on Unifize's standout customer support. She praises the promptness of the team, often responding within an hour, sometimes even in 10 minutes, ensuring immediate assistance. Erica shares her initial experiences as a new user of Unifize, emphasizing the value of regular team meetings in her learning process. She is particularly impressed by the platform's ability to tailor features to specific needs, such as creating custom PDFs, and the team's proactive approach to fulfilling complex requests. Erica's account highlights Unifize's dedication to responsive and personalized support, making the user experience both seamless and adaptable.
03:22
Comparing Unifize vs QT9
In this detailed comparison, Dave Anderson shares his candid insights on choosing Unifize over QT9 for quality management at Efco. He praises Unifize for its superior collaboration features, emphasizing how it promotes more personal and effective problem-solving through direct conversations and teamwork, unlike QT9's focus on mere record-keeping. Dave highlights the difference in sales delivery and upfront communication about platform capabilities, which made Unifize stand out. This testimonial underscores the importance of collaboration in modern quality management systems and how Unifize excels in creating a more engaged and accountable team environment.
03:20
Managing your Design History File on Unifize
In this video, Clarissa talks about the transformative experience of managing Design History Files (DHF) using Unifize. She contrasts the challenges of traditional DHF management with the streamlined, intuitive approach offered by Unifize. Clarissa details how the platform efficiently links various documents, processes, and reports, facilitating a smoother review process for manufacturing readiness and design transfers, a feature she finds exceptionally beneficial for product development.
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.

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.