How does Adaptive Health create a product and bring it to the market
In this video, Natalie explains the comprehensive process Adaptive Health employs to bring a new product to market. She covers the stages from initial concept and formulation through to compliance checks, quality control, and final market release. Natalie emphasizes the meticulous attention to detail and the rigorous standards that are upheld throughout the process, showcasing how Unifize plays a pivotal role in ensuring efficiency and adherence to regulatory requirements.
Transcript

00:00 - 00:07
So the journey, I would say it depends on the product. Where it's launching, is it being driven by retail, which is usually an immediate need.



00:07 - 00:14
Is it direct to consumer, which we try to make sure that we do things the right way, not the fastest way.



00:14 - 00:26
So I would say anywhere from if it's a single ingredient, it might be a month or two, and that's, you know, the complete process, the more complicated formulas, 6 to 12 months.



00:26 - 00:31
Sometimes I may have formulated something and we sit on it because it's just not the right time.



00:31 - 00:34
So I would say anywhere from a few months to maybe 18 months.



00:34 - 00:37
But first I would say we start with ideation.



00:37 - 00:43
So ideas may come from our retail team where they're seeing trends in the industry.



00:43 - 00:55
It may come from an immediate need that, for example, there might be a, a new drug that's out that is targeting this mechanism of action for I'm just going to give an example, healthy body weight and blood sugar.



00:55 - 01:24
Okay. We know that's trending across all populations. How can we create something that's not a drug, but that mimics some of those mechanisms of action and gives people a safe and efficacious product that they can use on a long term basis? So first you would look at different ingredients that fit that need looking at the mechanism of action, the cost, the cost per kilogram, the cost per bottle.



01:24 - 01:45
Are there clinical studies? Once those clinical studies are analyzed, what claims can be made from those studies? How do you combine those claims across the formula? Looking at all the ingredient documentation, what is their carriers? What's the country of origin? Is this a safe ingredient? Looking at to the safety of the different ingredients.



01:45 - 01:47
All of that, you're putting the puzzle together.



01:47 - 02:00
Once that's done, you work with, we've worked with Biovation, our manufacturer or third party manufacturers to provide them with the formula. Any input that they have on overages or things that should be changed.



02:00- 02:20
Finding out the quote, initial request for quote, If a pilot needs to be done, working with the manufacturer on that piloting process, the commercialization quote, artwork, working very closely with legal and manufacturer or I'm sorry, marketing on what can be said, how to position the product.



02:20 - 03:07
Individuals in the retail team involved, product development, which includes quality, product development and quality assurance, legal, marketing, contract manufacturer. Sometimes we may have the formula created and then there's a backlog with the piloting process. So it takes time to get from the ideated formula to the proposed finished good, because without the pilot for some complicated formulas, you don't know if the capsules, if it can fit in the capsule or two capsules, can they get all the materials in time? Does the powder flow well? What changes need to be made so that sometimes will delay the process like analyzing the studies, sometimes there might be 10+ studies on a single ingredient.



03:07 - 03:12
So it's, you know, reading and analyzing the studies, figuring out the claims, what can be said.



03:12 - 03:27
And then I would say one thing is that we can improve on is once the product launches, are we checking back in to see how the product is doing? Should it stay in the market, should any changes be made, you know, and other iterations from there.



03:27 - 03:43
Unifize ensures that everything is being done from A to Z where without it you might do A to J and the other letters would fall off, unfortunately.



03:43 - 03:52
So it helps to create a consolidated, collaborate collaborative effort to create a product and have it launched and to maintain its cycle.

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

02:25
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
01:39
Future of Unifize in Efco
Dave Anderson explores the exciting prospects of Unifize within Efco in this forward-looking video. He discusses the evolution of quality management processes facilitated by Unifize, highlighting the platform's ability to enable trend spotting and proactive responses to various challenges. Dave shares insights on integrating Unifize across different company operations, including warranty claims and quality records management, and addresses the ongoing transition from paper-based to digital systems. This journey with Unifize not only aims to enhance operational efficiency but also to lay the groundwork for future innovations in managing company workflows.
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.
03:22
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.
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.
00:28
Resolving Out of Specs and getting the product to market faster with Unifize
In this detailed video, Mikala discusses how Unifize has streamlined the process of resolving out-of-specification (OOS) issues. She explains how the platform has reduced the time products are held in quarantine, from a month to mere hours, thereby preventing delays and backorders. Mikala highlights the cost savings and efficiency gains achieved through Unifize, showcasing its significant role in getting products to market faster while maintaining quality standards.
02:23
Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
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.
00:44
Under 24h response times from Unifize Customer Support
Dave Anderson praises the exceptional customer support of Unifize in this video, emphasizing the prompt and efficient response times to queries and issues. He shares his positive experiences, highlighting how Unifize’s support team consistently delivers solutions within hours, not days, ensuring minimal disruption to workflow. Dave's testimonial underlines the crucial role of Unifize’s customer service in enhancing operational efficiency and problem resolution, making it a valuable asset to any organization seeking to improve its process management.
03:00
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.
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.
01:23
Quantifying things that were previously deemed impossible
In this video, Seth Bozman from Efco shares his transformative experience with Unifize, emphasizing its critical role in revolutionizing how they track and manage work orders, particularly in quantifying costs of specials and parts in a manner previously unachievable. He highlights Unifize's impact on making their process more efficient, allowing for a significant increase in productivity by enabling a more precise cost analysis and facilitating an enhanced focus on floor operations. Seth's testimony showcases the power of Unifize in streamlining operations, improving data accuracy, and supporting proactive decision-making at Efco.
00:30
How to standardize institutional knowledge for enhancing clarity
Seth Bozman shares insights into how Unifize has played a crucial role in capturing and standardizing institutional knowledge at Efco. He highlights the challenge of relying on knowledge passed down through years of experience and how Unifize's structured approach to operational procedures has facilitated better decision-making. This video demonstrates Unifize's impact on preserving critical knowledge and ensuring it's accessible to all, thereby speeding up processes and enhancing efficiency.
01:01
Collaborating right from the shop floor using Unifize
Dave Anderson showcases the power of Unifize's mobile application, revolutionizing real-time collaboration directly from the shop floor. He highlights how team members can instantly join discussions, contribute insights, and make decisions without being tethered to a desktop computer. The introduction of barcodes on paperwork, a minimal but crucial use of paper, allows anyone to scan and immediately access the relevant discussion on Unifize. This feature underscores the platform's commitment to enhancing efficiency and communication across various departments, making it a game-changer for operational workflows.
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.
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.
00:48
How Unifize links raw materials to lots, formulas and finished products
Jesse Kolstad highlights Unifize's capability to seamlessly link raw materials to lots, formulas, and finished products. Providing a comprehensive view of the production process, Unifize ensures unparalleled traceability and accountability, enhancing production oversight at Biovation Labs.
00:48
Handling audits made simple with Unifize
The video details how Unifize has simplified the audit process, making it easier to present and access required documentation. It demonstrates the platform's ability to consolidate information in a central location, significantly reducing the time and effort involved in audit preparation and execution.
01:48
About Tedd and The Will-Burt Company
Tedd Carr, with 40 years at The Will-Burt Company, oversees a broad quality assurance and control remit that spans beyond the traditional confines of the department. His role touches all company areas, emphasizing the diverse and complex quality demands of their varied customer base in sectors such as aerospace and military, which presents a significant challenge in meeting each sector's unique requirements and expectations. The Will-Burt Company, an employee-owned enterprise, prides itself on a century of business, specializing in proprietary products and services for emergency communications, warfare, and payload elevation, as well as offering comprehensive manufacturing services.
00:57
Doing 95% internal audits remotely with Unifize
The Will-Burt Company's pivot to remote operations, as narrated by Tedd Carr, showcases the agility afforded by Unifize. Amid travel restrictions, they've successfully shifted 95% of internal audits to a remote format, utilizing Unifize to maintain stringent compliance without the need for physical presence in their Tulsa location. This transition underscores Unifize's conversational-driven software's strength in facilitating seamless and efficient audit processes.

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.