Our Medical Device Design Services & Product Development Process

In addition to the areas ISO 9001 and 13485 overlap, members of the GCMI and GaMEP teams discuss associated costs including personnel, the necessary rigors associated with ISO 13485 certification, areas and products of need ripe for market entry by the right businesses, the strongest elements of potential “upside,” and what interested manufacturers and component suppliers need to consider and do to get in the game.

Check it out.

High value insights for medtech innovators and startups via GCMI’s Saylan Lukas and Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech‘s Dean Hettenbach – jump in! Spoiler alert: be strategic about claims, plan for 2X the time and 2X the dollars, and allow for some ‘give’ in tolerances.

Check it out.

Quality does not bend to market forces like automobiles or other consumer goods. In the realm of medical devices quality is systemic, mandatory, codified and highly regulated because lives are literally at stake. It considers a device’s complexity, but it never, ever exempts it from safety standards and good manufacturing practices.

Check it out.

GCMI Director of Product Development Mike Fisher, joined Scott Hollister, Georgia Tech Coulter Department of Biomedical Engineering Professor and Patsy and Alan Dorris Chair in Pediatric Technology, and Meredith Capasse, Human Protections Program and Research Regulatory Affairs for Children’s Healthcare of Atlanta to walk as through the required steps and, more importantly, why they’re required for academic researchers and innovators with novel medtech ideas or technologies.

Check out the insights and recording.

Where does preclinical testing enter the design and development phase of new medical technologies and devices? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg share deep dive insights.

“At the end of the day, some testing requirements in the design and development phase simply cannot be done ‘on the bench,’ Evan says. “In design input requirements and confirmation activities within the design and development phase, only cadaveric or small scale in-vivo testing can determine if a device provides appropriate grip or traction for the user, or if it works as intended in a beating heart or vessels with blood flow. Read on.

How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question.

“How quickly can you get your feasibility study to look like your GLP study? When you’re doing any level of pre-GLP preclinical studies, you have to maximize the value of the information you are getting. You never want to go into verification and validation testing without knowing the answer to your questions.” Access the recording here.

Design validation ensures that you have made the “right” product – according to the customer’s needs. Design verification ensures that the team has made the product “right” – according to regulatory and engineering requirements.

How does verification and validation in the design and development process “translate” to preclinical?

Find the insights from GCMI / T3 Labs Preclinical Program Director Evan Goldberg tells us in this Q&A. Read more. 

Watch, listen and learn from the 2020 Southeast Life Sciences AdvanSE event:

• Top ways innovators burn cash unnecessarily
• How innovators can know they are wasting time and money prototyping
• How to know when a medtech innovation is ready for preclinical work
• The critical importance of activity sequencing in the medtech innovation pathway
• Critical questions to ask prospective partners in regulatory, IP, engineering and reimbursement

Click here to access the post and recording.

Jackson Medical used GCMI’s “Phase Zero” to streamline their pathway from concept to commercialization for their novel medical device that reduces the potential for never events like burns and fires in operating rooms.

Watch and listen to Professor James Rains’ and Kamil Makhneija’s insights as shared with Children’s Healthcare of Atlanta Pediatric Technology Center Chief Engineer Leanne West.

All types of innovators need to carefully protect their intellectual property (IP) from those who may infringe on their ideas and products, and themselves from inadvertently infringing on others’. Medtech innovation is no exception and the landscape is rife with pitfalls.

Smith, Gambrell and Russell’s Matthew Warenzak shares his insights on patent landscape reviews, patents and freedom to operate in the following Q&A.

Read more here.

A significant number of innovative medical technologies fall into FDA’s Class II classification, the vast majority of which require an FDA 510(k) submission. What exactly is a 510(k)? What types of products fall into the Class II, 510(k) category?

Grace Powers, principal consultant with Powers Regulatory Consulting, has 20 years of industry experience in medical devices including research and development. GCMI leans on Grace’s regulatory expertise frequently and she graciously shared her insights on the FDA 510(k) clearance requirements in one of our recent blog posts. Read more here.

At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this design output (product) and ensures that it meets all engineering requirements and user needs, respectively.

Have you made the right product? Have you made the product right? Read more about GCMI’s approach to medical device design verification and validation.

Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products.

Too many medtech development projects are unsuccessful because innovators discover major roadblocks too late in the process. Here are some of the top ways to give your medtech innovation a better chance for successful commercialization.

Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products.

Too many medtech development projects are unsuccessful because innovators discover major roadblocks too late in the process. Here are some of the top ways to give your medtech innovation a better chance for successful commercialization.

Prototyping is an exciting and important part of the medical product innovation process. Prototypes can give you something tangible to touch and feel – a physical representation of your ideas coming to life.

Because prototyping is such a fun and exciting part of the development lifecycle, it is very easy to burn time and money unnecessarily.

We offer some of the top items to consider when deciding if a prototype is needed.

Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. Read.

It’s crucial to maintain a capital efficient, yet flexible, process for medical device design services and product development process in order to have the greatest likelihood of arriving at your intended destination in the least amount of time.

Designing for manufacturability is a critical task. The effort to develop a component manufacturing process and an assembly process is just as critical. Making these two paths overlap as much as possible allows a development team time to improve on manufacturing methods prior to any pilot builds.

From our colleagues at Greenlight Guru:

“The goal for most creators of new medical devices is to be able to get them to market as quickly as possible, right? So, what commonly puts roadblocks in the way?

Compliance issues. What are the common issues and what happens with these non-compliances?”

Greenlight Guru founder and VP of QA/QR shares his insights. We thank Greenlight Guru for including GCMI on its “Ulimate List of Medical Device Incubators and Accelerators”.

IEEE 11073-20701™-2018 defines an architecture that binds the participant and communication model to the Web services data transport model defined in previous IEEE 11073™ standards.

PISCATAWAY, NJ, 14 Feb. 2019 – IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Standards Association (IEEE SA), today announced the publishing and availability of IEEE 11073-20701-2018 – IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding.

Read more.

AI Dominates, But Attention to Manufacturing, Supply Chain and Funding Remain Paramount to Success in Medtech Innovation in 2024 and 2025

AI’s potential and momentum in healthcare and medtech are massive. But the need for safety assurance remains paramount as regulators try to mitigate the risk of a technology that has many waypoints to achieve in the clinical care setting especially for diagnosis.

Check out the details in part 1 of our annual report.

A hospital acquired CLABSI occurrence typically increases the patient stay by 7-25 days, with a mortality rate of 10-40%. There are typically 250,000 – 500,000 CLABSI cases reported in the USA each year, with ~80,000 of those occurring in intensive care units (ICU), and almost always attributed to a lack of proper sanitization during central venous catheter (CVC) or peripherally inserted central catheter (PICC) maintenance.

Materials scientist Jud Ready, his team at Hub Hygiene and GCMI are working to eliminate a never event still relying on “Civil War technology.”

Check out the feature story.

“Testing always goes a bit different than you expect, especially when it involves two different types of fluids with different viscosities,” Victoria said. “How those properties impact seals and system materials create considerations and needs that are not always obvious or anticipated.”

Learn how GCMI’s medtech design, development and preclinical team supported Spring Capstone Team AdvanCED and their stem cell delivery implantable technology for glioblastoma procedures.

Check it out.

For patients whose condition would benefit most from right atrium pacing, no leadless option exists, leaving them subject to lead-related complications that arise from traditional pacemakers. GCMI-supported GT 2023 Capstone team Phantom Lead developed a leadless pacing device that utilizes transcatheter delivery for placement in an unconventional location within the heart.

Check it out.

With support provided by GCMI, and the unmet clinical need presented by Dr. Joyce Xu and Dr. Shelly Abramowicz, Team JAWWS created “enGAUGE, a new surgical depth gauge featuring a double hooking mechanism that hooks on to the bone for more stable insertion and effective engagement that utilizes single hand operation.”

Read on.

Sensors, AI, regulatory shifts and more. What is the current state of medtech innovation? GCMI Chief Medical Officer Dr. Emily Blum and Interim Director of Research and Development Engineering, Saylan Lukas share their perspectives and insights.

Check it out.

We proudly support Georgia Tech BME Capstone projects, including the Fall 2022 effort from Team Wristy Business, taking on an unmet need for scapholunate ligament tears.

Read on.

“We founded Augment Health, Inc. to commercialize this invention so we can get it into people’s hands and help them to achieve improved peace of mind and quality of life,” Meyers said. “The technology seeks not only to limit, if not eliminate, embarrassing events that seem inevitable for those who require catheters and urine collection devices, but also to minimize directly associated urologic and urinary health concerns.”

CreateX and GCMI-supported “alumnus” keeps patient and user needs as its north star.

Read on.

“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] would have taken years longer without GCMI’s Phase Zero and Phase One services.”

The winner of the 2021 competition for their innovative wearable pediatric stethoscope activated GCMI’s Phase Zero analysis and Phase One medtech innovation services to advance the cause.

Read on to examine the ways these activities have advanced the technology’s pathway to commercialization.

In 2014, a Children’s Healthcare of Atlanta nurse, Lynn Pogue, approached an engineer, Leanne West from Georgia Tech, to discuss the burden of IV monitoring. This is when Sherry Farrugia, the current Chief Executive Officer of GCMI, stepped in to help assemble the team that would begin the investigation into a new device capable of mitigating IV ‘infiltration’ or ‘leakage’ in pediatric patients.

Read on. 

In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance from GCMI and T3 Labs—to advance development of its needle guidance system.

“Don’t build first, listen,” Zea advises others with innovative ideas for new medical technologies. “This can be inherently difficult for engineers, designers and builders. But it’s immensely important. You’ll get it wrong if you don’t listen [closely to the customers’ or users’ needs first].”

“If we worked with another design and development firm, we wouldn’t have had the flexibility to do what we needed to do in the time frame we set. GCMI is unique in that we were able to choose the services that we needed precisely at the time we needed them. The way GCMI engages with their customers is unlike any other firm.” Read on to learn more about our capital efficient, phase-gated medtech development process.

As a non-profit affiliate of Georgia Tech, GCMI fills a specific role or roles for a period of time, allowing you to complete the work with no strings attached. Our team is here to help you design the right product, primed for manufacturing, then help you find the best way to get it to market – whether or not that means sticking with GCMI. Read on.

Georgia Bio, the state’s life science trade association, named GCMI, the Saldana Research Group and Georgia Tech 2021 Golden Helix Innovation Award recipients for our fast-response PPE program. The Innovation Award recognizes the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

Read more about the project and its impact.

Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th, Georgia Tech Associate Professor of Engineering Christopher Saldana and the team at GCMI shared the impetus, idea, regulatory requirements and processes that moved Chris’ team’s engineering idea out of his lab and into the hands of frontline healthcare professionals all in the midst of a pandemic.

Watch and listen.

Following closely on the heels of GCMI’s work with Georgia Tech and others to design, produce and deliver hundreds of thousands of PPE face shields to frontline health workers, Georgia Tech and GCMI have combined their resources to help solve another critical shortage in healthcare: hand sanitizer.

“Georgia Tech is about the power to convene. Companies and stakeholders are eager to come to the table here to make things happen,” said Dr. George White, Interim Vice President of Georgia Tech’s Office of Industry Collaboration.

Read more.

Project planning, also referred to as “Phase 1” at GCMI, follows directly after the feasibility phase, “Phase Zero.”  Phase 1 is the beginning of the formal product development process that complies with medical device regulatory requirements and with business strategy. This phase is all about determining the resources, the timing, and the work that’s required for product success.

Read more about our planning process: where it fits with product development and why it’s important.

In mid-March 2020, the shortage of personal protective equipment for healthcare providers responding to the COVID-19 outbreak had become a national emergency. By March 13 Christopher Saldana, Ph.D., associate professor of manufacturing at Georgia Tech and his mechanical engineering students and colleagues were already working on challenges and solutions for desperately needed protective personal equipment (PPE) for frontline healthcare workers.

Read more about how this collaboration produced and delivered more than 250,000 PPE face shields by April 7.

From the Delta News Hub: April 2, 2020: Delta Flight Products, the airline’s wholly owned subsidiary, is collaborating with Global Center for Medical Innovation (GCMI), a non-profit affiliate of the Georgia Institute of Technology, to manufacture face shields to protect hospital workers during the COVID-19 pandemic.

Using materials and designs provided by GCMI, Delta Flight Products is leveraging its best-in-class manufacturing facilities to quickly deliver an initial order of 2,000 shields to aid workers in New York by Friday, and an additional 4,000 for Atlanta-area hospitals in the following days.

Read more from the Delta News Hub.

When an innovator has identified a medical problem, taking an efficient approach to minimize risk and identify the viability of potential solutions is key. Our Phase Zero focuses on evaluating critical product elements early, minimizing risk, cost and effort.

Key questions:

• What is the clinical need or problem to be solved?
• How will the product’s critical features address clinical need?
• What is the product’s regulatory pathway?
• Can the innovator’s intellectual property be protected?
• Is there a market for the product?
• Who are the competitors?

Answering these questions validates the project direction and anticipates your resource requirements, timeline and team needs. What, then, should medical technology innovators with a ‘napkin sketch’ or research idea expect to get out of GCMI’s Phase Zero service offering?

“GCMI is unique in that we were able to choose the services that we needed precisely at the time we needed them. The way GCMI engages with their customers is unlike any other firm.” – Lou Malice, nFant CEO

“We would be quite naive about what’s next if not for GCMI. It’s a bootcamp on medical technology commercialization for academic researchers.” – Darren Roblyer, Ph.D., Boston University