Taking advantage of 3D printing in the manufacturing of medical devices.

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In a recent interview with MD+DI, Nicole Black, PhD, vice president of biomaterials and innovation at Desktop Health, discussed the importance of tackling difficult problems to drive innovation. Black, who will be giving a keynote address at BIOMEDevice Boston, believes that taking on challenging tasks can lead to greater rewards.

Black’s own experience exemplifies this belief. Her graduate work resulted in a startup company, which was later acquired by Desktop Metal. Black joined the newly formed division, Desktop Health, with a mission to create high-quality 3D-printing solutions for patients. Her team at Desktop Health focuses on finding valuable applications for extrusion-based 3D-printing in healthcare, specifically for end-use medical devices.

One of Black’s current projects involves using the AlignInk biodegradable material system to develop the PhonoGraft device for eardrum repair. The AlignInk system enables the creation of anisotropic tissue grafts, which have different material properties along different directions. This aligns with the natural structure of tissues in the body and allows for the growth of cells and extracellular matrix proteins in specific directions. By programming the structure of the final tissue, the PhonoGraft device aims to replicate the circular and radial fibers found in the native eardrum, enabling better sound conduction across a wide range of frequencies.

During her keynote address, Black will provide updates on the development of the PhonoGraft device and also discuss the broader implications of 3D-printing in the medical device field. In preparation for her talk, MD+DI asked Black several questions about these topics.

The AlignInk material system has the potential to revolutionize tissue graft manufacturing by creating grafts with anisotropic properties. By guiding the growth of cells and extracellular matrix proteins, these grafts can more closely resemble native tissues. This innovation has significant implications for the field of regenerative medicine, as doctors seek to repair and replace damaged tissues with materials that closely mimic the body’s natural structure and function.

Black’s work at Desktop Health highlights the power of pursuing difficult challenges and thinking outside the box in order to drive innovation in the medical device industry. Her dedication to finding solutions that can significantly improve patient outcomes is commendable, and her keynote address at BIOMEDevice Boston is sure to inspire attendees to tackle their own difficult problems in pursuit of innovative solutions.

A Unique Approach to 3D-Printing in Medicine

Traditional medical device companies have primarily used 3D printing for customization purposes, tailoring devices to fit individual patients. However, at Desktop Health, our approach to 3D printing in medicine goes beyond customization. We believe that 3D printing can be used as an end-use manufacturing method to create devices with unique structural and functional properties, leading to improved patient outcomes.

One of the key achievements that has allowed us to develop this approach is the advancement in material development. The material system we work with is a blend of biodegradable natural and synthetic polymers, designed to mimic the extracellular matrix surrounding cells in the body. This material is hydrophilic, allowing cells to grow onto the grafts, and porous, enabling the grafts to adhere to native tissue around the defect site through capillary action.

Finding medical-grade versions of these natural and synthetic polymers has been crucial for our work. Thankfully, we have seen an increase in the availability of materials companies providing their products in a medical-grade version.

In addition to the material system, the technology itself plays a vital role in our approach. The 3D-Bioplotter, the extrusion technology we use, allows us to apply high pressures to the ink systems, enabling them to flow through nozzles with small inner diameters. This technology has the widest range of accessible printing temperatures in the industry, which means we can tune the rheological behavior of inks through material and temperature modifications. As a result, we can produce high-resolution printed devices with consistent quality and reproducibility.

Now, let’s talk about why we chose eardrum repair as our first project at Desktop Health. The PhonoGraft device is our first major project because there is a clear, unmet need for improved eardrum repair grafts. As a former graduate student in Professor Jennifer Lewis’s Lab at the Wyss Institute for Biologically Inspired Engineering at Harvard, I was already familiar with the research and development of 3D printing and materials technologies to address significant challenges in various fields.

When I met Dr. Aaron Remenschneider and Dr. Elliott Kozin at Massachusetts Eye and Ear Hospital in 2015, I became aware of the challenges faced by patients who underwent eardrum repair procedures. Witnessing these procedures and listening to patients discuss their experiences inspired us to create grafts that could lead to better outcomes.

During our initial investigations into hearing outcomes following eardrum repair procedures, we discovered that the eardrum’s unique structure played a crucial role in sound conduction across different frequencies. Existing research had shown the importance of anisotropic stiffness and the effects of cutting oriented slits in the eardrum tissue. Despite these findings, there were no products that attempted to recreate the circular and radial architecture necessary for optimal sound conduction.

We also recognized that current eardrum repair procedures were invasive and time-consuming, often requiring general anesthesia and a full day at the hospital. Autologous tissue grafts sourced from a donor site, such as fascia or cartilage, added complexity and increased surgical time. Additionally, implanting these grafts to cover the perforation on the medial side of the eardrum posed challenges.

This is why we are excited about the PhonoGraft device. It combines innovation from two different perspectives to improve patient outcomes. First, we utilize microstructural control to replicate the eardrum’s unique architecture. Second, we design the device to be implanted through the ear canal in an awake patient by any ENT doctor trained in using an endoscope.

By approaching 3D printing in medicine with a focus on both macrostructure and microstructure, we are confident in our ability to create devices that will revolutionize the field and improve the lives of patients. Our journey has just begun, and we look forward to discovering even more applications for this groundbreaking technology.

if you’re simply curious about the cutting-edge developments in 3D-printing technology and how it is being applied in the medical field, this keynote address would be a great opportunity for you to learn more. The speaker, Dr. Black, will be discussing the innovative PhonoGraft device and its potential to revolutionize eardrum repair procedures.

The AlignInk system integrated into the graft of the PhonoGraft device allows for the body to remodel the graft into tissue that matches the circular and radial structure. This could lead to improved healing and hearing outcomes for patients. Additionally, the 3D-Bioplotter and unique support materials used in the device’s design enable macrostructural control during the implantation process.

One of the challenges faced in bringing these types of devices to market is the regulatory process. Custom patient-matched devices, which require validation for each individual design, present unique regulatory challenges. However, the PhonoGraft device is not a patient-matched device, which simplifies the regulatory process. The FDA has confirmed eligibility for the device to follow the 510(k) pathway, which requires demonstrating its safety and effectiveness compared to legally marketed devices.

Surprisingly, a small human confirmatory study is required for the PhonoGraft device, which is uncommon for the 510(k) pathway. However, this is a result of the device’s multiple innovations and the need to justify its safety and effectiveness. While unexpected, it demonstrates the commitment to innovation and meeting regulatory standards.

Moving forward, 3D-printing in the medical device space is expected to evolve in multiple areas, including orthopedics and the development of cylindrical grafts for various tissues. The recently-released PrintRoll platform, coupled with the 3D-Bioplotter and AlignInk material systems, will accelerate the development of these innovative medical devices. The ability to impart unique microstructural properties through 3D-printing will become increasingly important, surpassing the conventional manufacturing techniques currently used in the medical field.

If you’re interested in medical device innovation, biomaterials, biofabrication, or 3D-printing, attending Dr. Black’s keynote address would be highly beneficial. The talk will not only delve into the advancements in 3D-printing technology but also explore the journey from graduate work to startup acquisition. It will be particularly useful for those interested in entrepreneurship, including PhD students, postdoctoral research fellows, and individuals working in startup companies. However, anyone with an interest in this rapidly evolving field should seize this opportunity to gain insights into the future of medical device technology.

If you happen to be employed by a large corporation and have a keen interest in the world of 3D printing, then you might find my current role at Desktop Health quite intriguing. One of my main responsibilities is to establish partnerships with other companies in order to co-develop cutting-edge medical devices using 3D printing technology. The Biofabrication Innovation Office at Desktop Health, located in the Charlestown neighborhood of Boston, serves as the central hub for this collaborative endeavor. We are able to enter into joint development agreements with companies, enabling us to carry out both early-stage and late-stage research and development work.

Many medical device companies possess extensive knowledge and expertise within specific market sectors, and naturally, they have a deep understanding of customer needs within those industries. However, where they often fall short is in the areas of 3D printing and biomaterials development required to create entirely new medical devices from scratch. This is where our team at Desktop Health can step in and provide valuable support and guidance. We encourage individuals within large corporations who are interested in driving innovation to also engage and participate in these partnerships.

During such collaborations, it would be fantastic to receive questions from attendees about various aspects of the process. These topics could range from sourcing the right materials and formulating suitable inks to designing the devices themselves, considering the regulatory requirements for introducing a new medical device, and finally, developing appropriate test methods for the finished product.

In terms of the keynote address that I will be delivering at BIOMEDevice Boston, titled “Moving the Nozzle: 3D Printing for Medical Device Manufacturing,” I hope to convey the message that although innovation poses its fair share of challenges, the rewards are undoubtedly worth it. Many medical device companies often shy away from innovative projects due to the additional testing requirements imposed by regulatory bodies such as the FDA prior to device clearance. However, it is important to recognize that by taking the more innovative path, the ultimate payoff in terms of market potential and competitive advantage will far outweigh the alternative of choosing a less innovative approach.

My sincere hope is that individuals attending the keynote address will come away with the realization that tackling difficult problems is a positive thing. After all, easy problems tend to be less satisfying to solve. By embracing the trials and tribulations of innovative endeavors, individuals and companies alike can unlock new markets and achieve unprecedented levels of success.

For those interested in learning more about this topic, I will be delivering my keynote address at BIOMEDevice Boston on Thursday, September 21, from 1-2 p.m., on Center Stage. Further information about this event can be found using the provided hyperlink.

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