SHOW PREVIEW: BIOMEDevice Boston

BIOMEDevice Boston brings engineers, business leaders, disruptive companies, and innovative thinkers from the region’s top start-ups and medical device OEMs together to inspire the next life-changing medical device. The event will focus on key advances in robotics and 3D printing among other cutting-edge technologies. In this sneak preview, this year’s keynote speakers share their insights into two of these critical topics.

KEYNOTE: From Concept to Commercialization: It’s Not Brain Surgery, or Is It?

Wednesday, September 20, 1–2 PM | Center Stage

How does one take ideas and bring them to reality as life-changing medical devices? Or more importantly, how does one make sure their ideas will have an impact on people’s lives and be commercially viable? As a researcher, professor, lead investigator on federal government-supported grants, director of a state-funded MedTech accelerator, and founder of multiple medical device companies, Dr. Gregory Fischer has a unique perspective on what it takes to leverage all the resources around you to develop meaningful and successful medical devices.

His keynote will focus on key aspects related to conceptualizing, refining, and commercializing medical devices, looking at the challenge from multiple perspectives. As CEO of AiM Medical Robotics, Dr. Fischer will describe the journey towards bringing to life a game-changing MRI-compatible neurosurgery robot, and how critical it was to understand the patient journey and put oneself in the shoes of the patients and clinicians to truly identify the real challenges and unique ways to improve the experience for the patients, clinicians, and hospitals.

MDB: As new technologies make their way into medtech, how is this changing the landscape and development of medical devices?

Gregory Fischer: It is exciting to see the changing landscape of medical devices. There are many areas where robotic assistants, intelligent algorithms, greater use of interventional medical imaging, and semi-autonomous control will be game changers in enhancing patient care, streamlining workflows, and democratizing high quality healthcare. Moving forward we will see more and more robotics and intelligent medical devices creeping in, perhaps to the point where they become very natural progressions and not even thought of as robots.

MDB: Robotics is making it’s a huge impact in device development, both in manufacturing and in the devices themselves. Where do you see the biggest impact of robotics technologies in medtech?

GF: Teleoperation of robotics has already shown that it can improve dexterity and precision of motion. In the next generation, I anticipate we will see an explosion of intelligent systems that leverage intraoperative imaging, modeling, and other inputs for live feedback to perform “closed loop interventions.” Robotics coupled with meaningful feedback ensures that the procedure is performed exactly as anticipated, just like, for example, visual serving has become standard in many industrial robotics applications. On the manufacturing side, robotics enables flexible manufacturing lines that can enable more specialized devices as opposed one-size-fits-all solutions.

MDB: Your abstract mentions the critical role of the patient journey. How can medical device developers ensure that this is integrated into the design process?

GF: When creating medical devices, it is absolutely essential to understand the entire procedure from start to finish from the perspective of the clinical staff, patient, hospital, and others. One must put themselves in the shoes of the surgeon to truly understand what the real challenges are, and how a device can be used to solve those problems in a viable way. Whenever I go into the OR, my head is buzzing with ideas on how to streamline the procedures – it is so important to really understand the entire patient journey and where there are opportunities to enhance that experience for all those it touches. On the other hand, this is also critical in determining if an idea for an enhancement will in fact impart sufficient benefit, and in some cases a good idea may not fly due to various factors not initially considered because the big picture was not envisioned.

MDB: What do you see as the biggest challenge currently facing industry?

GF: Bringing new technologies to life in the medtech space is very challenging. It is a very long process and requires substantial patience, dedication, and capital. Large companies often are focused on products that are on short time horizons to reach market, and smaller companies have a hard time raising capital to support the long development cycle of exciting new device concepts. Unfortunately, many incredible concepts never make it to market, and therefore not into helping patients, because of commercialization challenges rather than the ideas.

KEYNOTE: Moving the Nozzle: 3D Printing for Medical Device Manufacturing

Thursday, September 21, 2023, 1­–2 PM | Center Stage

New technological developments are transforming 3D printing from a method primarily used for prototyping into a reliable manufacturing method for end-use medical devices. Additionally, innovative new materials for 3D printing are being developed to impart specialized functional properties into medical devices. One example is the proprietary AlignInk™ material system, a novel biodegradable material that imparts anisotropy into the final graft following extrusion from precise nozzles. This anisotropy can guide cell elongation and extracellular matrix protein deposition along the direction of a print path. Using extrusion-based printing systems such as the 3D-Bioplotter, complex print paths can be patterned that can become structured and functional tissue following implantation.

For many tissues in the body, including tendons, ligaments, muscle, cartilage, and vasculature, structure plays an important role in function of the tissue. One specific example of this is the tympanic membrane, or eardrum. The circular and radial arrangement of collagen fibers in the eardrum enables effective sound conduction across a wide range of frequencies. When a patient damages their eardrum, the most common solution is to harvest autologous tissue from the patient and place it via an invasive procedure.

Unfortunately, these autologous grafts do not remodel into the circular and radial fibrous structure that is present in the native eardrum. Thus, healing and hearing outcomes can be poor in patients. By using the AlignInk™ material system, Black’s team has been developing a novel 3D printed graft for eardrum repair, called the PhonoGraft® device, that has shown early promise in regenerating functional eardrum tissue following implantation in animal models.

This keynote will discuss the pathway that the AlignInk™ material and PhonoGraft® device technology have followed — starting from an academic lab setting, launching into a startup company, and then being acquired by Desktop Metal to “move the nozzle” in healthcare as part of Desktop Health. Beyond the innovations, we will also discuss factors that go into bringing a 3D printed medical device to market.

MDB: How do you see 3D printing changing the landscape and development of medical devices?

Nicole Black: We are going to see the 3D printing landscape transform from companies primarily using 3D printing for prototyping into companies adopting 3D printing for manufacturing millions of end-use medical devices. Importantly, the available biocompatible materials for use in 3D printing are rapidly expanding, and the resolution and reproducibility of 3D printers are constantly improving. For example, the Manufacturer Series 3D-Bioplotter from Desktop Health has a built-in high-definition camera to allow for high-accuracy calibration, parameter tuning, and mid-print logging of part dimensions to ensure batch-to-batch consistency.

In the past, 3D printing has been most closely affiliated with medical devices in the context of customization, which is commonly referred to as patient-matching by regulatory bodies. However, even for devices where customization does not play a role, new 3D printing technologies are bringing unique benefits to medical devices that are not easily achievable through conventional manufacturing techniques.

MDB: As 3D printing is embraced by healthcare developers, where do you see the biggest impact of this technology?

NB: The biggest impact of 3D printing technologies for healthcare developers will be the ability to impart advanced microstructural and macrostructural properties into implantable medical devices.

From the lens of microstructural properties, our team in Desktop Health is developing a materials technology called AlignInk^TM, which can impart anisotropy into parts, allowing for cell elongation and extracellular matrix protein deposition to be guided by the print path. Additionally, a start-up company called Dimension Inx, based in Chicago, has recently received 510(k) clearance for their novel device, CMFlex^TM. Their team is using the 3D-Bioplotter to impart high-resolution microporosity into scaffolds for bone regeneration in maxillofacial, mandibular, and intraoral defects. Their product is a great example of how highly controlled microstructure can be imparted into materials to improve patient outcomes.

From the lens of macrostructural properties, 3D printing will enable new, complex designs and material combinations that cannot be easily manufactured by other methods. For example, the 3D-Bioplotter can enable up to five materials to be combined in a single print. This can include thermoplastic materials, hydrogels, support materials, and more by using different printhead combinations.

It’s often difficult to get interpenetrating geometries from different materials from conventional manufacturing techniques; however, 3D printing allows one to program a complex material composition inside of a part. Additionally, 3D printer substrates will become more complex to allow for the creation of new geometries. For example, the PrintRoll^TM system, which Desktop Health recently released for the 3D-Bioplotter, allows cylindrical devices to be easily created by printing on top of a rotating mandrel. We are excited to see what new innovations will “roll out” from this innovation for vascular, respiratory, and other channel-like tissue grafts.

MDB: How are new materials making 3D printing a more viable option for healthcare, particularly in bioprinting tissues?

NB: Materials are at the crux of functionality of all devices, whether they are manufactured by 3D printing or by conventional manufacturing methods. While direct 3D printing of cell-laden inks is of growing interest for the development of thick tissues and organs, there are many challenges related to high costs, cell sourcing/scaling, vascularization, and complex regulatory pathways that can limit the practicality of this approach. Improvements in these areas will make it more feasible, but it may be decades until we see entire bioprinted organs being successfully implanted into humans.

The human body has an innate ability to repair itself — often, it just needs guidance. Thus, for many tissues, including your eardrum, intelligently designed grafts can support and guide the ingrowth of native cells, leading to tissue regeneration as the graft material degrades. I expect to see an increase in natural and synthetic biomaterials that promote and encourage cells from the patient’s own body to infiltrate and to remodel grafts. In particular, biomaterials that encourage angiogenesis, or the formation of new blood vessels, into these grafts will become more common.

Researchers are also discovering that porosity plays a large role in the immune system’s response to foreign materials, and the ideal pore size for regeneration is often different for different tissues in the body. Thus, the ability to carefully tune porosity gradients makes 3D printing an ideal option for manufacturing tissue grafts.

MDB: What do you see as the biggest obstacle to integration of 3D printing into medtech?

One large obstacle to the integration of 3D printing into medtech is the industry’s inertia. Most companies have been manufacturing their products by the same methods for decades. It makes sense — regulatory pathways are long and expensive, and so it is often prohibitive to explore new manufacturing technologies for existing products. Additionally, the industry’s risk-averse nature means that most innovative R&D is done at startup companies and smaller companies rather than at large players. Most large medtech companies bring in new products by waiting until a product from one of these smaller companies has received regulatory approval and secured market adoption. Thus, unlocking funding and talent for small and mid-sized companies will be critical to advancing 3D printing’s role in medtech.

In the Desktop Health Biofabrication Innovation Office (DH-BIO), located in the Charlestown neighborhood of Boston, we are aiming to lower this barrier of entry for companies to pursue innovation in 3D printing. We have state-of-the-art facilities and equipment for material development, alongside three Manufacturer Series 3D-Bioplotters. Additionally, our interdisciplinary team has incredible industry-specific knowledge into what can make a 3D printed device successful. We are interested in partnering with companies of all sizes through joint development agreements to develop innovative medical devices, and we are looking forward to “moving the nozzle in healthcare” alongside our partners.

KEYNOTES: WHY ATTEND?

Gregory Fischer

It is important for a diverse set of stakeholders to be in regular contact with one another and see the latest and greatest ideas. As a whole, we should all be striving for bringing new advanced technologies that can truly help patient care to the market. Getting to interact with peers, see how they are approaching problems, and identify successful strategies will be a win-win for all of us in the medical device space, as well as the patients our devices will benefit.

Nicole Black

I feel it is important for the industry to attend this year’s BIOMEDevice conference as it’s a once-a-year opportunity to stay up to date on the latest innovations in the medtech field. I am always amazed by the incredible booths and talks from companies. Plus, for people who are not from Boston — it’s the greatest city in the universe! There is so much history and culture to explore while you’re here (and let me know if you want to stop by our DH-BIO office in Charlestown!)

Biotech Week Boston | September 18–21, 2023

Biotech Week Boston is a series of co-located events that each have their own scientific agendas. Attendees of these events come together during shared networking receptions to facilitate cross-event networking. In addition to BIOMEDevice, the following events will be taking place:

• Bioprocess International
• Cell & Gene Therapy Manufacturing & Commercialization
• Next Generation Protein Therapeutics Summit
• Compliance Congress for Specialty Products
• Independent Medical Education & Grants Summit
• Finance and Accounting for Bioscience Companies
• Next Generation RNA Modalities

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