Medical Design Briefs - September 2023 - 25

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.
Black's keynote will discuss the pathway that the AlignInk™
material and PhonoGraft®
device technology have followed -
starting from an academic lab setting, launching into a start-up
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
proto typing 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 builtin
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™, 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
Medical Design Briefs, September 2023
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!)
510(k) clearance for their novel device, CMFlex™. 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
Biotech Week Boston
September 18-21, 2023
Biotech Week Boston is a series of co-located events
where each has its own scientific agenda. 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
www.medicaldesignbriefs.com
25
http://www.medicaldesignbriefs.com
Medical Design Briefs - September 2023

Table of Contents for the Digital Edition of Medical Design Briefs - September 2023
