Getting paid is the hard part | The Lattice Brief (8/30/26):

August 30, 2026 | 0 Comments

This week: why clearing the FDA is not the same as getting paid for a 3D-printed stent, a world-first metamaterial bone prosthesis out of Madrid, fresh bioprinting and bone-repair research, and 3DHEALS’s Biomaterials Frontier event on September 10.

The big thing

A better 3D-printed stent is the easy part. Getting paid is the hard part.

New York University’s newest stent, BRIDGE, is a good device. It is 3D-printed and biodegradable, built to drain gastric leaks after weight-loss surgery. Its lattice drains about twice as much, bends far tighter without kinking, then dissolves with no removal endoscopy. So, if I am the patient, this is a better device. In US medical devices, being “better” is just the price of admission, not the payout. As our recent piece focusing on reimbursement puts it, better isn’t billable. Entrepreneurs beware.

Start with who gets paid. Medicare pays for the procedure, not the stent. A better bundled supply inherits the price of the thing it replaces. Endoscopic leak drainage doesn’t even have a billing code that fits, with cases falling back on a pseudocyst code or an “unlisted” one. A 3D-printed stent adds “nothing extra” just for being better. Furthermore, a stent that dissolves removes the retrieval endoscopy that a doctor currently bills. So, the first buyers are integrated, bundled-payment systems that keep the savings, and not fee-for-service proceduralists. Healthcare economics in America is complicated. A regular mental exercise on reimbursement early in a device’s life cycle could protect innovators and investors from future heartaches. Similar evaluation will be equally important to a device’s viability in other global markets, depending on the target patient population. With a trend toward point-of-care 3D printing in healthcare systems, in-house production of small batches of innovative devices could be economically viable. Read our case study on this and let us know what you think.

One hero of this story we did not talk much about is the biodegradable feature of this drainage stent. The combination of 3D printing design plus a stereolithography-printable biodegradable resin made the stent a differentiated device with a defensible “moat.” However, this moat also carries the most risk. Acidity, degradation profile, mechanical properties, softness versus hardness, immunogenicity, and thrombogenicity are all intricately related to the materials science within a new device. The industry learned that the hard way with Abbott’s Absorb bioresorbable coronary stent, which was withdrawn in 2017 after safety signals. Granted, something in the heart carries higher risk than in the gut. Ultimately though, what earns payment and what earns trust are the same thing: good outcomes across real patients.

That said, we will highlight the exciting advancements made in 3D printable biomaterials in 3DHEALS’s next virtual event, Biomaterials Frontier, on September 10. This world-class panel covers topics not just on bioabsorbable materials and relevant applications (like breast implants for lumpectomy), but also metamaterials for orthopedic implants, human collagen produced in bioreactors for bioprinting, ML/AI for new biomaterial development, and more.

Biomaterials Frontier - 3DHEALS virtual event, September 10. Register on Zoom.

Regulatory watch

No new FDA 510(k) clearances for additive-manufactured devices this week.

Clinical & research

Also this week

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Better Isn’t Billable: How a New (3D-Printed) Medical Device Actually Gets Reimbursed

August 30, 2026 | 0 Comments

A biodegradable, 3D-printed pigtail stent for gastric leaks can be a valuable teaching tool for medical 3D-printed device entrepreneurs. This mental exercise with a recent novel design shows the reimbursement logic every device team should learn before they fall too deep in love with their own inventions. Medical device reimbursement in the United States often rewards factors other than clinical performance. A recent preprint makes the gap easy to see. It describes BRIDGE, a 3D-printed, biodegradable double-pigtail stent for draining gastric leaks after sleeve gastrectomy. The design is clever. Its lattice mid-section is built from a triply periodic minimal surface (TPMS). It bends around a radius that is roughly seven times tighter than that of a commercial biliary stent, without kinking. It drains about twice the fluid. And because it is printed from a biodegradable resin, it is designed to dissolve on its own rather than be removed during a second endoscopy.1

So it is better.

However, the question that decides whether it becomes a product is a different one. What gets paid, and to whom? In the United States, clinical superiority and payment are only loosely related. The space between them is where most device companies get their education. An endoscopic leak drain is a good place to learn the lesson. Here are some of the steps to reason it out.

What the procedure pays today

Start with the problem the device treats, because the money follows the problem. Gastric leak occurs in 1% to 3% of primary sleeve gastrectomies and as many as 10% of revisions. It is the complication surgeons fear most. It turns a routine bariatric case into weeks of drainage, repeat procedures, and sometimes an intensive-care stay. The mainstay treatment is endoscopic internal drainage with double-pigtail stents. It closes most leaks. And it does so with stents designed for the bile duct and pressed into service off-label because nothing better is available.1

Here is the first thing to absorb. Medicare pays the physician for the procedure, not for the stent.

And the procedure it covers depends on how the pigtail is placed. If an interventional radiologist places it through the skin into the collection, the claim is a percutaneous drainage code with its own predictable payment. If an endoscopist deploys it transluminally across the leak, the claim is coded as an upper-GI endoscopy code. That is the route BRIDGE is built for, and the coding gets murkier. The closest listed option, 43240, is written for draining a pseudocyst.2 A post-surgical leak is not a pseudocyst. So many of these cases land on 43499, the “unlisted” upper-GI code a payer reviews and prices by hand.3 That invites delay and denial.

Either way, the stent itself is a supply. Its cost is buried inside the facility payment for the procedure. That is an outpatient APC. Or, for the septic inpatients, most of these are DRGs. A percutaneous drain runs a hospital somewhere between $28 and $55 apiece.6 A fancier printed device might cost more to make. But the hospital’s payment does not move to cover it. Build a better version of a bundled supply, and it inherits the price of the thing it replaced.

(See Glossary section for all abbreviations.)

What actually changes the payment

If a superior device does not automatically earn more, what does? Three things, from the flimsiest to the most durable.

The first is a temporary top-up.

Medicare will pay a little extra for a while. Outpatient, this comes through pass-through. Inpatient, it comes through the New Technology Add-on Payment (NTAP). The price of entry is the same for both. The device has to be new. It has to be expensive enough that the existing bundle can’t absorb it. And the hard part is that it has to be a substantial clinical improvement over what’s already in use.4 There is a gate hidden inside the word “new.” CMS also asks whether the device is already adequately described by an existing payment category. This is where a genuinely new design earns its keep. A better plastic pigtail looks like every other pigtail and gets waved into the bundle, but a device that dissolves in the body is harder to call the same thing you already pay for. Even after clearing the bar, the money is just temporary. Pass-through runs up to three years. Then the device drops back into the bundle.5

The second is a dedicated device code. A new CPT code is the more durable move. But it follows a new service, not a better instrument. That is the quiet opportunity here. Endoscopic internal drainage of a leak has no code that actually fits it. That is why the field is stuck between a pseudocyst analogy and an unlisted code. A device built specifically for the procedure gives the device maker something to hang a Category III code on. That is the emerging-technology tier. It records that the procedure is happening. With utilization and outcomes data behind it, that code can grow into a paying Category I code. The process is slow, measured in years. Like it or not, it will help the competitors too. It is the only lever that fixes billing for the whole field rather than renting a payment for one product.

The third isn’t a billing lever. For a device like this, it is often the one that matters most. A leak admission is expensive and long. Under a fixed DRG, the hospital swallows every extra day and every repeat scope. A device that empties the cavity faster, keeps the patient off a second or third procedure, or shortens the septic stay puts real money back in the hospital’s pocket. No code change required, but value is added. This lever sells on a spreadsheet the hospital keeps.

Which features carry weight

Sorting BRIDGE’s advantages against the clinical-improvement test is a useful exercise, but it doesn’t weigh them equally.

Biodegradability can be a strong one. Today, a patient undergoes roughly three endoscopies over about eight weeks. A stent designed to dissolve in six to eight weeks eliminates the need for a retrieval trip entirely.1 “One fewer procedure per patient” is a true improvement, and it is easy to measure.

That said, there is a potential wrinkle to the economics. The retrieval the new device deletes is a procedure the endoscopist currently bills. Innovation improves the system’s economics, partly by reducing a provider’s revenue. That is exactly why early adopters will be integrated systems and bundled-payment programs, not fee-for-service proceduralists. (Remember what Charlie Munger’s theory behind “incentives” is.) Less migration comes next. Every stent that stays put is a retrieval, and a failed-drainage rescue that the hospital doesn’t have to do. Better flow and easier placement are real but soft. “Easier for the endoscopist” isn’t something Medicare rewards unless it results in a shorter procedure or fewer complications that can be easily measured.

There is a catch a reviewer will find first and can sink the thesis. Once a device can’t be removed, its degradation timing is its safety profile. Dissolve too early, and it fails while the leak is still open. Linger too long, and it becomes the source of granulation, obstruction, or a fragment that drifts somewhere you can no longer reach it. So the elegant “no removal” story and the “less migration” story have to be proven together. The evidence that carries weight is the degradation curve’s reliability. Not just its average, but how much it varies across real patients. That is where the clinical dollars go. It is also where a printed polymer either earns trust or loses it. The industry has learned expensive lessons on resorbable stents very recently. 8

The 3D printing angle

The 3D printing that enables the lattice and patient-specific fit does not qualify for a reimbursement category. Nobody pays more because a device was printed. What changes with 3D printing is the regulatory road. A biodegradable, architected, possibly patient-matched implant probably won’t slide through on a 510(k) predicate. It is more likely to face a de novo or PMA review. That costs time and money. And, awkwardly, it also strengthens the payment case. Devices that clear the more rigorous regulatory pathways have historically fared better when they request a separate payment from CMS. The higher bar and the better lane turn out to be the same door.

Conclusion

For a device like this, here are some potential strategies to think about. Sell to hospitals on avoided cost now, while collecting the migration, reintervention, and length-of-stay numbers. Take those numbers into a pass-through or add-on application next. Aim at a moving target. CMS has proposed requiring even breakthrough-designated devices to demonstrate substantial clinical improvement again, starting with 2028 applications.7. Finally, go earn a real code. It is the only step that changes billing for good rather than borrowing it.

The lesson under all of it: better is the price of admission, not the final payout. In US device reimbursement, the money follows evidence of a difference a patient and a payer can both feel.

Which lever is your particular improvement actually pulling?

This piece is an educational illustration of US reimbursement concepts for new medical devices, not legal, coding, or reimbursement advice. Codes, rates, and CMS policies change; confirm current figures against primary CMS sources before relying on them.

Glossary

  • 510(k) FDA clearance route for a device shown to be substantially equivalent to an existing (predicate) device. The fastest, lowest-burden pathway.
  • Additive manufacturing / 3D printing: Building a part layer by layer. Enables lattice geometries and patient-specific shapes that extrusion can’t produce.
  • APC (Ambulatory Payment Classification): The bundled unit Medicare uses to pay hospitals for outpatient procedures. Devices used are packaged into it.
  • Bundled supply: A device whose cost sits inside a broader procedure payment instead of being reimbursed on its own.
  • Category I / Category III CPT codes: Category I codes are established procedure codes with set payments. Category III codes are temporary for emerging services that track usage before potentially becoming Category I.
  • CMS (Centers for Medicare & Medicaid Services): The federal agency that sets Medicare payment rules and rates.
  • CPT (Current Procedural Terminology): The AMA code set that identifies procedures for billing. The code, not the device, usually drives payment.
  • De novo FDA: pathway for novel low-to-moderate-risk devices with no predicate, creating a new device classification.
  • DPS (double-pigtail stent): A drainage stent with curled ends that anchor it. Used off-label for endoscopic internal drainage of leaks.
  • DRG (Diagnosis-Related Group): The bundled unit for an inpatient stay. The hospital receives a fixed amount regardless of individual supply costs.
  • EGD (esophagogastroduodenoscopy): Upper-GI endoscopy. The procedure family under which transluminal leak drainage is coded.
  • EID (endoscopic internal drainage): Placing a pigtail across a leak so one end sits in the cavity and the other in the GI lumen, draining internally.
  • FDA (Food and Drug Administration): The agency that authorizes devices for marketing. Clearance is separate from payment.
  • HCPCS Level II (C-code): Codes that can identify a specific device for tracking or pass-through. They do not by themselves add payment.
  • NTAP (New Technology Add-on Payment): A temporary inpatient add-on above the DRG for qualifying new technologies.
  • Pass-through (Transitional Pass-Through, TPT): A temporary outpatient add-on (up to three years) for qualifying new devices before they are folded into the APC.
  • PMA (Premarket Approval): The most rigorous FDA pathway for high-risk devices. Requires clinical evidence of safety and effectiveness.
  • SCI (substantial clinical improvement): The CMS test asking whether a technology meaningfully improves diagnosis or treatment over existing options. The gate for add-on payments.
  • TPMS (triply periodic minimal surface): A class of mathematically defined lattice geometries (for example, the Gyroid) used here to tune a stent’s flexibility and flow.

References

  1. Phowarasoontorn P, Ko Y, Makhambetova Z, et al. Biodegradable Architected Stents for Endoscopic Internal Drainage. bioRxiv; posted May 12, 2026. doi:10.64898/2026.05.08.723751. Preprint. Not peer reviewed.
  2. American Society for Gastrointestinal Endoscopy / American Medical Association. CPT code 43240: Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed). ASGE EGD Coding Sheet. asge.org
  3. American Gastroenterological Association. Coding Corner (Clinical Gastroenterology and Hepatology): where no specific CPT code exists for an endoscopic procedure, report the unlisted code 43499 and verify coverage with the carrier in advance. cghjournal.org
  4. Centers for Medicare & Medicaid Services. New Medical Services and New Technologies (NTAP eligibility: new, costly, and a substantial clinical improvement over existing technologies). cms.gov
  5. Gettysburg Healthcare Consulting. Medicare Transitional Pass-Through Payment (criteria; up to three-year duration before bundling). policypros.net
  6. IndexBox. Percutaneous Drainage Catheters Price in the United States, Market Insights (2026). indexbox.io
  7. Kelly S. CMS proposes repeal of add-on payment path for breakthrough devices. Healthcare Dive / MedTech Dive; April 17, 2026. healthcaredive.com
  8. https://www.tctmd.com/news/fda-warns-risk-major-adverse-cardiac-events-absorb-bvs

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Event Recap: New Approach Methodologies (NAMs)

August 26, 2026 | 0 Comments

In our recent 3DHEALS event, we dug deep into the world of New Approach Methodologies (NAMs), which describes any strategy for testing new medicines that replaces traditional animal testing. NAMs are particularly important to healthcare 3D printing enthusiasts, as they represent a burgeoning opportunity for bioprinted tissues and organ-on-a-chip platforms to reach close-term commercial success and dramatically change the regulatory landscape. The United States Food and Drug Administration’s shift away from animal testing in favor of more ethical and convincing alternatives is opening doors for innovators, but it is certainly not without its challenges. What exactly is a NAM? Will it actually lead to reduced costs and safer outcomes? Or will the allure of new technologies fool us into believing false promises? In this recap article, we’ll highlight the latest in NAMs from our event’s five expert industry panelists.

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What are New Approach Methodologies (NAMs)?

New Approach Methodologies (NAMs) broadly encompass organ-on-a-chip devices, bioprinted cells/tissues, and computational simulations (notably, artificial intelligence) to test the safety of new therapeutics. While one of the main motivators is to reduce animal testing for ethical reasons, there is strong interest in identifying NAMs that better model human responses to novel medications. After all, a mouse isn’t a human, and it certainly isn’t easy (nor cheap) to raise mice.

Dr. Mike Clements, Senior Vice President for Scientific Partnerships and Strategy at Axion BioSystems, described how this regulatory shift increases flexibility in how evidence can be acquired but that the scientific bar hasn’t changed: the new test still needs to be relevant, reproducible, and appropriate. While such a change sounds nice in principle, it opens up a plethora of complications. Flexibility begets variability and ambiguity, which is quite the opposite of what we would want in a pre-clinical test.

Dr. Clements stressed the importance of standardization as one way to advance NAMs. For studies involving human-derived induced pluripotent stem cells (iPSCs), standardization means identifying the key environmental variables that influence downstream results, such as cell culture temperature and density, and then defining practical acceptance criteria to ensure these variables don’t compromise the integrity of the test. By taking such steps to increase reproducibility, we are on our path to seeing new cell culture-based NAMs become a regulatory standard.

Unfortunately, NAMs aren’t going to make things easier any time soon; rather, it’s only the beginning of a new host of challenges. Standardization isn’t cheap: dedicated professionals will still have to run or supervise a number of quality control tests to ensure that these novel models work as intended. And while we don’t need highly complex models that capture everything about the human body, we risk settling on models that unintentionally oversimplify certain biological conditions due to technological or knowledge limitations.

Where do NAMs create value?

Graham Craig, Chief Commercial Officer at VoxCell, explained that the value of NAMs lies in their ability to answer human-relevant questions earlier in the drug development process, rather than waiting for clinical trials to reveal critical safety results. By tackling such questions earlier, companies may be able to discover safe and effective drugs faster and at lower cost.

Craig described how there are four decision categories where NAMs can provide improvements: (1) target engagement, (2) functional efficacy, (3) liability identification, and (4) exposure and tissue interaction. In other words, NAMs can provide new insights into whether the drug binds in a human-relevant context, its downstream biological effects, potential side effects, and its ability to localize to the target tissue site. These decision categories enable us to pinpoint the problem the NAM seeks to address and evaluate whether it is well suited to that purpose, rather than chasing the unrealistic goal of crafting a broad NAM that captures everything about human biology.

While NAMs are well-positioned to bring about improved insights in these decision categories, at the end of the day, they are still just models, representations of reality with limitations governed by our assumptions. For example, artificial intelligence (AI) and other computational NAMs (in silico models) can enable rapid drug testing through simulations trained on real-world data. However, such improvements cannot come to fruition if these computational models are fraught with biases from the data collection process, or if these AI models are constructed as black boxes without any way to explain their predictions.

NAMs present an exciting opportunity, but we must still be mindful to acknowledge and address their limitations. An understanding of how such limitations affect our conclusions and how they might help us design further tests to address those limitations is just as important as the results themselves.

What are current examples of NAMs?

FluidForm Bio is using its FRESH bioprinting technique to create remarkable tissue constructs for use as NAMs. Dr. Andrew Lee, the company’s Co-Founder and Senior Scientist, shared how their cardiac drug discovery platform involves using human cells and extracellular matrix, creating a computational design of the tissue architecture, performing robotic biofabrication of human tissue, and finally measuring the 3D tissue.

By using bioprinting, they are able to create a variety of tissue shapes, including rings, strips, bands, and 3D ventricular structures, that are capable of beating like the heart. As a result, they are able to measure the spatial, not just temporal, behavior of the tissues. In one use case, they can induce arrhythmia in their bioprinted tissues and show a restoration of normal function using a typical lidocaine treatment. They can also structurally mimic cardiac disease states by computationally designing and fabricating fibrotic tissue.

Another interesting avenue for NAMs is tissue-on-a-chip devices. Alexandre Civiere, Sales and Business Manager at REVIVO BioSystems, showed us the company’s microfluidics platform, which consists of skin tissue and collagen made from human primary cells. This tissue is then placed inside an automated, programmable microfluidic device that continuously pumps a liquid in contact with it. By having this continuous flow, they can collect biomarkers released by the tissue over time for longitudinal studies.

Civiere explained that they can also create a wound in the epidermis and measure changes in the pro-inflammatory marker interleukin-6 (IL-6) over time, with IL-6 expected to decrease as the wound closes. Interestingly, they measure tissue permeability using caffeine to assess recovery of the skin’s barrier properties, since caffeine permeability should decrease as the skin regrows. Ultimately, one could use this model to test the behavior of different drugs in a reproducible, high-throughput setting.

While NAMs might be seen as just another umbrella term to describe recent advancements in tissue models, they are actually an important reminder that regulatory and reproducibility considerations must occur early in the design process. Technologies such as bioprinting may enable companies to create highly customized, engineered solutions for clients, but companies interested in influencing the NAMs field must understand how these bespoke choices would fare in a regulatory context. And the innovators who are currently thinking about NAMs have the potential to greatly impact the future of drug development: as Civiere mentioned, they’re effectively contributing to the creation of a new standard when the standard doesn’t already exist.

Where is the future of NAMs heading?

Dr. Pranav Joshi, Senior Scientist at Bioprinting Laboratories Inc., shared that customers told them the real burden was in the preparation process. Addressing this operational burden would help transform models from promising organoids to assay-ready NAMs. To achieve this, quality control and automation can make NAMs more efficient and less error-prone. In particular, Dr. Joshi says that quality control needs to be distributed throughout the organoid lifecycle, with each QC gate having predefined acceptance criteria and clear corrective action.

The future of NAMs, therefore, lies in streamlining, automating, and validating rigorous quality control processes for novel assays. Integrating these considerations into a product has far-reaching benefits by pushing the industry towards greater standardization and reproducibility, increasing assay reliability for customers, and actively shaping the future of regulation.

Join us for future events

As we have seen from our five expert panelists, the NAMs’ perspective is essential when thinking about the latest advancements in bioprinting, organ-on-a-chip, and AI technologies. NAMs call to our attention the need for fit-for-purpose models, as well as the need for a thorough consideration of a new assay’s complexity, limitations, biases, and cost. If we aren’t careful, these issues will overshadow the benefits that cutting-edge innovations promise. We invite you to continue exploring new perspectives in healthcare 3D printing with us by subscribing to the 3DHEALS newsletter and our YouTube channel. To watch the full event you can also check out our on-demand archive here.

@3dheals

Organ Chip Workflows_ Overcoming the Biggest Caveats Moderator Dr. Lowry Curley challenges speakers on why NAMs have not entered into #pharma workflow more routinely for #drugdiscovery #CiPA #FDA #iPSC #Toxicity Check out our latest event recap with video highlights: https://3dheals.com/event-recap-new-approach-methodologies-nams/ Full event on demand: https://3dheals.com/courses/new-approach-methodologies-from-theory-to-validation/ #NewApproachMethodologies #DrugDiscovery

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About the Author:

Peter Hsu

Peter Hsu

Peter Hsu is an editorial intern for 3DHEALS.  He is currently an undergraduate at the University of Illinois Urbana-Champaign and studies bioengineering with a focus on cell and tissue engineering.  He is also minoring in computer science with interests in artificial intelligence and image processing.  Peter conducts research on using computer vision methods to analyze human tissue images and improve the robustness of machine learning workflows.  He is interested in the use of AI to assist tissue engineering and bioprinting research for medical applications.  He is passionate about science communication and leads STEM outreach lessons at schools in the central Illinois area.

Related Links:

Event Recap: Advancing 3D Surgical Planning

Communicating Your Science in the Bioprinting Space

Event Recap: 3D-Printed Devices In Orthopedics

Event Recap: Microfluidic Devices and 3D Printing

Expert Corner: AI in Healthcare 3D Printing: The Future is Now

Microfluidic Devices and 3D Printing (On Demand, 2025)

Event Recap: 3D Printed Pharmaceuticals

TPMS

Is the Artificial Lung an Architecture Problem? | The Lattice Brief

August 23, 2026 | 0 Comments

This week, the theme is function. The field is quietly shifting from printing shapes to printing behavior, letting geometry and materials, not just the device, do the medical work. Our big thing makes the case at its most literal: a 3D-printed lattice that could reinvent the artificial lung by treating architecture as the active ingredient. The same logic runs through the rest of the issue: bioprinted tissue that grows its own blood supply, an FDA-cleared denture resin winning on toughness rather than novelty, $30 patient-shaped MRI coils, and open-source prosthetics built to reach the people standard devices miss. We close in orbit with a podcast on why microgravity makes tissue easier to build, featuring CSO of the International Space Station, Dr. Michael Roberts, and an event on where biomaterials go next.

The big thing

The artificial lung may be an architecture problem

TPMS
A gyroid triply periodic minimal surface (TPMS) — the class of continuous, math-defined lattice the study 3D-prints as the artificial lung’s gas-exchange membrane.

I would not call ECMO “artificial lung” just as I would not call dialysis “artificial kidney”. That said, ECMO is the closest thing we have: a machine that oxygenates blood in place of the lungs, but only for a while. For half a century, the artificial lung has been a bundle of hollow fibers: pack thousands of gas-permeable straws into a housing, push blood past them, and let oxygen diffuse in. It works well enough that ECMO keeps the sickest patients alive, and well enough that the ECMO machine market still runs almost entirely on hollow-fiber oxygenators. The total market is roughly $0.65 billion in 2025 and is projected to reach ~$0.86 billion by 2030. “Well enough” is the tell. Blood threads unevenly through a fiber bundle, pooling in dead zones where it clots. This means that patients would need continuous anticoagulation, which makes them bleed. Additionally, the device stays outside the body as a bridge rather than a destination. A German-Dutch team led by Hannover Medical School’s Bettina Wiegmann recently proposed in the August issue of Advanced Materials that a 3D-printed gas-exchange membrane with a triply periodic minimal surface (TPMS) could solve the problems posed by hollow fibers and advance our ambition of an artificial lung. TPMS is a continuous, mathematically defined lattice that dictates where blood flows, how thin the diffusion barrier is, and where clots can’t gather. In simulation, optimized designs moved on average up to ~88% more oxygen than conventional fiber bundles, with smoother flow and fewer stagnation zones. That said, while architecture is the central theme in this paper, the researchers also included additional design elements, from printable silicone elastomers that can be made into membranes thin enough to breathe; a living endothelial lining made the membrane less thrombogenic; and an ambitious CT-derived geometry hints at a lung shaped to fit one patient’s chest.

The holy grail here is an implantable lung for the many and increasing number of end-stage patients who will never receive a donor organ. However, if the architecture is the active ingredient, then the incumbents’ fiber-winding lines look more like a legacy asset than a moat. History suggests the architecture is the easy part. ALung Technologies spent 25 years and north of $100 million turning a University of Pittsburgh lab device into the Hemolung Respiratory Assist System — FDA De Novo clearance in late 2021, acquired by LivaNova roughly six months later, and still a niche CO2-removal box rather than a lung. Draper has been building biomimetic microfluidic oxygenators since 2010 on NIH and Army money and reached clinical-scale flow in 2023 at 750 mL/min, the highest reported for a microfluidic device — elegant physics, no product. United Therapeutics and 3D Systems, partners since 2017, printed a lung scaffold of 44 trillion voxels that demonstrated gas exchange in animals in 2022 and predicted human trials “in under five years”; that window has quietly closed. OptiLung, a Texas-based early-stage startup, is commercializing a single-part, single-material 3D-printed oxygenator with a branching manifold that routes blood through vasculature-like channels and eliminates stagnant zones where hollow fibers clot. However, while the geometry is solved on the bench, questions about biocompatibility, efficacy, scalability, reimbursement, and more remain to be answered. Caveats abound here too: the results of this paper are in silico, early-stage, and no patient has been near it. Nonetheless, this is a paper worth reading and thoughts worth contemplating. Sources: Pflaum et al., “From Fiber Bundles to Architected Membranes,” Advanced Materials (2026), doi.org/10.1002/adma.74361.

Regulatory watch

Clinical & research

Also this week

From 3DHEALS

Podcast: Bioengineering in microgravity, with Dr. Michael Roberts (ISS National Lab) — Episode 123 of The Lattice Podcast: the ISS National Laboratory’s chief scientist on why removing gravity removes the scaffold problem that makes thick, vascularized tissue so hard to bioprint on Earth – from Redwire’s BioFabrication Facility to Auxilium’s orbital nerve-repair implants.

Event (Sep 10): Biomaterials Frontier — A 3DHEALS webinar on the defining shift of 2026 – from printing structure to printing function – convening researchers, founders and industry leaders across soft function-first bioresins, ion-releasing ceramics and bioactive glass, and titanium and titanium-tantalum lattices. Register to attend.

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Episode 123: Bioengineering in Microgravity with Dr. Micheal Roberts ISS/CASIS

August 23, 2026 | 0 Comments

For 25 years, humans have continuously manned the International Space Station. Today that same microgravity environment is becoming a laboratory for building human tissue, studying disease, and manufacturing biological products that can be impossible to make on Earth. Dr. Micheal Roberts, Chief Scientific Officer of the International Space Station National Laboratory, explains how on Earth, gravity forces bioprinted tissue to collapse before it can support itself. In microgravity that constraint disappears and biological structures hold their shape with no scaffold at all. This single physical fact has turned the ISS into the proving ground for manufacturing thick, vascularized human tissue. He traces the arc from space-grown protein crystals to Redwire’s BioFabrication Facility and Auxilium Biotechnologies’ nerve-repair implants, which printed eight devices in roughly two hours in orbit. With astronauts supporting 200 to 400 experiments during a typical six-month mission and the ISS approaching its planned end around 2030, Dr. Micheal Roberts makes the case for a new generation of commercial platforms that could turn low Earth orbit into a biomanufacturing hub. Now is the moment.

⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

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About Our Guest:

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Dr. Michael Roberts is the Chief Scientific Officer of the International Space Station National Laboratory and Vice President at the Center for the Advancement of Science in Space (CASIS). Before joining CASIS in 2013, Michael worked as a microbial ecologist, principal investigator, and research group lead at the Kennedy Space Center. Prior to arriving at NASA-KSC in 1999, Michael completed an undergraduate degree in biology at Maryville College, a doctorate in microbiology at Wesleyan University and post- doctoral research at the Center for Microbial Ecology at Michigan State University. Lowry holds a PhD in biomedical engineering from Tulane University, sits on the 3Rs Collaborative and FNIH Validation and Qualification Network, and has authored 6 patents, 20+ publications, and 100+ scientific presentations.

Key Topics

A microbiologist’s unexpected journey from Kennedy Space Center to the ISS National Laboratory

Why 25 years of continuous human presence in space have made this the right moment for biomanufacturing

Protein crystallization and the origins of biological manufacturing in space

The scaffold problem and microgravity’s unique advantages for 3D tissue printing

Engineering bioprinters for space, from heat dissipation to fluid separation and microfluidics

Redwire’s BioFabrication Facility, Auxilium’s DLP technology, and the move beyond extrusion

What happens to cells, organoids, and tissues when gravity is removed

How microgravity can accelerate models of aging, cancer, and disease progression

NASA’s  vascular tissue challenge and the race to create thick, functional, vascularized tissue

Wake Forest’s liver and kidney bioprinting work and new collaborations emerging from space research

The partnerships bringing together NASA, academia, startups, pharma, and government

Life after 2030 and the transition from the ISS to commercial space platforms

Varda, Starfall, and falling launch costs are reshaping access to low Earth orbit

The potential of space-based research for aging, cancer, longevity, and regenerative medicine

The biggest barriers to space biomanufacturing, including cost, logistics, regulation, and quality control

Orbital Edge, startup funding, and opportunities for the next generation of space entrepreneurs

Timestamps:

0:00 Welcome And Guest Introduction

3:51 From Microbes To Managing ISS Science

6:14 Why Space Biomanufacturing Now

9:55 Protein Crystals And Better Drug Design

15:35 Why Bioprinting Changes In Microgravity

24:24 Engineering Printers For Space Reality

27:59 Organoids And 3D Cell Culture Gains

35:25 Vascularization Challenge And Thick Tissues

39:45 Partnerships That Make The Ecosystem Work

46:06 Post ISS Platforms And Lower Launch Costs

49:34 Biggest Blockers Cost Logistics Regulation

54:35 Orbital Edge And Advice For Builders

56:40 Closing Thanks And Disclaimer

Resources

🔗 Contact Dr. Michael Roberts

🔗 Space Biomanufacturing, Research & Companies

🔗 Learn More About 3D Bioprinting from 3DHEALS!

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Interview with Graham Craig: Vascularized 3D Tissue Model

August 15, 2026 | 0 Comments
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Graham Craig is Chief Commercial Officer at VoxCell, a Canadian biotechnology company developing high-resolution, vascularized 3D tissue models as New Approach Methodologies (NAMs) for drug development. He leads VoxCell’s commercial strategy, global business development, and strategic partnerships, working to put more human-relevant preclinical models into the hands of pharmaceutical companies, CROs, and research institutions, so teams can generate decision-enabling data earlier and reduce reliance on traditional animal testing.

Graham brings more than 18 years of experience in commercialization and strategic partnerships across the pharmaceutical and biotech sectors. Before joining VoxCell he was Director of Corporate Development at AbCellera and held senior roles at STEMCELL Technologies. Earlier in his career he spent seven years as a commercial strategy consultant at IQVIA, advising pharmaceutical companies across Europe, Asia, and North America.

When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?

Graham: Like a lot of people, my first brush with 3D printing was seeing it as a neat gadget that my friend had. Watching his printer build a plastic F1 car layer by layer and thinking it was pretty clever. The moment that actually stuck with me came much later, when I first saw a bioprinter at work at VoxCell. Instead of plastic, it was polymerizing bioink, building a piece of tissue with an actual vascular network running through it. That reframed the whole thing for me. This was a way to recreate human biology outside the body, and I immediately started thinking about how that could help preclinical drug development.

What inspired you to start your journey/company/career/research in 3D printing (bio-fabrication/bio-printing)?

Graham: My professional background is commercial rather than at the bench. I’ve spent close to two decades helping pharma and biotech companies bring science to market, at IQVIA, STEMCELL Technologies and AbCellera. Through that period I saw two persistent and frustrating patterns: the struggle with building confidence that a preclinical drug might work in humans, and the subsequent “leap of faith” into clinical trials that often ended in failure. When I came across high-resolution bioprinting and the broader New Approach Methodologies movement, it was the first time I saw a credible, commercially viable path to generating human-relevant data early, before hundreds of millions of dollars and years of work are already on the line. Joining VoxCell was a chance to help move that from a promising idea into something the industry actually adopts.

Who inspired you the most along this journey in 3D printing (bio-printing/bio-fabrication)? This can be a mentor, a patient, a celebrity, anyone basically. You can name more than one as well.

Graham: Two people stand out. Dr. Karolina Valente, VoxCell’s founder and CEO, is my biggest influence on the bioprinting side, she built Canada’s first high-resolution 3D bioprinter and has been relentless about solving the vascularization problem many in the field thought was too hard. The other is Dr. Vassilis Lefkaditis, a decision science expert who mentored me early in my career and taught me the value of structure and data in decision-making processes –  a discipline that has had a tremendous impact on my career and shaped how I think about problems and opportunities commercially.

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What motivates you the most for your work? 

Graham: Two things, really. The first is impact on patients; if human-relevant models can help even a handful of good drugs survive to approval that would otherwise have failed, or spare patients from therapies that were never going to work, that’s enormously motivating. The second is the commercial challenge itself. I’m energized by the work of shifting an entire, understandably conservative industry toward a new way of generating evidence. Changing how an industry makes decisions is hard, and I find that genuinely exciting.

What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions? 

Graham: The biggest obstacle on the commercial side isn’t the technology,  it’s inertia. Drug development workflows, regulatory expectations and decades of institutional habit are all built around animal models and it’s a complicated network of internal stakeholders within each player. Even when a human-relevant model is clearly better, buyers reasonably ask whether it’s validated, reproducible and defensible to a regulator. Our answer has been to compete on evidence: generate rigorous, comparative validation data, lean into the growing regulatory momentum behind NAMs  (the FDA Modernization Act 2.0 is a good example) and build partnerships, like our collaboration with adMare BioInnovations, that let partners test the models against real programs and de-risk adoption for the rest of the market.

What do you think is (are) the biggest challenge(s) in 3D Printing/bio-printing? What do you think the potential solution(s) is (are)?

Graham: I am biased of course, but for bioprinting specifically, vascularization is still the central technical challenge. Without a functioning network of vessels you can’t keep complex tissue alive long enough for a meaningful experimental window, and you miss the very structure a drug needs to navigate in order to reach its target. That’s exactly the problem VoxCell was built to solve. Beyond that, the field has to crack reproducibility and standardization, so a model printed today matches one printed next month, possibly in in another lab, along with the throughput needed for routine industrial use. And the whole space needs regulators to keep formalizing how these models are qualified and accepted. The solutions are underway on all three fronts: higher-resolution printing of vascular structures, standardized protocols, and regulatory frameworks that are finally catching up to the science.

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If you are granted three wishes by a higher being, what would they be? 

Graham: I’m going to assume world peace, lottery numbers in advance and the ability to fly are all off the table. So, more realistically, given this is an industry interview: health and time with the people I love; the big industry players finally taking their own “leap of faith” with NAMs; and animal testing becoming the exception rather than the norm.

What advice would you give to a smart driven college student in the “real world”? What bad advices you heard should they ignore? 

Graham: Get comfortable working at the edges between disciplines. Some of the most successful people I’ve worked with aren’t the deepest specialists, they’re the ones who can weave between the science and the market, or between the lab and the clinic, and translate. Build real relationships, stay curious outside your lane, and protect your optionality early rather than over-committing to a rigid plan. The advice I’d ignore is the pressure to map out a long-term career path and get married to “where you see yourself in five years’ time”. The most interesting opportunities I’ve had weren’t on any plan I could have written at 22, they came from being prepared and saying yes when something unexpected showed up. Seek good advisors and pay it forward later.

What’s your favorite book you read this year and why? Alternatively, what’s your favorite book of all times you read and why?

Graham: Earlier this year I read An Elegant Defense by Matt Richtel, which tells the science of the immune system through four real patients’ stories. It takes something as intricate as immunology and makes it gripping and human. It resonated professionally as well, much of modern drug development now centres on immuno-based therapies, which we’ve been testing using the models we build at VoxCell. We’re very excited to show the pain points we can address for translational teams working on such novel therapies.

Episode #98 | Meeting the Bioprinting Vascular Challenge: VoxCell CEO Dr. Karolina Valente

Episode 122: New Approach Methodologies (NAMs) with Dr. Lowry Curley


Event Recap: The 3D Bioprinting Frontier


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The Lattice Brief: 3D Printing Materials, NAMs & Dental M&A

August 14, 2026 | 0 Comments

The Lattice Brief is 3DHEALS’ weekly intelligence roundup on healthcare 3D printing, bioprinting, biomaterials, and dental additive manufacturing. This week (August 14, 2026): ultra-tough and programmable 3D-printing materials from EPFL and Oak Ridge, an AI-guided new approach methodology (NAM) screening glioblastoma drugs in 3D-bioprinted tumor models, sub-10-micron bioprinted capillaries, Graphy’s takeover of dental-imaging maker Ray, and healthcare leading additive manufacturing’s latest earnings — plus upcoming 3DHEALS events on NAMs and biomaterials.

The big thing

Methods

A printed brain-tumor (GBM) model and an AI algorithm just did an animal study’s job

At the University of Southern California, a team paired a positive-unlabeled machine-learning model with a magnetic-field-guided 3D bioprinting platform to screen ultrasound-activated drugs in physiologically realistic glioblastoma (GBM) spheroids. GBM is one of the most deadly and devastating brain tumors, with no cure and high morbidity. (John McCain, Ted Kennedy, who suffered this terminal disease.) This New Approach Methodology (NAM) surfaced two already-approved drugs: carboplatin and memantine, that outperformed standard-of-care temozolomide under low-intensity pulsed ultrasound (PLOS ONE).

The result worth noting isn’t the two drug hits; it’s the workflow. A printed human-tissue model plus a computational screen did the kind of triage that has historically meant animal studies. This workflow is faster, cheaper, and in a system built from human cells rather than a mouse standing in for one. That is the practical shape of the FDA Modernization Act’s push toward human-relevant preclinical models. That said, caveats apply. This is one disease model, one organ system, one lab, one screen; sonodynamic therapy is early, and “beat temozolomide in a spheroid” is a long way from a clinical endpoint. If you are a skeptic of NAMs, you are not alone. A recent Economist article astutely pointed out that we might never completely abandon animal models. NAMs still face the validation and regulatory-acceptance questions that separate a promising in vitro result from a decision regulator will actually rely on. This is precisely the conversation 3DHEALS is hosting Next Thursday on August 20, New Approach Methodologies: From Theory to Validation. The more curious minds can also check out our recent podcast with Dr. Lowry Curley on this topic.

3DHEALS event - New Approach Methodologies: From Theory to Validation, Aug 20, 2026

Materials

The most interesting thing in medical 3D printing right now is the material

For a decade, medical 3D printing mostly sold geometry. This week, albeit quiet, is filled with material focused news. At the research frontier, the printed object is learning to do more than hold a shape. EPFL’s double-network granular elastomers are 3D-printable rubbers with up to 15x the fracture toughness and 3x the fatigue resistance of comparable elastomers (Science Advances), durability that matters for anything meant to flex inside the body for years. A Pusan National University–Oak Ridge team printed a smectic liquid-crystal-elastomer ink whose molecular alignment switches mid-print, so a single filament can be programmed to elongate or contract on heating (Nature Communications). Toughness and actuation, decided at the slicer.

At the other end, call it commoditization, 3D printing materials are crossing from novelty into standardized, qualified systems. Axtra3D and Keystone’s KeyPrint brand put KeySplint Hard Clear, a biocompatible resin, onto the Lumia X1. The unglamorous, biocompatibility-qualified material work now reaches chairs and clinics. And Sinto Advanced Ceramics Europe cleared an ISO 9001:2015 audit with zero non-conformities (3D Printing Industry), the quality bar that lets technical ceramics enter regulated sectors including medical technology. Even the deal-making is organizing around materials. Graphy, a shape-memory-alloy clear-aligner-material maker in South Korea, is taking control of dental device company Ray to push its aligner materials across Ray’s roughly 70-country installed base (BigGo Finance). The materials company is buying the hardware, not the reverse. While the dollar amount is small compared to its U.S. counterpart, interested readers may appreciate the corporate drama on display. Put together, it is the biomaterials thesis in miniature: from printing structure to printing function, and from lab novelty toward regulator-legible material systems. The Chemists rule the world! Stay tuned for the highly anticipated 3DHEALS September 10, Biomaterials Frontier event, where we aim to update our audience where biomaterial innovations are.

3DHEALS event - Biomaterials Frontier, Sep 10, 2026

Regulatory watch

  • No new additive-device 510(k) clearances this week — A quiet week at the FDA for AM devices; the regulatory signal was upstream (below). No DARPA or ARPA-H 3D-printing activity either.
  • PharmaTher establishes PERSONALIZ3D — A personalized-medicine platform pairing telehealth prescribing with a pharmacy-based pharmaceutical-3D-printing network for compounded medications, framed against recent FDA advisory-committee peptide recommendations. Pre-commercial, but a clear regulatory-tailwind bet.

Clinical & research

Also this week

From 3DHEALS

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Lattice Brief: FDA Clears First 3D-Printed Implant Made at the Point of Care

August 8, 2026 | 0 Comments

This week in healthcare 3D printing and 3D technologies: the FDA cleared the first 3D-printed implant made at a point-of-care institution, as Walter Reed’s 3D Medical Applications Center and 3D Systems turned a hospital into a cleared device manufacturer. Plus peer-reviewed bioprinting advances in vascularized bone and a breast-cancer tumor model, a patient-specific PEKK chest-wall reconstruction, catheter and pharmaceutical 3D printing of personalized peptides, and the latest on New Approach Methodologies (NAMs) and dental 3D printing from The Lattice podcast.

The big thing

The hospital becomes the manufacturer

On July 28, 3D Systems announced that Walter Reed National Military Medical Center’s 3D Medical Applications Center (3D MAC), working with the Defense Health Agency, had won FDA premarket clearance for its Titanium Cranial Plate (TCP) System. The implants would be used to treat U.S. active-duty personnel and fighters suffering from traumatic head injuries worldwide. This would be the first FDA-cleared implant ever granted to a point-of-care institution. This is also the first time a hospital crossing the line from care provider to cleared device manufacturer, inside its own walls.

That line has been blurry for years. The FDA regulates the manufacturing process and its output, not the printer; its 2021 discussion paper sketched models for producing devices at the point of care but left the framework famously unsettled. A cleared implant from a hospital-run lab would be the first hard data point on what “compliant” looks like in practice.

The commercial signal is there. Point-of-care is becoming a business. The same week, 3DPrint.com reported Ricoh selling its FDA-cleared, point-of-care patient-specific device unit to a management buyer who rebranded it Myrava (stay tuned for our upcoming podcast with Myrava soon). This serves as evidence that the segment is worth owning as a standalone company. In Europe, a Madrid public hospital became a certified device manufacturer under EU rules. What’s more interesting is the fact that vendors like 3D Systems that can carry a hospital from concept to clearance are also selling regulatory capability as much as printers.

Clinically, the case for in-house patient-specific implants is maturing. According to PubMed, a 2026 University of Basel study with 3D Systems showed point-of-care printing of functionalized PEEK cranio-maxillofacial implants within clinically acceptable accuracy. The promise is faster, better-fitting reconstructions for the patient in front of you.

Overall, this is an encouraging piece of news to all in medical 3D printing. However, whether it opens the floodgates or stays a well-resourced military exception is the question worth watching.

Regulatory watch

Clinical & research

Also this week

From 3DHEALS

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Lowry Curley

Episode 122: New Approach Methodologies (NAMs) with Dr. Lowry Curley

August 8, 2026 | 0 Comments

Not long ago, growing a human brain in a lab was science fiction. Today, brain organoids can test drugs, model neurological diseases, and even play Pac-Man! 89% of drugs manufactured through animal testing fail. That number rises to 94% in neurology, but still, animal testing has remained the industry default for over a century. Lowry Curley, PhD, founder of Luna LifeSci and founder and former CEO of 28bio (formerly AxoSim), argues that the FDA is now at an inflection point where lab-grown human mini-brains and organ-on-a-chip systems stop being a niche and become the way drugs are cleared. Curley built the neural microphysiological system platform that nearly every top-25 pharma company adopted, licensing brain-organoid intellectual property from Johns Hopkins and acquiring StemoniX’s microBrain technology in a 2023 all-cash deal. He explains what New Approach Methodologies (NAMs) are, why the FDA’s April 2025 roadmap and March 2026 draft guidance changed pharma’s posture, and why the open question for investors is who consolidates the space. 


⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

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About Our Guest:

lowry curley

Lowry Curley is a scientist-entrepreneur and developer of foundational neural microphysiological systems (MPS) technology that became the core platform of the first company he founded, AxoSim, which is now 28bio. He took AxoSim from a Tulane University spinout to a venture-backed company that counted nearly every top 25 global pharma company as a customer, translating early-stage neuroscience research into a validated, human-relevant platform for neurological drug discovery. As founder and CEO, he built a product pipeline on IP licensed from Johns Hopkins, UC San Diego, and Tulane, and led two acquisitions to expand the platform. He now runs Luna LifeSci, helping pharmaceutical and biotech companies adopt New Approach Methodologies (NAMs) in their preclinical programs and advising life science founders across commercialization and fundraising.

Lowry holds a PhD in biomedical engineering from Tulane University, sits on the 3Rs Collaborative and FNIH Validation and Qualification Network, and has authored 6 patents, 20+ publications, and 100+ scientific presentations.

Key Topics

Why nearly 90% of drugs and 94% of neurological therapies fail despite successful animal testing

Dr. Curley’s journey from academic biomedical engineering to founding AxoSim and Luna LifeSci

The science behind organoids, organ-on-a-chip systems, and human microphysiological systems (MPS)

How New Approach Methodologies (NAMs) are changing the future of preclinical drug development

Why the FDA’s recent guidance is accelerating the adoption of human-relevant testing technologies

How brain organoids are helping researchers model disease and predict drug responses

The challenge of translating promising academic technologies into scalable commercial platforms

How licensing university intellectual property fueled the growth of AxoSim’s technology platform

Why pharmaceutical companies are investing in predictive human tissue models over traditional animal studies

The acquisition of StemoniX and the evolution of the microBrain platform

How advances in tissue engineering are bringing human biology closer to the laboratory bench

The role of AI, automation, and advanced imaging in the next generation of drug discovery

Why commercialization, validation, and industry adoption remain the biggest hurdles for emerging life science technologies

Dr. Curley’s vision for a future where human tissue models reduce reliance on animal testing and improve clinical success rates

Timestamps:

00:00:00 – Welcome And Guest Background
00:01:14 – What NAMs Actually Mean
00:02:56 – Why Animal Models Fail Humans
00:06:24 – A Seizure That Changed Everything
00:10:32 – Funding A Platform With Proof
00:11:36 – Licensing And Acquiring To Scale
00:13:55 – Explaining Organoids To Skeptics
00:16:32 – Electrophysiology Readouts That Matter
00:20:04 – How A Brain Organoid Learns
00:22:02 – Organoid Intelligence And Ethical Lines
00:24:23 – FDA Pathways And ISTAND Momentum
00:32:56 – Startup Playbook For Faster Adoption
00:34:25 – Data Sharing And The Devil’s Case
00:43:21 – Luna LifeSci And Founder Focus
00:46:06 – Milestones To Watch Next
00:48:36 – How To Reach Dr. Curley
00:49:14 – Disclaimer

Resources

🔗 Contact Dr. Lowry Curley

🔗 Technologies & Research Discussed

🔗 Learn More About Organoids from 3DHEALS!