Solving Cold Chain Issues for
Drug‑Device Combination Products

Helping MedTech innovators ensure their combination products are up to the challenges in the cold chain.

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Cold Chain Challenges for Drug-Device
Combination Products

Medical device, diagnostic, and digital health innovators are reshaping healthcare. Technologies like AI, robotics, patient-monitoring wearables, drug-eluting stents, and many others are helping people live longer and healthier. But transporting these breakthrough medical technologies is a challenging proposition with complex regulatory requirements.

When your MedTech is a combination drug/biologic-device therapy, bridging existing data to a new NDA or BLA filing means demonstrating your therapy will meet rigorous cold chain requirements. Whether you’re a biopharma looking to add your therapy to a device (like an autoinjector for drug delivery) or a device manufacturer looking to include a therapy on your device (like a drug-eluting stent), you must demonstrate that the device functionality and drug efficacy, purity, and potency aren’t impacted in the transportation process.

How Modality Solutions Can Help

Modality Solutions’ transport validation studies and regulatory expertise help you meet rigorous FDA requirements for combination products and other innovative biomed devices. Our subject matter experts deliver everything you need to clear the hurdles and achieve a successful filing for your combination product or stand-alone medical technology.

  • Regulatory expertise with BLAs and NDAs. Combination products present issues that cross the regulatory and scientific boundaries of both centers. Modality Solutions works extensively with both, understands how they operate, and knows what they require.
  • Bridging strategies supported with transport simulation. When combining a device and a therapy, you need a scientifically sound and robust bridging strategy. Modality Solutions provides it — taking a risk-based approach that regulators will accept. We identify transportation risks and test them along the edges of the operating space in our one-of-a-kind transport simulation lab.
  • Engineering-based comparative analysis. We review existing studies and assessments, then identify whether the risk profile of the drug or biologic constituents could affect the risk profile of the combination product. This comparative analysis pinpoints any differences between the original drug and device and the proposed combination product that could impact the cold chain.

Case Studies

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ABBOTT VASCULAR CASE STUDY:

Addressing Temperature Excursions and Reducing Total Delivered Cost for an Innovative Combination Therapeutic

See how Modality Solutions identified temperature excursion reduction opportunities and minimized non-conformance rates for Abbott's Absorb stents.

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Why MedTech Innovators Partner with Us

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  • We provide specialized technical capabilities in medical device functionality and plunger movement / pre-filled syringes
  • We’ve helped obtain approval for or improved upon the cold chain post-approval for 20+ combination therapies.
  • We’ve worked with combination therapies of all types—including drug-eluting vascular scaffolds, pre-filled syringe medical and dental products, devices for repairing abdominalaortic aneurysms, granulocyte colony-stimulating factor (G-CSF) products, and many more.

Our Solutions for Drug‑Device
Combination Products

Regulatory Filing

Regulatory Filing

We help prepare you for a successful regulatory filing every step of the way—assessing your cold chain, drug stability, packaging, and third-party logistics qualifications; developing a validation master plan; conducting transport simulation testing; and preparing your team for the Common Technical Document (CTD) submission and pre-approval inspection.

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Transport Simulation

Transport Simulation

Whether you need turnkey support or you want to augment your in-house resources, our customizable Transport Simulation Solutions can deliver the robust data regulators expect during your drug’s review and approval. We assess transport risks, develop validation master plans, and rigorously test drug formulations and packaging for the five hazards that can occur in transport—concurrently and at the edges of the supply chain’s operating space—through our ISO-certified Advantage Transport Simulation Laboratory™.

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Engineering Consulting Solutions – Engineering Consulting

Engineering Consulting Solutions – Engineering Consulting

When you’re preparing for a new filing, responding to an Information Request, or looking to improve the supply chain for a commercial product, our Engineering Consulting Solutions are invaluable. Our cold chain subject matter experts draw on their extensive experience to help you overcome complex supply chain challenges, reduce risk, and meet regulatory requirements at every phase.

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Engineering Consulting Solutions – Thermal Packaging Testing

Engineering Consulting Solutions – Thermal Packaging Testing

Our subject matter experts have the unrivaled experience to help with thermal packaging design, development, and qualification—protecting biologics, pharmaceuticals, and medical devices from environmental hazards to ensure compliance, quality, and safety.

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Cold Chain Optimization

Cold Chain Optimization

We protect your finished drugs and materials, minimize your risks, and reduce your total delivered costs through our Cold Chain Optimization Solutions. These customized services include cold chain monitoring and control optimization, supplier agreement review/development, and a unique AI-driven shipper selection service that translates weather data into the inside temperature of a thermal shipper—enabling you to choose the container with the best cost/risk ratio.

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ASTM/ISTA Testing

ASTM/ISTA Testing

Modality Solutions can conduct rigorous, comprehensive testing of your therapeutic against a wide range of ASTM and ISTA standards at our independent Advantage Transport Simulation LaboratoryTM or a third-party lab—ranging from plunger movement studies to confirm sterility and efficacy, to drug-device functionality testing, and many other applications.

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Did You Know?

8.2%

The global market for drug-device combination products is forecast to grow at a compound annual growth rate of 8.2% through 2027.

77 M

The expanding geriatric population is expected to hit 77 million by 2034 in the US alone, spurring high demand for drug-device combination products.

Pervasive, chronic conditions like diabetes and cardiovascular disease will continue to drive demand for medical technology and BioMed devices.

Unique Capabilities We Can Put to Work For You

Cold Chain Engineering

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Transport Simulation Lab

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AI-Driven Cold Chain Optimization

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Emergency Response to Regulatory Inquiries

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What Our Clients Say

“Modality Solutions provided the expertise required to integrate our cold chain management systems.”

Todd Abraham, VP Operations, Endologix

“Their insight into the cold chain regulations was invaluable.”

-James Edwards, Supply Chain Manager, St. Renatus

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for your drug-device combination product?

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