Combination Product Safety and Efficacy Testing

Safety and efficacy testing for combination products.

What are Combination Devices?

“Combination devices” refers to the growing segment of medical products that are comprised of a combination of medical devices, pharmaceutical drugs, and/or biological agents. They can be integrated directly in one ‘single entity’ product, or consist of multiple related products packaged together as a ‘co-packaged’ combination device, intended for simultaneous or near-simultaneous use.

Combination products may take the form of:

  • a medical device enhanced by a chemical component (e.g. a drug-eluting stent)
  • a pharmaceutical product with a physical device delivery system (e.g. a measured dose inhaler)
  • a pharmaceutical enhanced by a biologic component (e.g. a monoclonal antibody combined with a therapeutic drug)
  • a vaccine vial co-packed with a sterile syringe
  • a surgical tray with various instruments, drapes, and antimicrobial agents

Approximately one-third of all medical products developed today are combination products. As these novel devices blur the lines between traditional medical devices, pharmaceuticals, and biologics, they require a unique approach for regulatory approval.

 

Combination Products Have a Unique Regulatory Approval Path

As technological advances merge product types and cross regulatory pathways, specific expertise in combination devices can help you win approval for your intended therapies. Successful testing of combination products requires expertise in the related but distinct disciplines of medical device testing, pharmaceutical testing, and biologic product testing.

The successful development of combination devices represents significant time, effort, and expense. Device failures negatively affect your reputation, your revenue, and most importantly, patient health. Consumers expect and deserve medical products that perform as expected, with minimal risk of adverse reactions. Are you completely confident that your combination product is safe and effective? Do you have concerns about successfully navigating the regulatory approval process?

Combination products are assigned a primary jurisdiction for regulatory approval based on the product’s primary method of action (PMOA). If the PMOA isn’t clear, sponsors may request that a designation be assigned based on predicate experience or expertise in testing.

To support the development of advanced medical devices, drug delivery systems, reusable medical devices, and combination products that include devices with pharmaceuticals or biologics, Toxikon offers a multidisciplinary approach to testing methodologies that mitigate risk while proving safety and efficacy.

 

Combination Device Testing from Concept to Final Product

It is important to partner with the right laboratory who will guide you from preclinical testing, through clinical trials, and ultimately to market. Customized preclinical testing helps ensure that your product will be reviewed by the correct authority and pass regulatory approval easily, reducing your time-to-market, maximizing your investment, and paving the way to successful commercialization.

With a strong foundation in toxicology, chemistry, and biocompatibility, Toxikon offers customized testing programs that have included:

  • combination device and drug product development
  • combination product evaluations
  • product classification determination
  • proof of concept studies
  • IND / NDA enabling studies
  • NCE characterization
  • synthesis and formulation studies
  • surgical efficacy studies
  • comprehensive biocompatibility analysis
  • sterilization support
  • reusable medical device cleaning validation

With over 40 years of preclinical medical device testing success, Toxikon can be your trusted partner to help you achieve your testing needs. We have the breadth and depth of knowledge and experience in medical device, pharmaceutical, and biologic testing to design custom testing programs that will efficiently and effectively position your medical products for regulatory clearance and timely launch.

 

Superior Quality and Accuracy

Toxikon is a preclinical contract research organization (CRO) accredited to ISO/IEC 17025 – an extensive set of standards confirming our competency as a testing laboratory. Our operations are governed by a rigorous quality management system, ensuring that you can trust the data we deliver in support of your products.

Additionally, we are registered with the United States Food and Drug Administration and the Japan Ministry of Health, Labor, and Welfare for drug and medical testing – and we have demonstrated success with working through these agencies to complete submissions and, when necessary, defend challenges.

 

Thought Leadership in Combination Product Testing

As the both the variety of and complexity of medical products increase, Toxikon is committed to staying at the forefront of testing by continually evaluating our study methods and research techniques.

Our distinguished scientific staff not only fully understand testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your combination device testing programs have access to the most current and effective methods available, executed under the supervision of industry-leading professionals. Our study directors understand the approval challenges that medical device developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.

 

State-of-the-Art Device Testing Facilities

Whether it’s raw materials, components, or finished devices, Toxikon has the staff, methodology, and facilities to ensure best-in-class safety and efficacy testing. With over 125,000 square feet of advanced research space, Toxikon testing facilities include:

comprehensive laboratories with top-tier analytical instruments

accredited vivarium facilities for large and small species

modern surgical suites with state-of-the-art monitoring, imaging and measurement systems

Toxikon’s facilities are registered with the United States Food and Drug Administration and United States Department of Agriculture, and are accredited by American Association for Accreditation of Laboratory Animal Care. We also comply with the NIH’s Public Health Service Policy on Human Care and Use of Laboratory Animals, holding an assurance allowing for the execution of federally-funded studies.

 

Customized Programs to Meet Unique Testing Needs

Toxikon offers a multidisciplinary approach to help you develop a customized risk assessment and testing methodology that proves safety and efficacy.

With our breadth and depth of knowledge and experience in all facets of biocompatibility, analytical chemistry, and microbiology, Toxikon is prepared to design custom testing programs that will efficiently and effectively position your advanced devices for regulatory clearance.

 

Combination Product Safety and Efficacy Testing
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To support the development of advanced medical devices, drug delivery systems, reusable medical devices, and combination products that include devices with pharmaceuticals or biologics, Toxikon offers a multidisciplinary approach to testing methodologies that mitigate risk while proving safety and efficacy.