Expert advice. Specialized testing.

Preclinical Medical Device Development & Solutions

Give your device a healthy start.

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comprehensive preclinical device, combination product and medical material testing

Six State-of-the-art OR suites across two accredited bi-coastal facilities

40+ years of expertise focused solely on preclinical testing

Embarking on a journey to design the next medical device breakthrough brings new considerations in the preclinical stage of development, such as: 

  • Are the materials being considered safe and biologically compatible? 
  • Does my implantable device work as intended & can you train physicians/field teams on how to use the device?
  • What is the make-up of the device’s materials & is it safe?
Craft the optimal preclinical strategy by collaborating with our medical device development specialists. Then access the preclinical resources necessary to make your initial development stage easier.

"whether you need to test a simple or complex device, combination product or medical materials, initiating a comprehensive testing plan or conducting a single, our medical device and solutions can help you prove out your device in its earliest stage of development:

Testing Capablities

Biocompatibility Testing

Proving your device is made of biologically compatible materials is a regulatory requirement of every device. Start with a solid plan that identifies the right biocompatibility testing for your specific device, and then move forward conducting your studies at one of our EN 45011, ISO 17025, GLP or GMP certified global laboratories that deliver high-quality scientific data and analytical support. Your customized testing roadmap ensures you get the data required to progress your device to the next stage of development, quickly and efficiently.

Access a full range of biocompatibility testing in the following critical categories:

  • Biological Evaluation Plans and Risk Assessments (ISO 10993-1)
  • Genotoxicity, Carcinogenicity and Reproductive Toxicity (ISO 10993-3)
  • Hemocompatibility (ISO 10993-4 and ASTM)
  • Cytotoxicity (ISO 10993-5)
  • Implantation (ISO 10993-6)
  • Sensitization (ISO 10993-10)
  • Systemic Toxicity (ISO 10993-11)
  • Chemical Characterization and Allowable Limits (ISO 10993-17 + 18)
  • Irritation (ISO 10993-23)
  • Bacterial Endotoxins LAL (USP <85>)
  • Biological Reactivity Tests, In Vitro (Cytotoxicity) (USP <87>)
  • Biological Reactivity Tests, In Vivo (Class Test) (USP <88>) 
  • Pyrogen Test (ISO 10993-11/Rabbit Pyrogen) (USP <151> )
  • Plastic Packaging Systems  & Materials of Construction (USP <661>)

Experimental study solutions

Sometimes you need more information to optimize your product concept to get to your final prototype. Gain valuable insight with an early surgical test using a built-for-purpose operating room (OR). An experimental study will provide you with a better understanding of how you can enhance your design or develop your concept further.  

Collaboration for the right model

Determining the appropriate model best suited to your study needs doesn’t have to be a challenge. Collaborate with our team to evaluate and develop animal model systems or select appropriate human anatomic models for various device types, including:

  • Cardiovascular
  • Dental
  • Drug delivery
  • Gastrointestinal
  • Neurologic
  • Ophthalmology
  • Orthopedic
  • Tissue engineering
  • Urogenital
  • Neurologic
  • Wound healing

GLP & non-GLP studies

Partner with our highly skilled veterinary team to choose the appropriate model and implement your study design under GLP or non-GLP standards, ensuring you get the information you need to progress your proof of concept. 

  • GLP: Conduct your GLP study under acute or chronic research protocols. Work closely with a program manager throughout the testing process, including protocol development and model selection, in-life phase, and authoring the final study report for regulatory submission. 
  • Non-GLP: Not every study requires the rigor of a GLP study. For exploratory research, non-GLP testing is an affordable approach to get quick decision-making insight to inform your early design. Your study is still performed under conditions similar to GLP and optional report and pathology are available upon request.  

Cadaver studies

Cadaver studies make it easier to assess the function of your device within the human body, potentially with more accuracy. Gain valuable experience visualizing your device in conjunction with the bones, muscles and organs that it ultimately will come into contact with in the living body. Full cadavers, partial cadavers and/or relevant tissues are available to support your study to exacting specifications, via approved vendors, while reducing the number of non-human models required for research.  

Surgical facilities, training and equipment

Six state-of-the-art surgical OR suites

Access six surgical OR suites that are fully equipped for your experimental surgery requirements. Start with guidance on selecting the right high-quality surgical models that meet exacting scientific and regulatory standards. Plus, enjoy full support, including model and OR preparation, necropsy and pathology support, surgery scrub, instrument preparation and laboratory tests, and even an engineering lab should your device require minor adjustments during testing. 

Imaging equipment

You have access to imaging equipment for documenting the placement and performance of your implanted device.

  • Cardiac catheterization lab
  • Fluoroscopy
  • General ultrasound 
  • ICE (intracardiac echocardiography)
  • IVUS (intravascular ultrasound) 
  • Laparoscopic towers
  • TEE (transesophageal ultrasound)
  • Transthoracic ultrasound

Education and training resources

Advance your sales team’s marketing efforts and investigator skills with hands-on clinical education to build knowledge or skills related to your medical device - using non-human and human anatomical models (tissue or cadavers).

With access to two bi-coastal facilities, four spacious surgical suites and a synergy of tools, providing your team with the best learning environment to achieve your training objectives is a whole lot easier. Your trainers can share techniques that provide your medical professionals with the level of expertise needed to ensure success.

Flexible learning space

Our educational facility site gives you access to an integrated training space that flexes to your curriculum. 

Start with an engaging didactic session, move into the OR for hands-on surgical training and end with a feedback or Q&A session. It’s all possible at one site for a full range of training programs:

  • Bioskills labs
  • Cadaver-based training
  • Clinical trainings
  • Clinical trial investigator training
  • Didactic training
  • Educational programs
  • Hands-on workshops
  • Nonclinical model-based training 
  • Product launches
  • R&D market surveys and product evaluations
  • Sponsor-designed, product-specific instructional courses
  • Surgeon-to-surgeon training
  • Symposia

Training options for larger groups

Train larger groups using state-of-the-art audio/visual equipment that provides multiple camera views and display options from each of the OR suites into onsite adjacent viewing rooms.

Conveniently located and filled with learning amenities

  • 15 Wiggins Dr Bedford, MA 01730
  • Located 15 minutes from the San Francisco International (SFO) airport
  • Six state-of-the-art surgical OR suites
  • Access to imaging equipment for viewing surgical results
  • Audio/visual capabilities for onsite viewing by larger groups
  • General surgical support team
  • Adjacent space for group learning sessions, networking and meal breaks
  • Catering support coordination

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