Developing a medical device involves much more than designing a product and determining whether it works. Medical device companies also need to understand how a device performs in realistic anatomical conditions, how surgeons interact with it, and whether the design meets the practical needs of the people who will ultimately use it.
That is where bioskills labs can become an important part of the product development process.
A hands-on session gives engineers, product developers, and physicians an opportunity to evaluate a device in an anatomical setting, identify potential challenges, and gather feedback that may not be possible through computer modeling or benchtop testing alone. Whether a company is evaluating an early prototype, refining an existing design, or preparing physicians to use a new device, a cadaver lab can provide valuable insight.
What Are Bioskills Labs?
A bioskills laboratory is a specialized facility designed to support hands-on medical education, training, research, and product development. Depending on the facility, sessions may involve physicians, surgeons, medical device engineers, researchers, and other healthcare professionals.
For medical device companies, bioskills labs can provide an environment for several different important parts of developing a quality device:
- Prototype evaluation
- Device testing
- Procedural simulation
- Surgeon feedback sessions
- Product demonstrations
- Physician training
- Design refinement
- Surgical technique development
Many sessions use human anatomical specimens to provide a realistic environment for evaluating how a device interacts with the body.
The goal is not simply to determine whether a product functions. It is to understand how it functions in practice.
Why Medical Device Companies Use Cadaver Labs to Test Products
A device can perform exactly as expected during engineering tests and still present challenges when introduced into a realistic anatomical environment.
Human anatomy has natural variation. Structures are positioned in three dimensions, tissues have different characteristics, and surgeons must work within the physical limitations of the body. A cadaver specimen allows medical device teams to evaluate these factors in a way that synthetic models or digital simulations may not fully replicate.
Hands-on testing can help answer questions such as:
- Can the device reach its intended anatomical target?
- Is there enough room to maneuver the device?
- Does the device interfere with surrounding anatomy?
- Can surgeons easily position and manipulate it?
- Does the device work as intended within the planned procedure?
- Are there design features that could be improved?
- Does the device introduce unexpected challenges during use?
These observations can give product development teams information they can use to refine a design before moving further through the development process.
Supporting Prototype Development
Early prototypes are designed to be tested and improved. A product that looks promising from an engineering perspective may reveal new considerations when a physician actually uses it.
A cadaver lab can provide an opportunity to evaluate a prototype before a company commits to a final design. Engineers can observe how physicians interact with the device and identify areas where the product could be modified.
For example, a surgeon might discover that a handle is difficult to manipulate from a particular position, that an instrument needs a different angle of approach, or that a component could be easier to access during a procedure.
These observations can be especially useful when engineers and physicians participate in the same session. Instead of relying solely on written feedback after the fact, the development team can see the challenge as it occurs and discuss potential solutions in real time.
Gathering Surgeon Feedback
Surgeon feedback is one of the most valuable components of hands-on medical device development.
Engineers understand how a device is designed and how its components are intended to function. Surgeons bring a different perspective based on their experience performing procedures and working with patients.
A bioskills session brings those perspectives together.
During a session, physicians can provide feedback on the device’s:
- Ergonomics
- Positioning
- Ease of use
- Size and shape
- Instrument access
- Procedural workflow
- Interaction with surrounding anatomy
- Overall usability
This type of feedback can help companies determine whether a product addresses the practical problems it was designed to solve.
It can also reveal opportunities that may not have been anticipated during the initial design process.
Evaluating a Device in Realistic Anatomy
One of the primary advantages of working with a real human cadaver is the opportunity to evaluate a device within realistic anatomical relationships.
A digital model may show where a structure is located, but hands-on testing can demonstrate what it is actually like to reach that structure with an instrument. Likewise, a benchtop model may demonstrate whether a component functions mechanically without revealing how surrounding anatomy affects its use.
Working with a cadaver can help teams evaluate the physical aspects of a procedure, including access, positioning, visualization, and instrument interaction.
This does not make cadaver testing a substitute for every other form of medical device testing. Instead, it adds another layer of information to the product development process.
Using Bioskills Labs for Product Demonstrations
Medical device companies can also rely on feedback from cadaver labs after a product has moved beyond the earliest stages of development.
Hands-on demonstrations can allow surgeons and other healthcare professionals to see how a device is intended to work within a procedural setting. This can be particularly useful when introducing a new device, surgical technique, or approach.
Rather than simply explaining how a product works through a presentation, a hands-on session allows participants to interact with the device and see its application firsthand.
These sessions may also help companies identify questions physicians have about the product and determine which aspects of its use may require additional training or explanation.
Supporting Physician Training
Medical device companies may need to train physicians before a new product is introduced more broadly. A bioskills laboratory can provide a controlled environment where physicians can become familiar with a device and practice its use.
Hands-on training can be particularly valuable for products that involve new techniques or require physicians to develop familiarity with specialized instruments.
Training in a controlled laboratory environment also gives participants an opportunity to ask questions, work through procedural steps, and become more comfortable with the device before using it in a clinical setting.
The specific goals and structure of a training session will depend on the product, procedure, participants, and applicable requirements.
Choosing the Right Bioskills Laboratory
Not every medical device development project has the same requirements. The right facility depends on the type of device being evaluated, the procedure involved, the number of participants, and the goals of the session.
When evaluating a bioskills laboratory, medical device companies may want to consider:
- Available anatomical specimens
- Facility size and layout
- Laboratory equipment
- Imaging and visualization capabilities
- Instrumentation and procedural equipment
- Technical and laboratory support
- Specimen preparation
- Safety procedures
- Number of participants the facility can accommodate
- Ability to customize the session
- Permanent or mobile laboratory options
A facility with experience supporting medical device companies can also help teams determine what resources will be needed before the session takes place. Good planning can make the difference between simply having access to a specimen and conducting a productive product evaluation.
When a Mobile Cadaver Lab Makes Sense
For some companies, bringing participants to a dedicated facility is not the most practical option. A mobile cadaver lab can provide greater flexibility by bringing laboratory capabilities to an appropriate location.
Mobile capabilities can be useful for companies that want to conduct hands-on training or product demonstrations closer to their headquarters, development teams, physician partners, or other participants.
A mobile setup may also be useful when a company needs to conduct sessions at multiple locations.
The exact capabilities of a mobile laboratory vary by provider, so companies should discuss their specific needs in advance. Factors such as specimen requirements, equipment, facility logistics, number of participants, and the procedures being performed can all affect what is needed for a successful mobile session.
Integrating Bioskills Testing Into Product Development
Bioskills testing works best as part of a broader product development strategy rather than as a replacement for other testing methods.
Medical device companies may use computer modeling, benchtop testing, engineering analysis, simulation, and other evaluation methods throughout development. Hands-on anatomical testing can complement these approaches by providing information about how a product behaves in a realistic physical environment.
The process may look something like this:
Design → Prototype → Hands-on evaluation → Surgeon feedback → Refinement → Additional testing
This iterative approach allows companies to identify potential issues and incorporate feedback as the product evolves. Involving physicians early can be particularly valuable because design changes are often easier to make before a product reaches later stages of development.
Making Product Development More Clinically Focused
Medical device development requires collaboration between people with different areas of expertise. Engineers understand the technical requirements of a product. Product teams understand the market and intended application. Physicians understand the realities of performing procedures and caring for patients.
Bioskills sessions create a setting where those perspectives can come together.
A well-planned session can give engineers an opportunity to watch physicians use a product, give physicians a chance to provide immediate feedback, and give the entire development team a clearer understanding of how the device fits into a real-world procedure.
Whether a company is evaluating an early prototype, gathering surgeon feedback, demonstrating a new device, or preparing physicians for its use, the right bioskills environment can make these sessions more productive.
For medical device professionals, bioskills labs offer a valuable bridge between product development and clinical application. By combining realistic anatomy, hands-on testing, and physician input, they can help companies identify opportunities for improvement and develop products with the needs of their end users in mind.