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Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

Efficiency in orthopaedic product development and regulatory approval depends partly upon a well-conceived plan for testing and evaluation of the device. The elements of the test plan are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for product performance and safety.

Charting the Plan

Regulatory approval in the form of a 510(k) clearance or premarket approval letter is the last step to commercial realization for an orthopaedic device. The plan for device testing must at minimum include FDA requirements for performance and safety testing. Generally speaking, tests required by FDA will also satisfy requirements for CE Mark and regulatory approvals in Canada, Australia and most other countries. The test plan begins with identifying FDA’s regulatory classification and product code for the device, which is done on FDA’s website for medical devices (www.FDA.gov/MedicalDevices/). This first search will yield a list of predicate devices, standardized test methods, applicable FDA guidance documents (including those associated with safety such as validation-test requirements for cleaning of reusable instruments), sterilization of products, shipping and handling and shelf life.

 

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Special Section: 
Testing

Methods to Determine
Sample Sizes

The complexity of the test plan is elucidated from the consensus standards and FDA guidance documents associated with a given device. By example, the elements of a test plan are straightforward for an FDA Class II, code HWC compression bone screw manufactured from ASTM F136 (Ti-6Al-4V alloy) with design conforming to ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws) and from publicly available product literature on sizes and lengths of predicate devices.

By second example, for a Class III device requiring a human clinical trial, the elements of a test plan would be complex and costly for a new ceramic material used in the manufacture of hard-on-hard hip articulation components. In this case, several FDA guidance documents and International Standards Organization (ISO) and American Society for Testing and Materials (ASTM) consensus standards apply, with costs easily exceeding $100,000 and four to six months of time for pre-clinical testing exclusively related to the hard-on-hard components of the hip system. In this same FDA website query, the requirement for human clinical trial would become evident, and the time and cost of a prospective RCT clinical study with 200 or more patients with two years follow-up would be identified as the “elephant in the room” component of the product development plan. FDA premarket approval (PMA) documents are publicly accessible on FDA’s website. Prior PMA documents regarding ceramic-on-ceramic hip devices would yield a comprehensive outline of the pre-clinical and clinical work required for PMA approval.  

The second step in developing the test plan is to research the scientific literature and company websites for publications and white papers that provide test methods, data and interpretation of data that applies to your product. This is especially important for testing methods that have not been “standardized” by ISO and ASTM.The third step in drafting the test plan is engaging the external and internal testing labs for estimated time and costs. For large companies, these resources are often part of product development or research departments, and test methods and protocols either recalled from prior work or created based on experience. For early-stage companies, external laboratories and universities are often the only option for obtaining test data required for regulatory documentation, and also can produce drafts of test protocols for inclusion into your test plan. These external resources characteristically have a wide range in cost and time that scales with increasing cost.

By examples, the cost of a data set for the static bending strength of a trauma plate may vary by 25% to 50% (and a few hundred dollars), while the cost of a large animal functional model for a new biomaterial may vary by as much as 200% (a few hundred thousand dollars) and the cost of a human clinical trial by 250% (into the millions of dollars).Therefore, substantial these resources are often part of product development or research departments, and test methods and protocols either recalled from prior work or created based on experience.

For early-stage companies, external laboratories and universities are often the only option for obtaining test data required for regulatory documentation, and also can produce drafts of test protocols for inclusion into your test plan. These external resources characteristically have a wide range in cost and time that scales with increasing cost. By examples, the cost of a data set for the static bending strength of a trauma plate may vary by 25% to 50% (and a few hundred dollars), while the cost of a large animal functional model for a new biomaterial may vary by as much as 200% (a few hundred thousand dollars) and the cost of a human clinical trial by 250% (into the millions of dollars).Therefore, substantial dollars can be saved by “shopping around.”

Read more: Tools for New Product Testing

At this point, the draft test plan should be in hand, consisting of outline protocols for each test, estimated cost, number of test samples/devices and time to perform the test. This may be in the form of a short paragraph or a three- to five-page protocol synopsis for an animal study. For novel devices with no clear predicate device, complex devices such as hip, knee, shoulder or spine arthroplasty systems and devices with one or more new biomaterials, it’s essential to engage FDA with a pre-submission (pre-sub) for 510(k) or PMA. The FDA pre-sub process begins with submission of a document to FDA summarizing the device description, indications for use, specific tests to establish substantial equivalence for 510(k) clearance or PMA and specific questions of FDA regarding the completeness of the test plan. Approximately two to three months later, FDA will provide detailed, written responses to your questions and often will include additional advice and guidance regarding test plans. After receiving FDA feedback, a conference call or face-to-face meeting may follow for clarification of information provided by FDA; no new information can be introduced at this stage of the pre-sub process.

Tips of the Trade

In summary, to minimize risk of increased costs and time delays to product commercialization:

  • The regulatory path and required tests should be determined BEFORE commissioning a product development project. The time- and cost-intensive parts of the test plan should be identified and fed into the business plan, which then drives the decision to develop the product (or not). 
  • When in doubt, ask FDA. If the test plan associated with the device is “complex,” an FDA pre-sub is recommended. FDA feedback de-risks the time and cost of the test plan. It is impossible to define FDA current thinking, as product knowledge is continually evolving with experience (MDRs), data from prior regulatory submissions and scientific publications. 
  • Make the most out of regulatorily-required testing by including performance measures and tests that show marketable superiority to competitive devices.
  • Scour literature and websites for competitive product data that supports your regulatory testing. FDA often accepts published predicate device data.
  • When engaging external entities for test services, obtain a minimum of two to three quotations for a given test. Regardless of type or complexity of work, there is a large range in costs and time to deliver services across all elements of the test plan.


Robert A. Poggie, Ph.D., is President of BioVera. His previous employers and functions include Smith & Nephew, Implex, Zimmer and Pipeline Orthopaedics, with responsibilities in applied research, biomaterials, clinical research, medical education and regulatory affairs. He can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

Image courtesy of Orthopaedic Innovation Centre

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