Case Studies: Design & Validation Consulting for Medical Device Manufacturers
Case Study #1: Startup Device Firm
Case Study #2: Midcap Device Manufacturer
Case Study #3: Global Device Manufacturer
| Case Study #1: Startup Device Firm | |
Objective |
Get the product into clinical trials without having to wait for long term testing. |
Client Need |
A start up company submitting an IDE consulted with Alquest to obtain approval for clinical trials on a permanent implant device prior to performing any biocompatibility testing. It was critical for them to get into clinical trials to secure their next round of funding, and the timeline was not conducive to performing long term biocompatibility testing. |
| Objective | Get the product into clinical trials without having to wait for long term testing. |
Approach |
Alquest prepared a comprehensive biological safety evaluation plan and biological risk assessment for their materials, processes, and final device. This plan and report were submitted to the FDA with short term biocompatibilty testing. |
Outcome |
This approach enabled them to enter clinical trials without the delay of lengthy implant and chronic toxicity studies. At their pre-IDE meeting, the FDA was very responsive and granted approval to move forward. Additionally, the FDA was receptive of a biological safety plan that required minimal testing and substantially less money. Most importantly, by utilizing a comprehensive biological safety evaluation plan and risk assessment, this company was able to shave several months off of their timeline to enter clinical trials, and secure their next round of funding. |
Take Away |
All testing labs provide data but not all contract research organizations (CROs) are able to provide the technical and regulatory support when clients need to look at alternative means of addressing biological safety. This particular case allowed for a quicker entry to clinical trials, an important step in start up companies that follow the IDE regulatory path. A comprehensive plan and execution can be well received by regulatory agencies, and therefore allowing the product to move forward in the development cycle. |
| Case Study #2: Midcap Device Manufacturer | |
Client Need |
A medical device manufacturer of custom reconstructive implants for individuals with severe trauma requiring reconstructive surgery. This custom work requires rapid turnaround as the parts are built to order while the patient waits for surgery. The client needs to deliver this product rapidly, and delays are unacceptable to the marketplace. |
Objective |
Provide the client with guidance and justification to eliminate the need to perform bacterial endotoxin testing on every lot of product, thus getting the product to market much quicker. |
Approach |
Alquest worked with quality, engineering, and regulatory departments to both structure a study and craft a submission change. |
Outcome |
The submission was accepted and the customer was able to conduct testing on standard implants (when time was not as critical) and skip testing, thus saving a day on custom implants. |
Take Away |
All testing labs provide data but not all contract research organizations (CROs) are able to provide the consulting expertise needed to address time to market pressures, and how to accelerate product delivery. In the end, the company achieved its goals, impressed the end customer with quick delivery, and saved money on testing. |
| Case Study # 3: Global Device Manufacturer | |
Client Need |
A large multinational medical device manufacturer with annual sales exceeding 6 billion dollars was undergoing an up-classification of their devices in the EU. The notified body was asking for all biological safety gaps of all products to be identified and addressed. Numerous products could be detained from EU sales by this endeavor if lengthy testing was required. |
Objective |
Provide the client with guidance and reports addressing all gaps in biological safety. |
Approach |
Rather than attempting to address this issue by testing, the approach was to identify any and all gaps in biological safety effects, and work them through a risk assessment process as outlined in ISO 14971. Each material and variations of that material were identified, grouped as families, and researched by Alquest. |
Outcome |
All reports were completed within a few months time and delivered to the Notified Body to fulfill their request. |
Take Away |
All testing labs provide data but not all contract research organizations (CROs) are able to provide the consulting expertise needed to address biological safety through comprehensive testing. Not only would the testing to fulfill these gaps cost hundreds of thousands of dollars, but the time “off market” waiting for testing to be completed would have potentially cost them millions. |