Overview

In an economy where only smart decisions count, it pays to have an experienced professional help you succeed. Laughlin Engineering Firm, LLC offers seasoned professionals to help you with your medical device industry needs. Our consultants offer engineering, clinical and regulatory services. Our focus is on start-ups to mid-sized companies who need help getting their product to market, either in the US or internationally. We have expertise in a variety of areas including neuromodulation, cardiac rhythm management, orthopedics, drug delivery and surgical instruments.

Field Clinical Engineering

The clinical trial is arguably the most important step toward achieving FDA approval. A strong presence in the operating room is a must to ensure successful implants and quality data. Our field clinical engineering consultants have the technical acumen to understand your technology and how it interacts within a body. We have extensive experience working in the operating room and collaborating with surgeons. We will do our best to protect the integrity of the trial data and company interests in an ethical and professional manner. Skilled at acting as liaisons between R&D and clinicians, our field clinical engineers are adept at presenting the latest technical developments to clinicians as well as reporting important information including device performance and usage data to R&D. As market launch approaches, we can help you develop a field team and training materials. Our engineers keep focused on matters that will affect the commercial launch including implant techniques, patient feedback, and training requirements for surgeons, clinicians and sales professionals.

Clinical Trial Support

We offer full range of support to help you achieve your goal. As a clinical trial nears, we can help you design your protocol, interview investigators or assess your current strategy to see if you are addressing the key issues. We can help you tackle issues such as study center inventory, field staff requirements and study center staffing requirements. Laughlin Engineering Firm, LLC has the experience it takes to spot liabilities and the talent to see weak areas which need to be addressed. We have regulatory, clinical and engineering consultants to provide a well rounded approach. We also offer technical review services for medical device study protocols for institutional review boards.

Regulatory Submissions

Laughlin Engineering Firm, LLC, offers a wide range of regulatory solutions for our clients. We can develop and implement strategies for regulatory submissions including PMA, IDE, 510k and marketing approvals. We can aid in the design and review of contracts, warranty and product liability claims, and copyright and trademark filings. Compliance related services include handling product complaints, internal audits and facility inspections. Our consultants are also qualified to handle legal issues associated with product registrations, quality system registrations, FDA export clearance and distributor contracts. We have extensive experience dealing with the FDA and foreign regulatory bodies and have experience attending FDA panel reviews.

Human Factors Engineering

Minimizing risk, reducing error, and enhancing usability are all subjects of great concern for patient safety and to the FDA. Laughlin Engineering Firm, LLC can assist you with your human factors needs whether you are at the exploratory stage or in need of usability testing. We consider all modes of interaction with the device, whether it be patient or clinician. Our thorough approach will consider all foreseeable modes of failure and human error. Our consultants have applied human factors engineering to analyze device design and safety. We consider aspects such as the experience level of the end user - patient vs. clinician, the user environment - clinic vs. home, and user interface design - hardware vs. software. Failure is never an option, but it is always a possibility - allow us to help you minimize your risk by applying human factors principles to your product's design and recommended usage.

Product Development/Testing

Our engineering experts can help you design a product or develop a testing protocol for your product. When time is a factor and manpower is short, Laughlin Engineering Firm, LLC, can step in and help. We are experienced with quality testing and human factors engineering and are able to help at any stage of the project. We have experience with implantable devices, externally worn equipment, and surgical tools. We can also help you design and implement your pre-clinical testing. The consultants at Laughlin Engineering Firm, LLC have experience using animal and cadaveric models and are qualified to manage the experimentation.

Clinician and Sales Force Training

Communicating ideas is a strong suit of Laughlin Engineering Firm, LLC. We have experience relating complex concepts to a variety of different audiences, including surgeons, sales professionals and even juries. We have trained international sales teams abroad and have prepped surgeon investigators on the implant techniques used in clinical trials. Projects may include the development of visual training aids or the management of cadaver and animal training labs. Whatever your training needs, we have it covered.