In an economy where only smart decisions count, it pays to have an experienced professional in the operating room. If your company's success requires quality information from surgeons and clinicians, Mr. Laughlin has the experience to help. Acting as a liaison between R&D and the field, Mr. Laughlin can help facilitate the flow of useful information to help improve the next design spec or implant strategy. Mr. Laughlin has supported clinical trials involving a varied array of indications, device designs and implant methods/locations. He has trained surgeons and sales professionals using cadaveric and animal models. He has also performed implant testing and biomechanical studies involving cadaveric models. In addition to his technical skills, he has authored PMA submissions and has aided in protocol design. Mr. Laughlin takes a multi-disciplinary team-oriented approach when formulating opinions and contributions.

Laughlin Engineering Firm, LLC, provides professional consulting to class III medical device companies in all stages of development. At the pre-clinical stage, Mr. Laughlin can help your team develop testing strategies which produce useful results. Areas of study which are useful to device companies include implant techniques, device/tissue interactions, and human factors. Feasibility studies are often the last chance for meaningful device improvements prior to commercial launch. Mr. Laughlin’s ability to communicate with surgeons and interact with operating room staff allows him to effectively provide technical support and gather data to report to R&D. As the pivotal study approaches, Mr. Laughlin can help you assess your clinical engineering needs as well as help you develop a field team and select officers. As pivotal trial support, Mr. Laughlin keeps focused on matters that will affect the commercial launch including implant techniques, patient feedback, technical support requirements for sales staff and training requirements for surgeons, clinicians and sales staff. Mr. Laughlin can also aid in the development of study protocols and submissions to the FDA.

As a professional engineer, Mr. Laughlin has the technical acumen to understand your device and how it interacts within a body. He has a good rapport with surgeons and is very familiar with the operating room environment. He is not afraid to ask questions and is very tactful when providing technical support. He will do his best to protect the integrity of a trial and company interests in an ethical and professional manner. As a liaison between R&D and clinicians, Mr. Laughlin is adept at presenting the latest technical developments to clinicians as well as reporting important information including device performance and usage data to R&D. He is sensitive to the value of “soft-data” gleaned from feedback from patients and clinicians. This data is reported and quantified as best as possible.

When dealing with high-tech products, it is often a challenge to create audience specific training aids. Mr. Laughlin has experience bridging the divide between the scientific community and the rest of the world. He has a proven track record which runs the gamut from developing demonstrative evidence for presentation to jurors and tools for training surgeons and sales staff. Mr. Laughlin has written product manuals and is familiar with labeling requirements. He has even trained a European sales force on the implantation of a neuroprosthesis in a university laboratory in Budapest, Hungary. Whether your training needs involve in-service meetings, an animal or cadaver lab, or an experienced professional in the operating room, Laughlin Engineering Firm, LLC can help you meet your goals.

Implantable devices that Mr. Laughlin has studied or contributed to its development include devices that implant subcutaneously, laparoscopically,require tunneling, require dissection and use specialized implant tools. He has supported neuromodulation trials with indications in the areas of seizure control, bladder control, headache, pain management and bariatric surgery. His experience with such a wide range of indications and implant techniques gives him the versatility to understand many different device/patient interactions.

Mr. Laughlin has experience testing with cadaveric specimens. He has performed biomechanical experiments of orthopedic implants, kinematic testing of joints and anatomic tests of implant techniques. He can help you design and perform experiments or demonstrations using cadaveric or animal models.

Areas of Expertise

• Field Clinical Engineering
• Orthopedic Implants
• Neuromodulation Devices - Neuroprostheses
• Operating Room Engineering Support
• R&D Engineering: Clinical Feedback; Device Improvements; Tool Development
• Pre-clinical testing: Cadavers; Animals
• Implant Technique Development
• Authoring: Protocols, FDA Submissions, Product Manuals
• Training: Surgeons, Clinicians, Engineers, Sales Professionals
• Development of Training Aids
• Marketing: Promotional Materials; Clinician Interaction; Patient Feedback