Welcome to Clinical Proctoring Solutions, Inc.
Clinical Proctoring Solutions specializes in offering independent, unbiased clinical excellence in the areas of Product Training, Case Coverage, Subject Management, and Clinical Proctoring and Certification for the Medical Device industry.
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We service medical device companies in need of high caliber clinical precision required for medical device implant for FDA studies or commercial launch, as well as Contract Research Organizations (CRO’s) seeking to sub-contract Field Clinical expertise to service sponsor contracts in the aforementioned areas.
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As part of our standards we employ highly credentialed, seasoned Field Clinical Engineers, Clinical Specialists, and Physician Proctors dedicated to applying their passion and craft outside of a traditional territory sales setting. Utilizing contract talent allows you to fulfill clinical expertise needs while keeping your headcount lean during your critical early launch stage. Get what you need, when you need it, at a fraction of the cost of full-time talent.
Benefits of Independent Proctoring
The value of utilizing an independent company for Training, Case Coverage, and Clinical Proctoring and Certification cannot be overstated. Consider the following perspectives from the various stakeholders in a medical device venture:
The Patient
Investors
Implanting Practitioner
Surgery Hosting Facility
Let’s begin with the patient as they are the core reason a medical device company exists. As we have all been a patient at some point in our lives, we are familiar with the vulnerability of entrusting our health, and indeed our lives to medical professionals. Many of us can tell some amazing stories of excellent care, and unfortunately even some not so excellent. Patients deserve to know that they can trust a practitioner to do the best possible job on their surgery, implant, or procedure without any concerns of integrity of the medical device manufacturer or product, the practitioner, or the surgery facility.
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Use of an independent proctoring and certification company ensures that training, procedures, and techniques are being carried out in a detailed, prescribed manner that is void of pressure for a procedure to be “good enough.” This pressure can come when sales and clinical representatives employed by a company or sponsor are put in the potentially awkward position of being responsible for the quality of an implant while at the same time feeling pressure to consider an implant case to be good enough to certify the physician as competent, and move on toward generating commercial sales. The reassurance that an unbiased independent third party service brings to the equation can contribute to a positive experience for patients, something we all deserve and would desire for ourselves and loved ones.
High clinical standards bring peace of mind to early stage company investors. Their interests are protected when solid foundations are built through strong clinical safety and efficacy, among other areas of focus. Weakness in clinical excellence can threaten the very existence of a company. All too often, there is keen focus on clinical excellence in the clinical trial phase in an all-out effort to reach market, but pressure to produce revenue upon FDA approval can potentially create a conflict of interest if that high level of excellence is not maintained. As pressure for sales mounts, the push for revenue can obscure clinical excellence in the area of proctoring and certification if safeguards are not in place. If proctoring and certification becomes compromised, so can product safety, efficacy, and company reputation. This can quickly lead to a downward spiral for a fledgling startup medical device company.
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An independent proctoring and certification company helps insure that all interests are protected, and creates a degree of separation that allows a medical device company to focus on their commercial rollout, while we, as independent experts, maintain focus on integrous device training and implant. We get to be the face of the friendly but stringent certifier, while the company remains the friendly face of long-term relationship the healthcare provider will see for the duration of the commercialization process. This combination ensures success of the product, integrity of the certification, and longevity of commercial relations. This all translates into increased viability and long-term financial stability for the startup company, and added protection for investors.
Physicians and mid-levels that go through an independent proctoring and certification process can rest assured that they are being trained objectively on a solid foundation of clinical excellence, void of any potential bias or pressure to pass the process and progress to sales. This sets them and their practice up for success as they are trained and tested in implant procedures correctly from the start, in a neutral and unbiased learning atmosphere. This, in turn, will help them increase revenue and develop their practice by building a solid reputation for success with implanting that product. Solid and consistent implants will also help protect practitioners by mitigating the potential for litigation.
Surgery centers and other facilities that host medical device procedures can feel more secure knowing that the highest level of integrity is being employed in the training of practitioners, as successful implants can result in more positive patient outcomes, higher facility reviews, and lower risk of complications. Ultimately, this translates into safer, happier patients, which is a rudimentary goal of health care and foundational to stable revenue.
Our Services
As part of our vision, Clinical Proctoring Solutions, Inc. offers the following specialty services:
Subject Case Coverage
For companies conducting an FDA study, product and implant training is followed by case coverage. This means that each study subject implant case is attended by a Clinical Specialist, Field Clinical Engineer, or Peer (within the specialty of the device) Physician. This offers the implanting investigator the best technical advice from the manufacturer, as well as best practices on the procedure to the benefit of the patient and sponsor alike.
Product Training
When a company/sponsor reaches the implant phase of an FDA study, they will need to execute competent product and implant training for the investigators and their staff prior to commencing implants. This requires site visits to review and practice the procedure and protocols using models and other visual and practical aids, along with cadaver labs if appropriate.
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Companies that have progressed to commercial phase of operations will need to have similar product and implant training sessions on site, with proctoring and certification to follow.
Subject Management
Once a subject in a study has been implanted, they will need ongoing observation and management by a Clinical Specialist or Field Clinical Engineer through the duration of the trial period. Their progress will be carefully noted and documented per protocol, and surgical revisions or reprogramming of settings are conducted as needed. The CS or FCE will also act as a liaison between the sponsor and the site.
Clinical Proctoring and Certification
Upon commercializing, a company will need future implanting physicians to be trained and proctored on how to conduct the surgery, just as investigators are trained during the trial phase. We utilize Clinical Specialists, Field Clinical Engineers and Physician Proctors to accomplish training of the surgical procedure via implant models, visual and practical aids, and cadaver labs as needed.
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After completion of clinical training, each physician or mid-level (regulations allowing) may be proctored through a minimum number of cases to prove competency. After the required number of cases is successfully achieved, the physician is certified and able to continue to implant in a commercial setting without further observation from a proctor, though they may still be accompanied by a company representative for support on an ongoing basis.
Meet our Founder
Rob Manno
Founder and President Rob Manno has been employed as a Clinical Manager and Clinical Specialist in the Neuromodulation space of the Medical Device industry in both a commercial and clinical study role for the past thirteen years. Prior to entering into the Medical Device industry, Rob has been an accomplished entrepreneur with several successful exits, and an experienced public servant as a Paramedic, a sworn Air Rescue Deputy Medic with a Sheriff’s department, and a Firefighter. He has served in and dedicated his life work to healthcare for over 30 years.
Throughout his clinical and business career Rob has established a reputation for providing excellent service that entails clear communication, thorough preparedness and preplanning, technical proficiency, and a personable and professional demeanor in managing people and conducting business. He thrives in environments with a clear sense of purpose and mission, and that are team oriented.
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On a personal note, Rob enjoys living on his family farm in Southern California with his wife and four children, where he loves spending time meeting new people at their weekly farm stand, making olive oil, and experimenting with new crops. He also enjoys spending time participating in ministry at his local church. He loves Jesus, he loves business, he loves medicine, and he loves people. These are all central motivators that have led Rob to serve in healthcare, and to offer Clinical Proctoring Solutions to meet your needs.
Endorsements
"During his four and a half years at Axonics, Rob made significant contributions to the success of our FDA pivotal study and field training efforts. He was a model of professionalism and consistency, and his positive attitude was much appreciated. Through his interactions with providers, patients, and our field team, I developed a great deal of respect for his integrity, reliability, and commitment to patient care and outcomes."
Dr. John Woock, PHD
Executive Vice President, Axonics
Career Opportunities
Career Opportunities
As part of our standards we employ highly credentialed, seasoned Field Clinical Engineers (FCE), Clinical Specialists (CS), and Physician Proctors dedicated to applying their passion and craft outside of a traditional territory sales setting. If you are interested in working in an excellent, professional, and friendly environment, please send us a resume for consideration. We are always looking for experienced talent in the following areas (and more) and will keep your resume on file if there are not current opportunities:
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Neuromodulation (all sub-specialties)
Orthopedics
Cardiology
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Note: We are grateful for the U.S. Supreme Court ruling on January 13, 2022 that upholds individuals’ right to a Medical or Religious Exemption from vaccinations. As such, Covid vaccination is not required for employment with Clinical Proctoring Solutions, Inc. We only require that you maintain access to healthcare facilities we service via the respective contracted vendor credentialing services. Since this court ruling, we are finding that Covid vaccination requirements are regularly being waived with submission of a Medical or Religious Exemption letter.
