RADx Tech Viability and Steering Panels: A Model for MedTech Translational Grant Review.

RADxSM Tech's mission is to rapidly accelerate deployment of SARS-CoV-2 tests and could not utilize typical grant application and review processes that can run 4 to 6 months. Instead, RADx Tech leveraged methodologies developed by CIMIT and utilized by POCTRN as described further in this special issue. RADx Tech uses a multi-stage review with two review panels, a Viability Panel and a Steering Panel, that are supported by subject matter experts and a Deep Dive team. Members of the panels have extensive commercialization and business experience in addition to scientific and technical knowledge. The Viability Panel is responsible for assessing whether the proposal is a good fit with the RADx Tech Program and whether it should be recommended to move into a Deep Dive. Less detailed information is requested in the application than a typical SBIR application since the application is refined and details added during the Deep Dive. The Steering Panel reviews the results from the Deep Dive and decides whether to recommend further funding. Everyone on the Viability Panel and Steering Panel reviews every application, thereby providing consistency and context for the reviewers. Utilization of an "assess, improve, and then select" process with review panels comprised of highly experienced review panel members has resulted in improved timing, efficiency, and effectiveness of reviews and has the potential to be extensible beyond RADx Tech.

The RADx Tech Deep Dive and Work Package 1 Process.

The RADxSM Tech program was a unique funding and support mechanism to accelerate the market introduction of diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. In addition to providing funding, the RADx Tech program provided unprecedented levels of non- monetary support. Applications were evaluated using a deep dive process which involved a 1- to 2-week intensive collaboration between the applicant and a team of experts from RADx Tech. The result of this deep dive was a very comprehensive understanding of the potential and risks associated with the proposed work, which was far beyond what can typically be understood in a written grant application. This detail allowed the deep dive team to provide a better-informed recommendation on how to proceed. In some instances, the recommendation was made to not fund the project; in other cases, the recommendation was made to provide the applicant with more funding or support to help maximize their probability of success. After the deep dive, the project moved to a Work Package 1 (WP1) phase that focused on further de-risking. The same RADx Tech team that conducted the deep dive also worked with the applicant through the WP1 phase of the program. This allowed for joint responsibility of the work with the common goal of rapid, successful product introduction.

The RADx Tech Deployment Core: A Model for Academic/Government Based Support of Large-Scale Manufacturing and Implementation of Medical Technologies.

This paper explores how the approach, process, and learnings of the RADxSM Tech Deployment Core in its support of manufacturing, deployment, and implementation of medical technologies is creating a replicable model for the future. Initially, the key construct of the RADx Tech Deployment Core was helping companies manufacture, commercialize, and develop a digital infrastructure for the purpose of SARS-CoV-2 testing and reporting. However, the team and RADx Tech leadership soon realized that the larger infrastructure to deploy testing in non-clinical environments was nonexistent and that wrap-around services were required to build the necessary bridge between manufacturing and end users. Furthermore, the unique communities that required testing (e.g., manufacturing plants, transportation hubs, K-12 schools, etc.) had different infrastructure requirements and outsized needs for education and support around testing plan implementation. The Deployment Core, therefore, quickly scaled a team to help to complete the picture and provide guidance to end users and ultimately help shape public policy around a useful data model.

Platysma-based myocutaneous clavicular island flap for intraoral reconstruction.

The clavicular myocutaneous island flap, with circulation provided by the platysma and superficial cervical fascia, was first performed by Paul Tessier in 1970, taking his motivation from the prior experience of John Barron with subcutaneous island flaps. A manuscript written by Dr. Tessier on his experience of 120 cases using the flap (which we will refer to as the BT, or Barron-Tessier flap) has been translated and is presented, as well the experiences of Matthews and Wolfe, who learned the procedure from Dr. Tessier, and Kamerer, an ENT/Head and Neck surgeon who learned the procedure from Matthews. In aggregate, we will present our joint experience with 443 cases of the BT flap. Because of its ease and speed of harvest, reliability, and provision of thin, pliable skin, we feel that, in many instances, it is equivalent, or even superior to microsurgical free flap for reconstruction of intraoral lining defects.

Breast reduction with dermoglandular flaps: Tessier's "total dermo-mastopexy" and the "yin-yang technique".

The use of dermoglandular flaps in reduction mastopexy was advocated by Paul Tessier, who never published his method, but had actually almost finished the following article before his death in June 2008. Dr. Tessier is acknowledged as the "father" of craniofacial surgery, but he had interest in aesthetic surgery, and was quite proud of the technique he had developed using dermoglandular flaps in reduction mammoplasty. He had literally hundreds of techniques and methods that he had developed but which never found their way into print, both because of his enormous surgical schedule, and perhaps his self-imposed standards for anything that he published, which were almost impossibly high. The technique proposed by Dr. Gargano is similar in some ways to Dr. Tessier, it seemed good that they will be published together.

The Arrhinias.

The Arrhinias consist of three groups of malformations: the Total Arrhinias (T-AR), the Hemi-Arrhinias (H-AR, often called Hemi-Nasal Ageneses) and the Proboscis Lateralis (P.L.) This work deals with 51 cases of Arrhinias gathered within 35 years (8 T-AR, 25 H-AR, and 18 P.L): their anatomy, clinical signs, and some indications for treatment; but it does not extend to a discussion for their etiopathology. However, the T-AR and the H-AR represent ageneses, whereas the P.L represents a dysgenesis. The anomalies common to the three groups of Arrhinias are many: the agenesis of the nasal bones, the telecanthus which is often in contrast to the hypo-telorbitism, the obstruction of the naso-lacrimal passage, the ectasia of the lacrimal sac with an erosion of the inferomedial angle of the orbit, the hypopneumatization of the maxillary sinus and a small maxilla, the unerrupted canines, the flattened fronto-nasal process, the obliteration of the cribriform plate, the dysplasia in the root of the eyebrows, the transverse hypoplasia of the upper lip, the frequency of microphthalmia, colobomas of the iris and nystagmus. Cleft lip and palate are frequently associated with the Arrhinias (see Table I) and also other facial malformations, but in different proportions, according to groups. They are: cryptophtalmias, eyelid coloboma, fronto-orbital encephalocele, agenesis of the premaxilla or prolabium, microtia. (See Table II) The basic principles of the treatment are the following: In the T-AR, a nasal passage should initially be bored through the maxilla, or there should be a displacement of the two halves of the mid-face by a procedure known as "facial bipartition". This nasal passage should be epithelialized and maintained wide open to the pharynx until the nasal construction. In the H-AR, it is sufficient to create an epithelialized passage through the curtain of bone where one would expect the pyriform rim to be and carry this passage through the septum into the contralateral nasal airway. Then, regardless of the type of arrhinia, the nasal construction is carried out with a forehead flap and bone grafts. The first grafts are either iliac or tibial, and subsequent ones are generally outer table calvarial grafts harvested from the parietal region. Later, there are further procedures: a maxillary advancement, a lengthening of the central midface, the final stages of the nasal construction, the elevation of the medial canthus, and the restoration of the infero-medial angle of the orbit (but rarely an efficient lacrimal drainage). The earliest stage for surgery can be debated. A strategy for treatment is suggested. Finally, 20 brief comments are made, which are as much questions asked concerning the three groups of arrhinia and their relationship with other centro-facial and latero-facial malformations.