Our business accommodates a diverse mix of factors, both theoretical and of the more practical, day-to-day variety. Today I'm sharing insight about those
factors and our recent and upcoming activities.

As I wrote in August -- we know the Snuggle Helper® 
product will make a difference.  Quantifiable outcomes speak volumes in addition (or opposition) to passionate beliefs, though. We're looking forward to a quantifiable opportunity to assess and improve our product.  Field reports are great sources of insight for product improvement, so we already use field data. Controlled studies, which yield critical insights from highly trained observers, are invaluable as well.  We stand to benefit greatly by using both, as we position ourselves to participate in our first formal study.  

Credible studies call for vexing levels of detail.  Study owners must identify
and track statistically significant factors in contrast with credible baseline
data.  They must clearly identify and mitigate  confounding factors, and most importantly, align the study goals and objections in accordance with end-user plans and objectives. For a study to earn peer-reviewed publication, it's also vital to document the study findings in terms of statistical interventions which are sound in their clinical focii. (That is, it's vital that the study findings don't reek of commercialism.) We plan to support a study with these considerations in mind.  
When the study owner/planner initiated study design activity many weeks ago, a question arose regarding the Food and Drug Administration (FDA) approval of our product (an important matter for clinical enterprises). The FDA is currently undergoing determination activity for Snuggle Helper®, to provide a disposition for it as a medical device or as a non-medical device.  Depending on the outcome of that determination over the next few weeks, Infant Guard can find itself pursuing roughly parallel, yet very different short term pathways:  
  • An "is a medical device" finding will result in steps to derive and adhere to
    new regulatory guidelines for a new type of Class 1 medical product.  Our subsequent focus would shift to establish a far greater presence in clinical environments. 
  • A "not a medical device" finding will find us aggressively pursuing commercial activity and pressing for greater visibility and acceptance of Snuggle Helper® in the public eye (in addition to establishing a greater presence in clinical environments.)

We have enhanced our capabilities as the FDA determination exercise has
gone forward.  Regulated medical device providers must (among many other things) implement traceability of production activities from supply chains through end-users, as well as through supporting versions of specification and design documentation. 
Archives must be made available to inspectors and auditors.  We have implemented our documentation control framework and we're proud of the results.  In the event that a non-medical-device determination is rendered, we, our suppliers, manufacturing partners, and customers will still benefit from the framework thanks to the added accountability and traceability it provides; we'll be better able to refine our products and build our production capacity while maintaining an integrated focus across the business.

Proper governance is key for a reputable study.  We are looking forward to upcoming review board activity and we've completed initial statistical power studies. Despite the difficulty of projecting cross-disciplinary activity, we anticipate results analysis to commence in early 2014 following clinical activity.  Even thus far, the undertaking has been effort intensive, but our company and our customers stand to benefit from the results.

To say that things we have been interesting in recent weeks would be an understatement.  More to come, obviously.

Best regards and thanks for bearing with such a latent update.



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