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Why New Product Ideas Often Fall Short

Airo Mobile Intraoperative CT

A Regulatory Strategic Plan (RSP) used to bring a medical product to market requires solid regulatory knowledge married with scientific/engineering/clinical expertise using critical thinking skills.  An RSP does not focus solely on the path to obtain regulatory approval or clearance but also links the approval/clearance to how the product is manufactured, promoted and how future product revisions or line extensions are introduced to the market.  If done properly and maintained over the course of a medical product’s lifecycle a company will have a more predictable product development timeline that can be adjusted as new information becomes available and a product regulatory risk profile that can be actively managed during post market release.  If implemented effectively, the RSP will result in improved operational process efficiency, reduced operational costs, and a reduction in time to market.  If the results of product development or the experience after commercialization is not as predicted, the RSP will better position you to make adjustments and, unfortunately, make the difficult decision to cancel a development project or recall/remove a product from the market.   

RSPs focus on the ENTIRE product lifecycle not just “getting FDA approval”.   An RSP is not developed or maintained in isolation.  It is 

  • integrated into a company’s product design inputs,
  • identifies the testing (preclinical and clinical) required for approval/clearance,
  • is reflected in your risk management documents,
  • assures that the product manufactured is the product that was cleared/approved,
  • identifies the operational/manufacturing requirements required to assure compliance with regulatory/standard requirements for Quality Systems (Good Manufacturing Practices),
  • defines the boundaries of labeling content/promotional activities and
  • identifies the ongoing regulatory submission maintenance requirements. 

What are the consequences of an inadequate RSP or one that is poorly implemented?  First of all, RQMIS is not one of those consulting firms or webinar companies that send out “alarming” emails that suggest a new area of interest from FDA that will sink your company if you don’t comply.  We believe in providing ongoing advise/support that integrates an RSP within your business operations.  This RSP will balance your operational culture with the regulatory/quality/clinical requirements required to gain and maintain product commercialization.  You should never simply restate regulatory requirements within your company’s operations procedures.  In the same vain, you should not simply take a set of boilerplate SOPs/WIs from a consultant and insert your company name (yes, I have seen this happen).  Nor should you expect that testing required for a premarket submission 5 years ago will be the same for your product today.  All of these approaches will likely get you into more trouble than you think.

The net effect of not preparing/implementing an RSP can result in frustrating delays, cost overruns and not meeting customer expectations.  It can also result in more serious outcomes such as product disapprovals, warning letters, injunctions, seizures and legal actions.  History is replete with failures directly linked to poor regulatory strategic planning.  This history is typically linked to poor planning, lack of regulatory/quality/clinical knowledge/information, lack of information management/integration, and yes, at times, a company’s culture that encourages exceedingly liberal interpretations of regulatory requirements that affect one of the seven components of an RSP.  Although RQMIS believes from experience that the last reason is not the typical reason medical product failures occur, we have seen it occur first hand and results can be disastrous.  

RQMIS consultants have been directly involved with resolving import bans, warning letters, resurrecting premarket submission that were on the road to no where, PMA Not Approvable Letters, Clinical Study suspensions/restarts, Congressional Hearings, FDA Investigations, Product Recalls, Health Hazard Assessments , etc.  all of which were a result of a lack of an RSP or one that was poorly designed or ignored.  Our deep understanding in developing and implementing RSPs is founded on how we have seen companies fail to do them and how they have worked effectively.

Synthes and Vertebroplasty


Case Study on RSP Failure to:

  • integrate into a company’s product design inputs actual medical device (spinal implant) usage which ultimately caused product failure and patient deaths due to inadequate design verification/validation testing,
  • implement the clear boundary of labeling content/promotional activities defined by FDA and internal regulatory department


  • Four company executives given prison sentences and fined
  • Company fined and required to sale product line to 3rd party
  • Huge legal cost to defend company
  • Internal resource drain and loss of focus during investigation over a three to five year period
  • Damage to company reputation
  • Ongoing civil lawsuits from plaintiffs representing deceased patients

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President/founder of RQMIS Inc. a consulting company with experience in the Medical Device/Biotechnology Industry focused on Regulatory/Clinical/Quality Affairs and Product Management.   RQMIS Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).

Seven years experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District.  This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start-up and large multinational medical device companies.  Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea. 

Provides companies with regulatory and clinical strategic advice on bringing novel technologies to the United States and EU markets in the clinical fields of orthopaedics/neurosurgery/diabetic care (spine, restorative/reconstructive, sports medicine and wound healing), gastroenterology/urology/gynecology/pulmonology/cardiology/plastic surgery  (endoscopy/laparoscopy/minimally invasive/biliary stents).  The devices involved have included active implantables, long term implants, electromechanical, ultrasonic imaging and PACS products. 


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