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Design Control

Design Control or as the Europeans like to refer to it, Product Realization, is clearly the most critical phase in the product lifecycle.  It requires critical input from Research and Development, Marketing, Manufacturing, Quality, Regulatory, and Clinical (not listed based on importance).  If managed well it will feed off of critical information gathered/created during the Product Idea phase (i.e., Research/Prototyping phase) and create as its first step a clear set of objective design input requirements.  These design input requirements will ultimately evolve into design specifications or outputs.  The ultimate objective evidence that must be produced to satisfy the developer (the medical product company) and 3rd Parties (FDA, Notified Bodies, Competent Authorities, Insurance Companies) is the objective evidence produced during design verification and design validation.  However, it is often the case that the Medical Product Developer and the 3rd Party don’t always think alike.  Even more challenging is the fact that the 3rd Parties themselves often don’t agree what the objective evidence should be (i.e., FDA doesn’t always agree with Notified Bodies/Competent Authorities or vice versa).  Thus the critical need to integrate Regulatory, Clinical, Quality and Insurance Reimbursement demands into the design control/product realization process.  To do this a medical product developer/manufacturer must have integrated operational processes and the current Regulatory, Clinical, Quality and Insurance Reimbursement information/knowledge/experience to assure the creation of the required objective evidence to achieve regulatory approvals and insurance reimbursement coverage.

There is a clear history of the advantages that were achieved by medical product companies that integrated this Regulatory, Clinical, Quality and Insurance reimbursement knowledge into their development process.  Cardiac stent manufacturer JNJ understood these requirements and applied unique clinical validation protocols to gain first to market status with their drug eluting stent while creating a more significant validation hurdle for its competitors.  On the flipside, managing your regulatory strategy in the manner that 23andMe, Inc. did with their Saliva Collection Kit and Personal Genome Service or Anulex Technologies with their spinal disc repair device are excellent examples of very poor planning and management with severe consequences.  Refer to separate Blog postings under Design Controls for each of these examples.

RQMIS consultants have seen both sides of how medical product companies perform in this arena.  They have a solid appreciation as to the benefits of planning and implementation of Design Controls with a well thought out Regulatory Strategic Plan (RSP).  These plans incorporate regulatory classification/submission requirements, verification and validation requirements (including clinical studies), submission writing and negotiation, etc.   We are technically trained (engineering, microbiology, chemistry, clinicians/surgeons, statisticians, etc.) so that we can assist in integrating regulatory strategy with verification and validation study protocol desing to satisfy these 3rd Parties.   

Tell us about any success or challenges you have experience with.  It would be beneficial to all of us to learn from the mistakes we have seen or experienced.

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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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