JD Consulting Principal and Medical Industry Consultant

Jack Dhuwalia, MS ChE, MBA, DTM

Jack DhuwaliaJack understands customer needs in reducing risks, increasing productivity, regulatory compliance and reducing time-to-market. His clients appreciate his dedication, attention to detail to help figure out quickly what needs to be addressed, then doing it.

He is an expert trouble-shooter specializing in the medical industry. He has been problem-solving in R&D, manufacturing, regulatory and quality areas. Since 1992, he co-founded JD Consulting, a firm specializing in the medical industry, including: devices, in vitro diagnostic devices, biologics and drugs.

Jack has expertise in design control, risk management, root cause analysis and CAPA. He teaches a graduate-level medical products life-cycle class at UCI.  He is a guest lecturer at USC on quality and regulatory issues. He is a published author and has spoken on Root Cause Analysis and CAPA during FDA-OCRA events. He enjoys sharing his knowledge and public speaking.

He has served as the Membership Chair for the Orange Empire Section of ASQ and was on the executive board of OCRA, a professional organization for quality / regulatory affairs.

Jack Dhuwalia Vision:

Jack Dhuwalia’s vision for JD Consulting is to provide medical product development and manufacturer clients with innovative and efficient (cost effective, timely and compliant) solutions. To this objective he brings more than 25 years of broad experience in medical product development, quality systems, project management, operations, materials application, and process engineering. Jack's clients benefit from his understanding of the inter-relationship of disciplines from R&D concept design through large-scale process engineering that achieve workable solutions very quickly. He delivers excellent results with effective communications skills in new and fast changing environments. He provides customized and cost-effective solutions.

As an active leader in the Southern California medical products community, Jack is an active senior member of industry organizations. Jack is a certified Six Sigma Black Belt, Toastmaster DTM. He presents programs on supplier quality, design controls, root cause analysis, failure analysis, CAPA, materials controls, risk management and lean manufacturing.

Diverse Products and Markets:

  • Cardiovascular
  • Drug Eluting Stents (DES)
  • Brachytherapy (radio-active isotopes)
  • Respiratory care
  • Biologics
  • Photo-dynamic therapy
  • Hollow fiber dialyzers and oxygenators
  • Blood oxygenators and tubing sets

Partial List of JD Consulting Clients:

  • Advanced Minerals
  • Amersham Health (Division of GE)
  • DES – specialists in cardiovascular products
  • Edwards Lifesciences LLC
  • OrthoBiologics Inc (Integral
  • Mallinckrodt Medical
  • Medtronic Cardiopulmonary
  • QLT
  • Sorin Biomedical
  • SynCardia Systems

Key Successes:

Regulatory Affairs/Compliance
  •  Class II device company in India passed a 5-day FDA inspection
  •  Warning letter (W/L) remediation of an IVD company
  •  Resolved a W/L for design control of Class II brachytherapy product – passed FDA inspection
  •  Eliminated a potential W/L by a robust sterile packaging; eliminated rescheduling of surgeries
  •  Prevented a recall of artificial heart by sterile packaging testing
  •  Prevented a recall of a Class II IVD product while the company was already under a W/L
  •  Prevented a possible recall of Class II biologic start-up by improving sterile packaging
Quality Systems 
  •  Designed and implemented a design control program and trained staff
  •  Implemented CAPA to resolve problems for good
  •  Completed process, package and sterilization validations including injection molding
  •  Completed IQ, OQ and PQ for medical processes
  •  Identified, installed, validated specialized test equipment to support manufacturing
  •  Reduced process risk by 83% using process mapping, risk analysis, FMEA and process improvements
  •  Completed Biocompatibility testing program of a combination product
Problem Solving:
  •  Developed packaging to reprocess finished product of a biologic start-up without redesigning packaging
  •  Revived a PTCA product line by identifying the root cause and implementing solution
  •  Improved performance of an $8M catheter line, increasing sales by 80%
  •  Saved over $250K analyzing the sterilization assurance problem
  •  Solved a significant quality/regulatory problem for brachytherapy – saving over $400K per year
  •  Resolved bottle-neck problem for dialyzer and oxygenator production lines using Six Sigma tools and Lean
Packaging and Sterilization:
  •  Implemented sterile packaging projects including design and packaging process validations
  •  For three new cardiovascular products, completed package design and validated packaging
  •  IQ, OQ and PQ of several packaging systems to complete validation
  •  Reduced 90% Tyvek™ requirement for sterile pouches  - demonstrated multiple sterilization cycle
  •  Completed E-Beam sterilization validation of DES
  •  Resolved sterilization testing problems for DES
  •  Delivered completed  results for DES exposure to E-Beam Irradiation
  •  Resolved inconsistencies with E-beam sterilization process for combination product
  •  Sterilization cycle development through sterilization process validations of EtO, Gamma, and e-Beam Irradiation
  •  Increased E-Beam sterilization productivity by 100% without redesigning packaging
Technology Transfer:
  • Successful manufacturing technology transfer of an embolectomy catheter to Singapore
  • Successfully transferred three hollow fiber processes between domestic and international operations
New Product Development, Time to Market:
  • Development through successful market introduction of a dialyzer (artificial kidney)
  • Special 510(k), design history file and risk analysis for a RF device for dermatology
  • Development thru 510(k) of a unique guide-wire exchange system for PTCA
  • Qualification/validation including design, development and  510(k)  for a phonation valve
  • Design, development and 510(k) for a 75% less expensive transducer protector
Employment History:

Baxter Healthcare Corporation - 1986-1991

  • R&D Section Manager cardiovascular products, LIS division, PTCA products

CD Medical Inc. (Cordis Dow Corp.) - 1979-1986

  • Technical Services and Development (TS&D) Engineering Specialist II, Project

Special Activities, Honors and Patents:

  • Recipient of the U S Vice President’s “Hammer” Award
  • Recipient of LIS division, Baxter Healthcare President’s award; solved a quality problem that shut the plant down
  • Speaker at FDA’s town-hall meeting addressing Dr. Shuren, Dir., CDRH, in Irvine on October 7, 2010
  • Speaker at FDA/ Orange County Regulatory Affairs Discussion Group (OCRA) conference on Corrective and Preventive Actions (CAPA)/Root Cause Analysis
  • Instructor at UCI for product life-cycle management
  • Holder of two US design patents in cardiovascular area

Professional Affiliations:

  • Senior member of ASQ
  • Past Board member for OCRA and of ASQ
  • Member of Forensic Expert Witness Association (FEWA) and Professional Service Providers (PSP)
  • Attended and presented several FDA seminars/workshops on regulatory and quality issues

Education and Certification:

  • MBA - Nova University, Ft. Lauderdale, Florida
  • MS ChE - University of Missouri, Columbia, Missouri
  • Certified Six Sigma Black Belt – ASQ

Jack may be contacted by calling 949-701-0214 or by This e-mail address is being protected from spambots. You need JavaScript enabled to view it.  

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