Medical Device Manufacturing Consultants

With the continued growth of the medical device market, even during the time of downward overall market growth, medical device companies are venturing into more and unique applications. These require GMP (Good Manufacturing Practice), must meet somewhat unclear FDA regulations (21 CFR part 11), have to have a 510k filed, and require even more extensive process validation (software code, firmware, manufacturing data, etc.).

There are numerous things that can vex and frustrate the development and introduction of a new medical device, including:

  • Sterilization
  • Pharmaceutical packaging or other packaging (surgeons would like to have custom packages to enable better quality control in the operating theater and reduced chances of infection and accidental loss of devices in the patient)
  • Reusability and need to have better labeling and use instructions
  • Preparation for FDA inspection
  • Data collection and reporting
  • Machine validation
  • Facility validation
  • FDA clinical trials
  • Failure Modes Effects Analysis (FMEA)
  • Medical device research and development
  • Plus, understanding of the role that reimbursement plays in the selection of the device and the procedure

Many of the FDA regulations have evolved over the years and are subject to interpretation. The FDA may concentrate on a specific area that has caused issues and the supplier needs to be aware of the key drivers at the time of device introduction. It is a truism that the data sometimes outweighs the product itself but this data is the key demonstration of the readiness of the medical device to be used in or on a patient.

Quality and reliability are the key terms used, and the need to have zero defects in these devices can be an onerous requirement outside of medical consultants, test labs, software developers and specialized sterilization and packaging. I once heard it said that if these devices were 99% reliable and were implanted or used successfully 99% of that time, then out of 100 patients, one would either die, suffer injury, or a decreased quality of life. Many times the lack of training, accountability, good manufacturing practices, good internal audits, corrective action programs or even the hiding of defects could bring increased suits, loss of market credibility or death. The adverse impact on one person is unacceptable.

While the use of the courts can be counter productive it has also helped to improve compliance to the FDA requirements, good manufacturing practices, data compliance and better quality of life to the patient. It can also help to reduce the cost of doing business if these FDA regulations are met, medical devices designed to achieve zero defects, the production process for medical devices strictly adhered to, the internal GMP audits at rigorous and address the right items, and the FDA is involved in the process.

The design, manufacturing, quality, and reliability of the medical device is driven by the manufacturer adhering to these FDA protocols, GMP regulations, design for patient use and control of the sources of supply so that there is not introduced to the system any unknown and uncontrolled products or components. This is particularly true for the electronics and related mechanical parts of the system. Incorrect electronic components (resistors, capacitors, power supplies, boards, and firmware) have endangered patients and need to be removed from the system.

The best medical device is that which:

  • Fully complies to the FDA 21 CFR part 11
  • Meets the GMP
  • Incorporates an aggressive corrective action process
  • Audits the process of medical device manufacturing so that it fully complies
  • Is designed to address the worst case applications
  • Controls the components and software and drives to full compliance through validating the design, the process, the GMP and the sterilization and packaging

This article was written by Herb Dwyer, an Lead Consultant with over 25 years of experience in the industry. Herb can be contacted at 317-536-7013, or via email at



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Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.


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