Project Practitioners > Managing Projects in the Medical Device Marketplace

Managing Projects in the Medical Device Marketplace

By Matt Glei

I have been a Project or Program Manager, Director or VP in medical device companies for the last 30 years. Over those years the level of rigor and professionalism has changed a lot. Some of that change was because we grew up. Some was because this is a highly-regulated industry.

Background:

The Food and Drug Administration [FDA] was established by Congress when it passed the Food and Drugs Act of 1906. This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines.

Since that beginning the FDA has come to regulate a number of different products:

Food safety, food additives and dietary supplements

Medical products: medicines, biologics and medical devices

Radiation safety

Drugs and devices used for animals

Cosmetic products

The FDA also regulates labeling for foods, over-the-counter medicines and dietary supplements, as well as drugs and medical devices

FDA's regulatory approaches are as varied as the products it regulates.

Some products -- such as new drugs and complex medical devices -- must be proven safe and effective before companies can put them on the market.

Other products -- such as x-ray machines and microwave ovens -- must measure up to performance standards.

And some products -- such as cosmetics and dietary supplements -- can be marketed with no prior approval.

These differences are dictated by the laws the FDA enforces and the relative risks that the products pose to consumers

Internationally there are similar agencies established in most countries as well as internationally-recognized standards that products must comply with. For this discussion, let’s assume that the requirements are well-harmonized and consistent. This has been a focus of these organizations for many years and much progress has been made.

The differences between the regulated medical device market (as an example of the most process-intensive regulations) and unregulated industries are significant:

Regulations:

The key set of regulations is the US Code of Federal Regulations Title 21, Part 800 – 900. This outlines the FDA’s authority and the company’s responsibilities for the products. Section 820 outlines the requirement for companies to have a Quality System in place during the development of the product as well as when the product is in distribution and support. This Quality System Requirement is consistent with Europe’s Medical Device Directive EC92 and ISO 13485. The FDA and other agencies put these requirements in place because they observed how many product injuries and deaths resulted from designers NOT doing some of the basics during the design phase.

There are national and international standards for safety for various general devices and many of these must be tested for compliance in order to make a submission to the FDA or MDD body.

In addition there are specific device-specific regulations or guidance. Some of these are published by the FDA and others by other national and international organizations, such as the IEC, AAMI and ANSI. An example of this is IEC60601-2-49, the cardiac monitoring standard.

Submissions:

Before a company can market a medical device, it must make a determination of what submission path is necessary – some very simple devices are exempt and must only follow the general controls requirements (above). Documentation requirements are minimal: device labeling, establishment registration and device listing.

Others may additional require use of the quality system as well as proving that the device is similar to an existing device already proved to be safe and effective and raises no new concerns. This is referred to as a pre-market notification or 510(k), a reference to the paragraph of the CFR that defines this process. The documentation details are thorough. This process can take between 90 – 180 days, depending on the questions asked by the FDA.

The newest, most complex or life-support devices require a premarket approval [PMA] which means the company must prove that the device is both safe and effective. This usually requires significant clinical trials to prove safety and effectiveness in addition to use of the quality system. Documentation level of detail is very deep. This process can easily take 2 years (or more) depending on the time to develop the technology and test it in clinical trials. Note that a New Drug Application can take 10+ years.

Compliance:

Even after the device is designed, prototyped, tested, submitted, approved and shipped, the company must maintain control of the product and the manufacturing process and trace each product or lot of products to the purchaser. In addition, the company monitors complaints and any medical device reports [MDRs] that report possible injury or death caused by the device. The company or the FDA may initiate a recall of the product based on a complaint or MDR and closure of these are tracked very formally.

This background could go on and on, but what does this mean for a project manager and a company?

First, you must establish a quality system. This also means that you must establish detailed design controls, document controls, purchasing, process, installation, servicing, etc. In addition, design controls drills down into subjects near and dear to our hearts as PMs:

  • design planning
  • design inputs
  • design outputs
  • design review
  • design verification
  • design validation
  • design transfer
  • design changes [control]
  • design history file

Second, you must use the quality system you’ve established – all of it, all the time. The last item under design control is the design history file [DHF]. It contains not only the plans, specifications, drawings, SW code and tests completed, it also contains proof that you did all the required tasks and followed your design control process. This is auditable by FDA and other international auditors, so this isn’t a wish.

Third, as you make improvements or changes to your released product, you must use the quality system (and design controls) to make and prove any modifications.

Although this seems like a lot of bureaucracy, it actually can make product development better, faster and higher quality. I have established several generations of quality systems and design controls in at least three companies over a period of 25 years and find that if you build a system that adds value for the developer rather than a mindless set of checkboxes for the auditor, it can make product development better.

Such systems ask you to develop your requirements somewhat before you start writing code or building final prototypes. Requirement > specs > architecture> design > code > tests > closure, is a general flow. This is not a waterfall method where all activity in one area is done before moving on (very un-real-world). But it does want to prevent you from writing the code or completing the hardware, then producing a lot of now-useless documentation. Under a quality system, if it wasn’t documented (according to your own rules), IT NEVER HAPPENED!

These systems also require formal project planning documents, product risk management, requirement capture and change control, plans and protocols for testing, document designs and design review activity, requirements tracing through to verification or validation testing, human factors evaluation, and so on – all skills that project managers "know" can help a project. One advantage in having a quality system is that the individual project manager doesn’t have to invent or justify a process during the project. The organization has had to work to develop it before the project is officially approved. This is similar to having a project management office already developed and in place (and not just for big companies (like most PMOs).

Since all medical devices are subject to these requirements, it is a level playing field. A poor design approach and poor documentation will always lead to numerous questions from the FDA reviewer or auditor. Answering these questions or even re-doing the work will cost you time to market. In other cases, using the process will make it a lot less likely that a patient or user will be injured by the product under any circumstances.

Matt Glei, KnowhowConsulting.biz



Related Resources
The medical device industry has many lessons that all of us can use to improve how project are planned and executed. Maybe more importantly we can adapt a different mindset to running projects that integrates a quality system approach throughout the planning, execution, validation and close-out phases. We've listed a few other site resources to provide broader perspective on this idea.


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