From The Editor | June 13, 2017

3 Pros Keeping Your Device On The Market


By Bob Marshall, Chief Editor, Med Device Online

How To Survive A Chemical Management Audit

This article is the finale of a five-part series examining vital relationships in each stage of medical device development. Read parts one, two, three, and four here.

You’ve led your medical device through the development process and finally transferred it to manufacturing. It’s time to sit back, relax, and enjoy the fruits of your labor, right? WRONG! We should take a moment to celebrate the efforts of our engineers, designers, supply-chain partners, manufacturing teams, and quality and regulatory experts. But, once the product is released into interstate commerce in the U.S. or distributed internationally, we face the full burden of regulation. In the final chapter of this series, we will discuss three key individuals who sustain a device from release until the device is retired.

A Complaint Is A Gift

Does anyone actually aspire to become a complaint-handling specialist? Through the recent high school graduation season, I talked with dozens of young graduates and listened to their hopes and dreams for the future. I don’t recall any of them having “become a part of XYZ Mega-MedTech’s designated complaint-handling unit” on their wish list. Dealing with unhappy customers all day, every day, seems like a thankless job. And yet, it is necessary from a regulatory standpoint and vital to the success of your business!

A former colleague introduced me to a wonderful book called A Complaint is a Gift, by Janelle Barlow and Claus Moller. The book describes the perspective you want your complaint handling specialist(s) to adopt. Actually, your entire organization should view complaints as gifts. In the book, Barlow explains that we won’t know how to improve our devices and diagnostics if we don’t know what our users find wrong with them. When our customers complain, they give us valuable information about what is important to them, and they may also give us ideas for new features or next-generation products.

Consider, from a human psychological perspective, why we complain. For many people, a complaint is a means to see a situation rectified; they want to continue doing business with a company, but they need some changes made to sustain the relationship. If a customer doesn’t complain, they likely have quietly chosen to take their business somewhere else. They have given up on the product and likely, on the company.

This is why a complaint is a gift. It’s an opportunity for a second chance.  Do we view it that way? We need positive, detail-oriented people in our complaint-handling units who are compassionate and excellent listeners. They must keep excellent records to keep us compliant, but they also must truly care about resolving complaints to keep our customers. Remember: it’s a complaint-handling unit, NOT a compliance-handling unit. The focus is on customer service. 

Without A Quality Culture, You Risk A "Staff" Infection

An effective internal auditor can help to prevent “bad things” from happening during assessments by third parties, such as customers, ISO registrars, and FDA inspectors. I am amazed when medical device companies trivialize their internal audit programs, and then are surprised when the company performs poorly in external audits and inspections. Even worse, the quality assurance department or the internal auditor often is blamed as responsible for the company’s poor third-party audit performance. I want to discuss what it takes for a quality system auditor to be successful, and many of you may think I am going to rattle off the obvious traits desirable in a good auditor. But, no. The American Society for Quality (ASQ) and others have documented well the necessary skills for an auditor, but those traits are only part of an effective internal auditing system.

The most important thing is for a quality system auditor to have the authority and support to effectively undertake an independent assessment of the systems and processes within an organization. Oh, I know, the highest-ranking member of quality assurance always has some reporting relationship to the president or CEO for independence, but an effective auditor needs more to succeed. The internal auditor will thrive within a quality culture that flows from the top of an organization down. Leadership must model respect for quality and engage in the process.

I recall a COO at a medical device company who had difficulty delegating responsibility to his operations team. He was a bit of a control freak. When the quality system at the company was under revision, he had his name assigned as the process owner for all organizational functions, including purchasing, manufacturing, calibration, and facilities. He did this despite having directors or managers in charge of each of these functions. The problem was, when it came time to audit those functions, the COO (documented process owner) always seemed to have travel plans or an important customer meeting to attend. Think of the message that sends to the organization: “I want to be in charge of all functions, that is, until it’s time for quality to audit them…”  

PMs Give Us The Business

Coming to the end of this series, I feel that I have failed to give any attention to one group of professionals who often seem to have the most responsibility — and the least authority — in any medical device or diagnostic company. Let’s hear it for the project and program managers (PMs)! I bring this role up now because, once a device is released, every change made to it is a project that must be managed. Your PM needs to make sure that specifications and drawing are revised and released; new regulatory filings are prepared, or an appropriate justification for not doing so is documented; risk management is updated to analyze any new safety concerns; appropriate regression testing (verification & validation) is completed and documented; and supply chain impact is assessed, among other things.

This is a microcosm of the role that PMs play in new product development, but perhaps even more important, because the products are released and generating revenue — any hiccup can have significant effects on the company’s bottom line. Project and program managers must be organized, effective communicators, comfortable holding individuals on the team accountable and, most importantly, focused on the project plan, associated tasks, and schedule of deliverables. Once a project plan is established with input from the team, the PM can focus on accountability for task and deliverable commitments, which helps to prevent the perception of personal attacks. It's not personal, it’s just (the medical device) business.

Check out other installments in this series here.