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New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices

Check this out

https://www.forbes.com/sites/danmunro/2018/07/29/new-documentary-film-is-scathing-indictment-of-fdas-regulation-of-medical-devices/#1942520226b8

 

 

4 Keys To Choosing The Right Regulatory Consultant

4 Keys To Choosing The Right Regulatory Consultant

By Bob Marshall, , Chief Editor, Med Device Online

I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, 18 months into my tenure as chief editor of Med Device Online, I want to share some perspective on outsourced support. These important relationships can make or break your business.

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4 Keys To Choosing The Right Regulatory Consultant

By Bob Marshall, , Chief Editor, Med Device Online

I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, 18 months into my tenure as chief editor of Med Device Online, I want to share some perspective on outsourced support. These important relationships can make or break your business.

The Right Consultant Has Worked With Your Device Classification

Since hockey season has ended here in Pittsburgh, with our Penguins exiting in the second round, would the NFL’s Steelers consider inviting Penguins center Sidney Crosby to their upcoming training camp? Of course not. In addition to the overlapping seasons and contractual issues, Crosby would lack the necessary football-specific skills. Sure, Crosby is a superior athlete, in excellent shape, with a proven training regimen and a strong competitive mindset, but he would have no ball-handling skills.

It’s the same with consultants. They might know the ins and outs of device design controls or complaint handling, but if all of their experience is with ultrasound imaging systems, and you are trying to bring a new orthopedic implant to market, you are unlikely to be well-served. Don’t get me wrong: design controls, and especially validation of ultrasound systems, bring unique and significant challenges, but those challenges are different from the material concerns presented by implants. A consultant who has worked in your particular device space will be familiar with specific guidance documents and applicable standards, enabling him or her to be more efficient and effective.

That said, seeing Crosby “bat” several goals into the opposing net toward the end of the season, and into the playoffs, makes me think the Pittsburgh Pirates could use his stick in the lineup.

The Right Consultant Has Experience With Your Regulatory Pathway

Many engagements with regulatory consultants begin with the creation of a regulatory strategy document. This strategy informs a client of potential pathways to get their device to market. Prior to engaging a consultant for this type of support, inquire about their experience with the various pathways and supporting submissions, especially when you anticipate needing follow-on support.

Has the consultant prepared pre-submission documentation and participated in the associated meetings with FDA? Have they prepared 510(k) submissions? Have they prepared IDE submissions and handled clinical study documentation? Have they prepared PMA documentation and supplements? You don’t want to get a regulatory strategy document from one consultant, only to have to find a new partner to support your submission, if at all possible.

The Right Consultant Has Experience With Your-Sized Business

This is potentially the biggest area for disconnection. I have seen regulatory and quality consultants who spent their entire careers in larger medical device companies — prior to transitioning to consulting roles later in their careers — struggle when working with startups. Larger device companies have mature systems (often overly complex and conservative) not directly applicable to a startup. Startups must be lean and agile, and often have to take greater risk, given their minimal funding.

You don’t want to build out a full quality management system (QMS) before the startup has any devices in commercial distribution. Early on, the basic disciplines of document and design control need to be established, but production and process controls — along with things like CAPA and complaint handling — are not needed. The right consultant for a startup will understand the need to build a progressive QMS and help limit the burn rate of cash.

Conversely, a consultant having experience exclusively with startup medical device companies often will struggle to help a larger client. They can be easily frustrated by the scale of the QMS and struggle for the patience to operate within the system. However, this type of mismatch can be beneficial for a larger company if they are looking to simplify their QMS as part of a lean initiative.

The Right Consultant Has Fees Consistent With Your Need

How much does should you pay for a consultant? As much as necessary, and not a penny more!

If you are looking for short-duration support from a highly-skilled expert, it likely will be expensive; perhaps $200 to $300 per hour, or more, in leading markets like California or Boston. You may be able to obtain this level of support from a small firm, or even from a “single-shingle” sole proprietor, at a lower rate, but recognize the down side. Although less overhead enables smaller firms and individual consultants to provide lower rates, those consultants have little to no capacity to add resources if the need is greater than anticipated, or if you need to accelerate the schedule. A consultant’s hourly rate should be less than what you pay an attorney to protect your intellectual property, but significantly more than someone from a temporary employment agency might command.

Consider the following story, common across the internet (I found this version on LinkedIn):

A giant ship engine failed. The ship’s owners tried one expert after another, but none of them could figure but how to fix the engine. Then they brought in an old man who had been fixing ships since he was a young. He carried a large bag of tools with him, and when he arrived, he immediately went to work. He inspected the engine very carefully, top to bottom. Two of the ship’s owners were there, watching this man, hoping he would know what to do. After looking things over, the old man reached into his bag and pulled out a small hammer. He gently tapped something. Instantly, the engine lurched into life. He carefully put his hammer away. The engine was fixed! A week later, the owners received a bill from the old man for ten thousand dollars. “What?!” the owners exclaimed. “He hardly did anything!” So they wrote the old man a note saying, “Please send us an itemized bill.

The man sent a bill reading:

Tapping with a hammer………………….. $ 2.00

Knowing where to tap…………………….. $ 9,998.00

What Is The Consultant Looking For?

Since we’ve talked about what a medical device company should look for when considering engaging a regulatory consultant, let’s turn the tables and conclude with a thought about one of the most important things a consultant is looking for when proposing to provide support to a medical device company.

They will evaluate their ability to guide you. A consultant can provide a lot of experience and knowledge, but only if you allow them to do so. Remember, you engage a consultant because you don’t know what needs to be done. You have to listen to them. You would be surprised at how many times, when I was a consultant, a prospective client called me in for a meeting, and then proceeded to tell me how much they knew about medical device quality systems and regulations.

From the very first meeting, a consultant is evaluating your willingness to listen and follow their direction. A consultant knows ultimate success of a project, and the ability to get the device to market, depend upon cooperation and collaboration. You typically are paying a significant fee for the expertise you require; remember, you hold the keys to making sure you get maximum value for your investment

 

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