Ee Bin Liew hi..how about...

a hospital visit? go to the neonatal department and let them see what a fetal monitor does. Ask if any of them had their kid hooked up to one before? what happens? what's being monitored and what if the alarm fails? ask the hospital to demonstrate servicing and interview the service engineer.

share a story? about any intimate experience with any medical device, from a wound dressing to a stent, something that strikes them, impacts them. Great story telling leaves a deep impression.

recount the challenges of a person when someone learns a habit? be it cleanliness, sports, or even to kick a bad habit. how much time and effort and commitment it takes...

explanatory videos? a picture (or a video) speaks a thousand words... have someone from another department post that video about quality and regulatory and the impact to their work..

finally, forget the rules. what does your conscience and common sense say? it won't be long before we realise that they are already written in the regulations...

be always positive and persistent! hope it helps...

Kaushik Lodh I actually made a presentation about Product liability and Consumer product Safety Improvement Act (2008), its legal ramifications ( fines and 5 year prison time), cited a couple of cases showing how the Supreme court decided that state law causes of action against a manufacturer whose device entered the market through the expedited Section 510(k) process were not preempted. And then enforced the paradigm of collective responsibility and data driven decision making.

Seems to be working, but its a work in progress.

Thank you for your input.

Andrew Kyle You have to register with the FDA and pay the Medical Device Tax. Ignore the FDA at your own risk. You must ensure the device is listed with the FDA and attempting to do so after marketing it is not going to be conducive to your regulatory oversight when the FDA visits. Expect a 483 and serious warning.

Kaushik Lodh You know Andrew, this question has always bothered me. I do not own the company I am talking about, the guys who do, keep telling me it is a off the shelf monitoring device, like a pulse oximeter, to be used for infant monitoring at home.

I understand even a tooth brush is a class 1 medical device, so this bothers me that these guys are not concerned about the FDA and registration, compliance, etc.

How do I double check?

Alan Rapacki Oh man, I was definately one of the people you're talking about. I was in R

Andrew Kyle Act in haste....repent at leisure. Don't act in haste

Charles Griswold When I took over the Quality System for a small medical device company, it was only because everyone else was either indifferent, to down right hostile, about doing even simple documentation. Why the resistance? Like most people, they saw paperwork as an obstruction to their productive/lucrative/creative path. Some reasons we learned to value the Quality System:

1) We have seen Quality catch mistakes. When the Quality system catches a mistake of mine, I am grateful. No one who takes pride in their work wants even unimportant errors to go out. Caught mistakes should be advertised because most people do not realize how many mistakes (big and small) are caught with even a basic quality procedure.

2) Drill, correct, repeat. I am sorry to say, there is little substitute for training though repetition. It takes the average person 7 times of repetition to learn something new. It probably took me 2 years to learn the quality documentation basics from older engineers starting out. Once someone has learned proper Quality Procedure, you will have a hard time getting them to do it any other way.

3) Tell your start up folks two words- Due Diligence. Every ISO compliant distributor your company wants to sign is going to do a quality audit before they sign a contract with you. The entire financial future of your company will rest on having the quality documentation up to snuff. No savvy investor, or company, is going to buy another company with lousy documentation of it's products, regardless of how great their product might be. Without good documentation, how else would the investor know for sure what they were buying? How much money and time would they need to spend trying to make the products ISO13485 compliant?

Fred Adler If you want a copy of our last ISO 13485 inspection report so you can see what it entails by titles of documents and systems, give me an email.

All of the above include great recommendations and advice. Do not ignore, even if you keep that information in your own file. Does the 'off the shelf' device already have a CE mark ? If so, it should also be considered under the FDA guidelines.

I'm currently working with a start-up that is too busy designing and building the first test article of the medical device to bother with documentation. I recognize your situation.

The argument for process (best practices) and documentation (prove you did it) depends on the audience.

Developers: documentation that's postponed is more work and takes more time to get done. One the one hand, your memory has faded. On the other hand, you know a lot more detail and you're at risk of writing more than you need to write. In the past I led projects that featured writing Wednesdays: Every Wednesday morning, before you can go have fun in the lab, sit at your desk and get your documentation current. Typically we were done in 2-3 hours. Everyone on the team agreed we kept it painless.

Managers: we need to manage schedule risk. Here are the things we are doing that raise schedule risk: postponing writing means not only it will take longer but also we aren't sure how much longer. Documenting later means you're documenting when you're racing to the finish line, the poorer writing and rushed editing will be visible. The biggest schedule risk we are facing isn't even on the schedule: how long will the FDA and the Notified Body take to review our submission when the documentation has lots of red flags in it?

Preston Smith has a lot to say about taking variability and unpredictablity out of the schedule, look him up and read.

Executives: You want to do a hazard analysis because you want to not only take steps to manage your product liability, you want to be able to show when you're being subjected to discovery that you did so.

Have I been successful? Umm, a little. It is a Sisyphean task.

Kaushik Lodh Thank you for your replies Andrew and Liew. I was looking for answers and found some yesterday. http://www.fda.gov/downloads/ForIndustry/FDABasicsforIndustry/UCM239011.pdf and also http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081352.pdf

I also contacted FDA director at Irvine, CA and asked for information, she offered to look up the information about whether the product needed FDA clearance.

But when I spoke to the CEO of the company, he was adamant that he had spoken to a consultant who had spoken to some FDA official and had come to the conclusion after also seeing several similar products from larger companies being sold in the market without FDA clearance, that his company's product does not need FDA clearance.

Andrew I understand your comment about the letter and GMP.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/

We are trying to follow some regulatory guidelines, but the crew is very fresh and really underpaid.

I can only advise, but it is their company and they have to decide.

But just to be on the safe side, we will document what we are doing, and maybe start some formal interaction with the FDA.

Any suggestions are welcome.

Chris Elliott When you say "like a pulse oximeter" is it a pulse oximeter? If it is, it certainly needs FDA clearance and I believe that there is no predicate for a home use pulse oximeter.

Try giving them one of Dr. Christopher Devine's books and ask who will be the CJO ?

Kaushik Lodh Hey Chris,
Yes it is a Pulse ox that too for continuous infant monitoring to identify life threatening emergencies. However the CEO opines that it is more of a device for the Mom, to provide peace of mind.

My gut tells me to email the label details to the FDA director, and get her opinion. But I have a moral obligation to follow the wishes of the company's decision makers.

Tough call.

Jean Bigoney, RAC, CQE "But when I spoke to the CEO of the company, he was adamant that he had spoken to a consultant who had spoken to some FDA official and had come to the conclusion ***after also seeing several similar products from larger companies being sold in the market without FDA clearance***, that his company's product does not need FDA clearance."

The portion between the triple asterisks is in my opinion the WORST POSSIBLE method of determining the regulatory category that is appropriate for your product.

This reminds me of teenage kids who badger their parents to let them stay out all night because "all the other kids are doing it."

Every day I see websites from companies that are clearly in violation of federal law as it pertains to medical devices. And frequently when I am approached by potential new clients, they wave such websites under my nose as "proof" that they
a) do not require clearance
b) are allowed to claim that their widget cures cancer
etc etc etc

The only reliable source of information is FDA.

If you need to get someone to comprehend that they disregard federal law at peril of risking their fortune and reputation, search out some Warning Letters. Once a CEO of a company makes it into that Hall of Shame, every google search therafter will pull up evidence of illegal activity. This is not how you want to be known.

And don't worry, FDA will hold corporate officers personally liable and accountable for the actions of their organizations, both in a civil and criminal context, but not the regulatory grunt who told them what they didn't want to hear.

Andrew Kyle A single 483 is a good cure for that poorly thought out position

Better safe than sorry when betting your company on the leadership of large companies with legions of attorneys

Fred Adler Check out EMERGO online for some of their online presentations. Make the FDA guidance's from FDA.gov available to everyone, Go to FDA.gov and simply search, "medical device definition" and discover everything falls under FDA scrutiny that you can imagine (bedpans, tongue depressors, sunglasses with a UV claim). Subscribe to the Gray Sheet or the one appropriate and circulate them with sign offs so they can see for themselves actions being taken now. They need to be aware that regulatory growth and expansion in the last few years has snagged everyone.

Andrew Kyle Go to FDA.GOV. Search for the description of a medical device.

List the factors that make your device a "medical device" as defined by the FDA. You may be able to justify that it is not a medical device or that it is a Class 1 exempt medical device.

If in your judgement, it is a medical device, then you have to follow the rules or risk legal actions. The FDA is a powerful and pervasive reality in our business. The best advice I can give you is to comply if you think you fit or if you do not, then in writing declare that you have reviewed the definition and then document the reasons you do not believe your device fits that definition. Sign and date the document and keep it as a letter to file.

Otherwise, the invention will not be able to stay in the market as you will have to establish GMP processes for a medical device even if exempt from pre-market approval.

Ee Bin Liew Yes, Andrew is absolutely right, definition comes first.

FDA says.. a device is:
"•an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: ◦recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
◦intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
◦intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

If you go global, the GHTF definition is accepted by many..
Medical Device
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
• disinfection substances,
• aids for persons with disabilities,
• devices incorporating animal and/or human tissues,
• devices for.in-vitro fertilization or assisted reproduction technologies.

In Vitro Diagnostic (IVD) Medical Device
‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
Note 1: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.
Note2: In some jurisdictions, certain IVD medical devices may be covered by other regulations."

Do check also the EU MDD and ISO13485 definitions. They are all slightly different and you'd like to have complete coverage, this link may help

http://www.tuv.com/en/india/services_in/product_testing_in/medical_devices_in/what_is_a_medical_device.html

What is and is not a medical device is not a personal opinion - there are laws and regulations defining them and you just have to assess for applicability.

Lastly, if the off the shelf product really does not fall under any definition for whatever reason and is not considered a medical device, then consumers will just buy their own off the shelf eventually, wouldn't they?

Andrew Kyle There is CE classification matrix for medical devices. You can answer simply yes/no questions to arrive at your CE Classification

That result will determine whether you need an AR or NB in the EU. Become very familiar with iec60601 Third edition and the collateral standards.

Unfortunately the Medical business is highly regulated and as others have written requires lots of documentation. Memory is not sufficient. However in the end the GMP is really common sense based on objective data and continuous monitoring

It is good business

Jean Bigoney, RAC, CQE Can someone explain the relevance of the term "off the shelf" to this particular case?

Ee Bin Liew it's a pulse oximeter? if yes, regardless for whom, it's a medical device, end of story. any of the definitions we've referred to, or the decision tree as Andrew mentioned would give the same conclusion, with objective evidence.

but your post also alludes to a larger issue on the quality/regulatory education for an organisation, and the dangers of 'shopping for answers' and merely trusting consultants' words (who has talked to whom? what was said? what the other examples quoted? what rationale did the FDA give for saying it's not a medical device?)... without objective evidence.

Jean - off-the-shelf in the most-often used sense is taking something that we use normally or typically apply for general use (could be a part, a product, or even software) and re-apply it for a specific use, and in this case, for healthcare use..... but the way I read 'off the shelf' above seems to suggest 'over the counter'......

Keith - the first rule for playing in the regulated industry "if it ain't documented, it didn't happen". Do decide as a group if they can live with this rule for as long as the company is in existence, then decide if they want to play in this industry.

Charles Griswold In this case, the usage of "off the shelf" probably refers to an industrial USA version of the monitor, where only GMP standards need be meet, if that. The idea, I assume, is to have the monitor's design later revised for each additional market requirement. UL, 21CFR820, ISO13485, CE, etc. For a start up company with an unclear market, short on capital, I suppose it makes sense to do it this way? Although I suspect they will have to start from scratch, in that ISO13485 and CE electronic medical devices, usually require tight design controls and risk analysis from the concept phase forward.
Before Quality Managers scold such a development process, it should be noted that the application costs and required tests for meeting each standard can easily exceed the entire development budget of a GMP product.

Joel Blatt In my experience with medical diagnostics, any device that measures a physiological (medical) parameter -- regardless of how used or purchased (professional use or OTC) -- has to meet FDA guidelines. Exactly what the appropriate approval mechanism should be is best left to DIRECT conversations with FDA. To do otherwise is foolish and jeopardizes the entire enterprise. As stated in Ee Bin Liew's comment, you don't know who or how competent the consultant was; nor do you know the contact within FDA or what was actually said.

Kaushik Lodh I am grateful that so many people have posted their thoughts and enriched this discussion.

Thank you.

Robert Houghland I agree that this is a medical device and must follow the regulations as stated by the other contributors. Regulatory issues aside, I would say that following procedures and providing documentation at the beginning also makes the transition from design to manufacturing much easier and will help assure that you get the product you want. As a contract manufacturer I have seen everything from sketches on napkins to extremely detailed drawings and specifications, i.e., every nut, bolt and washer listed and dimensioned. Make certain that you document the intended use, the performance requirements, the testing requirements and the acceptance criteria as well as the physical attributes. As this is a new product, change control is very important since it is likely that several iterations will occur before the design is finalized. When it is time to produce the product you want to be ready and you do not want to be blindsided by errors or omissions.
Robert Houghland

Armin Beck It is very difficult to change the mind set of engineers by taking away their freedom of spirit. Engineers are not used to work in a regulated industry. The only way to make people comply with the system is to make them responsible and accountable by setting crystal clear objectives. If they do not comply you need to set example by negative performance evaluation up to separate them from responsibilities or the company. However the question is how to motivate? Generally nobody can be motivated and or need direct motivation. You need to generate an environment for self-motivation. You need to build your core team with member who are self-motivated to accomplish the goal(s) and not want to play in the sandbox all the time. Every start-up needs that foundation and that is the hardest part of building a company. Finding people who can “think out of the box” is very easy but finding people who are not living in a box is the art.

Armin

Ee Bin Liew well, I can't agree that it takes away the freedom of spirit. When I was one of the 'cowboy' engineers in earlier times, I could still do whatever I want with the team, but I was being reminded of the 'payback' of having the documentation catching up with the activities. This was tough of course but it made sense anyway from a continuity standpoint (what if I am fired tomorrow?). Then next it was all those risk assessments and approvals which were a pain but that taught us cross functional/stakeholder buy-in for changes are important - again, it made sense. There were less arguments down the road, ,and always a document to prove the decisions we made then. The freedom to think out of the box for the technical solutions, or to have the process move nimbler and quicker was still there.

But what really ticked me off were onerous procedures that just added un-necessary layers, or clear conservatism - perhaps from their personal fears, or plain mis-interpretation of the standards/regulations (I read and do my homework too - you have to know thy enemy to beat the enemy ;-) ). Then I'll try to find ways to go around it. I could not accept that I had to follow a procedure or a person that didn't make sense. Eventually, either i was convinced through more communication (or hypnotism??), or the procedure was revised.

sounds familiar?

I empathize with you and have had very similar challenges in my past. More recently, patient testimony has been very impactful for my team. Getting a live person to attest to how the technology impacted their life speaks volumes and sheds a lot of tears. When you can't obtain another spokesperson, use videos. There are many on the internet. Seek a similar technology and go to the manufacturer's website and download what you can.

It sounds like you are making a device. At the end of the day, ignorance or busy underpaid engineers will not hold up in preventing the CEO and head of QA/RA go to jail. One other tool I use is withheld revenue. If there is the potential to miss sales use this angle. Be very careful.

I'm also a mother of twins that were born premature and were neonates. If I can help you in any way, please let me know.

Good luck~

Marie Rajkovacz Kaushik and all the commenters - I do so appreciate all your thoughts and input. This is a very challenging position. My question is why hasn't this particular medical device not been audited by your registrar? Any findings would allow the progress and cooperation you seek from others internally. A change in culture is slow for sure and you are doing many right things to bring change. You and others here have cited many examples to explain and justify to your internal customers.

Joel Blatt Marie brings up a good point. One way to convince your colleagues is to have an outside regulatory consultant do an internal audit. Bringing in an outsider (outsiders are always "experts") can expose vulnerabilities that FDA would cite in an inspection or items that it would request as part of a regulatory filing. I have seen many times that having an internal audit report can be a powerful tool for building consensus.

Kaushik Lodh Hello Good people,

This company does not have the desire to spend money to hire outside experts.

I have advised them, and am gently goading the team along towards filing the regulatory paper work. Honestly, it is a bit of a challenge. However I will admit, it is a wonderful learning experience for me.

Working in a larger organization where I controlled a piece of the puzzle versus this experience where I am doing it pretty much single handedly is an every opening experience. I realize even more that what the FDA wants us to do is to not only protect the customers but also us (the company). It lays down clear criteria for V&V and documentation.

Human beings are fallible, and our trademark trait is: we will definitely make a mistake. Now to what magnitude this/these mistake/s are and how much we can control these risks is what the FDA endeavors to control.

I believe this experience is teaching me to be a more effective leader.

I do not believe that like in a larger company I can lay down the law, and hold people accountable with performance reviews and with-holding bonus / raise / promotions. In a smaller organization where people are already underpaid, the value of the engineer to the organization is greater than the value of the organization to the engineer. For example I work almost free of charge for them (because the cause they are working for is close to my heart).

I have taken an approach of weekly presentations during the Monday all-hands meeting chaired by the CEO and instituted a Thursday afternoon (after lunch 1:00pm when people are complacent) QA RA meeting.

The guys here are loud, cheerful and while they are a bit intimidated by the scepter of regulatory affairs, but when they do get it, there is almost a child like enthusiasm towards it.

I am trying to maintain this enthusiasm, honestly I use cartoons and animations in my presentations to drive home certain points! But ultimately I realize if I want to convey a message, I have to do it in a language my audience understands.

:)

Joel Blatt Kaushik, actually you CAN hold people's feet to the fire -- starting with the CEO. You can use a simple telephone call to FDA (with the CEO present) to clarify the regulatory requirements that the company must meet. It's then the job of the CEO to get his team to toe the line. If the CEO fails to follow FDA's guidance, then it may be time to leave. You don't want to be the fall guy.

Kaushik Lodh Joel, I agree with your assessment about the FDA call. And I fully appreciate your comment.

I intend to make the phone call you talked about, and indeed get these people in line. I do enjoy their trust and respect, and they know I am 100% on their side.

But right now, the people here are still in denial. I had an argument with the "CTO" (Who is a senior in Engineering school and simply does not know better) and the CEO called me at 4:30am to chew me out. I fought back with reason, and he apologized. I have to gently massage the idea in, and get things rolling. If I rush or scare them, they will just run, and the whole product will fail, and this thing will not take off the ground.

And that is unacceptable to me.

Because I do not have the option to leave. I am not doing it for the money (I work almost free of charge) or for the company. I am doing this to prevent infant mortality. I have faced the pain myself, and I just want to fight the ailment.

My own company Freya's Memories, named after my baby daughter, is for creating a working paradigm for SIDS prevention. I have spent the last several months after my personal tragedy to understanding SIDS and interacted with the greater part of all doctors, scientists, researchers across the world working on this, and believe me, I do not have answers, just some clues.
I am still filing patents and can't talk much about it. But trust me, infants are the toughest of patients!

Suffice to say, this Pulse Ox will not stop SIDS, but it can be a part of the paradigm of "Freya's Memories" and thats why I work almost free of charge and am totally committed to it.

The enormity of the task, and the personal pain make it a nightmare. How do you fight an enemy you can't see, and that strikes without warning?

I am not sure if I can do it... But I am sure gonna keep trying.

Richard Schrenker I had to check the calendar to make sure... nope, not April 1. It's pretty clear this is a medical device. If it were me, I'd tell my client that they were going to meet with FDA and me, or I would walk away. I wouldn't risk my credibility by being associated with people this irresponsible. As for engineers feeling reined in by regulations, in over three decades in the field I haven't met one yet who doesn't get the value that requiring the explicit demonstration of engineering rigor brings. Do they get frustrated by aspects of the bureaucracy? Of course they do. Do they deliberately ignore it? Not a one. Walk away while you still have a good reputation, dude. Walk away.

Hi Kaushik,
Thank you for your compassionate drive to solve a serious problem for infants. Are your employee performance measures linked to actual quality metrics? I would make sure all quality metrics are linked to employee performance and bonus payments to instill an atmosphere of "quality comes first and infant patients come first."

All the comments have been good. Since you are trying a lighter handed way of persuading people, I would suggest you try to convince the underpaid and overworked, that the knowledge and experience gained working under FDA compliant rules is a marketable job skill. It's like getting a certification, adding a programming skill, it is something of value. In the right market it, once they have a couple years of experience under such a system, they will increase their earning potential and expand the number of jobs they qualify for, while beating out other applicants who haven't worked under such rules. For executives, it would open a lot more high paying doors and a better chance of being retained if the company is bought by a larger medical device firm.

For you personally, I would say go ahead and do what you can if you want to. It needs to be clear that just like employees don't come to work wearing a speedo, they don't ignore the process and paperwork either. Nobody has to like it, they just have to do it. It is part of their job now, even if it wasn't part of their job before. I doubt anyone could argue that the company can change a dress code for its employees at any time for any reason. Why should they be allowed to argue they don't have to follow the rules needed to built and market the core product?

Having said that, I would say that when you set up the quality systems you will need, strive for two key things.

1. Be consistent on how the rules are interpreted.

2. If a rule is making work impossible (not just a bit slower due to documentation) then have a way to fix the rule so that is still enforces compliance but doesn't bring people's work to a halt.

In other words, your change control system needs to be able to accept refinement requests of various documents and processes, get them evaluated quickly, and get them implemented fast if changes are going to be accepted. This is really helpful when you are first building the documentation supporting new processes. There will be a lot of changes needed at first.

This links will help you (or your management) determine according to the FDA (as opposed to hearsay) that their product is or isn't a medical device. You might suggest that if they are positive it's not a device, then getting written confirmation from the FDA is a no-risk situation. It would certainly provide concrete answers if their investors ever ask management ask about the FDA.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051521.htm#2

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051637.htm

You can also search the FDA database for similar devices and see what their classification was. SIDS monitors are not a new idea.

Jean Bigoney, RAC, CQE Kaushik, first let me say that I am very sorry to hear what happened to your baby daughter. If it is indeed possible for a device to help prevent such tragedies, I am sure you will be a part of finding it.

It's clear that this is a device. You goal is to prevent death in infants. It's a no-brainer.
"But trust me, infants are the toughest of patients!"
This is precisely the reason why FDA would come down even harder on a company that is trying to ooze past Federal regulations. FDA generally has stricter rules regarding trials for any device or drug intended for pediatric patients.

Unlike Joel, I doubt that one phone call to FDA will accomplish anything. Nowadays they do one of two things. If you emailed them, they email you back with the links to guidance documents, FDA web pages, and regulations. If you called them, they tell you to submit a pre-sub.

An outside expert would not cost very much and if your guys are not willing to spend that, frankly if I were in your shoes and this is your company we are talking about I would give these kids a deadline to learn the basics of regulatory and if they cannot or will not I would quietly show them kids the door. If this is not your coimpany I would bail. I am something of a pessimist but I've been around the block a few times. It isn't hard to find examples of good ideas that ended up in the trash can because of poor implementation. You can spend your money up front to get your regulatory ducks in a row or you can "save" the money and get hit with higher costs when you are running your shoestring operation, selling "off-the-shelf" widgets and claiming to prevent death in infants.

You seem like a bright guy. I understand that you are doing this without pay because it is a cause you believe in. However I fear that at the rate things are going, in a year you'll have a sad business story to tell on top of having the tragedy of losing your baby girl. Find a company that is run by grown-ups or get some grown-ups to work on this. FDA isn't the oinly regulated industry. Engineers shouldn't need cartoons or animations to convince them to abide by federal law.

Jean Bigoney, RAC, CQE Kaushik, you state that the "company does not have the desire to spend money to hire outside experts."

You may wish to read these links in the order posted.

* 2013, revised from 1992 -

FDA's thinking on pulse oximeters
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm341718.htm

* 2005 -

A 510(k) summary for a pulse oximeter intended among other target patients for infants
http://www.masimo.com/nellcorfiction/PDF_FF/k051439+LNOP+Blue+with+Summary.pdf

* August 12 2014 -

A warning letter sent by FDA to that same company for failing to abide by GMP (the inspection was in October 2013) and furthermore informing them that their two previous responses to a 483 Warning Letter were "inadequate."
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410636.htm

* August 14 2014 -

An 8-K filing with the securities and exchange commision discussing the FDA letter of August 2014
http://www.sec.gov/Archives/edgar/data/937556/000119312514310931/d776328d8k.htm

* October 6 2014 -

A NPR story on the company reporting on the implications of the current situation they face with FDA
http://www.npr.org/blogs/health/2014/10/06/353524314/masimo-medical-company-may-be-falling-short-of-its-patient-safety-ideals

* Deadline October 31 2014 -

A call for experts to discuss how the company should deal with the warning letter that FDA sent and avoid further enforcement actions
http://slingshotinsights.com/projects/36

I strongly suspect that any expert willing and able to fill this need can name his/her price.

An ounce of prevention is worth a pound of cure.

Ee Bin Liew Thanks Jean for the links - because it's not just valuable for Kaushik it is valuable for the rest of us too. If utilized well, that already saves a ton of consultant money :-)

Kaushik - after reading your responses, this cannot be the only company that helps you achieve your objectives. have a good look-around if you can.

Ned Kraft This is a standard startup problem. "We don't have time for all this administrative overhead." is a standard answer. Until your leadership gets on board, no amount of presentations, scare tactics or other arm twisting can make a difference. Sadly, only pain and suffering leads to the realization that something needs to be different. Startup leaders are usually visionaries who are extremely smart and skilled. To get an admission that they don't know something is often difficult without some suffering. Starting early can save months and millions, but it's rare. Good luck! If you would like to chat, drop me a private reply and I'll share what I know.

Jonathan Wacks Run away from them-they are inexperienced, and will never "get it".

Been there, done that...

Andrew Kyle Richard's statements reflect the simple concept

Pay the piper now or later... you will pay. It is so brain dead to let engineers dictate regulatory compliance (and I am an engineer) that I cannot believe that this can even be a topic of discussion. No regulatory compliance ... you will get a 483 and your company will fail. I would walk away if their management does not have the gonads to direct and manage the company in harmony with the FDA. The FDA looks to management for its oversight not the engineers habits and preferences. If anyone thinks that the FDA will accept that line of reasoning, they are amateurs.

Find another place to work or a non-medical product to develop. Your management is not sane nor medical device centric in their thinking.

Jonathan Wacks Yup.

Ned Kraft As Andrew said, it's pay now or pay later. Although if you do not have FDA approval on any product it may be best to put your limited resources into getting the product ready and budget extra for consultants to help get your compliant when you raise your next round. As the CEO, it's your company to run. Start-ups attract people who like the wild west so there will be a time when you'll need to fire or write-up one (or more) people to let them know the landscape is changing. One CEO told me at an Eli Goldratt seminar years ago "Tell them the exact same message 100 times. Anyone who doesn't get it after that has to go." He fired half of his executive staff and then they got down to business. Pep talks work for 48 hours, rules enforced consistently around behavior move quickly through the ranks.