Julie Omohundro Lack of a clue, usually.

Reginaldo Hermanson Regulatory affairs, certification...

I think lack of coherence.

We were waiting for clinical data on prototype efficacy , and now this raising funds and awareness thru this https://www.indiegogo.com/projects/amni-nik-pre-sale-fundraiser#/story

Somashekar BV Poor design plans ... Poor design plans which do not include regulatory and its budget.

Victoria Trafka I have seen the following reasons (besides budget) for medical device launch delays or even project cancellations:

Additional design or functional requirements added well into the project
Unfavorable functional or mechanical testing results
Unforeseen regulatory or compliance issues that arise late in the project
Project timelines not allowing for design iterations
Long lead times for manufacturing
Packaging and sterilization items left out of the project timeline

Most of these can be grouped in the category of insufficient planning or teamwork to create a realistic and inclusive project plan. But it's also true that the development process is a fluid process and things do change. A team needs to work together to create a solid plan and if things change, they adjust together and keep everyone informed.

In over 30 years working with medical technology, I have never once seen a product, device or technology launched on time. Not once.

Julie Omohundro I don't think I've ever seen any organization do much of anything on time, on target, or on budget. :)

I have seen a good number of "launches" that were late, but still with no product available for purchase.

Reginaldo Hermanson PDCA: P- Plan ; D- Do ; C- Check ; A- Action and start again...
This is part of our business, no problem.

How about finding out too late that product design is not aligned with customer needs? I would also include poor clinical outcomes, particularly for transformational technologies. This could be either due to poorly understood mechanism of action, or poorly designed trials.

We would all agree that the road to a successful product launch is filled with potholes as outlined in the earlier messages. Compounding these challenges is the pressure from executive management to deliver the revenue forecasted for the product. We are trying to deliver to commitments based on schedules that assume that significant milestones will be met or managed.

We all must also accept that sometimes it is better to terminate a project when we recognize that the product will not deliver the expected performance - a very difficult decision as the project moves closer and closer to commercialization.

Joseph Patrissi Keep the comments coming! Your knowledge and experience will be shared within this group with hopes to better understand how we can increase our device to market success ratios, and to be on the look-out for common pitfalls. In the end, there are people who desperately need help. It is our responsibility to assist, by giving our best effort and coordination; within the budget and resources we have available. "A wise person learns from their mistakes. A wiser person learns from the mistakes of others." Please continue to share. - Joe

Julie Omohundro Bouncing of Ron's comments, I think a lot of problems can be traced to a root cause of poor management of expectations up front.

I think this usually occurs because product developers feel the need to simplify/downplay the challenges and uncertainty involved in order to secure finding. I don't think this is limited to start-ups, but also includes products being developed internally in a large company, where often product teams are essentially competing with each other for limited internal resources, and executive management must "pitch" products in their pipeline to shareholders much like start-ups to their investors.

A lot of people would say "poor planning" instead, and certainly there is that, but I think often those involved have one (more realistic) plan in their head and another (more attractive) plan on paper. And then others know better, but are in denial and believe in their rosy, best-case scenario based plan, too..

William Thoma My favorite was when the CEO put in place by the equity group that lead the most recent round of funding caused the founders to leave. Out the door went the ability to make it work. At least the people responsible were wasting their own money.

Julie Omohundro It's a difficult balance, investors and founders.

Founders have the ability to make it work, but don't always have the ability to get it through the process to market, so it can work. These founders clearly got themselves in a situation where they lost control, a common case in point. I know many founders who would have liked to have left, if they could have taken the product with them, but often they gave that option up to get the investments. And they themselves were too invested in the product (and often in the promise of ka-ching as well) to walk away.

Investors usually don't have the ability to "make it work," but...if you are lucky...have the ability to get it through the process to market. A lot of them don't have the ability to get it through the market process, either, which means they bring only money to the table. If there is anything the long history of device startups failing far more often than succeed should have taught us (but clearly hasn't), it's that technology + money does not = successful device start-up.

On rare occasion, the investors will not only have the ability to get it to market, but also the ability to "make it work" in the event the founders depart, but that is exceedingly rare and not a situation most investors who have this level of knowledge would want to find themselves in, regardless. Survivable, but painful.

Burrell (Bo) Clawson A founder considers himself to be God! Potential investors flee.

Over-reliance on the engineering & technical aspects and not on what the customer sees. True story: As member of contract developer/manuf company I called on a company interested to have us manuf there device, as they had already designed & developed the product. I sat with the Prdt Dev. team, marketing, etc (about 6-7 in total) as they proudly showed me a snazzy presentation and explained to me how they developed their device and how great it will be.

After one hour I asked one question- the device was made for the back of an ambulance but yet the delivery system was very sensitive and had to be held in place, motionless, for about 10 seconds. How do you expect that to occur in an ambulance rushing its way to the hospital?

There was silence as they looked at each other. They were so interested in the technical aslects that they didn't even consider the patient and environment. The project was shelved for a new design.

In following what Ron, Julie, and Bo have offered, there does appear to be another factor to be balanced and that is the engineering design with QA/QC follow up. The founder may have policy directions and product goals, the investors may have financial expectations, but in the flurry of the launch the engineering and QA/QC may get lots of lip service, but have limited clout and control of the product. Under those conditions: what are your experiences and how can the communications be managed to avoid confrontation of these parties, but result in persuading the investors / founder to rely upon and make their decisions based on the available technical information?

Dr Gloria Esegbona ✔️ A big factor is trying to get the product perfect before launching. Without realizing there is no such thing - and you just have to put something out there (minimal viable product) for the user and they will help you work out out to refine the product into something useful & dare I say beautiful. Once I realized this I started developing products and services within 3 days max. The rest of your time is then just spent on refining again & again - which can be very enjoyable if you are passionate about your product.

Reginaldo Hermanson Really funny case related by Barry Weinstein, returning to PDCA, probably this same project / device could be used in a different enviroment, an ICU for exemple. Developers must be flexible and look for all possibilities before to abort a project.

Burrell (Bo) Clawson As a side note on what I said, there is an easily overlooked aspect of cooperation between founders and investors which is absolutely needed if we all are going to succeed.

Too often founders want to "retain control" for a startup and spend inordinate time with investors trying to get all sorts of odd forms of stock, warrants, etc.

Too often investors want not only majority control, but little work by their directors they put on the board, "because this is an easy startup" or they are just lazy.

Negotiating with the investors to get the investor's top guy as a director who has experience in the startup's field can help avoid making missteps ought to be key.

Getting rapid market penetration means making as few mistakes as possible. That benefits everyone.

Julie Omohundro Joseph, regrettably I've found that those that desperately need help and those that are willing to be helped and those who can be helped are often groups that get much, much smaller as you move from left to right.

Even before I started in medical devices, I had learned how many people will not seek help until their situation becomes desperate. When they finally do seek help, what they so often want is someone who will somehow make things come out right for them without changing the way they are doing things, which is what got them into their desperate situation in the first place.

And then there is the challenge of simply trying to communicate with founders who have no experience in the industry at all. I think many simply cannot be helped.

Burrell (Bo) Clawson Julie, so true. I believe not seeking help is caused by fear of having to learn and indeed trust other more knowledgable people.

Caroline Winslow Naivete! Always believing the process takes ¼ of the time it does and 1/5 of what it will cost.

Dr Gloria Esegbona ✔️ Julie you are right - but a lot these problems stems from not keeping the user in mind - and iterating the product based on their experience and input. With this method you will always end up with a useful product - always - perhaps not one for your original target market; but the insights that unfold in iteration enable it to be used in another market/ context as Reginaldo mentioned. Then last but not least it helps if the founder has some experience in the product.

Julie Omohundro Dr. C, you raise an interesting issue that may have different applicability in different circumstances.

I don't think I've ever heard the terms "QA" or "QC" spoken in the context of your typical "get rich quick" startup, where the goal is not to start anything, but to sell it. QA and QC are seen as functions associated with post-market manufacturing. These types of start-ups don't plan/want to get any farther post-market than FDA clearance/reimbursement code and then sell the product/company, with the expectation that whoever acquires it has QA/QC capabilities which can be implemented post-acquisition.

In these start-ups; the only activity I've seen related to QA/QC has been in the development of design inputs and verification, which foreshadow post-market QA/QC. But I haven't seen anyone give this any real consideration.

Where you are developing a product that you expect to manufacturer and sell over the long term, that is where I would see QA/QC coming into play. However, in my role I haven't seen that side of things, to the extent that I don't even know what you mean by "engineering and QA/QC may get lots of lip service, but have limited clout and control of the product." I would be interested to hear more about your experience/observations in this area.

Julie Omohundro Barry, my own personal favorite story was told by an FDAer, back in the 90s.

A start-up team came to FDA for what is now known as an "informational" meeting. The principals put on a very nice presentation about their device....technology, materials, principles of operation, manufacturing processes, etc. After the presentation, the principals looked expectantly at the FDA. One of the FDAers commented that they seemed to have done a nice job in bringing the device thus far, and then asked, "so what is it used for?" The principals looked confused, and then replied, in essence, "You tell us."

Presumably these founders came from the far R side of R&D and were working from the model in which a new technology is discovered (eg, a slightly sticking adhesive) and then licensed to companies that think they can develop it into a product (e.g., Post-It Notes). Coming from that perspective, they had assumed that, when FDA evaluated new devices for medical use, FDA would try figure out what medical use it might have, rather than determine whether it was safe and effective for whatever use the company intended to market it for.

To me this is a classic example of founders with whom the challenge of communication regarding the development process can be daunting, to say the least. Sometimes these founders can have a "light bulb moment," where they get it, but often they remain hopelessly trapped in one wrong model or another. The frustrating part is that otherwise promising technologies will usually remain trapped in there with them.

Ee Bin Liew if the product has not launched despite having (all) the funding, then if we work backwards, it's either.
1. can't make 'em (no manufacturers)

1. can't market 'em (no distribution, no market clearance)

1. can't even get the first one out (internal bickering, trying to be perfect)

1. no resources to manage any of the above 3 points.

so it could dovetail to.. not knowing how to communicate, lack of coherence (as Ulrika said earlier) and form partnerships (which include hiring resources).

if the product had actually launched (i.e. can reach customers' hands), but not successful.. that's a separate question.. cheers.

Caroline Winslow Julie O - Wise words about left to right. I am not a rocket scientist, but as a consultant I often find that the analysis of the "problem/s" is the easy part and is quite evident from the outside. Then, your model of needing/seeking help kicks in and the percentage of product launch and subsequent success is low.

My favorite was being given the launch date at the same time I was being assigned to a new product development project.

Another classic is when an entrepreneur believes their product will get through a 510(k) review process in less than 90 days.

Julie Omohundro Jon, or even in 90 days. :)

Echoing a lot of the above, I think that timelines are certainly something that I see in a professional capacity quite often. A lot of companies, be they startups or otherwise, seem to underestimate the amount of time that it takes to take an idea from the drawing board to a commercially viable and fully regulatory approved device. Often people seem to think that it's simply a case of coming up with a design, and a few months later you will be on the market.

Burrell (Bo) Clawson Julie, I agree. Even assuming you can get through in less than a year can be optimistic.

A device can get bogged down when founders &/or investors pull the plug on funds, too. Pick your deep pockets carefully. A friend had committments to do 2 rounds of funding from a well known VC group. Round one was delivered and they worked gaining momentum for a year. June 1, the next tranche was due.

May 25th, they get a call. The VC said that with the dot com bust underway, they wouldn't be able to deliver the funds. No launch. Just BK.

Julie Omohundro "The first half of the project takes 90% of the time. The other half takes the other 90%."

Robert Barzelay Lots of good points. I posted one of my experiences on my blog. It covers many, if not all issues raised here.
http://www.globalstrategists.com/blog/a-startup-gone-down-the-drain

Jerry Robinson I think it means getting more creative about how we raise funds. It's all hard....

Jerry Robinson boy... great link Robert... and I see so much of that, too.. I would have to guess that you got a nasal hair view from the founders... (ie, the look down their noses... you look up the nostrils and see the hairs....)

So many train wrecks in the early part of what you describe..

may be the horror stories will help someone avoid the same Corporate Hubris...

thanks for posting...

Re: A STARTUP GONE DOWN THE DRAIN
Sr, Barzelay,
Great blog!

Burrell (Bo) Clawson Help, Help. If we don't know and don't have experience in a subject, or specifically like fundraising or marketing, then we should get expert help before we start developing a product, not after the product is done.

I too have seen startups who think "We can cut the cost 20% and have a better product than our competitor." That is not enough to gain market share when an established competitor can temporarily start offering 10-20% discounts. A detail like that should derail a professionally reviewed business plan from day 1.

Jerry Robinson y

Jerry Robinson But who tells the emperor that he has no clothes on..

If the founders have $$tons - then who would they pay to tell them this - and who will stick their heads up to say "there is a problem here"...

I have stuck my head up a few times.. it seemed to have no effect other than label me "not a team player"... that I was sometimes right - not always - did not seem to matter...

The "20% less" is an auto derail - for anyone who understands or "says they understand" business. An ordinary sustaning innovation can cut 20%, without a lot of thought... MBAs who think they are clever.. shuttle accounting and production offshore - and tell themselves how "innovative" they are.. when in fact - they have killed the next product generation of the company..

Disruptive innovation - is in the 10x space.. cost is reduce by 10x... or I can reach 10x the customers by my clever ideas...

Napoleon used put the "20% 'er types" up front to lead the infantry charges...

Julie Omohundro Robert, I wish your story were unusual. Has anyone worked with a start-up that did virtually none of these things? Just off the top of my head, I could think of two that did virtually every single one. It's like they are all following the same playbook.

Jerry Robinson I think they do... somewhere.. there is the "great flawed book of medical device startups" that they all seem to follow...

At the UT Dallas Business school.. there was a real difference of opinon between the startup guys and the sustaining business guys over this point..

I came to see it - as that investors did things that worked for them.. and look to do the same now.. but TIMES have changed...

--jr

The company I work for started looking at this early this year. We've been doing global clinical trials at Phase 3 and linking in GP's into the trials since 1992 simply because GP's struggle to get the trials done themselves on time and efficiently.

To our amazement we've noticed Medtech companies still trying to push trials through GP surgeries direct. With even the best intentions in the world unless they are dealing with consortia it's going to be a challenge in the current environment. No concentration of effort...not the day job...site opening costs....patient pressure...you name it!

Julie Omohundro Richard, this is probably a whole different discussion, but are you referring to device companies managing their own trials instead of contracting them out to a CRO?

Jerry Robinson Julie.. what are the cost differences in (a) managing their own and (b) contracting them out?

and if.. you do trials out side the US - how does that complicate things?

--jr

Julie Omohundro Jerry, now THAT is indeed a whole other discussion. If there are several people here who would be interested in this topic, I will start a separate discussion on it.

Jerry Robinson I suspect you are right... but the profit - non-profit discussion shuold quickly get down to cost and efficiency - so there are likely several discussions here...

NPs should not be founded to enrich the managers or officers.. and that is really the situation so many times...

Burrell (Bo) Clawson Jerry, interesting you note your last point. A very large hospital system was targeted by the IRS recently because their retention of billions in "reserve funds" was an indication to the IRS that it was not a non-profit.

Yi Dong made the technology work too late and lost trust of the investors.

Julie Omohundro Bo, I don't know what the IRS was thinking, probably something about how to get more tax money, but I would agree in principle. I think "non-profit" is a poor term to use; I prefer "not for profit" (N4P) I also like the slogan used by one local N4P: "Not for profit, but for service."

N4Ps have a mission. Organizations and individuals who provide funding for N4Ps do so because they support the mission and expect that their funds will be used to pursue the mission. Usually this is exactly what an N4P claims when soliciting funds. Any N4P that is sitting on a large reserve is not using those funds to pursue its mission.

This is okay if, for example, the reserve is being built up to fund a large capital improvement project in the future, but this needs to be clearly spelled out, including the specific nature of the improvement, documentation showing how much the improvement will cost, and a clearly defined point at which the N4P will stop sitting on the reserve and move forward with the improvement.

Julie Omohundro Oops...this is not the non-profit discussion!

Jerry Robinson related, though..