A tipping point for bio

Bio hacking lab at Share Conf 2013

It’s both my job and a great pleasure to be looking out for signals that point to something fundamentally new and interesting. Something that might be driven by a technology (or a combination of technologies) that will have a massive impact on the way we live – or at least offers that opportunity.

Over the last ten years, just to name a few, these mega trends (or tectonic shifts) include the whole way we connect more deeply online through what today is called Social Media and a normal part of our everyday lives; the way these connections started following us around more seamlessly through the mobile web; the way manufacturing and “reproduceability” changed through 3D printing and the fabbing movement; how the physical world joined us online in the Internet of Things, turning our physical environment more responsive.

Let’s look at all things bio

But for a couple of years now, there have been more and more signals – weak and odd and quirky at first, but quickly gaining strength – around biology: bio synthesis, DIY bio hacking and the like.

Just like 3D printing before, this all very much happens in the space of atoms – or of the organic – but with the thinking of the web overlaid. A combination of atoms & bits in the most literal way. And much like what later became known as Social Media started out with a myriad of competing terminologies (ubicomp, social computing, web 2.0…), I don’t think that the final terminology has yet emerged, making it somewhat harder to follow the many parallel discussions around bio/organic hacking in a structured way.

This phase of competing ideas and terminologies is usually a good sign that something is interesting enough that stakeholders from different angles are feeling out the same area, trying to figure out what’s going on there and where to take it. It’s when stuff is at Peak Interesting, long before the real impact becomes tangible. And no doubt, this area will have massive, profound impact on society, business, medical, industry. And no doubt this impact will come in many unexpected ways.

Tipping point

We’ve been talking about this for a while, and just a little while back I remember mentioning that the the signals are still just a little bit too scattered for me to fully engage. Not quite there yet, for the way I operate. But just now, this recent brief blog post over on O’Reilly Radar about the BioFabricate Summit kind of put me over the edge. I mentally mark this as a personal tipping point for the signal-to-noise ratio that triggers my dig-deeper impulse.

So I’ll be reading up on bio fabrication, bio hacking, bio synthesis. If I find enough interesting stimulus, the next step for me will be to think about a new conference around the issue: I still find it the best way to dive in and get all the players together.

If you’re aware of interesting stuff happening around this, particularly in Europe, please do share. Thanks!


This is fascinating stuff. As a traditionally trained scientist, knowing how expensive and time consuming it is to do biochemical research, I find it simultaneously difficult to believe and unbelievably exciting that this kind of research/production could be made more available. Also, having 10 years experience in various parts of pharma (from early research through development to regulatory approval), I think there’s a lot that needs to be re-evaluated in the way bio-research is undertaken. Riffyn is something that should be happening in academic labs everywhere (pharma certainly spends a lot of time on improving processes). Academic hubris, it’s a wonderful thing. As a regulator, I’m slightly nervous about the health-applied products (medical devices) – not necessarily in whether they are safe, but whether the start-ups understand exactly what the regulatory requirements involved are. Manufacturing plastics for lego bricks using bacteria is one thing, manufacturing plastics for a human implant using bacteria is another and lands you under a whole different set of rules. I have mentioned it briefly to you before – one needs a really clear view of what regulations your product is going to fall under and you need to include all of these requirements right from the start in your development process. Otherwise you’ve invested years and millions to fail at the end (or be massively delayed, lose investors, lose your buisness). I’ve seen it happen out of academic start ups in the biotech/pharma field … and these are people that really should know better. I think one thing we can be sure of is that governmental rules will not keep pace with the development of emerging technolgies such as these, so a start up needs to be prepared to play by rules not necessarily designed with their technology in mind. It may be useful, should you set up a conference which includes medical devices and such technologies, to include regulators as speakers. But that’s what I see, with my focus on life science applications and regulatory requirements. We tend to be a sceptical bunch, it comes with the job. I look forward to more posts on the subject – I’m not actively looking into bio-hacking at the moment, so you are probably going to be my main source of information!

Jacinta, thanks for that feedback. I have to admit I’m only at the very beginning of looking more into this – so far it’s been lots of largely disconnected blips on my radar here and there, and only slowly a more coherent image of what’s going on is emerging for me. From your experience, is there a central go-to place for regulation-related information and questions, or do founders in the field have to go the hard route and research everything from scratch? This is going to be quite interesting to watch evolve, no doubt…

For Europe: http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm For US: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm That’s for people who want to make Medical Devices. If they want to make a biological drug, it’s a different set of guidelines.

I also spent more time thinking on the weekend about random people randomly modifiying bacteria in random ways with no oversight and I’m more concerned now than I was last week. If people are sticking to commercially available E.coli, which can’t survive outside fof the lab then ok. But if they start playing around with wild-type strains we could start seeing nasty things happening fast. What if someone creates a wild-type E.coli heavily producing prion proteins and releases that? You’d never be able to track the source, and you’d never be able to get it under control. Orson Scott Card wrote a great short story many years ago called “I put my blue genes on”…

Of course, you can argue that any PhD student now could do that and yes, they could. There is no real security in how we do things now. But the repercussions to us and the planet of people hacking around in bacteria are significantly larger than people hacking around in computers (except maybe nuclear launch codes). Something I’d like to see addressed.

I’ve been looking into the various standards and regulations for medical devices, and I particularly agree with this statement of Jacinda: “start-[ups] need to be prepared to play by rules not necessarily designed with their technology in mind”.

In the EU market, you need a CE mark in order to sell your medical device. If it’s a Class I (low risk) medical device, you’re allowed to self-certify. A Notified Body needs to audit and/or test your Class II or III (high risk) device. The EU Council uses the Medical Device Directive (MDD) 93/42/EEC, which partner countries have to implement. Standards are “voluntary”, but if you’re not using a standard you’ll have to be able to explain this to your notified body. It makes sense to conform to the standards, as you’ll also be conforming to MDD 93/42/EEC and the FDA (US) regulations that they’ve been aligned with.

Unfortunately standards are expensive. While MDD 93/42/EEC can be downloaded for free, you’ll probably also need copies of the following standards if you’re developing (for example) a medical device app:

ISO 62304:2006 £218 ISO 60601-1-6:2010 £146 ISO 62366:2008 £232 ISO 14971:2012 £232 ISO 13485:2012 £218

That’s more than £1k just to get started.

ISO 62304:2006 advises following additional guidelines specific to software: ISO 12207:2008 £264 ISO 61508-3:2010 £232 ISO/IEC 90003:2004 £204

That’s an additional £700, just for reading the standards. Depending on the complexity of your device/app, you’ll need to be prepared to pay the notified body to audit all your documentation, and also pay the necessary registration fees to your local regulator.

In the medical device world, most of the standards are process standards, meaning you have to have the necessary quality control and development processes in place before you start designing your product. This explains why start-ups run into delays and problems, as it’s not as simple as just getting your device tested and certified after you’ve designed it.

Hi Gerrit,

Thanks for weighing in. Just to make sure I understand this correctly – you have to pay these fees not just at the point of certification, but upfront at the very outset of your research/design phase? Just to access and read the standards definition?

Am I missing something important here or is that somewhat insane?


The EU Directive you must follow is free to read: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

As I understand it, it is recommended to follow ISO standards (in lots of things in this world, not just Medical Devices), but accessing these costs money. http://www.iso.org/iso/catalogue_detail.htm?csnumber=38421. ISO partially funds itself this way, I think. This is a bit like how, in producing a pharmaceutical, EU Guidelines state you have to conform to testing and standards described in the European Pharmacopoeia but to find out what those are, you have to buy the book for 400€, which is updated every three months and you must always conform with the current version, so you always need to update….

You don’t have to conform to ISO standards for medical devices, but you should still know what they are so you can explain why you don’t conform to them if asked.

Anyway, I’m wondering if we’re pulling you off the path too much, because a lot of what you will be interested in is bio-production of non medical products. I don’t want to bog you down in irrelevant details!